Description

Bimatoprost Impurity Iii CAS NO 1163135-96-3 is a specified impurity of Bimatoprost, a synthetic prostaglandin analog. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is essential for quality control laboratories and manufacturers in the pharmaceutical industry to ensure the purity, safety, and efficacy of Bimatoprost-based drug products, such as those used to treat glaucoma and for cosmetic applications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Bimatoprost Impurity Iii in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug development and manufacturing.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to ensure compliance with stringent pharmacopeial specifications (e.g., ICH Q3A/B, USP, EP) for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance impurity profile.
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Bimatoprost Impurity Iii
CAS No.	1163135-96-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bimatoprost Related Compound Iii; Bimatoprost EP Impurity Iii; Bimatoprost USP Impurity Iii; Bimatoprost Degradant; Prostaglandin F2α analog impurity; (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-penten-1-yl]cyclopentyl]-5-heptenoic acid impurity; Bimatoprost Process Impurity
EINECS	Contact for details

Quality Control

Our Bimatoprost Impurity Iii is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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