This certificate of analysis from Octagon Chemicals Limited summarizes the results of quality testing on a batch of Polymyxin B Sulphate. The testing found that the specific rotation, pH, loss on drying, sulphated ash, sulphate content, heavy metals, sum of PB1, B2, B3, B1-I, levels of PB3 and PB1-I, total impurities, and assay were all within the specified USP40 standards. The batch was deemed to meet the requirements and is approved for storage in a well-closed container at ambient temperature.

1. OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
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Product name Polymyxin B Sulphate (Cas 1405-20-5)
Batch No. 20190301 Mfg. date 2019.03.08
Rep. Date 2019.03.11 Exp. date 2022.03.07
Packaging 1kg/tin Test according to USP40
Test Items Standards Results
Specific rotation -90 ~ -78 -85.2
Identification Should conform Conforms
PH 5.0~7.5 6.2
Loss on drying NMT6.0% 5.2%
Sulphated Ash NMT0.75% 0.3%
Sulphate 15.5%~17.5% 16.2%
Heavy metals NMT20ppm <20ppm
Sum of PB1, B2, B3,
B1-I
NLT80.0% 93.5%
PB3 NMT6.0% 1.26%
PB1-I NMT15.0% 10.2%
Total Impurities NMT17.0% 6.5%
Assay
(on dried basis)
NLT6500IU/MG 8890IU/MG
Conclusion It meets the requirements of USP40 Standards
Storage Store in a well-closed container at ambient temperature
Prepared by: LI Reviewed by: WEI Released by:Zhang