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Certificate of Analysis · Standard specification

alpha-Methyl-DL-Phenylalanine COA

Certificate of Analysis and technical specification for alpha-Methyl-DL-Phenylalanine — CAS 1132-26-9. Applies to all consignments of this product and grade.

Product Namealpha-Methyl-DL-Phenylalanine
C.A.S. Number1132-26-9
Product CategoryVitamins, Minerals & Amino Acids
Product GroupAmino Acids
Grade / Standard98% min.
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
2IdentificationConforms to the structure of the substanceCompliesFTIR / Chemical test
3SolubilityAs per specificationCompliesVisual / Monograph
4AssayNot less than 98.0 % w/w98.66Titrimetry / Instrumental
5Specific Optical RotationAs per monographConformsPolarimetry
6Loss on DryingNot more than 0.5 % w/w0.15Gravimetry
7Residue on IgnitionNot more than 0.1 % w/w0.055Gravimetry
8ChlorideNot more than 0.05 %0.0024Turbidimetry
9Lead (Pb)Not more than 3 ppmLess than 0.5 ppmICP-MS
10Heavy Metals (as Pb)Not more than 10 ppmLess than 5 ppmICP-OES
11Total Aerobic Microbial CountNot more than 1000 cfu/g134 cfu/gIP / USP <61>
12Total Yeast & Mould CountNot more than 100 cfu/g3 cfu/gIP / USP <61>
13Escherichia coliAbsent in 1 gAbsentIP / USP <62>
14Salmonella speciesAbsent in 10 gAbsentIP / USP <62>

This document sets out the standard specification for alpha-Methyl-DL-Phenylalanine 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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