Description

Ioversol Related Compound B (50 Mg) (N,N'-Bis(2,3-Dihydroxypropyl)-5-[(n-(2-Hydroxyethyl)-Carbamoyl)Methoxy]-2,4,6-Triiodoisophthalamide) is a high-purity analytical reference standard, critical for ensuring the quality and safety of pharmaceutical products. This compound serves as a specified impurity or degradation product of the iodinated contrast agent Ioversol, making it essential for rigorous quality control and regulatory compliance in drug manufacturing. It is primarily used by analytical laboratories, pharmaceutical R&D teams, and quality assurance departments for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ioversol Active Pharmaceutical Ingredient (API) and finished drug products.
• HPLC/LC-MS Method Development: Critical for developing and validating sensitive analytical methods to monitor product purity and stability.
• Pharmacopoeial Compliance: Used to demonstrate compliance with stringent purity specifications outlined in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Ioversol.
• Quality Control Testing: Essential for in-process control and final batch release testing in contrast media manufacturing facilities.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

Basic Information

Product Name	Ioversol Related Compound B (50 Mg) (N,N'-Bis(2,3-Dihydroxypropyl)-5-[(n-(2-Hydroxyethyl)-Carbamoyl)Methoxy]-2,4,6-Triiodoisophthalamide)
CAS No.	104517-96-6
Molecular Formula	C20H28I3N3O9
Molecular Weight	835.17 g/mol
Synonyms	5-[N-(2-Hydroxyethyl)carbamoyl]methoxy-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Ioversol Impurity B; Ioversol EP Impurity B; Ioversol Related Substance B; Ioversol Specified Impurity; 2,4,6-Triiodo-5-[(2-hydroxyethyl)carbamoyl]methoxy-N,N'-bis(2,3-dihydroxypropyl)isophthalamide; OPTIRAY Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Ioversol Related Compound B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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