Description

Rosuvastatin Related Compound 6 is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the active pharmaceutical ingredient Rosuvastatin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of Rosuvastatin-based drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific related compound in Rosuvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this compound under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life and storage guidelines.
• Quality Control and Batch Release Testing: Essential for routine QA/QC testing to ensure that Rosuvastatin API and drug products meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways and behavior of Rosuvastatin.

Basic Information

Item	Details
Product Name	Rosuvastatin Related Compound 6
CAS No.	521973-99-9
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity 6; Rosuvastatin EP Impurity G; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid; Bis(desmethyl) Rosuvastatin; Rosuvastatin N,N-Didesmethyl Impurity; 521973-99-9; Rosuvastatin Related Substance G
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Related Compound 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and strength conform to high-grade reference standard specifications, typically exceeding 95% purity (HPLC). Comprehensive Certificates of Analysis (COA) are provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

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