Description

Tryptophan EP Impurity E is a high-purity reference standard critical for pharmaceutical quality control and analytical method development. This compound is essential for the accurate identification and quantification of process-related impurities in L-Tryptophan and its pharmaceutical formulations, ensuring compliance with stringent pharmacopeial standards. It is primarily used by analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method validation, stability studies, and release testing of L-Tryptophan active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and to calibrate impurity detection limits.
• Pharmacopeial Compliance: Critical for testing to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and ICH guidelines for impurity profiling.
• Quality Control & Assurance: Enables precise impurity identification in raw material qualification, in-process control, and final product batch release.
• Research & Development: Supports studies on degradation pathways, synthesis optimization, and the stability of Tryptophan-based pharmaceuticals.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.

Basic Information

Product Name	Tryptophan EP Impurity E
CAS No.	287170-99-4
Molecular Formula	C11H12N2O2
Molecular Weight	204.23 g/mol
Synonyms	(2S)-2-Amino-3-(1H-indol-3-yl)propanoic acid impurity E; Tryptophan Impurity E; L-Tryptophan Related Compound E; 1H-Indole-3-propanoic acid, α-amino-, (αS)-; EP Impurity E of Tryptophan; Tryptophan Specified Impurity E; (S)-2-Amino-3-(1H-indol-3-yl)propanoic acid impurity
EINECS	Contact for details

Quality Control

Our Tryptophan EP Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmacopeial reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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