Description

Peramivir Impurity 30 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antiviral drug Peramivir by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing. The material is supplied with comprehensive analytical data to support method validation and regulatory filings.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Peramivir drug substance and drug products.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Peramivir API.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides essential impurity characterization data required for regulatory dossiers submitted to agencies like the FDA, EMA, and PMDA.
• Research and Development: Supports impurity profiling and route scouting during the synthetic process development of Peramivir.

Basic Information

Product Name	Peramivir Impurity 30
CAS No.	2758048-79-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 30; Peramivir EP Impurity 30; Peramivir USP Impurity 30; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid (Potential Structure); Peramivir Process Impurity; Peramivir Degradant; Zanamivir Impurity (Structural Analog)
EINECS	Contact for details

Quality Control

Our Peramivir Impurity 30 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (NMR, MS, IR), purity determination by HPLC, and control of specific impurities. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in pharmaceutical applications requiring high data integrity.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.