Description

Desmopressinepimpurityc CAS NO 160848-60-2 is a high-purity chemical reference standard, specifically identified as an impurity of the peptide hormone Desmopressin. This compound is critical for analytical method development and validation in pharmaceutical quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify this specific impurity in Desmopressin Acetate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure specificity and accuracy.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine QC testing to confirm that Desmopressin batches meet stringent purity specifications as per pharmacopeial guidelines (USP, EP).
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in R&D to study the synthetic pathways, degradation mechanisms, and metabolic pathways related to Desmopressin.

Basic Information

Product Name	Desmopressinepimpurityc
CAS No.	160848-60-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Desmopressin EP Impurity C; Desmopressin Related Compound C; 1-[(4R,7S,10S,13R,16S,19R)-10-(2-Amino-2-oxoethyl)-19-(2-amino-2-oxoethyl)-7-(2-carbamoylethyl)-16-(4-hydroxybenzyl)-13-(1H-imidazol-5-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicos-4-yl]-N-(carbamoylmethyl)-N-methyl-L-prolinamide; Desmopressin Impurity; DDAVP Impurity C
EINECS	Contact for details

Quality Control

Our Desmopressinepimpurityc is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed batch-specific data, supporting compliance with cGMP and relevant pharmacopeial standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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