Description

Rosuvastatin D-5 Enantiomer Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the stereochemical purity and regulatory compliance of Rosuvastatin, a widely prescribed statin medication. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) for method validation, impurity profiling, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify, quantify, and monitor the specified enantiomeric impurity during Rosuvastatin API synthesis and purification processes.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating sensitive chromatographic methods, such as HPLC and UPLC, to separate and detect stereoisomeric impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Rosuvastatin drug substances and finished dosage forms to ensure compliance with stringent pharmacopeial limits for related substances.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over potential impurities.
• Stability Studies: Used as a marker to assess the degradation pathways and shelf-life of Rosuvastatin formulations under various stress conditions.
• Academic & Contract Research: Supports research in synthetic chemistry, pharmacokinetics, and metabolic studies related to statin drugs.

Basic Information

Product Name	Rosuvastatin D-5 Enantiomer Impurity
CAS No.	2375865-91-9
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin D-5 Stereoisomer; (5R)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin Enantiomeric Impurity D-5; Rosuvastatin Related Compound D-5; (5R)-Rosuvastatin; Rosuvastatin Impurity D5; UNII-Contact for details; Rosuvastatin EP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin D-5 Enantiomer Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and strength. Our quality system is designed to meet the exacting standards of pharmaceutical reference material production. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, chiral purity, residual solvents, and identity confirmation (IR, MS). We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial (USP, EP) guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material in accordance with good laboratory practices to prevent contamination.

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%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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