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Certificate of Analysis · Standard specification

Butenafine Hydrochloride COA

Certificate of Analysis and technical specification for Butenafine Hydrochloride — CAS 101827-46-7. Applies to all consignments of this product and grade.

Product NameButenafine Hydrochloride
C.A.S. Number101827-46-7
Product CategoryActive Pharmaceutical Ingredients (APIs)
Product GroupAPI Salts
Grade / StandardFine chemical grade — assay on specification
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
4Clarity & Colour of SolutionClear; not more intensely coloured than referenceCompliesVisual (Monograph)
5pH (1 % w/v aqueous solution)As per monograph6.7Potentiometry
6Water Content (Karl Fischer)Not more than 0.5 % w/w0.19Karl Fischer titration
7Melting Range / PointAs per monographCompliesCapillary method
8Particle Size (d90)As per specification77 µmLaser diffraction

This document sets out the standard specification for Butenafine Hydrochloride 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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