ii-c- checking raw materials

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LABORATOIRES PHARMACEUTIQUES RODAEL S.A.S.
ZINCFANT product file
II-C- CHECKING RAW MATERIALS
II-C-1.
ACTIVE IN GREDIENT
II-C-1.1
Specification and routine tests
II-C-1.1.1.
Active substance described in a Pharmacopeia : Zinc Sulfate Monohydrate
Zinc sulfate monohydrate is an active substance defined in the American Pharmacopeia (USP), edition
28. Zinc sulfate is also defined in its heptahydrate form in the European Pharmacopoeia, 5th edition (EP)
in monograph 01/2005 n°0111.
As the finished product is the subject of a monograph in the USP, the active substance used must
comply with the two monographs as follows ( In accordance with USP28, supplemented by EP 5th
edition) :
II-C-1.1.1.1--
ANALYSIS SPECIFICATIONS AND ROUTINE TESTS
Analysis reference : Monograph USP28 supplemented by European Pharamacopoeia 5th edition
01/2005 n°0111.
Date of last revision : 18 Nov. 2005
Index n° : 03
Analysis
Specification
Aspect : poudre cristalline incolore à blanc,inodore, très
soluble dans l’eau, pratiquement insoluble dans l’alcool.
Appearance : white to colorless crystalline powder, odorless,
very soluble in water, practically insoluble in alcohol
Caractères
Characters
Identification - Identification
A) réactions des sulfates (EP2.3.1)
Reactions of sulfates
B) réaction du zinc (EP2.3.1)
Reaction of zinc
C) Dosage (EP2.5.11)
Assay
ESSAI – Tests
Réaction positive
Positive reaction
Réaction positive
Positive reaction
satisfait aux limites du dosage.
fulfils the assay limits
aspect de la solution S (EP 2.2.1 et 2.2.2 procédé 2)
appearance of the solution
limpide et incolore
clear and colorless
Acidité (USP 28)
Acidity
Absence de coloration rose par l’orange de méthyle
not colored pink by methyl orange TS
chlorures (EP 2.4.4)
chlorides
Maximum 300ppm
Alcalins et alcalino-terreux (USP28)
Alkalis and alkaline earths
Maximum 0,9%
Arsenic (méthode ISO11969-1996)
Arsenic
Plomb ( norme USP28)
Lead
Fer (EP 2.4.9)
Iron
DOSAGE – Assay
ZnSO4, H2O (EP 2.5.11)
Partie II-C-3
Maximum 14ppm
Maximum 0,002% (20ppm)
Maximum 100ppm
de 99,0 à 100,5%
from 99.0 to 100.5%
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II-C-1.1.1.2--
QUANTITY SAMPLED
Minimum 80 grams ( 20g for analysis and 60g for combinatorial library).
II-C-1.1.1.3--
Partie II-C-3
MONOGRAPH USP
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II-C-1.1.1.4--
ADDITIONAL TESTS IN ACCORDANCE WITH EUROPEAN PHARMACOPOEIA, 5TH EDITION
Appearance : white to colorless crystalline powder, odorless,
Solubility : very soluble in water, practically insoluble in alcohol
PREPARATION SOLUTION S. Dissolve 2.5 g of zinc sulfate monohydrate in carbon dioxide free water
R and make up to 50 ml with the same solvent.
APPEARANCE OF SOLUTION S. Solution S is clear (EP 2.2.1) and colorless (EP 2.2.2, Procedure II).
LIMIT TEST OF CHLORIDES (EP 2.4.4) : maximum 300 ppm.
Take a sample of 3.3 ml of the solution S and make up to 15 ml with purified water.
Decant the solution into a 20 ml test tube, add 1 ml of dilute nitric acid R, and pour this mixture in a
single movement into a test tube containing 1 ml of silver nitrate solution R2. Prepare the control in
the same conditions using a mixture of 10 ml of 5 ppm chloride solution (Cl)R and 5 ml of purified
water. Inspect the test tubes sideways against a dark background. After 5 min. in a shaded place, if
the solution to be inspected presents any opalescence, it is not more pronounced than in the control.
LIMIT TEST OF IRON (EP 2.4.9) : maximum 100ppm.
Take a sample of 2 ml of the solution and make up to 15 ml with purified water.
Decant 10 ml of the solution into a test tube, add 2 ml of a solution of citric acid R at 200 g/l, and
0.5 ml of Thioglycolic acid R. Mix, alkalize with ammonia R and make up to 20 ml with purified
water. Prepare the control in the same conditions using 10 ml of solution at 1 ppm iron (Fe) R.
After 5 min. any pink coloring in the solution to be inspected is not more intense than in the control.
II-C-1.1.2.
N/A
II-C-1.2
Active substance not described in any Pharmacopeia
Scientific data
II-C-1.2.1.
Nomenclature
Chemical name : Zinc sulfate monohydrate
Synonym : Sulfuric acid, zinc salt monohydrate
CAS : 7446-19-7
II-C-1.2.2.
Description
Appearance : Solid, colorless to white, odorless.
Empirical formula : ZnSO4 , H2O
Molecular weight : 179,45 g/mol
CAS registry number : [7446-19-7]
II-C-1.2.3.
Manufacturer
-Name and address of manufacturer
MERCK KgaA
64271 Darmstadt
Partie II-C-3
Page 35 / 424
Allemagne
Tel : +49 6151 72-2440
Trade name of the active substance : Zinc sulfate EMPROVE® USP.
Dr. Paul LOHMANN® GmbH KG
Hauptstraße-2
D-31860 Emmerthal
Deutschland
II-C-1.2.4.
Quality control during the manufacture of the active substance
No supplier’s data provided.
II-C-1.2.5.
N/A
Chemical development
II-C-1.2.6.
N/A
Impurities
Partie II-C-3
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II-C-1.2.7.
Partie II-C-3
Batch analysis
Page 37 / 424
Partie II-C-3
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II-C-1.2.8.
II-C-1.2.8.1--
Partie II-C-3
MERCK Documentation
SUPPLIER SPECIFICATIONS
Page 39 / 424
II-C-1.2.8.2--
Partie II-C-3
SUPPLIER STATEMENT
Page 40 / 424
II-C-1.2.9.
II-C-1.2.9.1--
Partie II-C-3
Lohmann®Documentation
SUPPLIER GMP CERTIFICATE
Page 41 / 424
II-C-1.2.9.2--
Partie II-C-3
SUPPLIER SPECIFICATIONS
Page 42 / 424
II-C-1.2.9.3--
Partie II-C-3
SUPPLIER STATEMENT
Page 43 / 424
II-C-1.2.10.
Partie II-C-3
Safety data sheet
Page 44 / 424
Partie II-C-3
Page 45 / 424
Partie II-C-3
Page 46 / 424
Partie II-C-3
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Partie II-C-3
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Partie II-C-3
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ii-c- checking raw materials

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