Nystatin® powder US

Characteristics:
A crystalline powder.

Application:

The product is suitable among others for the manufacture of creams, ointments, tablets and vaginal tablets after the addition of appropriate excipients.

Therapeutical category:
Polyene antibiotic with antifungal activity for oral and topical use.

Pharmacopoeia quality:
- USP
- Ph.Eur.
- BP 

Regulatory information:
US (FDA): available

Packaging & shipping:
the batch is packed in boxes containing 115 BoU each.

Nystatin powder is packed in one bag of 16.8 Kg and placed in one box containing the same weight  (1 bag = 115 BoU).

Appearance:
A yellow or slightly brownish powder.

Odour:
Characteristic.

Potency (microbiological): 
≥ 5000 IU/mg (on "as is" basis).

Loss on drying:
Equal to or not more than 5.0%.

Microbial count:
Total aerobic bacteria ≤ 100 cfu/g

Shelf-life:
3 years in the original packaging under 'storage conditions'.

Storage conditions:
Below 25°C, protected from light and moisture.