Description

Rosuvastatin Impurity 14 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Rosuvastatin, a widely prescribed statin medication. It is primarily utilized by analytical chemists and quality assurance professionals in pharmaceutical companies and contract research organizations (CROs) for method development, validation, and impurity profiling studies to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Rosuvastatin active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used in developing and optimizing chromatographic methods, primarily HPLC and UPLC, for accurate impurity separation and identification.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing of Rosuvastatin to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker to track impurity formation in Rosuvastatin under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Rosuvastatin.

Basic Information

Item	Details
Product Name	Rosuvastatin Impurity 14
CAS No.	1422954-13-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Related Compound 14; Rosuvastatin EP Impurity J; Rosuvastatin USP Impurity; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid Impurity; Rosuvastatin Degradation Product; Rosuvastatin Process Impurity; Statin Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

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 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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