Methionine EP Impurity A CAS 3226-65-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.3226-65-1
Molecular FormulaC5H11NO3S
Molecular Weight165.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Methionine EP Impurity A CAS 3226-65-1 chemical structure

Description

As a process- or degradation-related impurity, Methionine EP Impurity A (CAS 3226-65-1, C5H11NO3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, Methionine EP Impurity A is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 165.21 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Methionine EP Impurity A meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC5H11NO3S
Molecular Weight165.21 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1957
Nitrogen Atoms1
Sulfur Atoms1

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