Description

Oxiracetam Related Substance Isf3886 is a high-purity chemical reference standard and a key impurity identified in the synthesis and quality control of Oxiracetam. This compound is essential for pharmaceutical research and development, serving as a critical marker for ensuring the purity, safety, and efficacy of the final nootropic drug product. It is primarily required by analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and fine chemical industries for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Oxiracetam active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity profiles, ensuring compliance with pharmacopeial standards (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Process Chemistry & Optimization: Helps chemists identify and minimize the formation of this specific by-product during the synthesis and scale-up of Oxiracetam.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Oxiracetam Related Substance Isf3886
CAS No.	120428-80-0
Molecular Formula	C6H10N2O3
Molecular Weight	158.16 g/mol
Synonyms	4-Hydroxy-2-oxo-1-pyrrolidineacetamide; ISF 3886; Oxiracetam Impurity; Oxiracetam Related Compound; 1-(2-Amino-2-oxoethyl)-4-hydroxy-2-pyrrolidinone; 4-Hydroxy-2-oxo-1-pyrrolidineacetic acid amide; (4-Hydroxy-2-oxopyrrolidin-1-yl)acetamide
EINECS	Contact for details

Quality Control

Every batch of Oxiracetam Related Substance Isf3886 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with industry and regulatory standards for reference materials. Comprehensive Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results.

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 dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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