TABLE VII
Glatt Coating Machine: Evaluation for the Limit of Residues
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|---|---|---|---|---|---|---|---|---|
| API or Detergent | Equipment Area cm2 | DT Min. | DT Max. | Max. Dose Tablet Weight | Solubility | Min. Lot Weight (kg) | Max. Lot Weight (kg) | Calculated Limit of Acceptance (ppm or μg/cm2) |
| API A′ | 3433.90 | 25 mg/day | 100 mg/day | 320 mg | Freely soluble | 0.8 | 0.8 | 10 ppm |
| API B′ | 3433.90 | 25 mg/day | 200 mg/day | 1000 mg | Freely soluble | 0.8 | 0.8 | 10 ppm |
| API C′ | 3433.90 | 40 mg/day | 160 mg/day | 300 mg | Very soluble | 0.8 | 0.8 | 10 ppm |
| API D′ | 3433.90 | 125 mg/day | 300 mg/day | 1000 mg | Freely soluble | 0.8 | 0.8 | 10 ppm |
| API E′ | 3433.90 | 100 mg/day | 300 mg/day | 500 mg | Freely soluble | 0.8 | 0.8 | 10 ppm |
| API F′ | 3433.90 | 50 mg/day | 200 mg/day | 200 mg | Very soluble | 0.8 | 0.8 | 10 ppm |
| Kony ultra Detergent | 3433.90 | dodecil-benzensulfonic acid LD50 mice: 2 g/kg oral | * | * | Very soluble | * | * | * |
| NaOH LD50 mice: 500 mg/kg oral | * | * | Very soluble | * | * | * | ||
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↵* Does not apply.