Nystatin for human use

  • polyene macrolide antibiotic obtained from the fermentation of the strain Streptomyces noursei
  • effective against moulds and yeast, mainly against Candida Albicans. Candida causes fungal infections of the skin, mouth, vagina and the gastrointestinal tract
  • has shown no problems of drugs interactions and side allergic or resistance effects since 1950 when discovered

Standardní výroba

Parametry Limity
Loss on drying not more than 5 %
Microbiological assay not less than 4400 IU/mg (dried substance) or
not less than 5000 IU/mg (dried substance) for oral use
Particle size The particle size distribution range of nystatin is typically:
100 % of particles is less than 40 μm
90 % of particles is less than 10 μm

Pharmacopoeial Quality

USP, Ph. Eur., BP

Regulatory information/Certifi cation

GMP, Certifi cate of Suitability R1-CEP 2003-118-Rev 01, US DMF # 14056, EIR from FDA, U.S.A., national registrations in many countries all over the world

Packaging and Shipping

Standard: polyethylene bag in PET/Al/PE bag in fi ber drums (50 or 100 BOU).
Non-standard: according to requirements

Shelf-life

3 years in the original packaging

Storage conditions

Store below 25ÅãC, in tight, light persistent container