LEDIPASVIR(ACETONE)

Chemical Name

Ledipasvir(acetone)

CAS Number

Molecular Formula

Molecular Weight

1441674-54-9

C49H54F2N8O6.C3H6O  

947.08

Packing

20kg/drum

Storage

Store in a tightly sealed container away from heat and direct light, and in a cool dry place.

Application

Ledipasvir is most commonly used in combination with sofosbuvir for treatment in chronic hepatitis C genotype 1 patients.

Item

Specification

Appearance

Off-white to white powder

Identification

Meet the Requirements

Polymorphic Identity

XRD

Loss on Drying

≤7.13%

Residue on Ignition

≤0.10%

Heavy Metals

≤0.002%

Palladium

≤10ppm

Impurity

(by HPLC)

LPS-8≤0.15%

LPS-B≤0.15%

LPS-C≤0.15%

LPS-D≤0.15%

LPS-D2≤0.15%

LPS-one≤0.15%

Any unknown impurity≤0.10%

Total impurities≤1.0%

Residue Solvents

Isopropy acetate ≤5000 ppm

Ethyl acetate ≤5000 ppm

61324ppm≤acetone≤66324 ppm

N,N-Dimethyl formamide≤880 ppm

1,4-dioxane≤380 ppm

1,2-dimethoxyethane≤100 ppm

Assay

98.0%~102.0%