This certificate of analysis summarizes the results of quality testing performed on a batch of bacitracin produced by Octagon Chemicals Limited. The tests show that the bacitracin powder meets or exceeds all USP40 standards for identification, purity, microbial limits, and potency. The certificate concludes that the batch is approved for storage and meets standards for use as an active pharmaceutical ingredient.

1. OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-13071891945 FAX:0086-0535-6715688
Address: ROOM 5032,NO.9 YANAN ROAD,HANGZHOU,CHINA
sales@octagonchem.com
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Product name Bacitracin (Cas 1405-87-4)
Batch No. 20191009 Mfg. date 2019.10.09
Rep. Date 2019.10.11 Exp. date 2022.10.08
Packaging 10kg/drum Test according to USP40
Test Items Standards Results
Appearance White to pale buff powder
An almost white
powder
Indentification
TLC:should conform
HPLC:should conform
Conforms
Conforms
PH 5.5~7.5 5.79
Loss on drying NMT5.0% 1.38%
Residue on ignition NMT0.5% 0.09%
Composition
Bacitracin A:NLT40% 72.1%
Active bacitracin: NLT70% 90.1%
Limit of early eluting
peptides
NMT 20.0% 2.9%
Limit of Bacitracin F: NMT 6.0% 1.4%
Microbial assay NMT100CFU/gram 0
Assay(on dried basis) NLT65 Bacitracin units/mg 84Units/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