Description

Prostaglandin E1 Impurity 4 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of impurities in Alprostadil (Prostaglandin E1) drug substances and finished products, ensuring product safety and regulatory compliance. It is primarily used by analytical laboratories, quality control units, and R&D scientists in the pharmaceutical and biotechnology industries engaged in method development and validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Alprostadil (Prostaglandin E1) APIs and formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish and validate chromatographic methods for impurity profiling and quantification.
• Quality Control & Assurance: Critical for routine batch testing to monitor impurity levels and ensure drug product specifications are met.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability testing of Prostaglandin E1 products.
• Research on Prostaglandin Pathways: Useful as a tool compound in biochemical research to study prostaglandin metabolism, synthesis, and related biological activities.

Basic Information

Product Name	Prostaglandin E1 Impurity 4
CAS No.	217182-28-0
Molecular Formula	C₂₀H₃₄O₅
Molecular Weight	354.48 g/mol
Synonyms	PGE1 Impurity 4; Alprostadil Impurity 4; 11-Deoxy-15-dehydro Prostaglandin E1; 15-Dehydro-11-deoxy Prostaglandin E1; (5Z)-7-[(1R,2R,3R)-3-Hydroxy-2-[(1E,3S)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl]hept-5-enoic Acid; Prostaglandin E1 Related Compound D
EINECS	Contact for details

Quality Control

Our Prostaglandin E1 Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every 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. This material is light-sensitive (store away from light) and easily oxidized (store under inert atmosphere). For long-term storage, consider storing under an inert atmosphere (e.g., argon or nitrogen) at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.