Description

Carbocisteine Impurity 4 is a specified impurity of the mucolytic drug Carbocisteine, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of Carbocisteine-based drug products by enabling accurate identification and quantification of this specific impurity. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, testing, and approval of Carbocisteine.

Application

• Primary use as a pharmaceutical reference standard for Carbocisteine impurity profiling.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Carbocisteine drug substances and products.
• Used in stability studies to monitor the formation of degradation products in Carbocisteine formulations.
• Essential for quality control (QC) testing to ensure Carbocisteine meets pharmacopeial purity specifications (e.g., USP, EP).
• Supports regulatory submissions (e.g., ANDA, NDA) by providing impurity identification and characterization data.
• Utilized in research and development to study the synthesis pathway and impurity fate of Carbocisteine.

Basic Information

Product Name	Carbocisteine Impurity 4
CAS No.	118573-75-4
Molecular Formula	C5H9NO4S
Molecular Weight	179.19 g/mol
Synonyms	S-Carboxymethyl-L-cysteine Impurity 4; (2R)-2-Amino-3-[(carboxymethyl)sulfanyl]propanoic acid; L-Cysteine, S-(carboxymethyl)-; Carbocisteine Related Compound 4; Carbocisteine EP Impurity D; S-Carboxymethylcysteine Impurity 4
EINECS	Contact for details

Quality Control

Our Carbocisteine Impurity 4 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 purity, identity, and impurity profile as determined by advanced chromatographic and spectroscopic techniques. We support compliance with ICH guidelines and major pharmacopeias (USP, EP) for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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