Description

Rosuvastatin Impurity 30 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Rosuvastatin, a widely prescribed statin medication. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for method development, validation, and regulatory compliance. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Rosuvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure Rosuvastatin products meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Rosuvastatin to minimize impurity formation.

Basic Information

Product Name	Rosuvastatin Impurity 30
CAS No.	2124272-05-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 30; Rosuvastatin EP Impurity 30; Rosuvastatin USP Impurity 30; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid impurity; Rosuvastatin Degradation Product; Rosuvastatin Process Impurity; Statin Impurity
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity 30 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, 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 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 inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.