Description

Mesna Impurity 5 is a specified organic compound used as a critical reference standard in analytical chemistry and pharmaceutical development. This impurity is of significant importance for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Mesna, a chemoprotective agent. It is primarily required by quality control laboratories, research institutions, and pharmaceutical manufacturers involved in the synthesis, purification, and regulatory compliance of Mesna-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Mesna API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to confirm that impurity levels are within specified pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Mesna formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Mesna Impurity 5
CAS No.	500692-41-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mesna Related Compound 5; 2-Mercaptoethanesulfonic acid impurity 5; Sodium 2-mercaptoethanesulfonate impurity 5; Uromitexan impurity 5; Mesnum impurity 5; Mistabron impurity 5; Mesnex impurity 5
EINECS	Contact for details

Quality Control

Our Mesna Impurity 5 is manufactured and handled under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profiles. We support compliance with current Good Manufacturing Practices (cGMP) and relevant pharmacopeial standards for reference materials.

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. Handle and store in accordance with safe laboratory practices for chemical substances.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Water Content	Contact for details
Residual Solvents	Complies with ICH limits

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