Description

Oseltamivir Impurity 23 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiviral drug Oseltamivir Phosphate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and contract testing laboratories focused on antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Oseltamivir Impurity 23 in active pharmaceutical ingredient (API) and finished drug product testing.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling of Oseltamivir Phosphate.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug approval and lifecycle management.
• Research and Development: Aids in understanding the degradation pathways and chemical behavior of Oseltamivir during synthesis and formulation processes.

Basic Information

Product Name	Oseltamivir Impurity 23
CAS No.	2241125-39-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tamiflu Impurity 23; Oseltamivir Related Compound 23; (3R,4R,5S)-4-Acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic Acid Impurity; 5-Amino Oseltamivir Impurity; GS 4071 Impurity; RO 64-0796/002 Impurity
EINECS	Contact for details

Quality Control

Every batch of Oseltamivir Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.