Tinidazole

SKU : AP009
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CAS number

19387-91-8

molecular formula

C8H13N3O4S

standard

USP32/BP2010/EP6

Package

25kg/drum
ITEMS LIMIT
Appearance White or pale yellow crystalline powder
Solubility Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol
Melting range 125-128
Identification The IR spectrum corresponds to Tinidazole reference standard
Appearance of solution 5.0%(g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5
Related substances(TLC) Impurity-A:NMT 0.5%
Impurity-B:NMT 0.5%
Any other unspecified impurity: NMT 0.5%
At most one impurity more than 0.2%
Residual solvents(GC) Ethanol: NMT 1000 ppm
O-xylene: NMT 195.3 ppm
Loss on drying NMT 0.5%
Sulphated ash NMT 0.1%
Heavy metals NMT 20 ppm
Assay NLT 98.0% & NMT 101.0% (dried substance)

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