Description

Pravastatin 1,1,3,3-Tetramethyl Butylamine is a key pharmaceutical intermediate used in the synthesis of pravastatin sodium, a widely prescribed statin medication. This compound matters for its role in creating high-purity active pharmaceutical ingredients (APIs) that meet stringent pharmacopeial standards. It is primarily needed by manufacturers in the pharmaceutical and fine chemical industries engaged in the production of cholesterol-lowering drugs.

Application

• Primary Intermediate for the synthesis of Pravastatin Sodium API.
• Research & Development of new statin-based therapeutics and derivatives.
• Pharmaceutical Manufacturing for producing finished dosage forms under GMP conditions.
• Fine Chemical Synthesis as a building block for complex organic molecules.
• Contract Manufacturing Organizations (CMOs) supplying APIs to global drug companies.
• Analytical Reference Standard for quality control and method validation in laboratories.

Basic Information

Product Name	Pravastatin 1,1,3,3-Tetramethyl Butylamine
CAS No.	151006-14-3
Molecular Formula	C25H43NO5
Molecular Weight	437.62 g/mol
Synonyms	Pravastatin tert-Butylamine; 1,1,3,3-Tetramethylbutylamine Pravastatin Salt; Pravastatin with 2,2,4,4-Tetramethylpentan-1-amine; Pravastatin Amine Salt; SQ-31,000 Amine Salt; (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-Hydroxy-2-methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid compound with 2,2,4,4-tetramethylpentan-1-amine
EINECS	Contact for details

Quality Control

Our Pravastatin 1,1,3,3-Tetramethyl Butylamine is produced under strict quality management systems. We ensure compliance with ICH Q7 guidelines and relevant pharmacopeial standards for pharmaceutical intermediates. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, available upon request to guarantee traceability and consistency for your critical processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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