Iptacopan Impurity 7 CAS 1644670-76-7

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.1644670-76-7
Molecular FormulaC27H34N2O4
Molecular Weight450.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Iptacopan Impurity 7 CAS 1644670-76-7 chemical structure

Description

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

Iptacopan Impurity 7 (CAS 1644670-76-7) is a certified pharmaceutical impurity reference standard with the molecular formula C27H34N2O4 and a molecular weight of 450.57 g/mol.

Iptacopan Impurity 7 (C27H34N2O4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 Iptacopan 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

Molecular FormulaC27H34N2O4
Molecular Weight450.57 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Nitrogen Atoms2

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