Pregabalin Impurity 136 CAS CATO-C4X-1312136

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1312136
Molecular FormulaC9H17NO3
Molecular Weight187.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 136 CAS CATO-C4X-1312136 chemical structure

Description

The occurrence of Pregabalin Impurity 136 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Pregabalin Impurity 136 (CAS CATO-C4X-1312136, C9H17NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pregabalin Impurity 136 (C9H17NO3) contains an amino-acid-derived structure, 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. 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC9H17NO3
Molecular Weight187.24 g/mol
Purity97%+
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)2.0
Nitrogen Atoms1

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