Description

Rosuvastatin Impurity 24 (Sodium Salt) 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 analysis. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Primary use as a pharmaceutical reference standard for method development and validation.
• Critical component in impurity profiling and characterization studies for Rosuvastatin API and finished dosage forms.
• Used in stability studies to monitor degradation pathways and establish shelf-life.
• Essential for regulatory submissions (e.g., ANDA, NDA) to comply with ICH guidelines on impurities.
• Supports quality control (QC) testing in manufacturing to ensure batch-to-batch consistency.
• Valuable for academic and contract research organizations (CROs) conducting pharmacokinetic and metabolic research.

Basic Information

Product Name	Rosuvastatin Impurity 24 (Sodium Salt)
CAS No.	1347362-67-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 24 (Sodium Salt); Rosuvastatin EP Impurity 24; Rosuvastatin USP Impurity 24; Sodium (3R,5S,6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate (Impurity); Rosuvastatin Sodium Impurity 24; (E)-7-[4-(4-Fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Sodium Salt (Impurity)
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity 24 (Sodium Salt) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.