Description

Tryptophan Impurity 34 is a high-purity reference standard specifically identified as a process-related impurity or degradation product of the essential amino acid L-Tryptophan. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of final drug products. It is primarily utilized by research institutions, quality control laboratories, and manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in L-Tryptophan API and related drug substances.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing to monitor impurity profiles during API synthesis and purification processes.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in metabolic pathway studies and to investigate the chemical behavior and fate of Tryptophan-related compounds.

Basic Information

Product Name	Tryptophan Impurity 34
CAS No.	1285591-94-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tryptophan Related Compound 34; Tryptophan Impurity D; L-Tryptophan Impurity 34; Tryptophan Process Impurity; Tryptophan Degradant; (2S)-2-Amino-3-(1H-indol-3-yl)propanoic acid impurity; Tryptophan Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Tryptophan Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.