Description

Oseltamivir Ep Impurity E Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the antiviral drug Oseltamivir Phosphate. This compound is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily used by analytical laboratories and pharmaceutical manufacturers involved in method validation, stability studies, and regulatory compliance for Oseltamivir-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Oseltamivir Phosphate active pharmaceutical ingredient (API) and its finished dosage forms.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of Impurity E and establish shelf-life specifications.
• Quality Control & Batch Release: A critical component in the QC testing of Oseltamivir batches to ensure compliance with pharmacopoeial limits (e.g., EP, USP) for related substances.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Research on Degradation Pathways: Used in research to study the degradation chemistry and metabolic pathways of Oseltamivir.

Basic Information

Product Name	Oseltamivir Ep Impurity E Hcl
CAS No.	208720-78-9
Molecular Formula	C16H28N2O4 • HCl
Molecular Weight	356.87 g/mol
Synonyms	(3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, hydrochloride; Oseltamivir Impurity E Hydrochloride; Oseltamivir Related Compound E HCl; Tamiflu Impurity E HCl; 4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester hydrochloride; 5-Amino Oseltamivir Hydrochloride
EINECS	Contact for details

Quality Control

Our Oseltamivir Ep Impurity E Hcl is manufactured under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques including HPLC, NMR, and MS to ensure high purity and structural identity. Certificates of Analysis (COA) are provided, detailing purity, impurities, and analytical results. The material is suitable for use as a reference standard in compliance with ICH 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). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 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.