Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Summary of forced degradation results.
| Stress conditions |
Time
(min) |
Assay of active substance affected due to stress condition (%) | Assay of active substance under normal conditions (%) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| PCM | MP | PP | CTZ | PCM | MP | PP | CTZ | ||
|
Acid hydrolysis (0.1 M HCl) |
60 | 101.49 | 101.7 | 103.4 | 102.6 | 99.467 | 99.800 | 98.733 | 99.267 |
|
Base hydrolysis (0.1 M NaOH) |
60 | 110.276 | 102.243 | 104.335 | 105.096 | ||||
|
Oxidation (3% H2O2) |
60 | 113.784 | 96.722 | 96.245 | 96.688 | ||||
| Thermal (60ºC) | 60 | 100.53 | 105.47 | 104.38 | 105 | ||||
