Description

Misoprostol is a synthetic prostaglandin E1 analog with significant therapeutic activity. This compound is critical for pharmaceutical manufacturing due to its potent uterotonic and gastric cytoprotective properties. It is an essential active pharmaceutical ingredient (API) for manufacturers in the global pharmaceutical industry, particularly for products targeting obstetric, gynecological, and gastrointestinal applications.

Application

• Pharmaceutical API: Primary use as the active ingredient in medications for the prevention and treatment of gastric ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).
• Obstetric & Gynecological Formulations: Key component in drugs used for labor induction, cervical ripening, and the management of postpartum hemorrhage.
• Medical Abortion: Used in combination with mifepristone for early pregnancy termination.
• Research & Development: Serves as a critical reference standard and building block in pharmacological research for prostaglandin-related pathways.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for similar uterotonic purposes in livestock.

Basic Information

Product Name	Misoprostol
CAS No.	54122-46-2
Molecular Formula	C22H38O5
Molecular Weight	382.54 g/mol
Synonyms	SC-29333; Cytotec; (11α,13E)-11,16-Dihydroxy-16-methyl-9-oxoprost-13-en-1-oic acid methyl ester; Miso; PGE1 methyl ester analog; Prostagen E; Artrotec; Angusta; Misodel
EINECS	258-990-5

Quality Control

Our Misoprostol is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards, including USP and EP monographs where applicable. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles to ensure supply reliability and regulatory compliance for our global B2B partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	NMT 1.0%
Related Substances (HPLC)	Total impurities NMT 2.0% Any single impurity NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	+40.0° to +48.0° (c=1 in CHCl3)

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