Description

Peramivir Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the antiviral drug Peramivir. This high-purity reference material is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and analytical chemistry for method validation and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Peramivir drug substance and finished products.
• Method Development and Validation: Essential for developing, validating, and transferring analytical methods, particularly HPLC and LC-MS, in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor and control the level of this specific impurity, ensuring it remains within specified safety limits.
• Stability Studies: Employed to identify and quantify degradation products that may form during the stability testing of Peramivir formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to optimize purification processes.

Basic Information

Product Name	Peramivir Impurity 13
CAS No.	2641684-79-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 13; Peramivir EP Impurity 13; Peramivir USP Impurity 13; (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
EINECS	Contact for details

Quality Control

Every batch of Peramivir Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.