Description

Rosuvastatin Impurity 24 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Rosuvastatin Calcium. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the development and manufacturing of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Rosuvastatin API and finished dosage forms.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, primarily using HPLC and UPLC techniques.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Rosuvastatin.
• Quality Control Testing: Serves as a system suitability and calibration standard in routine QC release testing of Rosuvastatin batches to ensure specification limits are met.
• Process Chemistry Research: Aids in the identification of impurity sources during API synthesis, helping to refine manufacturing processes for higher purity and yield.

Basic Information

Product Name	Rosuvastatin Impurity 24
CAS No.	1347797-73-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 24; Rosuvastatin EP Impurity J; Rosuvastatin USP Impurity; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid impurity; Rosuvastatin Process Impurity; Rosuvastatin Degradant
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 3.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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