Description

Misoprostol Ep Impurity D is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the production and regulatory compliance of Misoprostol-based medications.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies of Misoprostol API.
• Used for quality control (QC) testing to ensure batch-to-batch consistency and compliance with pharmacopeial monographs (e.g., USP, EP).
• Essential for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control.
• Supports research and development (R&D) activities in process chemistry and formulation optimization.
• Utilized in contract laboratory services for third-party testing and certification.

Basic Information

Product Name	Misoprostol Ep Impurity D
CAS No.	1788085-79-9
Molecular Formula	C22H38O5
Molecular Weight	382.54 g/mol
Synonyms	Misoprostol EP Impurity D; Misoprostol Impurity D; 11-Deoxy-16-hydroxy-16-methyl-9-oxoprost-13-en-1-oic acid methyl ester; (11R,13E)-11,16-Dihydroxy-16-methyl-9-oxoprost-13-en-1-oic acid methyl ester; PGE1 analogue impurity; Misoprostol Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Misoprostol Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity, purity, and impurity profile verification via advanced chromatographic and spectroscopic techniques. Certificates of Analysis (COA) with detailed chromatograms and spectral data are available upon request to support your regulatory and quality assurance needs.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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