Description

Peramivir Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiviral drug Peramivir by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and regulatory bodies engaged in drug development and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Peramivir drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and track the formation of this impurity in Peramivir formulations under various stress and storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity characterization, degradation pathway studies, and process chemistry optimization during Peramivir synthesis.

Basic Information

Item	Detail
Product Name	Peramivir Impurity 1
CAS No.	1988779-13-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 1; Peramivir Impurity A; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid (Potential IUPAC); Peramivir Process Impurity; BCX-1812 Impurity; RWJ-270201 Impurity
EINECS	Contact for details

Quality Control

Every batch of Peramivir Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, test methods, and results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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