Description

Oseltamivir Impurity 15 is a designated impurity reference standard used in the analytical profiling and quality control of the antiviral pharmaceutical, Oseltamivir Phosphate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of antiviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Oseltamivir Impurity 15 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS/MS.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with stringent pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during the synthesis of Oseltamivir.

Basic Information

Product Name	Oseltamivir Impurity 15
CAS No.	2254819-34-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oseltamivir Related Compound 15; Oseltamivir EP Impurity 15; Oseltamivir USP Impurity 15; (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester impurity; Tamiflu Impurity 15; GS 4104 Impurity 15
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 atmosphere or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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