Description

Latanoprost Impurity 3 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Latanoprost. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug manufacturing. It is an essential material for analytical chemists and quality control professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of impurities in Latanoprost drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor and quantify the level of this specific impurity, ensuring it remains within acceptable limits as per ICH guidelines.
• Stability Studies: Used to track the formation of this impurity over time 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 impurity control strategies.
• Chemical Research: Acts as a building block or intermediate for synthetic chemists working on prostaglandin analogs or related compounds.

Basic Information

Product Name	Latanoprost Impurity 3
CAS No.	2278245-92-2
Molecular Formula	C26H41FO7
Molecular Weight	484.60 g/mol
Synonyms	Latanoprost Related Compound 3; Latanoprost EP Impurity C; Latanoprost USP Impurity; Prostaglandin F2α analog impurity; (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid Isopropyl Ester (Fluorinated Derivative); Latanoprost Process Impurity; Latanoprost Degradant
EINECS	Contact for details

Quality Control

Our Latanoprost Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, spectroscopic identification (NMR, MS, IR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. Our quality commitment aligns with the principles of ICH Q3A(R2) and Q3B(R2) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This material is hygroscopic (moisture-sensitive). Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.