Description

Oseltamivir Impurity 15 is a designated impurity standard used in the quality control and analytical profiling of the antiviral active pharmaceutical ingredient (API) Oseltamivir Phosphate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Oseltamivir Phosphate API and its formulations.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Stability Studies: Used to monitor the formation and growth of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and justify specification limits.
• Quality Control Testing: Employed in routine batch release testing of Oseltamivir API to ensure it meets the stringent purity requirements of pharmacopeial standards (USP, EP).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Oseltamivir by identifying and controlling process-related impurities.

Basic Information

Product Name	Oseltamivir Impurity 15
CAS No.	187226-83-1
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; 5-Amino-oseltamivir; Oseltamivir EP Impurity G; Oseltamivir Related Compound G; Oseltamivir Carboxylic Acid Impurity; Tamiflu Impurity 15; 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, (3R,4R,5S)-
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 15 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified criteria.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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