Description

Oseltamivir Impurity 50 CAS NO 651324-06-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiviral drug Oseltamivir Phosphate by serving as a key impurity marker. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference standard for the identification and quantification of Impurity 50 in Oseltamivir Phosphate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other filings to regulatory bodies like the FDA, EMA, and PMDA.
• Research and Development: Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Oseltamivir.
• Pharmacopeial Testing: Acts as a reference material for testing against specifications outlined in the USP, EP, BP, or other international pharmacopeias.

Basic Information

Product Name	Oseltamivir Impurity 50
CAS No.	651324-06-0
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 Impurity K; Oseltamivir Related Compound K; GS 4071 Amine; GS-4071 Amine; (3R,4R,5S)-4-Acetylamino-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 50 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, NMR, and IR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters. We support compliance with cGMP, ICH Q3A/B, and other relevant regulatory 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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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