Description

Travoprost Impurity 11 is a specified impurity and degradation product of the active pharmaceutical ingredient Travoprost, a prostaglandin analog used in ophthalmic solutions. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Primary use as a pharmaceutical reference standard for Travoprost drug substance and product analysis.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Used in stability studies to identify and quantify degradation pathways of Travoprost formulations.
• Essential for quality control (QC) and quality assurance (QA) laboratories to monitor impurity levels against ICH guidelines.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing characterized impurity data.
• Valuable for research and development of new ophthalmic formulations and generic drug applications.
• Used in pharmacopoeial testing to comply with monograph specifications for Travoprost.

Basic Information

Product Name	Travoprost Impurity 11
CAS No.	2218532-66-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Travoprost Related Compound 11; Travoprost EP Impurity J; Travoprost USP Impurity; Prostaglandin F2α analog impurity; (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3R)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-buten-1-yl]cyclopentyl]-5-Heptenoic Acid Impurity; Travoprost Degradant; Travoprost Process Impurity
EINECS	Contact for details

Quality Control

Our Travoprost Impurity 11 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality commitment aligns with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

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