Description

Tryptophan Impurity 3 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound, identified by CAS NO 164068-19-3, is essential for ensuring the purity and safety of active pharmaceutical ingredients (APIs) and finished drug products containing tryptophan or related compounds. It is primarily used by quality assurance and research & development professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tryptophan API and finished drug products according to ICH guidelines.
• Analytical Method Development & Validation (HPLC/LC-MS): A critical component for developing, optimizing, and validating chromatographic methods for purity analysis.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity profiles and ensure product stability over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research on Metabolic Pathways: Serves as a tool in biochemical research to study the metabolism and degradation pathways of tryptophan and its derivatives.
• Calibration of Analytical Instruments: Used to calibrate and qualify equipment like HPLC and mass spectrometers for accurate impurity detection.

Basic Information

Product Name	Tryptophan Impurity 3
CAS No.	164068-19-3
Molecular Formula	C11H12N2O2
Molecular Weight	204.23 g/mol
Synonyms	(2S)-2-Amino-3-(1H-indol-3-yl)propanoic acid impurity 3; Tryptophan Related Compound 3; L-Tryptophan Impurity C; 1H-Indole-3-propanoic acid, α-amino-, (αS)- (9CI); Tryptophan EP Impurity C; Tryptophan USP Related Compound C; Indole-3-pyruvic acid derivative
EINECS	Contact for details

Quality Control

Every batch of Tryptophan Impurity 3 is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines (e.g., USP, EP).

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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