Description

Lomitapide is a small molecule inhibitor of microsomal triglyceride transfer protein (MTP) used as a key active pharmaceutical ingredient (API). This compound is critical for the development and production of specialized lipid-lowering medications. It is primarily required by pharmaceutical manufacturers and research institutions focused on metabolic disorders and cardiovascular disease.

Application

• Active Pharmaceutical Ingredient (API) in the manufacture of prescription medications for homozygous familial hypercholesterolemia (HoFH).
• Reference standard for analytical method development and validation in quality control laboratories.
• Key intermediate in advanced pharmaceutical research for novel lipid metabolism therapies.
• Biochemical research tool for studying microsomal triglyceride transfer protein (MTP) function and inhibition.
• Process development and scale-up activities within contract development and manufacturing organizations (CDMOs).
• Formulation studies for oral dosage forms such as capsules and tablets.

Basic Information

Product Name	Lomitapide
CAS No.	182431-12-5
Molecular Formula	C39H37F6N3O5
Molecular Weight	741.73 g/mol
Synonyms	N-(2,2,2-Trifluoroethyl)-9-[4-[4-[[[4'-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide; BMS-201038; AEGR-733; Lojuxta; Juxtapid
EINECS	Contact for details

Quality Control

Our Lomitapide 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, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) are provided with each shipment, detailing compliance with relevant internal and customer-specific specifications.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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