Description

Rosuvastatin Related Compound 4 is a high-purity chemical reference standard, critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Rosuvastatin Calcium through precise impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for compliance testing and research and development.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Rosuvastatin Calcium bulk drug and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical standard for developing, calibrating, and validating chromatographic methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of the API.
• Regulatory Compliance & Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and impurity spectrum.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Rosuvastatin formulations.
• Research & Development: Facilitates chemical research into the metabolism, degradation pathways, and synthesis of Rosuvastatin and its related substances.

Basic Information

Product Name	Rosuvastatin Related Compound 4
CAS No.	404958-69-6
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin Impurity 4; Rosuvastatin EP Impurity D; Rosuvastatin USP Related Compound D; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Our Rosuvastatin Related Compound 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data for identity, purity, and related substances. We support compliance with ICH, USP, and EP guidelines, and specifications can be aligned with your specific pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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