Description

Glutathione Impurity 9 CAS NO 17297-99-3 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the purity and safety of Glutathione-based drug substances and finished products by accurately identifying and quantifying related substances. It is primarily used by research institutions, quality control laboratories, and manufacturers in the pharmaceutical and biotechnology sectors for impurity profiling and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Glutathione Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product consistency meets stringent pharmacopeial standards (e.g., USP, EP).
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation over time under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate product understanding and control.
• Research & Development: Used in metabolic pathway studies and to understand the degradation chemistry of Glutathione.

Basic Information

Item	Detail
Product Name	Glutathione Impurity 9
CAS No.	17297-99-3
Molecular Formula	C20H32N6O12S2
Molecular Weight	612.63 g/mol
Synonyms	L-Glutathione, oxidized disulfide impurity; GSSG-related impurity; Oxidized Glutathione dimer impurity; Bis(γ-glutamylcysteinylglycine) disulfide; Glutathione disulfide analog; (2S)-2-Amino-4-{[(1R)-1-[(carboxymethyl)carbamoyl]-2-[(2R)-2-[(2R)-2-amino-3-carboxypropanamido]-3-(carboxymethylamino)-3-oxopropyl]disulfanyl]ethyl}amino}-4-oxobutanoic acid; Glutathione Oxidized Impurity
EINECS	Contact for details

Quality Control

Every batch of Glutathione Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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