|
|
;)
326.83[5786-21-0].
197K
.
731—
Dry it at 105
for 4 hours: it loses not more than 0.5% of its weight.
281:
not more than 0.1%.
231:
0.002%.
| Standard
solution |
Dilution | Concentration (µg of RS per mL) |
Percentage (%, for comparison with test specimen) |
| A | 3 in 10 | 30 | 0.3 |
| B | 1 in 5 | 20 | 0.2 |
| C | 1 in 10 | 10 | 0.1 |
| D | 1 in 20 | 5 | 0.05 |
621. Examine the plate under short-wavelength UV light, and compare the intensities of any secondary spots observed in the chromatogram of the Test solution with those of the principal spots in the chromatograms of the Standard solutions: no spot from the chromatogram of the Test solution with an RF value of about 0.82, corresponding to 1,4-bis(8-chloro-5H-dibenzo[b,e][1,4]diazepin-11-yl)piperazine; about 0.67, corresponding to 8-chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one; or about 0.10, corresponding to 8-chloro-11-(1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine, is larger or more intense than that obtained from Standard solution B, Standard solution C, or Standard solution A, respectively; no other secondary spot from the chromatogram of the Test solution is larger or more intense than the principal spot obtained from Standard solution C (0.1%); and the sum of the intensities of all secondary spots obtained from the Test solution corresponds to not more than 0.6%.
467:
meets the requirements.
467:
meets the requirements.