Description

Rosuvastatin Ep Impurity C is a high-purity chemical reference standard, specifically identified as an impurity of the widely prescribed cholesterol-lowering drug, Rosuvastatin. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control testing of active pharmaceutical ingredients (APIs). It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry who require reliable reference standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Rosuvastatin Ep Impurity C in Rosuvastatin API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research on Drug Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Rosuvastatin, supporting formulation improvement.

Basic Information

Product Name	Rosuvastatin Ep Impurity C
CAS No.	1620823-61-1
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity C; Rosuvastatin EP Impurity C; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic acid; Rosuvastatin Related Compound C; Rosuvastatin Epi Impurity; Rosuvastatin Isomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Ep Impurity C (CAS 1620823-61-1) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with pharmacopeial standards (e.g., EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
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)	≤ 5.0%
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.