Description

Rosuvastatin Related Compound 3 is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Rosuvastatin, a widely prescribed statin medication. It is primarily used by analytical laboratories and pharmaceutical manufacturers for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Rosuvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Rosuvastatin products, supporting Good Manufacturing Practice (GMP).
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate product safety.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Rosuvastatin.
• Research & Development: Facilitates chemical and metabolic pathway research related to statin drugs in academic and industrial R&D settings.

Basic Information

Product Name	Rosuvastatin Related Compound 3
CAS No.	325471-28-1
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity 3; Rosuvastatin EP Impurity C; Rosuvastatin USP Related Compound C; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin N-Oxide (common misidentification); Rosuvastatin Sulfoxide; ZD4522 Related Compound 3; Crestor® Related Compound 3
EINECS	Contact for details

Quality Control

Our Rosuvastatin Related Compound 3 is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch is characterized and tested using validated methods, including HPLC, NMR, and Mass Spectrometry, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, impurities, and analytical results. Our quality commitment aligns with the requirements for reference standards as per USP, EP, and 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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid repeated or prolonged exposure to ambient conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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