Description

Oseltamivir Mono Hydrochloride is the active pharmaceutical ingredient (API) form of the antiviral prodrug oseltamivir. This high-purity compound is the critical intermediate for the synthesis of the final drug product, Tamiflu®, a cornerstone in the global defense against influenza viruses. It is essential for pharmaceutical manufacturers and research institutions developing antiviral therapies, particularly for the treatment and prophylaxis of influenza A and B.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use as the key intermediate in the commercial manufacturing of the antiviral drug Oseltamivir Phosphate (Tamiflu®).
• Antiviral Drug Formulation: Direct incorporation into solid dosage forms (e.g., capsules, tablets) following final salt conversion, under strict Good Manufacturing Practice (GMP) conditions.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material for developing new influenza treatment protocols, combination therapies, and dosage forms.
• Generic Drug Manufacturing: Essential for producers of generic antiviral medications, ensuring a reliable supply chain for cost-effective influenza treatments.
• Biochemical Research: Used in virology and pharmacology studies to investigate neuraminidase inhibition mechanisms and influenza virus resistance patterns.
• Strategic Stockpiling: Supplied for government and institutional pandemic preparedness programs to build reserves of antiviral raw materials.

Basic Information

Product Name	Oseltamivir Mono Hydrochloride
CAS No.	204255-09-4
Molecular Formula	C16H29ClN2O4
Molecular Weight	348.87 g/mol
Synonyms	(3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, hydrochloride; GS 4104; Oseltamivir HCl; Ro 64-0796/002; Tamiflu® Intermediate; Ethyl (3R,4R,5S)-5-amino-4-acetamido-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate hydrochloride
EINECS	Contact for details

Quality Control

Our Oseltamivir Mono Hydrochloride is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols are designed to ensure batch-to-batch consistency, high purity, and compliance with relevant pharmacopeial guidelines (e.g., USP, EP) for API intermediates. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results for identity, assay, purity, and specified impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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