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QUININE HCL - DFI-578676

Published:02/05/2019

Description

AppearanceWhite or almost white or colourless, fine, silky needles, often in clusters, soluble in water, freely soluble in ethanol (96%)
Appearance of solutionSolution S is clear and not more intensley coloured than reference solution Y6
Shelf life60 Months
Country of ManufactureIndia

Specification

Identification(A,B,C,D,E)Conforms
pH6 to 6.8
Specific Rotation245 to 258°
Dihydroquinine(impurity C)<=10%
Eluted before Quinine(Any impurity)<=5%
Impurities(Any other) Max:2.5%
Sulphate Max:500ppm
BariumPasses
Loss on drying6 to 10%
Sulphated ash Max:0.1%
Assay99 to 101%

Microbiological

Bacterial Count<=1000cfu/g
Yeasts & Moulds<=100cfu/g
Escherichia ColiAbsent in 10g
SalmonellaAbsent in 10g
Pseudomonas aeruginosaAbsent in 10g
Staphylococcus aureusAbsent in 10g

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