Module 3 - Strategic case studies in practice

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PART IIF: STABILITY

1. Stability tests on active ingredients.

Not applicable

2. Stability tests on the finished product.

Check Specification

4.5 - 5.5

Phenylephrine Hydrochloride (mg/capsule)

4-Aminophenol (pg/capsule) - 15 Maximum.

For additional methods see the following pages.

Results:-

Results on both batches are satisfactory afterl8 months at room temperature, 11°C and 37oC in the proposed packaging.

Conclusions:-

The results are normal for this type of product and therefore indicate that this product will remain satisfactory over the proposed shelf life.

On-going stability studies:-

Stability studies will continue to confirm the proposed shelf life.