Description

Peramivir Impurity 7 Hcl 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 key impurity marker. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and impurity profiling. The precise characterization of this impurity is fundamental for meeting stringent pharmacopeial guidelines and ensuring drug efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Peramivir Impurity 7 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure Peramivir batches comply with specified limits (e.g., ICH Q3A/B thresholds).
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Peramivir, supporting process optimization and impurity minimization strategies.

Basic Information

Product Name	Peramivir Impurity 7 Hcl
CAS No.	1352062-19-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 7 Hydrochloride; Peramivir Impurity 7 Hydrochloride Salt; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-[(diaminomethylidene)amino]-2-hydroxycyclopentane-1-carboxylic acid hydrochloride; Peramivir EP Impurity G HCl; Peramivir USP Impurity HCl; Peramivir Degradant 7 HCl
EINECS	Contact for details

Quality Control

Our Peramivir Impurity 7 Hcl is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with relevant specifications. Our quality commitment supports your needs for reliable and traceable materials in regulated environments.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.