Description

Pidotimod Impurity 11 is a specified impurity and reference standard used in the analytical profiling and quality control of the immunomodulatory drug Pidotimod. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Pidotimod-based formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pidotimod Impurity 11 in drug substance and finished product testing.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Pidotimod API.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Pidotimod meets stringent pharmacopeial (e.g., USP, EP) or in-house purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., CMC sections for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to identify and control the formation of this impurity during Pidotimod manufacturing.

Basic Information

Product Name	Pidotimod Impurity 11
CAS No.	325481-51-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S)-3-[(2S)-2-Amino-5-oxo-4,5-dihydro-1,3-oxazol-4-yl]pyrrolidine-2,5-dione; Pidotimod Related Compound; Pidotimod Degradation Product; Pidotimod Process Impurity; (S)-3-((S)-2-Amino-5-oxo-4,5-dihydrooxazol-4-yl)-2,5-pyrrolidinedione; Pidotimod Oxazolidinone Impurity; Pidotimod Impurity B (may vary by pharmacopeia); 325481-51-4
EINECS	Contact for details

Quality Control

Our Pidotimod Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results for identity, purity, and impurities. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place.

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%
Related Substances (HPLC)	Individual unknown 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.