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GLIBENCLAMIDE |
| Product Name |
: |
Glibenclamide BP/EP/USP |
| Chemical Name |
: |
5-chloro-N-(4-[N-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-2-methoxybenzamide |
| CAS Number |
: |
10238-21-8? |
| Chemical Formula |
: |
C23H28ClN3O5S? |
| Molecular Mass |
: |
494.01 g/mol |
| Therapeutic Category |
: |
Antidiabetic |
| Test |
Specification |
| Description |
White or almost white crystalline powder |
| Identification |
(A) Not less Than 169°C and not more than174°C (B) Examined between 230nm and 350nm the solution shows an absorption maximum at 300 nm and a less intense maximum at 275nm. the Specific absorbance at the maxima are 61 to 65 and 27 to 3 |
| Solubility |
Practically insoluble in water, Sparingly soluble in methylene chloride, slightly soluble in ethanol (95%) and in methanol. |
| Heavy Metals |
NMT 20ppm |
| Loss On Drying |
NMT 1.0%w/w |
| Assay on dried basis by HPLC |
NLT 99.0%w/w and NMT equivalent of 101.0%w/w |
| Sulphated Ash |
NMT 0.1 %w/w |
| Related Substances by HPLC |
Impurity A NMT 0.5 % Impurity B NMT 0.5 % Any other Impurity NMT 0.2 % Two such Peak NMT 0.1 % Total of other impurities NMT 0.5 % |
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