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CAFFEINE ANHYDROUS POWDER - DFI-336232

Published: 09/08/2019

Description

AppearanceWhite or almost White crystalline powder or silky white or almost white crystal.
Appearance of solution(Bp, Ph.Eur)Solution 's' is clear and colourless
Molecular FormulaC8H10N4O2
Molecular weight194.19
StoragePreserve anhydrous Caffeine in well closed containers
Shelf life60 Months

Specification

Solubility(Ph.Eur)Sparingly soluble in water freely soluble in boiling water, slightly soluble in ethanol 96%, It dissolves in concentrated solution of alkali benzoate or salicylate
Solubility(USP)Sparingly soluble in water and alcohol, freely soluble in chloroform, slightly soluble in ether.
Identification A(Bp)By melting range
Identification C(Bp)By chemically
Identification D(Bp)By chemically
Identification(E, Bp)It complies the test for loss on drying
Identification(F, Bp)Reaction xanthines
Identification A(USP)The infrared absorption spectrum
Identification B(USP)The retention time of the caffeine peak in the chromatogram of the assay preparation correspond to that in the chromatogram of the standard preparations as obtained in the assay
Acidity(Bp, Ph.Eur)Not more than 0.2 ml of 0.01 ml sodium hydroxide is required to change the colour of the indicator to blue
Related Substances(Liquid chromatography Bp, Ph.Eur)Unspecified impurity
Impurity A(Bp, Ph.Eur)0.10%
Impurity C(Bp, Ph.Eur)0.10%
Impurity D(Bp, Ph.Eur)0.10%
Impurities(F, Bp, Ph.Eur)0.10%
Impurities(other, Bp, Ph.Eur)<0.10 %
Impurities(Total, Bp, Ph.Eur)<0.10%
Chromatographic purity(USP Individual)Not more than 0.1%
Sulphate<500 ppm
Heavy metals(USP)<0.001%
Loss on drying(Bp, Ph.Eur)<0.5%
Water<0.5%
Sulphated ash(Bp, Ph.Eur)<0.1%
Residue on ignition(USP)<0.1%
Assay(A on anhydrous basis Bp, Ph.Eur)Not less 98.5 % and not more than 101.5% of C8H10N4O2 calculate with reference to dried substances
Assay(B on anhydrous basis , USP)Not less than 98.5% and not more than 101.0% calculate on anhydrous basis
P.aeruginosaShould be Absent
ChloroformShould be Absent
PackagingThe material should be packed in the double polythene bag and kept in fiber drum
Chromatographic purity(USP Total)not more than 0.1%

Microbiological

Fungi<100 cfu/gm
Yeasts<100 cfu/gm
Moulds<100 cfu/gm
Bacterial Count(Total)<1000 cfu/gm
Escherichia ColiShould be Absent
SalmonellaShould be Absent
Staphylococcus aureusShould be Absent
Candida albicansShould be Absent

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