CAS number: 1400-61-9

Molecular formula: C47H75NO17

molecular weight: 926.09

Chemical structure:

Sr No.TestSpecificationResult
1AppearanceYellow or slightly brownish powder, hygroscopic , yellow to light   tan powder, having an odor suggestive of cereals. Is hygroscopic, and is   affected by long exposure to light ,heat, and airYellow powder, hygroscopic, having an odor suggestive of cereals
2SolubilityFreely soluble in dimethylforamide and in dimethylsulfoxide   sparingly to slightly soluble in methanol, in n-propyl alcohol and in n-butyl   alcohol practically insoluble in water and in alcohol ,insoluble in   chloroform and in etherCorresponds
    A 230/ A280
    A 291/ A205
    A 319/ A305
    Identification ,ultraviolet
    Absorption A230/A279 (sh)
Absorption maxima at 230 nm ,291 nm,305 nm ,319 nm And a shoulder   at 280 nm
    0.83 to 1.25
    0.61 to 0.73
    0.83 to 0.96
    0.90 to 1.25
Identification BComplies with requirementsCorresponds
Identification CComplies with requirementsCorresponds
Identification DComplies with requirementsCorresponds
Identification EComplies with requirementsCorresponds
Absorbance at 305 nmNot less than 0.600.823
4Loss on drying –USP 39Not more than 5.0 %1.35
BP 2016, Eur.Ph 9th edition3.67
5Heavy metalsNot more than 20 ppm< 20
6Sulphated ashNot more than 3.5 %0.67
7Assay – USP 39Not less than 4400 USP Nystatin Units/mg or where intended for use   in the extemporaneous preparation of oral suspensions,not less than 5000 USP   Nystatin Units/mg6199

BP 2016 / Eur.Ph.9th editionMinimum 4400 IU/mg (dried substance ) and minimum 5000 IU/mg   (dried substance ) if intended for oral administration6435
8Abnormal toxicityIn conformity with BP 2016 and Eur.Ph. 9th edition  (2.6.9)Corresponds
9SuspendibilityNot less than 90.0 %93.2
10CrystallinityIt reveals birefringenceCorresponds
11pH ( 3.0 % aqueous suspension )Between 6.0 and 8.07.51
12Composition USP 39 – Nystatin A1
    Any other individual component
Minimum 85.0 %90.57
Maximum 4.0 %1.17

BP 2016/ Eur. Ph. 9th edition -Nystatin A1 Any other compoundMinimum 85.0 %91.26

Maximum 4.0 %1.16
13Microbiological quality TAMC,CFU/g TYMC,CFU/gNot more than 10330

Not more than 102< 1

Specified Micro-organisms Bile –tolerant gram-negative bacteria/g   Escherichia coli/g Salmonella/g Pseudomonas aeruginosal/g Staphylococcus   aureus /gAbsentAbsent


15 Residual solvents Methanol   AcetoneNot more than 0.3 %NA

Not more than 0.5 %NA
16Partical SizeNot more than 45 µm35.73