Description

Misoprostol is a synthetic prostaglandin E1 analog with significant pharmacological activity. This compound is critical for its potent uterotonic and gastric cytoprotective effects, making it a key active pharmaceutical ingredient (API) in therapeutic formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of medications for 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 Therapeutics: Used in formulations for labor induction, cervical ripening, and the medical management of early pregnancy loss.
• Research & Development: Serves as a critical reference standard and biochemical tool in pharmacological and reproductive health research.
• Drug Formulation: Incorporated into various dosage forms, including oral tablets and vaginal suppositories, requiring high-purity active ingredients.
• Regulatory Compliance: Supports the production of generic and branded drugs requiring adherence to strict pharmacopoeial standards (e.g., USP, EP).

Basic Information

Product Name	Misoprostol
CAS No.	103601-27-0
Molecular Formula	C22H38O5
Molecular Weight	382.54 g/mol
Synonyms	(±)-Misoprostol; SC-29333; Cytotec® (Brand Name); 11,16-Dihydroxy-16-methyl-9-oxoprost-13-en-1-oic acid methyl ester; 15-Deoxy-16-hydroxy-16-methyl-9-oxoprostaglandin E1 methyl ester; Miso; PGE1 analog
EINECS	Contact for details

Quality Control

Our Misoprostol is manufactured and tested to meet the stringent requirements for pharmaceutical active ingredients. Quality assurance protocols are designed to ensure batch-to-batch consistency, high purity, and compliance with relevant pharmacopoeial monographs. Certificates of Analysis (COA) documenting identity, purity, and impurity profiles are provided with each shipment to support your regulatory and formulation needs.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen) at a controlled room temperature of 15-25°C (59-77°F) to minimize oxidation and degradation. The container should be kept in a cool, dry, and well-ventilated area separate from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to 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

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