Description

Oseltamivir Impurity 17 is a designated impurity reference standard used in the pharmaceutical development and quality control of the antiviral drug Oseltamivir Phosphate. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling.

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 and validating sensitive and specific chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Stability Indicating Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Oseltamivir formulations.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure every batch of API meets stringent pharmacopeial specifications for impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify the control strategy.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Oseltamivir, aiding in process optimization.

Basic Information

Product Name	Oseltamivir Impurity 17
CAS No.	1035895-88-5
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 Oseltamivir; Oseltamivir EP Impurity I; Oseltamivir Related Compound I; Oseltamivir Carboxylic Acid Amine Impurity; GS 4071 Amine; Ro 64-0802 Amine
EINECS	Contact for details

Quality Control

Our Oseltamivir Impurity 17 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines and pharmacopeial 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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if necessary for prolonged use.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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