Microbiological testing of globules

Microbiological testing of globules

Microbiological testing of globules

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Jan 26, 2021 - Pharmacy

Microbiological testing of globules

 

In the European Pharmacopoeia (Ph.Eur.), monograph 2153 defines active ingredient-free pellets for homeopathic preparations as solid preparations made from sucrose, lactose, or other suitable excipients. 

These active ingredient-free pellets form the basis for the well-known globules. The Ph. Eur distinguishes between two different types of globules

The impregnated homeopathic pellets are the active ingredient-free variant, which are impregnated with one or more liquid homeopathic preparations.

In contrast, the active ingredient-free pellets in the coated homeopathic pellets are coated with a sucrose syrup in which the homeopathic preparations are contained (dissolved). Regardless, other triturations (for example, mineral active substances triturated with milk sugar) can also be incorporated.

Both groups are intended for sublingual or oral use. Even though the water activity of the two product groups is likely to be very low (low moisture content, high sugar content), the Ph.Eur. requires a microbiological purity test for globules. The acceptance criteria are the same for the active ingredient-free pellets as well as for the two variants of the globules.

The following acceptance criteria are required in the respective monographs.

 

To comply with the requirements of the Ph.Eur., globules also require microbiological testing. As a microbiological laboratory specialized in pharmaceutical testing, BAV Institute can gladly support you in this regard.