Hold Time

Why pH of Pharmaceutical Solutions Changes by Holding Time?

Why pH of Pharmaceutical Solutions Changes by Holding Time?

Byipharmacist

1. Degradative effects of Active Pharmaceutical ingredients which may be: e.g. Epinephrine in solution undergoes racemization and oxidation, but if the pH is maintained at 3.0 or lower, little reaction occurs. Atropine sulfate rapidly hydrolyzes in solution, but if the pH is maintained with a buffer system at about 3.5 to 4.0 ,hydrolysis does not…

Hold Time Management in Pharmaceutical Manufacturing
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Hold Time Management in Pharmaceutical Manufacturing

Byipharmacist

Manufacturers should ensure that the products are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures.   Manufacturing processes should be shown to be capable of consistently manufacturing pharmaceutical products that are of…