Product Description
Diatrizoic Acid
Xi'an Libang Pharmaceutical Co.,Ltd has developed Diatrizoic Acid API since 2003, as its biggest manufacturer in China.
The typical quality attributes for Diatrizoic Acid as follow:
Chemical name: Benzoic acid, 3,5-bis(acetylamino)-2,4,6-triiodo-.3,5-Diacetamido-2,4,6-triiodobenzoic acid
Solubility: Very slightly soluble in water; soluble in ammonia solution or sodium hydroxide solution.
Fuction: Amidotrizoic Acid Dihydate is used for producing the radiopaque contrast agent for intravascular use named as Diatrizoate Meglumine and Diatrizoate Sodium Injection or Diatrizoate Meglumine Injection.
Advantage: Control the Free aromatic amine limit within a lower acceptance criteria.
| TEST | SPECIFICATION | RESULT |
| Appearance | White, odorless powder | Conforms |
| Identification | (1) It responds to the Thin-Layer Chromatographic Identification Test | Conforms |
| (2) Positive reaction | Conforms | |
| Water | 4.5%~7.0% | 5.6% |
| Residue on ignition | NMT0.1% | 0.06% |
| Iodine and iodide | NMT 0.02% of iodide |
Conforms |
| Heavy metals | NMT 0.002% | Conforms |
| Free aromatic amine | NMT 0.05% | 0.008% |
| Ethyl alcohol | NMT 0.5% | Not detected |
| Acetic acid | NMT 0.5% | Not detected |
| Bacterial endotoxins | NMT 1.5 EU/g | ＜1.5 EU/g |
| Microbial Limit | Total aerobic microbial count: ＜1000 cfu/g | Conforms |
| Total yeast and molds count: ＜100 cfu/g | Conforms | |
| Assay | 98.0%～102.0%(Calculated on the anhydrous basis) | 99.2% |
