Description

Oseltamivir Impurity CAS NO 212504-89-7 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of the antiviral drug Oseltamivir Phosphate by serving as a key marker in impurity profiling and analytical method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, quality control, and compliance testing of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Oseltamivir Phosphate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, qualifying, and validating HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Regulatory Compliance & Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Stability Studies: Acts as a reference point in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Research & Development: Utilized in synthetic chemistry research to study reaction pathways, optimize processes, and minimize the formation of this specific impurity.

Basic Information

Product Name	Oseltamivir Impurity
CAS No.	212504-89-7
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 C; Oseltamivir Related Compound C; 4-Acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid; 5-Amino-4-acetamido-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylic acid; GS 4104 Impurity; Tamiflu Impurity
EINECS	Contact for details

Quality Control

Our Oseltamivir Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided and can be tailored to support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.