Description

Oseltamivir Impurity 17 is a designated impurity reference standard used in the analytical profiling and quality control of the antiviral drug Oseltamivir Phosphate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for method development, validation, and stability studies in the production of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Oseltamivir Phosphate API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to accurately identify and quantify this specific impurity.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor the formation of Impurity 17 under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Employed in synthetic route optimization and process chemistry research to understand and control impurity formation during API synthesis.
• Pharmacopoeial Testing: Used to verify compliance with impurity limits specified in pharmacopoeial monographs (e.g., USP, EP, BP).

Basic Information

Product Name	Oseltamivir Impurity 17
CAS No.	2413185-88-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Oseltamivir Related Compound 17; Oseltamivir EP Impurity 17; Oseltamivir USP Impurity 17; Tamiflu Impurity 17; (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid impurity; GS 4104 Impurity; 5-Amino-3-(1-ethylpropoxy)-4-(acetylamino)-1-cyclohexene-1-carboxylic acid related substance
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 17 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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