Description

Rosuvastatin Impurity 2 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Rosuvastatin, a widely prescribed statin medication. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Rosuvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, primarily HPLC and UPLC, for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug dossiers.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Rosuvastatin.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop robust purification processes for the Rosuvastatin API.

Basic Information

Product Name	Rosuvastatin Impurity 2
CAS No.	1659301-57-1
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Related Compound 2; (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 B; Rosuvastatin USP Impurity 2; Rosuvastatin Impurity B; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl(methylsulfonamido)]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and advanced spectroscopic techniques (NMR, MS) for structural verification, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a desiccated environment 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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