Header for print stylesheet
Go

Nystatin, for extemporaneous oral suspension - US

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

Packaging & shipping:
Double polyethylene bags that are placed in a laminate aluminum bag (composed by PET12 +AL9 + LDPE50) which is sealed, all in a carton boxes.

  • Packaging size: 100 BoU for Nystatin Powder & 75 BoU for Nystatin Micronised.
  • Packaging type: Corrugated box with DSM logo and DSM tape
  • 100 BoU pack has 2 bags of 50 BoU each.
  • 75 BoU box has single bag
  • 3 boxes i.e 300BoU for Nystatin powder and 225 BoU for Nystatin micronised (these amounts are also our minimum order quantities) placed on pallet and shrink wrapped
  • Pallet size: Euro pallet 1200 x 800 mm

Corrugated boxes: Slotted cardboard box, with folding top & bottom (FEFCO 0201), White outer layer, Sleeve joints: Glued with waterproof glued (FEFCO test 09, DIN 53133)
Length (inside): 785 ± 3 mm, Width (inside): 385 ± 3 mm,
Height (inside): 495 ± 3 mm, Sheet Plano: 2.15 M2, Weight:1678 gm

Appearance:
Light hazel powder with characteristic odour.

Odour:
Characteristic.

Potency (microbiological):
"as is": equal to or more than 5500 IU/mg.

Absorbance:
305 nm: > 0.6.

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

Microbial count:
Total aerobic bacteria = 10² 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.

Sales offices

For more information, please contact us.

[an error occurred while processing this directive]

footer for print stylesheet