CHANGZHOU HIGHASSAY® CHEMICAL CO., LTD

Items

USP injection Standards

Appearance

White to orange powder. No visible evidence of contamination by foreign matter

Identification

UV

UV/Vis

IR

Color

Loss on drying

5.0% max

Absorbance ration

362/381=0.57 to 0.61

381/405=0.87 to 0.93

Residue on ignition

0.5% max

Solubility

Passed test

Amphotericin A

5% max (on dried basis)

Related substances

Amphotericin B methylester: 2.0% max

Any individual unknown: 2.0% max

Total unknown impurities: 7.0% max

Total impurities : 9.0% max

Assay (microbial )

840ug/mg min (on dried basis)

Assay (HPLC)

90% min (on an anhydrous weight basis)

Microbial limits

Total aerobic count: 100cfu/gram max

Salmonella species: Negative

Eschenchia coli: Negative

Bacterial endotoxins

1EU/mg max

Residual solvents

Ethanol: 5000ppm max

DMF: 6000ppm max

Acetone: 5000ppm max