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Certificate of Analysis · Standard specification

Riboflavin (Vitamin B2) COA

Certificate of Analysis and technical specification for Riboflavin (Vitamin B2) — CAS 83-88-5. Applies to all consignments of this product and grade.

Product NameRiboflavin (Vitamin B2)
C.A.S. Number83-88-5
Product CategoryVitamins, Minerals & Amino Acids
Product GroupB-Complex Vitamins
Grade / Standard98% USP/BP/EP
Physical FormYellow-orange crystalline powder
Country of OriginIndia
PackingStandard export packing — bags, drums, carboys, IBC or ISO tank as applicable
StorageCool, dry, well-ventilated place in tightly closed original packing

Analytical Specification

S. No.Test ParameterSpecificationTypical ResultMethod
1DescriptionYellow-orange crystalline powderCompliesVisual
2Identification (A) — Infrared absorptionConcordant with reference spectrumCompliesIR Spectrophotometry
3Identification (B) — Chemical / chromatographicPositive for the substanceCompliesAs per monograph
4SolubilityAs per specificationCompliesVisual / Monograph
5AssayNot less than 98.0 % w/w98.97HPLC / Titrimetry (Monograph)
6Specific Optical RotationAs per monographConformsPolarimetry
7Loss on DryingNot more than 0.5 % w/w0.13Gravimetry
8Residue on IgnitionNot more than 0.1 % w/w0.057Gravimetry
9ChlorideNot more than 0.05 %0.0027Turbidimetry
10Lead (Pb)Not more than 3 ppmLess than 0.5 ppmICP-MS
11Heavy MetalsNot more than 20 ppmLess than 10 ppmICP-OES / Limit test
12Related Substances — any individual impurityNot more than 0.10 %0.032HPLC
13Related Substances — total impuritiesNot more than 0.50 %0.188HPLC
14Residual SolventsComplies with ICH Q3C limitsCompliesHeadspace GC
15Total Aerobic Microbial CountNot more than 1000 cfu/g78 cfu/gIP / USP <61>
16Total Yeast & Mould CountNot more than 100 cfu/g4 cfu/gIP / USP <61>
17Escherichia coliAbsent in 1 gAbsentIP / USP <62>
18Salmonella speciesAbsent in 10 gAbsentIP / USP <62>

This document sets out the standard specification for Riboflavin (Vitamin B2) and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.

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