Description

Rosuvastatin Impurity 3 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 Calcium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Rosuvastatin Calcium API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Rosuvastatin formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency of the API.
• Research & Development: Used in R&D to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Rosuvastatin.

Basic Information

Product Name	Rosuvastatin Impurity 3
CAS No.	1803023-44-0
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin EP Impurity C; Rosuvastatin Related Compound C; Rosuvastatin Sulfoxide N-Oxide; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl-N-(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines and pharmacopeial 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 must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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