Description

Oseltamivir Impurity CAS NO 227600-02-4 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Oseltamivir Phosphate. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of antiviral medications. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Oseltamivir API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating 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) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of drug products.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Oseltamivir Impurity
CAS No.	227600-02-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oseltamivir Related Compound; Oseltamivir Impurity Standard; Tamiflu Impurity; (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester impurity; GS 4071 Impurity; Ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate; 227600-02-4; Oseltamivir EP Impurity
EINECS	Contact for details

Quality Control

Our Oseltamivir Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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