Description

Oseltamivir Impurity 48 is a designated impurity standard used in the analytical profiling and quality control 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 methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines (USP, EP) and regulatory filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Oseltamivir Impurity 48 in Oseltamivir API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Oseltamivir Phosphate.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Supports R&D efforts in process chemistry to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Oseltamivir Impurity 48
CAS No.	651324-04-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid; Oseltamivir Carboxylic Acid Impurity; Oseltamivir Related Compound 48; GS 4071 Impurity; Tamiflu Impurity 48; 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, (3R,4R,5S)-
EINECS	Contact for details

Quality Control

Our Oseltamivir Impurity 48 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and suitability for use as a reference standard. Each batch is characterized using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support our clients' regulatory needs with full traceability and documentation.

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. The container should be kept tightly sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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