Description

Pidotimod Impurity 37 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the immunomodulatory drug Pidotimod. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

This impurity standard is utilized in various critical quality control and research applications, including:

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• HPLC/LC-MS Calibration: For the precise quantification of Pidotimod Impurity 37 in active pharmaceutical ingredient (API) and finished drug product batches.
• Stability Studies: Monitoring the formation and levels of this specific impurity under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Providing essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Process Chemistry Optimization: Identifying and minimizing the source of this impurity during the synthesis and purification of Pidotimod.
• Quality Control Testing: Routine testing in QC laboratories to ensure every batch of Pidotimod API meets the strict impurity limits set by pharmacopeial standards.

Basic Information

Product Name	Pidotimod Impurity 37
CAS No.	2165766-24-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pidotimod Related Compound 37; Pidotimod EP Impurity G; Pidotimod Process Impurity; (4R)-3-[(2S)-2-[[(4R)-2-oxo-1,3-thiazolidine-4-carbonyl]amino]propanoyl]-2-oxo-1,3-thiazolidine-4-carboxylic acid (potential IUPAC); Pidotimod Degradant; Pidotimod Specified Impurity
EINECS	Contact for details

Quality Control

Our Pidotimod Impurity 37 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure identity, purity, and stability conform to the highest standards for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory compliance.

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 solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH Q3C

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