Description

Misoprostol is a synthetic prostaglandin E1 analog with significant therapeutic applications. This active pharmaceutical ingredient (API) is valued for its potent uterotonic and gastric cytoprotective properties, making it a critical component in pharmaceutical manufacturing. It is essential for producers of gynecological, obstetric, and gastrointestinal medications requiring a reliable, high-purity active ingredient. Misoprostol CAS NO 59122-46-2 is supplied under stringent quality control to meet the exacting standards of the global pharmaceutical industry.

Application

Misoprostol is a versatile API with several key medical applications:

• Pharmaceutical Formulations: Primary use as the active ingredient in tablets for the prevention and treatment of NSAID-induced gastric ulcers.
• Obstetrics & Gynecology: Used in medications for labor induction, medical management of miscarriage, and postpartum hemorrhage prevention.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research related to prostaglandin pathways.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for similar uterotonic indications in animals.

Basic Information

Product Name	Misoprostol
CAS No.	59122-46-2
Molecular Formula	C22H38O5
Molecular Weight	382.54 g/mol
Synonyms	(+)-(11α,13E)-11,16-Dihydroxy-16-methyl-9-oxoprost-13-en-1-oic acid methyl ester; SC-29333; Cytotec® (brand name); PGE1 methyl ester analog; Miso; ART-001; U-46,073; (±)-Misoprostol
EINECS	261-625-7

Quality Control

Our Misoprostol is manufactured and tested to meet the highest pharmaceutical standards. Quality assurance protocols are designed to ensure identity, purity, strength, and composition, aligning with ICH Q7 guidelines for active pharmaceutical ingredients. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests including identification, assay, related substances, residual solvents, and microbiological examination. We support compliance with cGMP, FDA, and EMA regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a cool, dry place. Recommended long-term storage temperature is 2-8°C (refrigerated). For short-term or in-use storage, keep at controlled room temperature (15-25°C) in a desiccated environment. Handle under an inert atmosphere if the container is opened for an extended period to minimize degradation.

Specification

Item	Specification
Appearance	White to off-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 ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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