Acetylcysteine Impurity 1

A New Stability Indicating RP-​HPLC method for simultaneous estimation of acebrophylline and N-​acetylcysteine in tablet dosage form and its validation as per ICH guidelines
By Kathirvel, S.; Indukala, P. C.; Sruthi, Mohan; Gayathri, Ramya M.; Rajesh, A.
From International Journal of Pharmacy and Pharmaceutical Research (2019), 16(2), 422-435.
 
A novel stability indicating RP-​HPLC method for the simultaneous estimation of N-​acetylcysteine and Ambroxol in combined tablet dosage form
By Kinjawadekar, Vedang; Boddu, Snehalatha; Ghadge, Ojaswi
From International Journal of Pharmaceutical Sciences and Research (2017), 8(5), 2161-2167
 

Acetylcysteine Impurity 1 is chemically 2-Methyl-4,5-dihydrothiazole-4-carboxylic acid, sodium salt. Acetylcysteine Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Acetylcysteine Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Acetylcysteine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.