Nystatin® micronized US

Characteristics:
A microfine crystalline powder.

Application:
The product is suitable among others for the manufacture of suspensions.

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

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

Regulatory information: 
US (FDA): available

Packaging & shipping:

the batch is packed in boxes containing 83 BoU each.

Nystatin powder is packed in one bag of 12.2 Kg and placed in one box containing the same weight  (1 bag = 83 BoU).

Appearance:
Light hazel powder.

Odour:
Characteristic.

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

Absorbance:
305 nm: ≥ 0.6.

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

Microbial count:
Total aerobic bacteria ≤ 100 cfu/g

Particle size (laser diffraction):
min. 90%: < 10 µm.
min. 99%: < 16 µm.

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

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