Nystatin

CAS:1400-61-9
Name:Nystatin
Formula:C47H75NO17
Molecular Weight:926.09
EINECS:215-749-0
Density:1.31 g/cm3
Boiling Point:1132.1 °C at 760 mmHg
Flash Point:638.5 °C
Solubility:insoluble in water
Appearance: Yellow powder
Assay: 99%
Package: in bags ,drums or customer require
Storage: a cool & dry place protected from light, keep drum close when not in use.
Application: Used for APIS.

CERTIFICATE OF ANALYSIS

Product name
Nystatin
CAS No.
1400-61-9
Outer Packing
16.4kg / cardboard drum
Production date
2017-03-14
Shelf life
2020-0313
Standard adopted
USP&EP
Items of analysis
Specification
Results
Appearance
a yellow or slightly brownis powder
Conforms
Description
With a characteristic odor, soluble in dimethylformamide, slightly soluble in methanol, almost insoluble in water, alcohol and ether
Conforms
UV spectroscopy A230 nm/A279nm
0.90-1.25
1.06
UV spectroscopy A291 nm/A305nm
0.61-0.73
0.66
UV spectroscopy A319nm/A305nm
0.83-0.96
0.92
UV spectroscopy A230 nm/A280nm
0.83-1.25
1.04
Potency(USP)
≥5000u/mg
6760u/mg
Loss on drying
≤5.0%
4.0%
sulphated ash
≤3.5%
0.2%
absorbance at 305nm
≥0.60
0.85
Heavy metals
≤20ppm
Conforms
PH
6.0-8.0
7.7
Total aerobic bacteria
≤1000 CFU/g
<5
yeast and moilds
≤100 CFU/g
<5
Composition HPLC:Nystatin A1
≥85.0%
91.2%
Any ather compound
≤4.0%
1.3%
Conclusion
Qualified

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