White Powder Diatrizoic Acid USP Amidotrizoic Acid Dihydate

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-
Diacet , amido-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%

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