Description

Iopromide Impurity CAS NO 102275-80-9 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in the pharmaceutical industry, particularly those involved with non-ionic iodinated contrast media.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Iopromide and related compounds.
• Method Development & Validation: Critical for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurities in active pharmaceutical ingredients (APIs).
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure batch-to-batch consistency and compliance with strict pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to identify and track degradation products formed during the stability testing of Iopromide drug substances and finished formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to understand and minimize impurity formation.

Basic Information

Product Name	Iopromide Impurity
CAS No.	102275-80-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iopromide Related Compound; Iopromide Impurity A; Ultravist Impurity; Iopromide EP Impurity; Iopromide USP Impurity; N-(2,3-Dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide
EINECS	Contact for details

Quality Control

Every batch of Iopromide Impurity CAS NO 102275-80-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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