Description

Oseltamivir Impurity CAS NO 221386-94-3 is a high-purity reference standard used in the pharmaceutical development and quality control of the antiviral drug Oseltamivir Phosphate. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical component in impurity profiling and stability studies for Oseltamivir Phosphate drug substance and drug products.
• Used in pharmaceutical quality control (QC) laboratories for routine batch release testing against established specifications.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data.
• Essential for pharmacopoeial compliance testing, ensuring adherence to USP, EP, or other international monographs.
• Valuable for research and development into the degradation pathways and metabolism of Oseltamivir.

Basic Information

Product Name	Oseltamivir Impurity
CAS No.	221386-94-3
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 Acid Impurity; Oseltamivir Carboxylate Impurity; GS-4071 Impurity; Tamiflu Impurity; Ro 64-0802 Impurity; 4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of our Oseltamivir Impurity is manufactured and tested under strict quality management systems. The product is characterized using advanced analytical techniques including HPLC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications and support GMP/GLP compliance.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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