Description

Oseltamivir Impurity 20 is a designated impurity standard used in the pharmaceutical development and quality control of the antiviral drug 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 analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, validation, and batch release of Oseltamivir and its related formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Oseltamivir Phosphate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor process-related impurities.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory specifications for impurity profiles.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Oseltamivir.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish the safety profile and control strategy for impurities in the drug product.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Oseltamivir synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Oseltamivir Impurity 20
CAS No.	212504-90-0
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-4-acetamido-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid; Oseltamivir Related Compound; Oseltamivir EP Impurity; Oseltamivir Process Impurity; GS 4071 Impurity; Tamiflu Impurity 20
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 20 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated analytical methods, including HPLC, NMR, and MS, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

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%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
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.