Description

Iohexol Ep Impurity F CAS NO 1215856-35-1 is a specified impurity and reference standard used in the quality control of Iohexol, a widely used non-ionic, low-osmolar contrast medium. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of X-ray contrast media.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iohexol Ep Impurity F in Iohexol active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and calibrating high-performance liquid chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Pharmacopoeial Compliance: Supports compliance with stringent pharmacopoeial standards (e.g., USP, EP, JP) that set limits for known and unknown impurities in contrast media.
• Stability Studies: Employed in forced degradation and long-term stability studies of Iohexol to monitor impurity profiles and ensure product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to health authorities like the FDA and EMA.
• In-House Quality Control: Serves as an in-house working standard for routine batch release testing of Iohexol API and formulations.

Basic Information

Product Name	Iohexol Ep Impurity F
CAS No.	1215856-35-1
Molecular Formula	C19H24I3N3O9
Molecular Weight	821.02 g/mol
Synonyms	1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodobenzene-1,3-dicarboxamide; Iohexol Impurity F; Iohexol Related Compound F; Iohexol EP Impurity F; 5-[Acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide; Iohexol Process Impurity; Iohexol Degradant
EINECS	Contact for details

Quality Control

Every batch of Iohexol Ep Impurity F 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 NMR to ensure it meets the high 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 needs.

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, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Water Content	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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