Description

Isosorbide 5-Mononitrate CAS NO 16051-77-7 is a key organic nitrate ester and a major active metabolite of isosorbide dinitrate. This compound matters as a critical pharmaceutical intermediate and active pharmaceutical ingredient (API) used in the production of cardiovascular medications. It is primarily needed by pharmaceutical manufacturers and research institutions developing treatments for angina pectoris and chronic heart failure, where it acts as a potent vasodilator.

Application

• Pharmaceutical API: Primary use as the active ingredient in anti-anginal and vasodilator medications for treating coronary artery disease.
• Cardiovascular Drug Synthesis: A crucial intermediate in the synthesis of finished dosage forms like extended-release tablets and capsules.
• Clinical Research: Used in pharmacological studies investigating nitrate tolerance, hemodynamics, and new delivery systems.
• Veterinary Medicine: Employed in veterinary cardiology for managing cardiac conditions in animals.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical labs.

Basic Information

Product Name	Isosorbide 5-Mononitrate
CAS No.	16051-77-7
Molecular Formula	C6H9NO6
Molecular Weight	191.14 g/mol
Synonyms	ISMN; 5-ISMN; Isosorbide Mononitrate; 1,4:3,6-Dianhydro-D-glucitol 5-Nitrate; (3R,3aS,6R,6aS)-Hexahydrofuro[3,2-b]furan-3,6-diyl Dinitrate (mixture); 5-Nitratoisosorbide; Monoket (trade name); Imdur (trade name related)
EINECS	240-185-3

Quality Control

Our Isosorbide 5-Mononitrate is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications, including compliance with relevant pharmacopeial monographs (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) documenting identity, purity, and impurity profiles is provided with each batch to ensure full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent 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)
Water (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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