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Certificate of Analysis · Standard specification

Ascorbic Acid (Vitamin C) Plain COA

Certificate of Analysis and technical specification for Ascorbic Acid (Vitamin C) Plain — CAS 50-81-7. Applies to all consignments of this product and grade.

Product NameAscorbic Acid (Vitamin C) Plain
C.A.S. Number50-81-7
Product CategoryVitamins, Minerals & Amino Acids
Product GroupWater-Soluble Vitamins
Grade / Standard99% USP/BP/EP
Physical FormWhite 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
1DescriptionWhite 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 99.0 % w/w99.36HPLC / Titrimetry (Monograph)
6Specific Optical RotationAs per monographConformsPolarimetry
7Loss on DryingNot more than 0.5 % w/w0.05Gravimetry
8Residue on IgnitionNot more than 0.1 % w/w0.023Gravimetry
9ChlorideNot more than 0.05 %0.0114Turbidimetry
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 %0.033HPLC
13Related Substances — total impuritiesNot more than 0.50 %0.113HPLC
14Residual SolventsComplies with ICH Q3C limitsCompliesHeadspace GC
15Total Aerobic Microbial CountNot more than 1000 cfu/g114 cfu/gIP / USP <61>
16Total Yeast & Mould CountNot more than 100 cfu/g18 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 Ascorbic Acid (Vitamin C) Plain 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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