Description

Prostaglandin E1 Impurity 2 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by serving as a key marker in impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the development and quality control of prostaglandin-based APIs and finished dosage forms.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Alprostadil (Prostaglandin E1) active pharmaceutical ingredients (APIs) and drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, qualifying, and validating chromatographic methods, such as HPLC and UPLC, to ensure regulatory compliance.
• Quality Control & Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and assess drug product stability over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Prostaglandin E1.

Basic Information

Product Name	Prostaglandin E1 Impurity 2
CAS No.	41692-11-9
Molecular Formula	C₂₀H₃₄O₅
Molecular Weight	354.48 g/mol
Synonyms	15(R)-15-Methyl Prostaglandin E1; 15(R)-15-Methyl PGE1; 15-Methylprostaglandin E1; 11α,15α-Dihydroxy-15-methyl-9-oxoprost-13-en-1-oic acid; Alprostadil Impurity; Alprostadil Related Compound; PGE1 Impurity B; PGE1 Related Substance
EINECS	Contact for details

Quality Control

Every batch of Prostaglandin E1 Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment to support your quality and regulatory requirements.

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 hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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