Description

Atorvastatin Methanamine Salt CAS NO 908852-19-7 is a key pharmaceutical intermediate, specifically a salt form of the active pharmaceutical ingredient (API) Atorvastatin. This compound is critical for enhancing the stability, solubility, and bioavailability of the final drug product, ensuring consistent therapeutic performance. It is primarily required by manufacturers in the pharmaceutical industry for the production of cholesterol-lowering medications (statins).

Application

• Active Pharmaceutical Ingredient (API) Synthesis: A crucial intermediate in the manufacturing process of Atorvastatin calcium, the active component in leading statin medications.
• Pharmaceutical Formulation Development: Used in pre-formulation studies to improve drug solubility and stability profiles for solid dosage forms like tablets.
• Research & Development: Serves as a reference standard and building block in medicinal chemistry research for developing new cardiovascular therapies.
• Process Chemistry & Scale-up: Employed in pilot plants and commercial-scale production to ensure robust and reproducible manufacturing of the final API.
• Quality Control Laboratories: Used as a high-purity analytical standard for method development and impurity profiling in pharmaceutical QC.

Basic Information

Product Name	Atorvastatin Methanamine Salt
CAS No.	908852-19-7
Molecular Formula	C₃₃H₃₅FN₂O₅ • CH₅N
Molecular Weight	Approx. 583.66 g/mol (as free base equivalent)
Synonyms	Atorvastatin Methylamine Salt; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid compound with methanamine; Atorvastatin N-Methylamine Salt; Atorvastatin Amine Salt; Lipitor Intermediate; CI-981 Amine Salt
EINECS	Contact for details

Quality Control

Our Atorvastatin Methanamine Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods (IR, NMR), to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to 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.