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By certification 
Isoniazid or Isoniazide BP EP USP CAS 54-85-3 
Product Name: Isoniazid
Synonyms: Isoniazide, Isoniazidum
CAS Number: 54-85-3
Characteristics: white or whitish crystalline powder
Assay: 98.0%~102.0%, 99.0%~101.0%
Formula: C6H7N3O
Package: 25Kg/Cardboard Drum
Usage: Isoniazid (Isoniazide) is mainly been given orally to fight against active tuberculosis (TB) infections.
Preparations like Isoniazid Tablets, Isoniazid Syrup, Isoniazid Capsules are already been produced in large scale. And the combination Rifampin and Isoniazid Capsules, Rifampin, Isoniazid, and Pyrazinamide Tablets, Rifampin, Isoniazid, Pyrazinamide, and Ethambutol Hydrochloride Tablets, etc.
Certificate of Analysis – Isoniazid
Testing Item |
Standard |
Result |
Appearance |
Colorless crystals, white or whitish crystalline powder |
Complies |
Solubility |
Should Comply |
Complies |
Melting Range |
170~173 |
171 |
Identification |
Should Comply |
Complies |
PH |
6.0~8.0 |
6.9 |
Clarity of solution |
Not more than No.1 cloudy standard solution |
Clear |
Color of solution |
Not more deeper than comparative solution |
Complies |
Dissocialative Hydrazine |
Should comply |
Complies |
Loss on drying |
≤0.5% |
0.1% |
Related Substances |
Single Impurity≤0.35% |
Not Detected |
Total Impurity≤1.0% |
Not Detected |
|
Residue on ignition |
≤0.1% |
<0.1% |
Heavy Metal |
≤0.001% |
<0.001% |
Assay (Isoniazid) |
98.0%~102.0% |
99.85% |
