Description

Tryptophan Impurity 21 (Rac-Tryptophan Ep Impurity G Hcl) is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities and degradation products in Tryptophan-based APIs.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: A key component in forced degradation and long-term stability studies to understand the degradation pathways of Tryptophan and related compounds.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Contract Research & Manufacturing (CRO/CMO): Used by service organizations to support client projects requiring high-fidelity impurity analysis and control.

Basic Information

Product Name	Tryptophan Impurity 21 (Rac-Tryptophan Ep Impurity G Hcl)
CAS No.	1313016-72-6
Molecular Formula	C11H13N3O2 • HCl
Molecular Weight	255.70 g/mol (Free base: 219.24 g/mol)
Synonyms	rac-Tryptophan EP Impurity G Hydrochloride; (RS)-Tryptophan Impurity G HCl; DL-Tryptophan Related Compound G; Tryptophan Impurity G (Rac); 2-Amino-3-(1H-indol-3-yl)propanoic acid hydrochloride (racemic); Amino Acid Impurity Standard; Tryptophan Diastereomer Impurity; Pharmaceutical Secondary Standard
EINECS	Contact for details

Quality Control

Every batch of Tryptophan Impurity 21 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing results for purity, related substances, residual solvents, and other critical parameters. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP 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. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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