Description

Rosuvastatin Impurity 52 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Rosuvastatin, a widely prescribed statin medication. It is primarily utilized by analytical chemists and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for identifying and quantifying process-related impurities in Rosuvastatin Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC) and LC-MS methods to ensure accurate impurity detection.
• Stability Studies: Employed in forced degradation and long-term stability studies of Rosuvastatin to monitor the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Quality Control (QC) Testing: Acts as a system suitability standard in routine QC laboratories to ensure the accuracy and precision of impurity assays for Rosuvastatin.
• Research and Development: Used in synthetic chemistry research to study the formation pathway and chemical behavior of this impurity during the Rosuvastatin manufacturing process.

Basic Information

Item	Details
Product Name	Rosuvastatin Impurity 52
CAS No.	918544-87-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 52; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Impurity; Rosuvastatin EP Impurity I; Rosuvastatin USP Impurity; Rosuvastatin Process Impurity; 918544-87-3; Rosuvastatin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 52 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A, Q3B, and relevant pharmacopoeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results from advanced analytical techniques like HPLC, LC-MS, and NMR is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.