Description

Rosuvastatin Impurity Sodium Salt (5-Oxo Rosuvastatin Sodium Salt) is a high-purity reference standard and synthetic intermediate critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of Rosuvastatin, a leading statin medication. It is primarily used by analytical laboratories, quality assurance departments, and R&D teams in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other analytical methods to validate assay procedures and ensure accurate impurity profiling of Rosuvastatin API and finished dosage forms.
• Method Development and Validation: Used in the development, optimization, and validation of stability-indicating analytical methods as per ICH Q2(R1) guidelines.
• Quality Control & Assurance: Critical for routine batch release testing in API manufacturing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track degradation products of Rosuvastatin.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Acts as a key intermediate or marker in synthetic route development and optimization for Rosuvastatin production.

Basic Information

Product Name	Rosuvastatin Impurity Sodium Salt (5-Oxo Rosuvastatin Sodium Salt)
CAS No.	1422619-13-3
Molecular Formula	C22H27FN3NaO6S
Molecular Weight	503.52 g/mol
Synonyms	5-Oxo Rosuvastatin Sodium Salt; Rosuvastatin 5-Oxo Impurity Sodium Salt; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid 5-oxo sodium salt; Rosuvastatin Related Compound; Rosuvastatin EP Impurity; Rosuvastatin USP Impurity; 5-Keto Rosuvastatin Sodium Salt
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity Sodium Salt is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as per relevant pharmacopeial guidelines. We support compliance with ICH, USP, and EP standards, and specifications can be tailored to meet specific customer or regulatory 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.