Description

Glutathione Impurity CAS NO 139595-20-3 is a high-purity chemical reference standard used in the analytical profiling and quality control of Glutathione and related pharmaceutical products. This compound is critical for ensuring the safety and efficacy of final drug formulations by enabling the accurate identification and quantification of process-related impurities. It is an essential tool for pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical testing of Glutathione API (Active Pharmaceutical Ingredient) and finished drug products.
• HPLC/LC-MS Method Development: Used as a critical system suitability component and for calibrating analytical instruments to detect and measure trace impurities.
• Quality Control & Assurance: Essential for establishing impurity profiles, setting specification limits, and ensuring batch-to-batch consistency in manufacturing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation of degradation products in Glutathione formulations under various stress conditions.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes by identifying and tracking specific impurity formation.

Basic Information

Product Name	Glutathione Impurity
CAS No.	139595-20-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Glutathione Impurity; Glutathione Related Compound; (2S)-2-Amino-5-[[(2R)-1-(carboxymethylamino)-1-oxo-3-(sulfanyl)propan-2-yl]amino]-5-oxopentanoic acid; γ-Glutamylcysteinylglycine Impurity; GSH Impurity; Oxiglutatione Impurity (check isomer); Thiolated Glutathione Derivative
EINECS	Contact for details

Quality Control

Every batch of our Glutathione Impurity is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Reported on COA
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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