Description

Pidotimod Impurity C is a specified impurity and reference standard used in the analytical profiling of the immunomodulatory drug Pidotimod. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the purity and safety of the final active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, research institutions, and manufacturers involved in the development, production, and quality assurance of Pidotimod and related pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pidotimod Impurity C in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Pidotimod Impurity C
CAS No.	162148-17-6
Molecular Formula	C9H12N2O4S
Molecular Weight	244.27 g/mol
Synonyms	(4R)-3-[(2S)-2-Amino-5-oxo-5-(propylamino)pentanoyl]-4-thiazolidinecarboxylic Acid; (R)-3-((S)-2-Amino-5-oxo-5-(propylamino)pentanoyl)-4-thiazolidinecarboxylic Acid; Pidotimod Related Compound C; Pidotimod EP Impurity C; Pidotimod USP Impurity C; Pidotimod Degradation Product; Pidotimod Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pidotimod Impurity C is manufactured and controlled under a strict quality management system. The product 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 provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive (store away from light). Keep the container tightly sealed in a dry environment 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.