Description

Latanoprost Impurity CAS NO 733036-95-8 is a high-purity reference standard used in the pharmaceutical development and quality control of Latanoprost, a prostaglandin analog medication. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of ophthalmic drug products by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those producing generic or branded glaucoma treatments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development, validation, and routine quality control testing of Latanoprost Active Pharmaceutical Ingredient (API) and finished drug products.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies as per ICH Q3A/B guidelines.
• Stability Studies: Used to monitor and quantify the formation of this specific impurity during forced degradation and long-term stability studies of Latanoprost formulations.
• Process Chemistry R&D: Employed by process development scientists to optimize synthesis and purification steps, aiming to minimize the formation of this impurity in the final API.
• Contract Research & Testing Labs: Essential reagent for third-party laboratories offering analytical testing and impurity characterization services to the pharmaceutical industry.
• Academic Research: Used in university and institutional research focused on prostaglandin chemistry, drug degradation pathways, and advanced analytical techniques.

Basic Information

Product Name	Latanoprost Impurity
CAS No.	733036-95-8
Molecular Formula	C26H40O5
Molecular Weight	432.60 g/mol
Synonyms	Latanoprost Related Compound; (5Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoic Acid Isopropyl Ester; Latanoprost EP Impurity; Latanoprost USP Related Substance; Prostaglandin F2α analog impurity; 13,14-dihydro-15-keto Latanoprost; Isopropyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate
EINECS	Contact for details

Quality Control

Every batch of Latanoprost Impurity (CAS 733036-95-8) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing via validated analytical methods (typically HPLC) to ensure identity, purity, and strength conform to the highest standards suitable for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.