Description

Glutathione Ep Impurity D (Tfa Salt) is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This compound is specifically used for the identification, quantification, and monitoring of related substances in the production of Glutathione and its derivatives. It is an essential material for analytical laboratories and manufacturers in the pharmaceutical and biotechnology sectors, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for HPLC, LC-MS, and other analytical methods in quality control laboratories.
• Impurity Profiling: Critical for method development and validation to monitor and control Glutathione-related impurities during API synthesis.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity for stability studies and specification setting.
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Glutathione-based compounds.
• Process Chemistry: Serves as a key intermediate or marker in the optimization of synthetic routes for Glutathione and its analogs.

Basic Information

Product Name	Glutathione Ep Impurity D (Tfa Salt)
CAS No.	283159-88-6
Molecular Formula	C13H19F3N4O8S
Molecular Weight	448.37 g/mol
Synonyms	L-Glutathione, S-oxide, TFA salt; Glutathione sulfoxide TFA salt; γ-Glu-Cys-Gly sulfoxide trifluoroacetate; GSH Ep Impurity D; (2S)-2-Amino-5-[[(2R)-1-(carboxymethylamino)-3-(trifluoroacetoxysulfinyl)-1-oxopropan-2-yl]amino]-5-oxopentanoic acid; Glutathione Epimer Impurity D Trifluoroacetate; N-(N-L-γ-Glutamyl-3-sulfinyl-L-cysteinyl)glycine TFA salt
EINECS	Contact for details

Quality Control

Every batch of Glutathione Ep Impurity D (Tfa Salt) is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and strength. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept sealed in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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