Category
Amidotrizoic acid
CAS Number
162193-52-4
Molecular Formula
C₁₁H₁₀I₂N₂O₄
Molecular Weight
488 g/mol
Synonym

3,5-Bis(acetylamino)-2,4-diiodobenzoic acid (as per EP) ; 
3,5-bis(Acetylamino)-2,4-diiodobenzoic Acid ; 3,5-Diacetamido-2,4-diiodobenzoic Acid;

Keywords
Fine Chemicals
Aromatics
Amines
Pharmaceutical Standards
Intermediates
Impurities Manufacturer in India
Impurities manufacturer and Suppliers in Hyderabad india
High-Quality Pharmaceutical Reference Standards
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Amidotrizoic Acid EP Impurity B (CAS No. 162193-52-4; molecular formula C₁₁H₁₀I₂N₂O₄; molecular weight 488) is a pharmaceutical impurity reference standard used for Amidotrizoic acid impurity profiling, HPLC analysis, related-substance testing, quality control, analytical method development, and method validation. Manasa Life Sciences, an India-based manufacturer and supplier of analytical pharmaceutical impurities, offers comprehensive analytical documentation and quality-supporting data for research and regulatory applications, with documentation aligned, where applicable, with EP, USP, EMA, and ICH regulatory and quality guidelines. Relevant ICH guidance covers impurities, analytical validation, specifications, GMP, and pharmaceutical quality systems. Product documentation may include COA, potency/assay, analytical chromatograms, characterization data, specifications, and applicable GLP/GDP documentation, depending on the product and batch. EMA guidance also highlights appropriate analytical procedures, validation information, batch analysis, specifications, and reference standards/materials within pharmaceutical quality documentation.