Description

Iopromide Impurity 44 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the pharmaceutical agent Iopromide, a widely used non-ionic, low-osmolar contrast medium. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in the production of injectable contrast media.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Iopromide Impurity 44 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development and Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection in Iopromide.
• Stability Studies and Forced Degradation: Employed as a marker to monitor the formation of specific degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Essential for routine quality control testing to ensure Iopromide batches meet pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive proof of impurity identity and supporting the establishment of acceptable limits.
• Research on Metabolic Pathways: Can be used in research settings to study the metabolism and pharmacokinetics of Iopromide and related compounds.

Basic Information

Product Name	Iopromide Impurity 44
CAS No.	2756222-41-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iopromide Related Compound 44; Iopromide EP Impurity C; Iopromide USP Impurity; 5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide Impurity; 1-N,3-N-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[methyl(2,3-dihydroxypropyl)carbamoyl]isophthalamide Impurity; Ultravist Impurity 44; Ioversol Impurity Analog
EINECS	Contact for details

Quality Control

Our Iopromide Impurity 44 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents and moisture content. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and expiration dates. Our quality commitment ensures the material is suitable for use as a reference standard in GMP/GLP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.