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Certificate of Analysis · Standard specification

Penicillin G Acylase COA

Certificate of Analysis and technical specification for Penicillin G Acylase — CAS 9014-06-6. Applies to all consignments of this product and grade.

Product NamePenicillin G Acylase
C.A.S. Number9014-06-6
Product CategoryPharmaceutical Intermediates
Product GroupEnzyme
Grade / StandardEnzyme Grade
Physical FormOff-white powder/liquid
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 powder/liquidCompliesVisual
2IdentificationConforms to the structure of the substanceCompliesFTIR / Chemical test
3Clarity & Colour of SolutionClear; not more intensely coloured than referenceCompliesVisual (Monograph)
4pH (1 % w/v aqueous solution)As per monograph6.8Potentiometry
5Water Content (Karl Fischer)Not more than 0.5 % w/w0.29Karl Fischer titration
6Melting Range / PointAs per monographCompliesCapillary method
7Particle Size (d90)As per specification132 µmLaser diffraction

This document sets out the standard specification for Penicillin G Acylase 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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