Description

Oseltamivir Impurity A CAS NO 1364932-19-3 is a specified impurity and a key reference standard used in the quality control of the active pharmaceutical ingredient (API) Oseltamivir Phosphate. Its primary value lies in enabling pharmaceutical manufacturers to ensure the purity, safety, and efficacy of their antiviral drug products through precise analytical testing. This compound is essential for research, development, and quality assurance laboratories in the pharmaceutical industry, particularly those involved in the production and regulatory compliance of neuraminidase inhibitor medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Oseltamivir Phosphate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Oseltamivir batches meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits for this impurity.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Oseltamivir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Oseltamivir Impurity A
CAS No.	1364932-19-3
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 A; Oseltamivir Related Compound A; Tamiflu Impurity A; 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, (3R,4R,5S)-; 1364932-19-3
EINECS	Contact for details

Quality Control

Our Oseltamivir Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This product is light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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