| Drug product: Pyridostigmine Bromide |
|
Dosage: 30 mg |
Packaging: Amber glass bottle |
| Storage |
Appearance |
Average weight (%) |
Hardness
[N] |
Friability
[%] |
Disintegration tine [%]
15 min |
Dissolution time [t80%]
60 min |
Moisture content [water absorption ratio] |
Content (Assay)
[% LC] |
| Months |
Conditions |
| Specifications |
White, round, flat tablet |
<5% |
≥ 70 N |
≤ 1% |
≥ 15 min |
≥ 70% |
>10% |
95.0-105.0% |
| Initial |
-- |
Complies |
4.34% |
116.4 N |
0.27% |
3.05 min |
82.55% |
77.98% |
98.73% |
| 1 |
40 ± 2°C/
75 ± 5% RH |
Complies |
4.68% |
114.2 N |
0.27% |
2.46 min |
81.95% |
91.42% |
98.52% |
| 3 |
Complies |
4.75% |
111.5 N |
0.35% |
2.35 min |
85.05% |
96.22% |
97.45% |
| 6 |
Complies |
4.98% |
112.3 N |
0.62% |
1.47 min |
83.91% |
124.02% |
95.74% |
| 3 |
25 ± 2°C/
60 ± 5% RH |
Complies |
4.50% |
114.4 N |
0.32% |
2.00 min |
82.35% |
92.02% |
97.28% |
| 6 |
Complies |
4.98% |
113.6 N |
0.34% |
1.56 min |
81.52% |
91.09% |
96.52% |
| 9 |
Complies |
4.89% |
114.2 N |
0.32% |
1.59 min |
81.50% |
91.90% |
96.16% |
| 12 |
Complies |
5.00% |
114.5 N |
0.27% |
2.09 min |
73.98% |
95.04% |
96.33% |
| 3 |
30 ± 2°C/
65 ± 5% RH |
Complies |
4.68% |
115.8 N |
0.29% |
2.75 min |
78.22%. |
89.05% |
98.52% |
| 6 |
Complies |
4.59% |
112.7 N |
0.32% |
2.22 min |
76.60% |
91.56% |
96.80% |
