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Certificate of Analysis · Standard specification

Black Pepper Extract Piperine COA

Certificate of Analysis and technical specification for Black Pepper Extract Piperine — CAS 94-62-2. Applies to all consignments of this product and grade.

Product NameBlack Pepper Extract Piperine
C.A.S. Number94-62-2
Product CategoryNutraceuticals & Herbal Extracts
Product GroupBioavailability Enhancers
Grade / Standard95% HPLC
Physical FormOff-white to light tan 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
1DescriptionOff-white to light tan crystalline powderCompliesVisual
2IdentificationConforms to the structure of the substanceCompliesFTIR / Chemical test
3SolubilityAs per specificationCompliesVisual / Monograph
4AssayNot less than 95.0 % w/w95.82Titrimetry / Instrumental
5Loss on DryingNot more than 5.0 % w/w1.52Gravimetry
6Total AshNot more than 5.0 % w/w2.30Gravimetry
7Bulk DensityAs per specification0.38 g/mLTapped density
8Particle Size — through 80 meshNot less than 95 %98.7Sieve analysis
9Pesticide ResiduesComplies with USP <561>CompliesGC-MS / LC-MS
10Aflatoxins (B1, B2, G1, G2)Not more than 20 ppbLess than 2 ppbHPLC-FLD
11Residual SolventsComplies with ICH Q3CCompliesHeadspace GC
12Lead (Pb)Not more than 3.0 ppmLess than 0.5 ppmICP-MS
13Heavy Metals (as Pb)Not more than 10 ppmLess than 5 ppmICP-OES
14Total Aerobic Microbial CountNot more than 1000 cfu/g76 cfu/gIP / USP <61>
15Total Yeast & Mould CountNot more than 100 cfu/g3 cfu/gIP / USP <61>
16Escherichia coliAbsent in 1 gAbsentIP / USP <62>
17Salmonella speciesAbsent in 10 gAbsentIP / USP <62>

This document sets out the standard specification for Black Pepper Extract Piperine 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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