Description

Tafluprost Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Tafluprost, a prostaglandin analog used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Tafluprost Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Tafluprost batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Tafluprost formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Tafluprost.

Basic Information

Product Name	Tafluprost Impurity 9
CAS No.	2099033-66-4
Molecular Formula	C25H34F2O6
Molecular Weight	468.53 g/mol
Synonyms	Tafluprost Related Compound 9; 15-Deoxy-15,15-Difluoro Prostaglandin F2α Ethyl Amide Impurity; 5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E,3R)-3-(ethylamino)-3-oxo-1-propen-1-yl]-3,5-dihydroxycyclopentyl]-, methyl ester, (5Z)-; Tafluprost EP Impurity G; Tafluprost USP Impurity; Degradation Product of Tafluprost
EINECS	Contact for details

Quality Control

Every batch of Tafluprost Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment and is available upon request.

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 (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Assay (HPLC)	95.0% - 105.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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