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Junta De Castilla Y Leon

CERTIFICATE NUMBER: 0905/25

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 94(1) of Regulation (EU) 2019/6 as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Spain confirms the following:

The manufacturer: Purity Chemicals S.L.

Site address:

Avenida Tren Expreso Parcelas 82-84, Venta De Banos, Palencia, 34200, Spain

OMS Organisation Id. / OMS Location Id.: ORG-100015500 / LOC-100024219

Is an active substance manufacturer that has been inspected in accordance with Art. 123(6) of Regulation (EU) 2019/6 and Art. 111(1) of Directive 2001/83/EC0.

Other

(Human) artículo 108, Real Decreto Legislativo 1/2015, de 24 de julio, artículo 64, Real Decreto Legislativo 1/2015, de 24 de julio, artículo 47 de la Directiva 2001/83/CE

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-11-27 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Art. 123(6) of Regulation (EU) 2019/6 and Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 80(5) of Directive 2001/82/EC and Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Veterinary Medicinal Products

Manufacture of active substance. Names of substances subject to inspection:

[7194]CALCIUM ACETATE(en)

[3782]MAGNESIUM ACETATE TETRAHYDRATE(en)

[3784]POTASSIUM ACETATE(en)

[3785]SODIUM ACETATE TRIHYDRATE(en)

[12047]OXALIC ACID DIHYDRATE(en)

[5606]AMMONIUM CHLORIDE(en)

[5608]AMMONIUM MOLYBDATE(en)

[24324]CALCIUM BROMIDE(en)

[8128]CITRATE SODIUM DIHYDRATE(en)

[7420]FERRIC CHLORIDE HEXAHYDRATE(en)

[6035]COBALT CHLORIDE(en)

[7915]COPPER CARBONATE(en)

[7419]COPPER CHLORIDE DIHYDRATE(en)

[1911]CUPRIC OXIDE(en)

[4509]COPPER SULFATE PENTAHYDRATE(en)

[1174]CHROMIC CHLORIDE HEXAHYDRATE(en)

[11541]SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE(en)

[11266]SODIUM DIHYDROGEN PHOSPHATE MONOHYDRATE(en)

[4842]FERRIC SODIUM ETHYLENEDIAMINETETRAACETATE(en)

[9000]ANHYDROUS BICALCIUM PHOSPHATE(en)

[1446]SODIUM PHOSPHATE DIBASIC DODECAHYDRATE(en)

[9236]IRON PERCLORHIDE(en)

[2896]MAGNESIUM LACTATE(en)

[3631]MAGNESIUM BROMIDE(en)

[3635]MAGNESIUM FLUORIDE(en)

[3637]MAGNESIUM HYDROXID(en)

[3840]MANGANESE CARBONATE(en)

[12055]MANGANESE CHLORIDE TETRAHYDRATE(en)

[3279]NICKEL SULFATE(en)

[446]POTASSIUM BROMIDE(en)

[456]POTASSIUM CHLORATE(en)

[19083]POTASSIUM IODATE(en)

[460]POTASSIUM IODIDE(en)

[11110]ANHYDROUS SODIUM SELENITE(en)

[511]SODIUM DIHYDROGEN PHOSPHATE(en)

[510]SODIUM FLUORIDE(en)

[1558]SODIUM MOLYBDATE(en)

[4072]SUCCINIC ACID(en)

[1835]TARTARIC ACID(en)

[1839]ANTIMONY POTASSIUM TARTRATE(en)

[12634]SODIUM THIOSULFATE(en)

[400]UREA(en)

[23828]AMMONIUM VANADATE(en)

[10047]ZINC ACETATE DIHYDRATE(en)

[1849]ZINC OXIDE(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:CALCIUM ACETATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MAGNESIUM ACETATE TETRAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:POTASSIUM ACETATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM ACETATE TRIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:OXALIC ACID DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
recrystallization

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:AMMONIUM CHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:AMMONIUM MOLYBDATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:CALCIUM BROMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:CITRATE SODIUM DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:FERRIC CHLORIDE HEXAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:COBALT CHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:COPPER CARBONATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:COPPER CHLORIDE DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:CUPRIC OXIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:COPPER SULFATE PENTAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification by recrystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:CHROMIC CHLORIDE HEXAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE MONOHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:FERRIC SODIUM ETHYLENEDIAMINETETRAACETATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:ANHYDROUS BICALCIUM PHOSPHATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM PHOSPHATE DIBASIC DODECAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:IRON PERCLORHIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
filtration

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MAGNESIUM LACTATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MAGNESIUM BROMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MAGNESIUM FLUORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MAGNESIUM HYDROXID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MANGANESE CARBONATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:MANGANESE CHLORIDE TETRAHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Chemical synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:NICKEL SULFATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:POTASSIUM BROMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:POTASSIUM CHLORATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Purification by recrystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:POTASSIUM IODATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:POTASSIUM IODIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:ANHYDROUS SODIUM SELENITE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM DIHYDROGEN PHOSPHATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM FLUORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM MOLYBDATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SUCCINIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.4  Other:
Synthesis: hydrollysis of succinic anhydride

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:TARTARIC ACID

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification by recrystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:ANTIMONY POTASSIUM TARTRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:SODIUM THIOSULFATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
recrystallization

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:UREA

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
Purification by recrystallisation

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:AMMONIUM VANADATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.3  Salt formation / Purification steps:
inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:ZINC ACETATE DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Inorganic synthesis

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Drying and sieving

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

Active Substance:ZINC OXIDE

3.5 General Finishing Steps

3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.4  Biological Testing

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