Description

Rosuvastatin Impurity 90 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Rosuvastatin. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and impurity profiling studies. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Rosuvastatin API.
• Essential for pharmaceutical research and development (R&D) during process optimization and stability studies.
• Critical component in analytical method development and validation (HPLC, LC-MS) for regulatory filings.
• Used in quality control (QC) laboratories for routine batch release testing of Rosuvastatin.
• Supports pharmacopoeial compliance (e.g., USP, EP) by providing a traceable impurity marker.
• Valuable for academic and institutional research investigating the metabolism and degradation pathways of statins.

Basic Information

Product Name	Rosuvastatin Impurity 90
CAS No.	2226413-62-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 90; Rosuvastatin EP Impurity J; Rosuvastatin USP Impurity; (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; CRESTOR Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 90 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profiles as per current pharmacopoeial expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.