Description

Acetylcysteine Impurity 3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of Acetylcysteine, a widely used mucolytic and antidotal agent. It is an essential tool for researchers and quality assurance professionals in pharmaceutical, biotechnology, and contract research organizations (CROs) who require precise impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Acetylcysteine Impurity 3 in Acetylcysteine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Batch Release Testing: Integral for routine QC testing to monitor impurity levels, ensuring every batch of Acetylcysteine API meets stringent pharmacopeial (USP, EP, JP) and internal specification limits.
• Stability Studies & Forced Degradation: Employed as an analytical marker in stability-indicating methods to track impurity formation under various stress conditions (heat, light, humidity, pH).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive impurity characterization data required for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing Acetylcysteine synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Acetylcysteine Impurity 3
CAS No.	79560-92-2
Molecular Formula	C5H9NO3S
Molecular Weight	163.19 g/mol
Synonyms	N-Acetyl-S-(carboxymethyl)-L-cysteine; (2R)-2-Acetamido-3-[(carboxymethyl)sulfanyl]propanoic acid; L-Cysteine, N-acetyl-S-(carboxymethyl)-; Acetylcysteine Related Compound C; N-Acetyl-S-carboxymethylcysteine; ACC Impurity 3; NAC Impurity 3; S-(Carboxymethyl)-N-acetyl-L-cysteine
EINECS	Contact for details

Quality Control

Our Acetylcysteine Impurity 3 is manufactured under strict quality management systems. Each batch is subjected to rigorous identity, purity, and impurity profile testing using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the highest standards for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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