Lopinavir EP Impurity R CAS 943250-66-6

Description

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

CATO supplies Lopinavir EP Impurity R (CAS 943250-66-6), a pharmacopoeial impurity reference standard (molecular formula C47H58N4O7, MW 790.99 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Lopinavir EP Impurity R (C47H58N4O7) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 21.0, corresponding to approximately 21 ring(s) or double-bond equivalent(s). With a molecular weight of 790.99 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.

CATO manufactures Lopinavir EP Impurity R 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)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com