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White Powder Diatrizoic Acid USP Amidotrizoic Acid Dihydate

Minimum Order Quantity : 25 kgs Price : to be negotiated
Packaging Details : 50kg in a fiber drum (350cm*580cm) Delivery Time : propmt
Payment Terms : T/T, L/C Supply Ability : 50000 kg per year
Place of Origin: China Brand Name: LIBANG
Certification: Chinese GMP Model Number: USP

Detail Information

Stock: 1000 Kgs Cert: GMP
Dossier: DMF Avail Batch Quantity: 500kg
Storage: Store At Room Temperature HS Code: 2924.2990 99
High Light:

White Powder Diatrizoic Acid

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Diatrizoic Acid USP

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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-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%

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