Description

Rosuvatatin Impurity 24 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for quality control and regulatory compliance, ensuring the safety and efficacy of the final active pharmaceutical ingredient (API). It is primarily utilized by analytical laboratories, quality assurance departments, and research institutions involved in the production and validation of Rosuvastatin calcium.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Rosuvastatin API and finished dosage forms.
• Method Development & Validation: Essential for developing and validating analytical methods, particularly HPLC and LC-MS, to monitor impurity profiles.
• Quality Control (QC) Testing: Employed in routine QC testing of Rosuvastatin batches to ensure they meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance and product.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Serves as a key intermediate or degradation product for studying the synthesis pathway and degradation mechanisms of Rosuvastatin.

Basic Information

Product Name	Rosuvatatin Impurity 24
CAS No.	894787-93-0
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity 24; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid; Rosuvastatin Related Compound 24; Rosuvastatin EP Impurity I; Rosuvastatin USP Related Compound; 6(E)-Rosuvastatin; (E)-Isomer of Rosuvastatin; Bis-deprotected Rosuvastatin Intermediate
EINECS	Contact for details

Quality Control

Every batch of Rosuvatatin Impurity 24 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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 ≤ 1.0%
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.