Product Name:

Itraconazole

Description:

Itraconazole is a triazole antifungal agent. It inhibits the fungal CYP(cytochrome P450) oxidase-mediated synthesis of ergosterol. Itraconazole also acts as an effective hedgehog signaling inhibitor in a Ptch-independent manner, presumably by binding smoothened (Smo) at a site distinct from that targeted by cyclopamine and SAG. Itraconazole is an inhibitor of CYP3A4.

CAS:

84625-61-6

WF:

C35H38Cl2N8O4

MW:

705.63

EINECS:

1806241-263-5

Product Categories:

antifungal agent

Items

Specifications

Results

Appearance

White or almost white powder

Almost white powder

Identification

IR conforms to standard(2.2.24) 

Complies

Appearance of solution

Solution S is clear(2.2.1) and not more intensely colored than 
reference solution R6 or B6(2.2.2, Method II)

Complies

Related substances

(2.2.29)

Impurities B

Not more than 0.3%

Not detected

Impurities G

Not more than 0.3%

0.1%

Impurity E

Not more than 0.2%

Not detected

Sum of impurities C and D

Not more than 0.3%

Not detected

Unspecified impurities

Not more than 0.10%

0.06%

Total impurities

Not more than 0.8%

0.3%

Loss on drying

Not more than 0.5%(2.2.32)

0.1%

Sulfated ash

Not more than 0.10%(2.4.14)

0.03%

Assay                  

99.0% to 101.0%(%(2.2.20)