98% up by HPLC DMF Posaconazole 171228-49-2

Product Information

Product name

Posaconazole

CAS No.

171228-49-2

Molecular Formula

C37H42F2N8O4

Molecular Weight

700.78

Quality Standard

98% up by HPLC, DMF

Appearance

White to off-white powder

COA of Posaconazole

ITEMS

SPECIFICATION

RESULT

Appearance

White to off-white powder

Conforms

Melting point

167 〜171°C

167.5 〜168.0°C

Specific optical rotation

-28.5°〜-24.5°

The retention time of the major peak of the test

-27.2°

Identity

The retention time of the major peak of the test solution corresponds to that of the standard solution, as obtained in the Assay.

Conforms

The infrared absorption spectrum of this

product should corresponds to the reference spectrum.

Conforms

Crystallinity

There are characteristic peaks at 7.7°±0.2°,9.9°±0.2°, 17.8°±0.2°, 19.5°±0.2°, 20.0°± 0.2°(Crystal form 1).

Conforms

Water content (%w/w)

≤0.5%

0.1%

Residue on ignition

≤0.1%

0.02%

Related substances

QR0005DS-IN-01: ≤0.10%

QR0005DS-IN-02: ≤0.10%

QR0005DS-IM-08: ≤0.10%

QR0005DS-IM-06: ≤0.10%

Other maximum unknown impurity ≤0.10%

Total impurities: ≤0.40%

Not detected

0.01%

Not detected

Not detected

0.02%

0.07%

Enantiomeric and

 diastereoisomer

QR0005DS-IM-02: ≤0.10%

QR0005DS-IM-03: ≤0.10%

QR0005DS-IM-04: ≤0.10%

QR0005DS-IM-01+QR0005DS-IM-05+ QR0005DS-IM-06: ≤0.10%

QR0005DS-IM-07 ≤0.10%

Total isomer impurities: ≤0.50%

0.01%

Not detected

Not detected

Not detected

Not detected

0.02%

0.04%

Residual solvents

Methanol: ≤3000 ppm

Dichloromethane: ≤600 ppm

Acetone: ≤5000 ppm

Ethanol: ≤5000 ppm

Dimethyl sulfoxide: ≤5000 ppm

31 ppm

53 ppm

Not detected

Not detected

Not detected

Benzene

≤2 ppm

Not detected

Heavy metals

≤10 ppm

Conforms

Bacterial endotoxin

≤0.25 EU/mg

Conforms

Microbial limit

Total Aerobic Microbial Count (TAMC): ≤102 cfu/g

Total molds and Yeast Count (TYMC): ≤101cfu/g

Escherichia Coli: Absence

10 cfu/g

< 10 cfu/g

Not detected

Assay

C37H42F2N8O4： 98.0% 〜102.0% (on the anhydrous basis)

101.0%

Conclusion

Conform to Enterprise Standard

Usage