Description

Peramivir Impurity 33 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiviral drug Peramivir by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity standard is essential for maintaining stringent pharmacopeial standards in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Peramivir API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Peramivir meets the stringent purity specifications set by pharmacopeias (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Peramivir under various storage conditions over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes.

Basic Information

Item	Details
Product Name	Peramivir Impurity 33
CAS No.	2758048-78-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 33; Peramivir Impurity 33 (CAS 2758048-78-9); (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid (Potential IUPAC); Peramivir Process Impurity; Peramivir Degradant; Peramivir Specified Impurity; Rapiacta Impurity; BCX-1812 Impurity
EINECS	Contact for details

Quality Control

Every batch of Peramivir Impurity 33 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with the requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment supports compliance with cGMP and relevant ICH guidelines for impurities in new drug substances.

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 inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH limits

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