Tests Item | Standard |
Appearance | white or yellowish crystalline powder |
Identification | FT-IR：Spectrum of sample matches that of the reference standard |
HPLC：The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard. |
Water | Not more than 0.3% |
Heavy metals（Pb） | Not more than 10 ppm |
Residue on ignition | Not more than 0.1% |
Related compounds(HPLC) | Related compound A NMT 0.30% |
4,4’,4’’-methylidenetrisbenzonitrile NMT 0.20% |
Maximum individual unspecified impurity NMT 0.20% |
Related compound A NMT 0.30% |
Residual solvents | Methanol NMT 3000ppm |
Ethyl acetate NMT 5000ppm |
Isopropyl alcohol NMT 5000 ppm |
N,N-Dimethylformamide NMT 880 ppm |
Assay (HPLC) | 98.5% to 101.5%(on the anhydrous basis) |
