Pimecrolimus Impurity 7 CAS CATO-C4X-17317

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pimecrolimus Impurity 7.

CATO supplies Pimecrolimus Impurity 7 (CAS CATO-C4X-17317), a pharmacopoeial impurity reference standard (molecular formula C43H66ClNO10, MW 792.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pimecrolimus Impurity 7 (C43H66ClNO10) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 792.44 g/mol, it falls into the high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

CATO manufactures Pimecrolimus Impurity 7 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.

Physical & Chemical Properties

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
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