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VITAMIN B2 RIBOFLAVIN POWDER - DFI-747386

Published: 26/07/2019

Description

Appearanceorange fine yellow powder
Shelf life36 months
Country of originChina

Specification

IdentificationIn water it is pale yellow and has an intense yellowish green fluorescence which disappears upon the addition of mineral acids or alkalis
Acidity or AlkalinityCheck the colour of the test solution adding the respective solutions
Lumiflavin(A440 (USP))<=0.025
Lumiflavin(BP/EP)Not more intense than the principal spot in the chromatogram obtained with ref solution. (C) 0.025%
Absorbance(A373nm/A267nm)0.31-0.33
Absorbance(A444nm/A267nm)0.36-0.39
Particle size(by laser detection)95% passes through 80 mesh sieve
Specific Rotation(EP, BP, USP)Between -115° and -135°
Loss on drying<=1.5%
Residue on ignition(USP)<=0.3%
Residue on ignition(EP, BP)<=0.1%
Residual solvents(USP)Method IV <467>
Assay(on dry basis (USP, E101i))98.0%-102.0%
Assay(on dry basis (EP, BP))97.0%103.0%
Solubility(EP, BP)Very slightly soluble in water, practically insoluble in ethanol (96%)
Amines(Primary aromatic (E101i))<= 100 mg/kg, ppm
Total Heavy Metals<=10 ppm, mg/kg
Arsenic< 1.0 ppm, mg/kg
Mercury<0.1 ppm, mg/kg
Lead<0.5 ppm, mg/kg
Cadmium<1.0 ppm, mg/kg
Packaging25 kg/drum

Microbiological

Total plate count<1000 cfu/g
Yeasts & Moulds< 100 cfu/g
Escherichia ColiNegative mpn/g
SalmonellaNegative/25g
Staphylococcus aureusNegative/g

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