CERTIFICATE OF
ANALYSIS
|
PRODUCT
NAME |
RIBAVIRIN |
|
BATCH
NO. |
20010708 |
|
TESTING
DATE |
20010724 |
|
MANUF
DATE |
20010722 |
|
EXPIRY
DATE |
20040722 |
SPECIFICATION:
USP 24
RIBAVIRIN
IS A STABLE, WHITE CRYSTALLINE COMPOUND WITH A MAXIMUM SOLUBILITY IN WATER OF
142 mg/ml AT 25℃ AND WITH ONLY A SLIGHT SOLUBILITY IN ETHANOL. THE EMPIRICAL
FORMULA IS C8H12N4O5 AND THE MOLECULAR WEIGHT IS 244.20.
|
TESTS |
REQUIREMENTS |
RESULTS |
|
IDENTIFICATION |
|
|
|
A.
INFRARED ABSORPTION |
|
CONFORMS |
|
B.
TLC |
|
CONFORMS |
|
SPECIFIC
ROTATION |
-33.5 TO 37.0℃ |
-36.9° |
|
PH |
4.0
TO 6.5 |
6.3 |
|
LOSS
ON DRYING |
0.5%
MAX |
0.1% |
|
RESIDUE
ON IGNITION |
0.25%
MAX |
0.1% |
|
HEAVY
METALS |
0.001%
MAX |
CONFORMS |
|
CHROMATOGRAPHIC
PURITY |
INDIVIDUAL
PEAK: 0.25% MAX |
INDIVIDUAL
PEAK: 0.227% 0.08% |
|
|
TOTAL:
1.0% MAX |
TOTAL
:0.5% |
|
ASSAY |
98.9
TO 101.5% |
99.9% |
CONCLUSION:
IT MEETS USP.