Description

Oseltamivir Ep Impurity A CAS NO 1391047-93-0 is a high-purity reference standard critical for the analytical profiling and quality control of the antiviral drug Oseltamivir Phosphate. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and control this specific impurity, ensuring drug safety and compliance with stringent pharmacopeial guidelines. It is primarily used in the development, validation, and routine testing of Oseltamivir active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a certified reference standard for impurity identification and quantification in Oseltamivir Phosphate API.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for pharmaceutical quality control laboratories.
• Used in stability studies to monitor impurity profiles of Oseltamivir drug substances and products over time.
• Essential for regulatory compliance and filing, supporting submissions to agencies like the FDA, EMA, and PMDA.
• Valuable research tool for studying the degradation pathways and metabolism of Oseltamivir.
• Supports pharmacopeial testing to meet specifications outlined in USP, EP, and other international monographs.

Basic Information

Product Name	Oseltamivir Ep Impurity A
CAS No.	1391047-93-0
Molecular Formula	C16H28N2O4
Molecular Weight	312.41 g/mol
Synonyms	(3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic Acid; Oseltamivir Impurity A; Oseltamivir Related Compound A; Tamiflu Impurity A; 5-Amino-4-acetamido-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic Acid; GS 4071 Impurity A; EP Impurity A of Oseltamivir
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Ep Impurity A 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 conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and pharmacopeial requirements (USP, EP).

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 inert conditions or in a desiccator to maintain stability and purity.

Specification

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

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