Description

Perindopril is a potent, long-acting angiotensin-converting enzyme (ACE) inhibitor widely recognized for its cardiovascular therapeutic applications. This active pharmaceutical ingredient (API) is critical for the formulation of antihypertensive and heart failure medications, offering significant clinical benefits. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in cardiovascular drug production and advanced pharmaceutical research.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the treatment of hypertension (high blood pressure).
• Cardiovascular Drug Formulations: Essential component in medications for chronic heart failure and stable coronary artery disease.
• Combination Therapies: Used in fixed-dose combination drugs, often paired with other antihypertensive agents like indapamide or amlodipine.
• Reference Standard: Serves as a high-purity analytical standard in quality control laboratories for method development and validation.
• Clinical Research: Utilized in preclinical and clinical studies for developing new cardiovascular treatment protocols and generics.
• Generic Drug Manufacturing: Key raw material for producing bioequivalent generic versions of branded perindopril medications.

Basic Information

Product Name	Perindopril
CAS No.	99149-83-4
Molecular Formula	C19H32N2O5•C4H11N
Molecular Weight	441.60 (as tert-butylamine salt)
Synonyms	Perindopril tert-Butylamine; Perindopril Erbumine; S-9490; Acertil; Coversyl; Perindoprilat Ethyl Ester; (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)butyl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid tert-butylamine salt
EINECS	Contact for details

Quality Control

Our Perindopril is manufactured under strict quality management systems, ensuring compliance with major pharmacopoeial standards including USP, EP, and BP. Every batch undergoes comprehensive analytical testing for identity, purity, and potency. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for assay, related substances, residual solvents, and microbiological quality.

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 low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Water (Karl Fischer)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%
Microbiological Quality	Total aerobic microbial count: NMT 1000 cfu/g Total combined yeasts/molds: NMT 100 cfu/g Absence of specified pathogens

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