Alendronic Acid Impurity 7 CAS CATO-C4X-22427

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-22427
Molecular FormulaC11H27NO7P2
Molecular Weight347.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alendronic Acid Impurity 7 CAS CATO-C4X-22427 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 Alendronic Acid Impurity 7.

CATO supplies Alendronic Acid Impurity 7 (CAS CATO-C4X-22427), a pharmacopoeial impurity reference standard (molecular formula C11H27NO7P2, MW 347.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C11H27NO7P2, Alendronic Acid Impurity 7 contains an amide group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 347.28 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Alendronic Acid 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 FormulaC11H27NO7P2
Molecular Weight347.28 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)-1.0
Nitrogen Atoms1

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