Description

Oseltamivir Impurity D CAS NO 1346604-18-9 is a specified impurity of the antiviral drug Oseltamivir Phosphate, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Oseltamivir Impurity D in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC) or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Oseltamivir formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development (R&D): Supports process chemistry research to understand and minimize impurity formation during the synthesis of Oseltamivir Phosphate.

Basic Information

Product Name	Oseltamivir Impurity D
CAS No.	1346604-18-9
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 D; Oseltamivir Related Compound D; Tamiflu Impurity D; 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, (3R,4R,5S)-; 1346604-18-9
EINECS	Contact for details

Quality Control

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

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.