Description

Rosuvastatin Impurity 89 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Rosuvastatin, a widely prescribed statin medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify, monitor, and control Rosuvastatin Impurity 89 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed to understand the degradation pathways of Rosuvastatin and to establish stability-indicating methods.
• Quality Control and Release Testing: Essential for routine quality control testing of Rosuvastatin API to ensure it meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control and drug safety.
• Research and Development: Used in synthetic chemistry research to study the formation and mitigation of this specific impurity during the Rosuvastatin manufacturing process.

Basic Information

Product Name	Rosuvastatin Impurity 89
CAS No.	2226413-61-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 89; Rosuvastatin Specified Impurity 89; Rosuvastatin EP Impurity K; Rosuvastatin USP Impurity; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid impurity; Rosuvastatin Process Impurity; Statin Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 89 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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