| Condition | Initial | 3 mo | 6 mo | 9 mo | 12 mo | 18 mo | 24 mo |
|---|---|---|---|---|---|---|---|
| Long-Term 25°C/60% RH |
XYZ | X | X | X | XY | XY | XY |
| Accelerated 40°C/75% RH |
XYZ | X | X | — | — | — | — |
X = Description + Degradation + Water Content | Y = Microbiological Quality | Z = Uniformity of Dosage Units
| Test | Acceptance Criteria | Initial (B1) | Initial (B2) | Initial (B3) | 18m (B1) | 18m (B2) | 18m (B3) |
|---|---|---|---|---|---|---|---|
| Description | Orange film-coated... | Complies | Complies | Complies | Complies | Complies | Complies |
| Impurity 1 | ≤ 0.8% w/w | 0.101 | 0.111 | 0.121 | 0.501 | 0.511 | 0.521 |
| Impurity 2 | ≤ 0.4% w/w | 0.201 | 0.201 | 0.201 | 0.221 | 0.221 | 0.221 |
| Total Degradation | ≤ 2.3% w/w | 0.801 | 0.811 | 0.821 | 1.201 | 1.211 | 1.221 |
| Water Content | ≤ 0.2% w/w | 0.150 | 0.155 | 0.158 | 0.190 | 0.192 | 0.195 |
| Test | Acceptance Criteria | Initial (B1) | Initial (B2) | Initial (B3) | 6m (B1) | 6m (B2) | 6m (B3) |
|---|---|---|---|---|---|---|---|
| Description | Orange film-coated... | Complies | Complies | Complies | Complies | Complies | Complies |
| Impurity 1 | ≤ 0.8% w/w | 0.101 | 0.111 | 0.121 | 0.710 | 0.715 | 0.720 |
| Total Degradation | ≤ 2.3% w/w | 0.801 | 0.811 | 0.821 | 1.550 | 1.560 | 1.580 |
| Water Content | ≤ 0.2% w/w | 0.150 | 0.155 | 0.158 | 0.195 | 0.196 | 0.198 |
Stelbatolol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.
| Ingredient | Role | Amount per Tablet | % w/w |
|---|---|---|---|
| Stelbatolol | Active | 15.2 mg | 97.9% |
| Mannitol | Excipient | 145.0 mg | 1.0% |
| Maize Starch | Excipient | 13.8 mg | 0.5% |
| Calcium Carboxymethylcellulose | Excipient | 4.0 mg | 0.25% |
| Magnesium Stearate | Excipient | 2.0 mg | 0.35% |
| Ingredient | Large Batch (722,000 tabs) | Small Batch (371,000 tabs) |
|---|---|---|
| Stelbatolol | 10.98 kg | 5.98 kg |
| Mannitol | 104.72 kg | 52.36 kg |
| Maize Starch | 9.98 kg | 5.99 kg |
| Calcium Carboxymethylcellulose | 2.90 kg | 1.45 kg |
| Magnesium Stearate | 1.44 kg | 0.72 kg |
| Test Parameter | Method | Acceptance Criteria |
|---|---|---|
| Description | Visual inspection | An orange film-coated tablet, debossed with 175 on one side |
| Identification | ID by UHPLC | Consistent with the retention time and UV spectrum of the reference standard |
| Assay | Assay by UHPLC | 95% to 105% of label claim |
| Dissolution | Apparatus 2 (paddles) | Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes |
| Degradation Products | UHPLC | Total degradation products ≤ 1.4% w/w |
| Water Content | USP <921> | ≤ 1.0% w/w |
| Microbiological Quality | Ph Eur | Shall comply with the requirements of the Ph Eur |