Description

Tafluprost Impurity 7 is a specified impurity and degradation product of the active pharmaceutical ingredient Tafluprost, a prostaglandin analog used in glaucoma treatment. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Tafluprost-based ophthalmic solutions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Tafluprost API and finished drug products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC/UPLC methods to monitor degradation pathways.
• Quality Control & Assurance: Used in routine batch testing to ensure Tafluprost drug substances and products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to profile and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry R&D: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Tafluprost Impurity 7
CAS No.	733036-94-7
Molecular Formula	C25H34F2O6
Molecular Weight	468.53 g/mol
Synonyms	15-Deoxy-15,15-difluoro-13,14-dihydro-17-phenyl-18,19,20-trinor-PGF2α isopropyl ester; Tafluprost EP Impurity G; Tafluprost Related Compound G; 17-Phenyl-18,19,20-trinor-PGF2α 1-isopropyl ester, 15-deoxy-15,15-difluoro-13,14-dihydro-; (5Z)-7-[(1R,2R,3R,5S)-2-[(1E)-3,3-Difluoro-4-phenoxy-1-buten-1-yl]-3,5-dihydroxycyclopentyl]-5-heptenoic acid 1-methylethyl ester
EINECS	Contact for details

Quality Control

Every batch of Tafluprost Impurity 7 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality systems support compliance with cGMP and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure maximum stability.

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)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.