Description

Peramivir Impurity 6 is a specified impurity and degradation product of the antiviral drug Peramivir. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Peramivir drug substances and products. The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements in drug development and manufacturing.

Application

• Primary use as a certified reference standard for the identification and quantification of Peramivir Impurity 6 in Peramivir active pharmaceutical ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (HPLC, LC-MS) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Essential for stability studies to monitor impurity formation and establish degradation pathways of Peramivir under various stress conditions.
• Used in pharmaceutical research to study the chemical and metabolic behavior of Peramivir-related substances.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Employed in quality control laboratories for routine batch release testing and specification setting for Peramivir API.

Basic Information

Product Name	Peramivir Impurity 6
CAS No.	2124296-37-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 6; Peramivir EP Impurity 6; Peramivir USP Impurity 6; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid (Potential IUPAC); Peramivir Degradation Product; Peramivir Process Impurity; Zanamivir Impurity (Structural Analog); Influenza Neuraminidase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Peramivir Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 dry conditions. For long-term storage, consider storing under an inert atmosphere or with desiccant to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
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.