Description

Rosuvastatin D-5 Diastereomer Impurity is a critical chiral impurity used in the analytical profiling and quality control of Rosuvastatin, a widely prescribed statin medication. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference standard for method development and validation. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory compliance to meet stringent pharmacopeial requirements for impurity identification and quantification.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the D-5 diastereomer impurity in Rosuvastatin API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS method development and validation to establish specificity, accuracy, and detection limits for this specific stereoisomeric impurity.
• Quality Control & Assurance: Critical for routine batch testing in QC laboratories to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity profiles over the shelf-life of the drug product.
• Process Chemistry R&D: Used by chemists to optimize synthetic pathways and purification processes to minimize the formation of this diastereomeric impurity.

Basic Information

Product Name	Rosuvastatin D-5 Diastereomer Impurity
CAS No.	1025085-36-2
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	(3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid D-5 Diastereomer; Rosuvastatin Diastereomer D-5; Rosuvastatin Impurity D-5; (5R)-Rosuvastatin; Rosuvastatin EP Impurity D; Rosuvastatin USP Impurity D5; (3R,5S)-Rosuvastatin D-5 Isomer; ZD4522 D-5 Diastereomer
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin D-5 Diastereomer Impurity is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Our products are supplied with a detailed Certificate of Analysis (COA) that includes data from orthogonal techniques such as HPLC for purity, NMR and MS for structural confirmation, and chiral methods for stereochemical purity. We support compliance with ICH, USP, and EP guidelines, and specifications can be aligned with your specific pharmacopeial or internal method requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
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.