Description

Pidotimod Impurity E 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 pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent regulatory guidelines. It is primarily utilized in research and development, method validation, and as a critical component in the stability studies and batch release testing of Pidotimod active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Pidotimod Impurity E in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurities.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Pidotimod API and formulations meet specified impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Pidotimod to minimize the formation of this impurity.

Basic Information

Product Name	Pidotimod Impurity E
CAS No.	162148-16-5
Molecular Formula	C9H12N2O4S
Molecular Weight	244.27 g/mol
Synonyms	(4R)-3-[(2S)-2-Amino-2-carboxyethyl]-1,3-thiazolidine-4-carboxylic acid; (R)-3-[(S)-2-Amino-2-carboxyethyl]thiazolidine-4-carboxylic acid; L-Cysteinyl-L-thiazolidine-4-carboxylic acid derivative; Pidotimod Related Compound E; Pidotimod Degradant E
EINECS	Contact for details

Quality Control

Every batch of Pidotimod Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques, including HPLC, MS, and NMR, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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