Additional information on Acetylcysteine Impurity 22 (Sodium Salt)
Parent drug
Acetylcysteine
IUPAC Name
N-acetyl-S-(1-amino-3-hydroxy-1-oxopropan-2-yl)-L-cysteinate, sodium salt (1:1)
Synonyms
N/A
Description
Acetylcysteine Impurity 22 (Sodium Salt) is the sodium counterion form of a defined process-related impurity associated with cysteine acylation chemistry, plausibly arising from incomplete acyl transfer, side-chain oxidation, or salt-form equilibration during manufacture. The molecular composition C8H13N2O5.Na and molecular weight 249.26 plus 22.99 g/mol indicate an ionizable, polar species with limited volatility and strong chromatographic retention on reversed-phase systems. Quantification generally requires LC-MS/MS or high-resolution LC-MS, with UV detection often insufficient for low-level profiling. Its characterization is relevant to impurity fate studies, degradant mapping, and specification setting under contemporary ICH impurity control expectations.
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Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
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