Buserelin EP Impurity D CAS CATO-C4X-22124

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-22124
Molecular FormulaC60H86N16O13
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Buserelin EP Impurity D CAS CATO-C4X-22124 chemical structure

Description

CATO manufactures Buserelin EP Impurity D under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Buserelin EP Impurity D (CAS CATO-C4X-22124), a pharmacopoeial impurity reference standard (molecular formula C60H86N16O13C2H4O2, MW 1299.50 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Buserelin EP Impurity D (C60H86N16O13C2H4O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 26.0, corresponding to approximately 26 ring(s) or double-bond equivalent(s). With a molecular weight of 1299.50 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular FormulaC60H86N16O13 C2H4O2
Molecular Weight1299.50 g/mol
Purity>80%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)26.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms16

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