Description

Technical Parameters

Enalapril Maleate is an oral active angiotensin-converting enzyme inhibitor supplied as a white to off-white crystalline powder. Manufactured via optimized synthetic pathways, it serves as the active pharmaceutical ingredient for solid oral dosage forms targeting hypertension and congestive heart failure management. Production strictly adheres to current Good Manufacturing Practice standards, ensuring consistent physicochemical properties, controlled impurity profiles, and batch-to-batch reproducibility required for large-scale pharmaceutical manufacturing.

Product Specification

Parameter	Specification Data
International Nonproprietary Name	Enalapril Maleate
CAS Number	76095-16-4
Molecular Formula	C₂₄H₂₈N₂O₉
Molecular Weight	492.49 g/mol
Chemical Structure	(2S)-1-[(2S)-2-{[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino}propanoyl]pyrrolidine-2-carboxylic acid, (2Z)-but-2-enedioate
Physical Description	White to off-white crystalline powder
Solubility	Soluble in water, sparingly soluble in ethanol, freely soluble in methanol
Storage Conditions	Store in airtight containers, protected from light and moisture, at controlled room temperature
Shelf Life	36 months from manufacturing date verified via stability studies

Quality and Compliance

Assay	98.5% to 101.0% calculated on an anhydrous basis
Appearance of Solution	Clear and colorless
Identification	Infrared absorption spectrophotometry matching reference standards
Optical Rotation	-41.0° to -45.0° calculated on dried basis
Water Content	Less than or equal to 1.0% determined by Karl Fischer titration
Residue on Ignition	Less than or equal to 0.1%
Heavy Metals	Less than or equal to 10 ppm
Related Substances	Individual impurity less than or equal to 0.1%, total impurities less than or equal to 0.5% by HPLC
Residual Solvents	Compliant with strict international residual solvent limits for ethanol, methanol, and dichloromethane
Particle Size Distribution	d90 < 75 µm with customizable parameters upon request

Manufacturing and Supply Chain

Production Route

Multi-step organic synthesis with continuous in-process analytical monitoring

Facility Standard

Dedicated cleanrooms operating under current Good Manufacturing Practice guidelines

Batch Scale

Commercial-scale production capacity ranging from 100 kg to 500 kg per batch

Supply Capacity

Annual output scaling to multi-metric tons

Lead Time

2 to 4 weeks for standard ex-stock orders; 8 to 12 weeks for scheduled campaign production

Documentation and Regulatory Support

01/

Regulatory Dossier: Drug Master File available for regulatory submission and customer referencing

02/

Certificate of Analysis: Provided with every commercial batch detailing full analytical testing results

03/

Material Safety Data Sheet: Comprehensive safety, handling, and toxicological data documentation

04/

Stability Data: Long-term studies at 25°C with 60% relative humidity and accelerated studies at 40°C with 75% relative humidity

05/

Compliance Statements: Transmissible spongiform encephalopathy free, genetically modified organism free, residual solvent compliance, and genotoxic impurity risk assessment

Packaging and Logistics

Primary Packaging	Food-grade double low-density polyethylene bags, heat-sealed
Secondary Packaging	Moisture-barrier aluminum foil bag for oxygen and humidity protection
Tertiary Packaging	Rigid fiber drum or corrugated cardboard box with tamper-evident seals
Standard Net Weight	25 kg per drum

Pharmaceutical Application

Hypertension Management
Functions as a primary active ingredient in monotherapy or combination formulations to lower systemic vascular resistance and blood pressure. This application relies on precise assay control to ensure accurate dosing in tablet compression processes.

Heart Failure Treatment
Utilized in the formulation of oral medications designed to reduce cardiac workload, decrease ventricular remodeling, and improve survival rates in symptomatic heart failure patients. This application requires strict limit controls on related degradation substances.

Left Ventricular Dysfunction Reduction
Integrated into preventative cardiovascular regimens to slow the progression of health complications following myocardial infarction. This application demands rigorous particle size distribution consistency to achieve predictable dissolution profiles in solid oral dosage forms.

Diabetic Nephropathy Progression Delay
Employed in specialty formulations aimed at reducing renal hyperfiltration and delaying the onset of microalbuminuria in diabetic patient cohorts. This application depends on verified impurity profiles meeting stringent pharmacopeial thresholds.

fAQ

Q: What pharmacopeial standards does this product comply with?

A: The product is manufactured, tested, and released in accordance with current United States Pharmacopeia and European Pharmacopoeia monographs.

Q: Is a Drug Master File accessible for customer filings?

A: Yes, an active Drug Master File is maintained and available for reference authorization to support regulatory submissions in target jurisdictions.

Q: Can the particle size distribution be adjusted for specific direct compression requirements?

A: Yes, milling and micronization parameters can be adjusted during secondary processing to meet specific particle size distribution requirements for distinct formulation technologies.

Q: What are the recommended storage conditions to preserve stability?

A: Store in tightly closed containers in a dry, well-ventilated area away from direct sunlight, maintaining temperatures between 15°C and 25°C.

Q: What analytical methods are transferred for quality verification?

A: Validated high-performance liquid chromatography assay methods, related substance determination procedures, and residual solvent testing protocols are available upon request for quality control transfer.

Hot Tags: enalapril maleate, China enalapril maleate manufacturers, suppliers, factory