Description

Rosuvastatin Impurity 92 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 Rosuvastatin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Rosuvastatin Calcium API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels during API synthesis and purification.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the analytical procedures are performing as intended.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and formation mechanisms of impurities during the synthesis of Rosuvastatin.

Basic Information

Product Name	Rosuvastatin Impurity 92
CAS No.	404958-68-5
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Related Compound 92; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid; Rosuvastatin EP Impurity J; Rosuvastatin USP Impurity; Rosuvastatin Degradant; (E)-7-(4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 92 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP). 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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