Description

Iopromide Ep Impurity H CAS NO 185459-57-8 is a high-purity chemical reference standard used in the pharmaceutical industry. Its primary value lies in ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Iopromide, a widely used non-ionic, iodinated contrast agent. This impurity standard is essential for analytical method development, validation, and routine quality control testing. Pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories require this standard to meet stringent pharmacopeial requirements from the European Pharmacopoeia (EP) and other global regulatory bodies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Iopromide Ep Impurity H in Iopromide API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles as per ICH Q3A/B guidelines.
• Quality Control & Batch Release: Used in routine QC testing to ensure Iopromide batches comply with EP, USP, or in-house specifications for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling and characterization studies during the synthesis and purification process development of Iopromide.

Basic Information

Item	Details
Product Name	Iopromide Ep Impurity H
CAS No.	185459-57-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iopromide Impurity H; Iopromide Related Compound H; 1-N,3-N-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(methoxyacetylamino)-N-methylisophthalamide; 5-(Methoxyacetylamino)-1-N,3-N-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylisophthalamide; Iopromide EP Impurity H; Iopromide European Pharmacopoeia Impurity H
EINECS	Contact for details

Quality Control

Every batch of Iopromide Ep Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. We support compliance with cGMP, ICH, and ISO guidelines for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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