Description

Iopromide Ep Impurity D is a critical pharmaceutical reference standard used in the quality control and analytical development of contrast media. This compound, with CAS No. 154361-55-4, is essential for ensuring the purity, safety, and efficacy of iopromide-based diagnostic agents. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in iopromide active pharmaceutical ingredient (API) and finished injectable formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to separate and detect process-related impurities and degradation products.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of degradation impurities under various stress conditions (heat, light, pH) to establish product shelf-life and storage recommendations.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles, which is a mandatory requirement for drug approval.
• Research on Contrast Media Metabolism & Safety: Serves as a key analyte in research studies investigating the pharmacokinetics, metabolism, and safety profile of iodinated contrast agents.

Basic Information

Product Name	Iopromide Ep Impurity D
CAS No.	154361-55-4
Molecular Formula	C18H24I3N3O8
Molecular Weight	791.02 g/mol
Synonyms	5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Impurity D; Iopromide Related Compound D; Ultravist Impurity D; 1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide; EP Impurity D of Iopromide; Iopromide EP Impurity D
EINECS	Contact for details

Quality Control

Our Iopromide Ep Impurity D is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with relevant pharmacopeial standards (EP, USP). A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

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 under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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