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Certificate of Analysis · Standard specification

Deferasirox COA

Certificate of Analysis and technical specification for Deferasirox — CAS 201530-41-8. Applies to all consignments of this product and grade.

Product NameDeferasirox
C.A.S. Number201530-41-8
Product CategoryActive Pharmaceutical Ingredients (APIs)
Product GroupIron Chelators
Grade / Standard≥99% Pure
Physical FormWhite to yellowish 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 to yellowish crystalline powderCompliesVisual
2IdentificationConforms to the structure of the substanceCompliesFTIR / Chemical test
3SolubilityAs per specificationCompliesVisual / Monograph
4AssayNot less than 99.0 % w/w99.20Titrimetry / Instrumental
5Clarity & Colour of SolutionClear; not more intensely coloured than referenceCompliesVisual (Monograph)
6pH (1 % w/v aqueous solution)As per monograph5.5Potentiometry
7Water Content (Karl Fischer)Not more than 0.5 % w/w0.12Karl Fischer titration
8Melting Range / PointAs per monographCompliesCapillary method
9Particle Size (d90)As per specification113 µmLaser diffraction

This document sets out the standard specification for Deferasirox 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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