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%
Table 8: Summary of stability study results for pyridostigmine bromide 30 mg tablet.