Description

Peramivir Impurity CAS NO 383910-24-5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiviral drug Peramivir. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Peramivir active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurity profiles during drug synthesis and purification.
• Stability Studies: Used in forced degradation and long-term stability studies to understand the degradation pathways of Peramivir and to establish appropriate shelf-life specifications.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure product consistency and compliance with pharmacopeial standards.
• Process Chemistry Research: Aids chemists in optimizing synthesis routes by identifying and tracking the formation of this specific impurity, leading to cleaner and more efficient manufacturing processes.

Basic Information

Product Name	Peramivir Impurity
CAS No.	383910-24-5
Molecular Formula	C15H28N4O4
Molecular Weight	328.41 g/mol
Synonyms	(1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid; Peramivir Related Compound; Peramivir Impurity Standard; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-guanidino-2-hydroxycyclopentane-1-carboxylic acid impurity; BCX-1812 Impurity; RWJ-270201 Impurity
EINECS	Contact for details

Quality Control

Every batch of Peramivir Impurity CAS 383910-24-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, related substances, and residual solvents, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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