Description

Rosuvastatin Anhydro Lactone is a key pharmaceutical intermediate in the synthesis of Rosuvastatin, a widely prescribed statin medication. This compound is critical for ensuring the purity, efficacy, and safety of the final active pharmaceutical ingredient (API). It is primarily utilized by manufacturers in the pharmaceutical and fine chemical industries engaged in the research, development, and production of cardiovascular drugs.

Application

• Primary Intermediate in the commercial synthesis of Rosuvastatin Calcium API.
• Reference Standard for analytical method development and quality control in pharmaceutical laboratories.
• Process Impurity Standard for monitoring and controlling related substances during Rosuvastatin API manufacturing.
• Research & Development of novel statin derivatives and new synthetic pathways in academic and industrial settings.
• GMP Manufacturing for the production of finished dosage forms under strict regulatory guidelines.

Basic Information

Product Name	Rosuvastatin Anhydro Lactone
CAS No.	1246665-85-9
Molecular Formula	C22H26FN3O5
Molecular Weight	431.46 g/mol
Synonyms	Rosuvastatin Lactone; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid δ-Lactone; Anhydro Rosuvastatin; Rosuvastatin Impurity C; Rosuvastatin Related Compound C; ZD-4522 Lactone
EINECS	Contact for details

Quality Control

Our Rosuvastatin Anhydro Lactone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to stringent specifications. A detailed Certificate of Analysis (COA) is provided with every shipment, and we can support regulatory filings with relevant documentation.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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