Description

Rosuvastatin Impurity (5-Oxo Rosuvastatin tert-Butyl Ester) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity and intermediate in the synthesis and quality control of Rosuvastatin, a widely prescribed statin medication. It is primarily required by analytical laboratories and API manufacturers for method development, validation, and ensuring batch-to-batch consistency and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rosuvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance: A critical component in the impurity profile assessment to ensure Rosuvastatin batches meet pharmacopeial standards (USP, EP, ICH Q3A/B).
• Process Chemistry Research: Employed as an intermediate in synthetic pathway studies and for optimizing the manufacturing process of Rosuvastatin.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability testing of Rosuvastatin formulations.

Basic Information

Product Name	Rosuvastatin Impurity (5-Oxo Rosuvastatin tert-Butyl Ester)
CAS No.	854898-53-6
Molecular Formula	C26H34FN3O6S
Molecular Weight	535.63 g/mol
Synonyms	5-Oxo Rosuvastatin tert-Butyl Ester; Rosuvastatin tert-Butyl Ester Impurity; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid tert-Butyl Ester; Rosuvastatin tert-Butyl Ester 5-Oxo Derivative; Rosuvastatin Related Compound; Rosuvastatin Impurity O; Rosuvastatin EP Impurity F; ZD4522 tert-Butyl Ester Impurity
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity (5-Oxo Rosuvastatin tert-Butyl Ester) is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results, ensuring compliance with ICH guidelines and relevant pharmacopeial standards for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.