Description

Carbocisteine Impurity 5 is a specified impurity of the mucolytic drug Carbocisteine, identified by the CAS registry number 118492-49-2. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring drug safety and regulatory compliance. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals working within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carbocisteine Impurity 5 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles during drug stability studies.
• Quality Control & Batch Release: Used in-house by API manufacturers and finished dosage form producers to ensure each batch meets stringent pharmacopeial (e.g., USP, EP, JP) impurity limits.
• Regulatory Submissions: Supports regulatory filings (e.g., ANDA, NDA, CTA) by providing definitive characterization data for specified impurities as required by ICH Q3A and Q3B guidelines.
• Stability Studies: Enables accurate tracking of impurity formation and growth under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research on Degradation Pathways: Facilitates studies into the chemical degradation mechanisms of Carbocisteine, aiding in formulation optimization and packaging selection.

Basic Information

Product Name	Carbocisteine Impurity 5
CAS No.	118492-49-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	S-Carboxymethyl-L-cysteine Impurity 5; (R)-2-Amino-3-[(carboxymethyl)sulfanyl]propanoic acid impurity; Carbocisteine Related Compound 5; Carbocisteine EP Impurity 5; L-Carbocisteine Impurity 5; 118492-49-2; 2-Amino-3-[(carboxymethyl)thio]propanoic acid impurity
EINECS	Contact for details

Quality Control

Every batch of Carbocisteine Impurity 5 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques such as HPLC, GC-MS, NMR, and IR to confirm identity and establish purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. Our quality protocols are designed to support compliance with current Good Manufacturing Practice (cGMP) principles and relevant ICH guidelines for pharmaceutical reference standards.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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