Description

Rosuvastatin Ep Impurity A is a high-purity reference standard critical for the analytical profiling and quality control of Rosuvastatin, a leading statin medication. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity, ensuring drug safety and compliance with stringent pharmacopeial guidelines. It is primarily used in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Rosuvastatin Ep Impurity A in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling of Rosuvastatin.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to ensure Rosuvastatin API and formulations meet ICH, USP, or EP impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to determine drug shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Degradation Pathways: Used in forced degradation studies to elucidate the formation mechanism and chemical stability of Rosuvastatin.

Basic Information

Product Name	Rosuvastatin Ep Impurity A
CAS No.	1714147-50-8
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin E-Isomer; Rosuvastatin Impurity A; Rosuvastatin EP Impurity A; Rosuvastatin Related Compound A; (E)-Rosuvastatin
EINECS	Contact for details

Quality Control

Our Rosuvastatin Ep Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.