| Drug product: Potassium Iodate |
|
Dosage: 85 mg |
Packaging: PVC blister |
| Storage |
Appearance |
Average weight (%) |
Hardness
[N /kg/cm2] |
Friability
[%] |
Disintegration tine [Sec%] |
Dissolution time [t75%] 15 min |
Moisture content [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 |
4.35% |
113.2 N |
0.31% |
1.85 min |
87.8% |
124.66% |
97.30% |
| 1 |
40 ± 2°C/
75 ± 5% RH |
Complies |
4.60% |
112.2 N |
0.62% |
1.80 min |
88.7% |
167.02% |
96.74% |
| 3 |
Complies |
4.55% |
109.6 N |
0.74% |
1.72 min |
89.5% |
174.55% |
95.75% |
| 6 |
Complies |
4.57% |
104.5 N |
0.86% |
1.78 min |
90.0% |
1.82.34% |
95.43% |
| 3 |
25 ± 2°C/
60 ± 5% RH |
Complies |
4.49% |
114.5 N |
0.34% |
1.86 min |
78.9% |
130.40% |
98.22% |
| 6 |
Complies |
4.40% |
112.2 N |
0.44% |
1.72 min |
80.0% |
151.33% |
97.02% |
| 9 |
Complies |
4.89% |
110.5 N |
0.56% |
1.56 min |
83.9% |
160.24% |
97.11% |
| 12 |
Complies |
4.92% |
106.8 N |
0.60% |
1.45 min |
86.7% |
167.29% |
95.30% |
| 3 |
30 ± 2°C/
65 ± 5% RH |
Complies |
4.50% |
112.8 N |
0.42% |
1.75 min |
88.5% |
165.47% |
96.90% |
| 6 |
Complies |
4.67% |
111.5 N |
0.55% |
1.56 min |
89.3% |
171.20% |
95.30% |
|
