Polymyxin B Sulfate；CAS 1405-20-5

Item

Specification

Appearance

White to light yellow powder

Identification

Test for Composition of Polymyxins: the

retention times of the major peaks of the

Sample solution correspond to those of the

Standard solution.

Reaction with cupric sulfate in sodium

hydroxide solution

Reactions of sulfate

PH

5.0-7.5

Loss on Drying

≤ 7.0%

Residue on Ignition

≤ 5.0%

Particle Size

≥99% particles are less than 20 microns

≥90% particles are less than 15 microns

≥75% particles are less than 10 microns

≥35% particles are less than 5 micron

Related Substances

Single impurity ≤ 3.0%

Total impurities ≤ 17.0%

Total Aerobic Microbial Count

≤ 10cfu/g

Yeasts&Molds

≤ 10cfu/g

Composition of Polymyxins

(on dried basis)

Polymyxin B3≤ 6.0%

Polymyxin B1-I≤ 15.0%

Sum of polymyxins B1, B2, B3 and B1-I≥80.0%

Assay (on dried basis)

Polymyxin B≥6000U/mg