Pharmaceutical Products
Description
Tinidazole
C8H13N3O4S
CAS No.: 19387-91-8
Type: Antibiotic and Antimicrobial Agents
Standard: BP2007, USP31, EP6.0
Packing: 25kg/Drum.
Tinidazole is commonly used anti-anaerobic bacteria and antiprotozoal drugs.
Tests Standards Results
Appearance White or pale yellow crystalline powder Pale yellow crystalline powder
Solubility Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol Conforms
Melting range 125-128 126
Identification The IR spectrum corresponds to Tinidazole reference standard Conforms
Appearance of solution 5.0%(g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5 Conforms
Related substances(TLC) Impurity-A: NMT 0.5% 0.5%
Impurity-B: NMT 0.5% 0.5%
Any other unspecified impurity: NMT 0.5% 0.5%
At most one impurity more than 0.2% Conforms
Residual solvents(GC) Ethanol: NMT 1000 ppm 190 ppm
O-xylene: NMT 195.3 ppm 90 ppm
Loss on drying NMT 0.5% 0.08%
Sulphated ash NMT 0.1% 0.04%
Heavy metals NMT 20 ppm 19 ppm
Assay NLT 98.0% & NMT 101.0% (dried substance) 99.4%
Storage Protected from light
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HUBEI YUANCHENG SAICHUANG TECHNOLOGY CO., LTD
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