Ambroxol Impurity 27 CAS 50910-54-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.50910-54-8
Molecular FormulaC6H13NO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Impurity 27 CAS 50910-54-8 chemical structure

Description

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.

Ambroxol Impurity 27 (CAS 50910-54-8) is a certified pharmaceutical impurity reference standard with the molecular formula C6H13NOHCl and a molecular weight of 151.63 g/mol.

The molecular framework of Ambroxol Impurity 27 (C6H13NOHCl) is characterized by an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

CATO manufactures Ambroxol Impurity 27 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 FormulaC6H13NO HCl
Molecular Weight151.63 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1971
Halogen ContentCl-containing
Nitrogen Atoms1

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