Description

Oseltamivir Ep Impurity B CAS NO 2459182-55-7 is a high-purity reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient, Oseltamivir Phosphate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Method Development and Validation: Crucial for developing and validating analytical procedures for Oseltamivir Phosphate according to ICH guidelines.
• Quality Control (QC) Testing: Used in routine batch release testing of Oseltamivir Phosphate API to monitor and control impurity levels.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data.
• Stability Studies: Employed to track the formation of this impurity during forced degradation and long-term stability studies of drug substances and products.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Oseltamivir Ep Impurity B
CAS No.	2459182-55-7
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 Impurity B; Oseltamivir Related Compound B; Oseltamivir EP Impurity B; Tamiflu Impurity B; GS 4071 Impurity
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.