World (Jiangsu) Industry Co., Ltd

Products

	Polymyxin B Sulfate

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Model Number

wld-006

Identifications and passes tests:

pH (2%): 5.0 - 7.0

pH (0.5%): 5.0 - 7.5

Specific optical rotation: -78 ~ -90

Related substances: HPLC

Major impurity: NMT 3.0%

Sum of impurities: NMT 17.0%

Phenylalanine: 9% - 12%

Loss on drying: NMT 6.0%

Sulfated ash: NMT 0.75%

Sulfate: 15.5% - 17.5%

Heavy metals: NMT 20ppm

Total viable aerobic count: NMT 10cfu/g

Assay, microbiological (as is): NLT 6500IU/mg

Assay, HPLC (on dried basis):

Sum of polymyxin B1, B2, B3 and B1-l: NLT 80.0%

Polymyxin B3: NMT 6.0%

Polymyxin B1-l: NMT 15.0%

Particle size: NLT 99.0% ≤20μm by volume

NLT 90.0%: ≤15μm by volume

NLT 75.0%: ≤10μm by volume

NLT 35.0%: ≤5μm by volume

Packing: alu. Tin