Description

Rosuvastatin Impurity CAS NO 2290571-51-4 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Rosuvastatin, a widely prescribed statin medication. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Rosuvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates studies on the degradation pathways and synthesis process of Rosuvastatin, aiding in process optimization and impurity minimization.

Basic Information

Product Name	Rosuvastatin Impurity
CAS No.	2290571-51-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound; Rosuvastatin Specified Impurity; Rosuvastatin Process Impurity; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid impurity; Rosuvastatin Degradant; CRESTOR Impurity; IUPAC name to be confirmed; Pharmaceutical Reference Standard
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and controlled using validated methods, including HPLC for purity and identity confirmation via spectroscopic techniques. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant ICH guidelines.

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. Handle the container with care to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single 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.