Description

Prostaglandin E1 Impurity 4 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Alprostadil (PGE1) in pharmaceutical development and manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and research institutions working in the pharmaceutical and biotechnology sectors to ensure product purity and safety.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Alprostadil (PGE1) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for prostaglandin analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (thermal, photolytic, oxidative) as part of drug stability testing programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Facilitates metabolic and pharmacokinetic studies related to prostaglandin E1, aiding in the understanding of degradation pathways.

Basic Information

Product Name	Prostaglandin E1 Impurity 4
CAS No.	21003-46-3
Molecular Formula	C20H34O5
Molecular Weight	354.48 g/mol
Synonyms	11-Deoxy-13,14-dihydro-15-keto Prostaglandin E1; 15-Keto-13,14-dihydro-11-deoxy PGE1; 11-Deoxy-13,14-dihydro-15-oxo-prostaglandin E1; PGE1 Impurity D; Alprostadil Related Compound D; (5Z)-7-[(1R,2R,3R)-3-Hydroxy-2-[(1E,3S)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl]hept-5-enoic Acid
EINECS	Contact for details

Quality Control

Every batch of Prostaglandin E1 Impurity 4 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity and chromatographic purity.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere (e.g., argon or nitrogen) to minimize oxidation. For long-term storage, desiccate to protect against moisture. Allow the sealed vial to equilibrate to room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
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.