Description

Oseltamivir Diastereomer Iii Hcl is a key chiral intermediate and impurity reference standard used in the synthesis and quality control of the antiviral drug oseltamivir phosphate. This compound is critical for ensuring the stereochemical purity and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical R&D laboratories, quality control units, and manufacturers specializing in antiviral and neuraminidase inhibitor production.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and control related substances in oseltamivir phosphate API and finished dosage forms.
• Process Chemistry & R&D: Serves as a critical intermediate in route scouting and process optimization for the stereoselective synthesis of oseltamivir and its analogs.
• Quality Assurance/Control (QA/QC): Essential for method development, validation, and routine batch release testing to comply with ICH guidelines and pharmacopeial monographs (USP, EP).
• Regulatory Compliance: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized material for impurity profiling and stability studies.
• Academic & Contract Research: Utilized in universities and CROs for pharmacological studies and research into influenza virus mechanisms and resistance.

Basic Information

Product Name	Oseltamivir Diastereomer Iii Hcl
CAS No.	2413185-95-0
Molecular Formula	C16H29N2O4•HCl
Molecular Weight	356.88 g/mol (as HCl salt)
Synonyms	(3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, hydrochloride; Oseltamivir Diastereomer III Hydrochloride; Oseltamivir EP Impurity C HCl; Oseltamivir Related Compound C HCl; (3R,4R,5S)-4-Acetamido-5-amino-3-pentoxy-1-cyclohexene-1-carboxylic acid ethyl ester hydrochloride; GS 4104 Diastereomer III HCl; Tamiflu Impurity C HCl
EINECS	Contact for details

Quality Control

Our Oseltamivir Diastereomer Iii Hcl is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity assay and impurity profiling by HPLC, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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 (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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