Description

Peramivir Impurity 31 is a designated impurity standard used in the analytical profiling and quality control of the antiviral drug Peramivir. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Peramivir and related antiviral medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Peramivir Impurity 31 in Peramivir API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Peramivir.

Basic Information

Product Name	Peramivir Impurity 31
CAS No.	2758048-80-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Peramivir Related Compound 31; Peramivir EP Impurity 31; Peramivir USP Impurity 31; (1S,2S,3R,4R)-3-[(1S)-1-Acetamido-2-ethylbutyl]-4-(diaminomethylideneamino)-2-hydroxycyclopentane-1-carboxylic acid (Potential IUPAC); Peramivir Degradation Product; Peramivir Process Impurity.
EINECS	Contact for details

Quality Control

Our Peramivir Impurity 31 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, identity, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Residue on Ignition	≤ 0.5%

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