|
PRODUCT NAME:SULFADOXINE USP35 EXPIRY DATE:5 Years |
||
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
Description |
Yellowish-white Crystalline powder |
|
|
Solubility |
Very slightly soluble in water,slightly soluble in alcohol and in methanol,dissolves in solutions of alkali hydroxides and in dilute mineral acids |
|
|
Infrared Absorption |
Confirms to the spectrum obtained from sulphadoxine RS |
|
|
Ultraviolet Absorption |
Confirms to the spectrum obtained from sulphadoxine RS |
Confirm |
|
HPLC |
The retention time of the major peak Corresponds to that in the chromatogram of the Standard preparation |
Confirm |
|
Melting point |
197-200℃ |
197.4℃-198.4℃ |
|
Lose on drying |
≤0.5% |
0.25% |
|
Residue on ignition |
≤0.1% |
0.08% |
|
Organic Impurities(By TLC) |
≤0.5% |
≤0.5% |
|
No spot in the sample solution,other than the principal spot is greater in size and intensity than the spot from the standard solution |
||
|
Heavy metals |
≤0.002% |
≤0.002% |
|
Assay |
99.0-101.0% |
99.64% |
|
CONCLUSION |
Conform to USP35 |
|
