This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.
This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.
This certificate of analysis is for a batch of nystatin produced by Shaanxi Pioneer Biotech Co., Ltd. The batch number is PB180710 with a manufacture date of July 10, 2018 and expiration date of July 9, 2020. Analysis shows the nystatin powder meets all specifications for appearance, potency, solubility, pH, loss on drying, sulphated ash, heavy metals and conforms to BP2010/USP 35 standards. The certificate recommends storing the nystatin in an airtight container protected from light with a shelf life of 2 years.
BIOTECH Shaanxi Pioneer Biotech Co., Ltd Certificate of Analysis
Product Name Nystatin Manufacture Date July. 10 ,2018
Batch Number PB180710 Certificate Date July. 11 ,2018
Batch Quantity 300kg Expiration Date July. 9 ,2020
Analysis Specification Results
Appearance Yellow to slightly brownish powder, hygroscopic. Complies
Potency ≥4400 IU/mg 6200IU/mg Practically insoluble in water, freely soluble in dimethylformamide Solubility and in dimethyl sulphoxide,slightly soluble in methanol, practically Complies insoluble in alcohol. PH 6.0-8.0 7.1
Loss on Drying ≤ 5.0% 2.9%
Sulphated ash ≤3.5% 0.8%
Heavy metal ≤ 20ppm <20ppm
Conclusion Conform with BP2010/USP 35 Standard
Storage Store in In an airtight container , protected from light.
Shelf life 2 years when properly stored
Add: No.2Daxing East Road, Xi’an , China Web:www.pioneerbiotech.com