Description

Acetylcysteine Impurity 5 is a specified impurity used in the analytical profiling and quality control of Acetylcysteine, a critical pharmaceutical agent. This compound is essential for ensuring the purity, safety, and efficacy of Acetylcysteine drug substances and finished products by serving as a reference standard. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Acetylcysteine Active Pharmaceutical Ingredients (APIs) and formulations.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and that impurity levels remain within specified pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Acetylcysteine under various stress conditions (e.g., heat, humidity, light) during shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Acetylcysteine Impurity 5
CAS No.	87862-95-1
Molecular Formula	C5H9NO3S
Molecular Weight	163.19 g/mol
Synonyms	N-Acetyl-S-(carboxymethyl)-L-cysteine; L-Cysteine, N-acetyl-S-(carboxymethyl)-; N-Acetyl-S-carboxymethylcysteine; Acetylcysteine Related Compound; Acetylcysteine Impurity F (EP); S-(Carboxymethyl)-N-acetylcysteine; N-Acetyl-3-[(carboxymethyl)thio]alanine
EINECS	Contact for details

Quality Control

Our Acetylcysteine Impurity 5 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques, including HPLC for purity and spectroscopic methods for structural confirmation. We support compliance with ICH Q3A, Q3B, USP, and European Pharmacopoeia guidelines. Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.