Description

Enalapril Maleate CAS NO 76095-16-4 is the maleate salt form of enalapril, a widely used angiotensin-converting enzyme (ACE) inhibitor. This active pharmaceutical ingredient (API) is critical for the formulation of antihypertensive and heart failure medications, offering reliable therapeutic efficacy. It is primarily required by pharmaceutical manufacturers and research institutions engaged in cardiovascular drug development and production.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the treatment of hypertension (high blood pressure).
• Cardiovascular Therapeutics: Formulation of medications for congestive heart failure and left ventricular dysfunction.
• Generic Drug Manufacturing: Sourcing for the production of generic enalapril maleate tablets and other solid oral dosage forms.
• Clinical Research: Utilization in preclinical and clinical studies for cardiovascular disease research.
• Reference Standard: Serves as a chemical reference standard in analytical laboratories for quality control and method validation.
• Veterinary Medicine: Potential application in veterinary pharmaceuticals for managing hypertension in animals.

Basic Information

Product Name	Enalapril Maleate
CAS No.	76095-16-4
Molecular Formula	C20H28N2O5 • C4H4O4
Molecular Weight	492.52 g/mol
Synonyms	Enalapril Hydrogen Maleate; MK-421 Maleate; (S)-1-[N-[1-(Ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline Maleate (1:1); Vasotec® API; Renitec® API; Enalaprilum Maleas; Enalapril Maleate Salt; Enalapril Acid Maleate
EINECS	Contact for details

Quality Control

Our Enalapril Maleate is manufactured under strict quality management systems. The product undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, with specifications typically aligned with major pharmacopoeias such as USP and EP. A comprehensive Certificate of Analysis (COA) documenting identity, purity, and impurity profiles is provided with each batch to ensure full traceability and compliance.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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