Description

Dinoprostone Ep Impurity E is a high-purity reference standard critical for the analytical profiling and quality control of pharmaceutical active ingredients. This compound serves as a specified impurity in the synthesis and purification of Dinoprostone (Prostaglandin E2), a key pharmaceutical agent. It is essential for research and development laboratories, quality assurance units, and regulatory affairs departments within the global pharmaceutical and biotechnology sectors to ensure product safety and compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of process-related impurities in Dinoprostone API batches.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods in compliance with ICH Q2(R1) and Q3A/B guidelines.
• Quality Control & Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity profiles and ensure the stability of the final drug substance.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate control of the manufacturing process.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Dinoprostone Ep Impurity E
CAS No.	71431-28-2
Molecular Formula	C₂₀H₃₂O₅
Molecular Weight	352.47 g/mol
Synonyms	Prostaglandin E2 Impurity E; (5Z,13E)-(9S,11R,15S)-9,11,15-Trihydroxyprosta-5,13-dien-1-oic acid; 11-Deoxy-15-dehydro Prostaglandin E2; PGE2 Ep Impurity E; Dinoprostone Related Compound E; Prosta-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9S,11R,13E,15S)-; PGE2 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Dinoprostone Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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