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Nystatin, powder

Characteristics:
A crystalline powder.

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

Therapeutical category:
Polyene antibiotic with antifungal activity for oral and topical 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 30 or 80 ltr fiber drum.

30 ltr fiber drum (20 Bou)
size d x h = 34 x 40 cm
21 drums per pallet (3 layers of 7 drums)
pallet incl. drums l x w x h
= 120 x 80 x 135 cm
weight per drum = 5,5 kg
weight per pallet = 20 kg
approx weight per pallet = 135.5 kg

80 ltr fiber drum (100 Bou)
size d x h = 47 x 55 cm
8 drums per pallet (2 layers of 4 drums)
pallet incl. drums l x w x h
= 120 x 80 x 125 cm
weight per drum = 20.7 kg
weight per pallet = 20 kg
approx weight per pallet = 185.6 kg

Appearance:
Slightly brownish powder.

Odour:
Characteristic.

Potency (microbiological):
"as is": equal to or more than 4400 IU/mg.

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

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

Storage conditions:
Below 8 °C, protected from light and moisture.


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