Description

Rosuvastatin Methanamine Salt is a key pharmaceutical intermediate and salt form of the widely prescribed statin medication, rosuvastatin. This compound is critical for ensuring the stability, bioavailability, and manufacturability of the final active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers and research organizations engaged in the development and production of cardiovascular therapeutics for cholesterol management.

Application

• Primary Pharmaceutical Intermediate: Serves as a crucial precursor in the synthesis of Rosuvastatin Calcium, the active ingredient in cholesterol-lowering drugs.
• API Development & Research: Used in pharmaceutical R&D for process optimization, formulation studies, and the development of new rosuvastatin-based dosage forms.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for method development and validation.
• Process Chemistry: Integral to scale-up and commercial manufacturing processes under current Good Manufacturing Practice (cGMP) guidelines.

Basic Information

Product Name	Rosuvastatin Methanamine Salt
CAS No.	355805-96-8
Molecular Formula	C₂₅H₃₆FN₃O₆S • CH₅N
Molecular Weight	547.65 g/mol
Synonyms	Rosuvastatin Methylamine Salt; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic Acid Compound with Methanamine; Rosuvastatin Amine Salt; ZD4522 Methanamine Salt; Crestor Intermediate Salt Form
EINECS	Contact for details

Quality Control

Our Rosuvastatin Methanamine Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles. A Certificate of Analysis (COA) detailing results from tests such as HPLC assay, related substances, residual solvents, and identification is provided with every shipment to guarantee traceability and compliance with relevant pharmaceutical standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤1.0%
Heavy Metals	≤20 ppm

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