ABSTRACT

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c. Toxicity d. Batch size

From each group, one worst-case product is considered for cleaning validation. The following capsule products are encapsulated using this machine:

Indomethacin 25 mg capsule• Tetracycline 250 mg capsule• Oxytetracycline 250 mg capsule• Doxicycline 100 mg capsule• Fluoxetine 20 mg capsule• Azythromycin capsule•

The worst-case products among the above-mentioned products are as shown in Table 20.8.1.1.