Description

Clevidipine Butyrate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the synthesis of the ultra-short-acting calcium channel blocker, clevidipine. This compound is critical for the production of injectable antihypertensive medications designed for acute blood pressure control in clinical settings. It is essential for pharmaceutical manufacturers and research institutions developing or producing fast-acting cardiovascular therapies, where precise chemical structure and high purity are non-negotiable for efficacy and safety.

Application

• Primary Pharmaceutical Ingredient: Key intermediate in the synthesis of the API Clevidipine, an intravenous antihypertensive agent.
• Cardiovascular Drug Manufacturing: Used in the production of medications for the rapid control of severe hypertension, particularly during and after surgery.
• Research & Development: Serves as a critical reference standard and building block in pharmacological research for new calcium channel blockers.
• Generic Drug Formulation: Essential for companies developing generic versions of clevidipine-based injectable products.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) specializing in sterile injectable formulations.

Basic Information

Product Name	Clevidipine Butyrate
CAS No.	167221-71-8
Molecular Formula	C21H23Cl2NO6
Molecular Weight	456.32 g/mol
Synonyms	Butanoic acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic acid 3-methyl 5-(1-oxobutoxy) methyl ester; Clevidipine Butanoate; Clevidipine Butyrate Ester; H 324/38; (RS)-Clevidipine Butyrate; 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid 3-methyl 5-(butyryloxy)methyl ester
EINECS	Contact for details

Quality Control

Our Clevidipine Butyrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and identification by IR and 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, purity, and consistency for your critical manufacturing processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single 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.