Description

Rosuvastatin Related Compound 8 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Rosuvastatin, a widely prescribed statin medication. It serves as an essential tool for analytical chemists and quality control laboratories in the pharmaceutical industry, enabling precise identification and quantification of impurities during drug substance and product manufacturing.

Application

• Pharmaceutical Impurity Profiling: 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 and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control and Release Testing: Employed in routine QC testing to monitor impurity levels against strict pharmacopeial limits (e.g., USP, EP) to ensure batch-to-batch consistency and regulatory compliance.
• Stability Studies: Used as a marker to track the formation of degradation products in Rosuvastatin under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) stability testing protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this related compound during Rosuvastatin synthesis.

Basic Information

Product Name	Rosuvastatin Related Compound 8
CAS No.	521974-01-6
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity 8; Rosuvastatin EP Impurity H; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid; Rosuvastatin Sulfonamide N-Oxide; Rosuvastatin Related Substance H; Rosuvastatin N-Oxide Impurity; ZD4522 Related Compound 8
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Related Compound 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results against predefined specifications. Our quality standards align with the requirements for pharmaceutical reference standards, supporting compliance with cGMP, ICH, USP, and EP 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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