Nystatin, for extemporaneous oral suspension

Characteristics:
A microfine crystalline powder.

Application:
The product is suited for the manufacture of suspensions.

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

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

Regulatory information: 
USA: FDA
EU: EDQM
Italy: MOH
Taiwan: Dept. of Health
Russia: Ministry of Health
New Zealand: TTO
Australia: TGA
Canada: HPB
Ukraine: Ministry of health

Packaging & shipping:
Double Polyethylene bags that are placed in a sealed laminate aluminium bag (composed by PET12 + AL9+ LOPT50) all in a 120 ltr fiber drum (75 Bou).
size d x h = 47 x 75 cm pallet
4 drums per pallet (1 layer of 4 drums)
pallet incl. drums l x w x h
= 120 x 80 x 90 cm
Weight per drum = 17.3 kg
Weight per pallet = 20 kg
Approx weight per pallet = 89.2 kg

Appearance:
Light hazel powder with characteristic odour.

Odour:
Characteristic.

Potency (microbiological):
"as is": equal to or more than 5000 IU/mg.

Absorbance:
305 nm: > 0.6.

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

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 8 °C, protected from light and moisture.