非唑奈坦

ITEMS

SPECIFICATION

RESULTS

Appearance

White to off white microcrystalline powder

Conforms

Identification

RT by HPLC conforms to CRS

Conforms

Solubility

Very slightly soluble in water; Slightly soluble in methanol,Soluble in DMSO

Conforms

Water

≤0.5%

0.21%

Loss on drying

≤1.0%

0.70%

Residue on ignition

≤0.1%

0.04%

Heavy metals

≤10ppm

Conforms

Related substances

Any single impurity≤0.10%

0.09%

Total impurities≤0.50%

0.21%

Residual solvents

Methonal≤3000ppm

200ppm

Dichloromethane≤600ppm

5ppm

Toluene ≤890ppm

5ppm

Total solvents≤5000ppm

10ppm

(S)-Enantiomer

≤0.1%

0.02%

Physical form

Form II

Conform by XRPD

Particle size

D(90)≤100μm

62.38μm

Bulk density

For information only

0.48 g/mL

Tapped density

For information only

0.59 g/mL

Assay

(on anhydrous basis)

（

）

98.0%~102.0%

99.78%

Storage Condition

Sealed and stored in a dry place at room temperature.