Items

Standard

Appearance

White or yellowish-white crystalline powder

Completeness of solution

Clear and free from undissolved solids

Identific rotation

IR

Specific rotation

-32.0°～-38.0°

Limit of ethynyl group

7.13～7.57%

Loss on drying

≤0.5%

Residue on ignition

≤0.1%

Granularity

D90＜30μm,D50＜10μm,D10＜2μm

Related substances

TLC:Individual impurity≤0.5%

Total impurities≤1.5%

HPLC：Individual impurity(254nm) ≤0.5%

Total impurities(254nm)≤1.0%

Residual solvents

Ethanol ≤5000ppm

Isobutanol ≤5000ppm

Toluene ≤890ppm

Tetrahydrofuran ≤720ppm

Methanol ≤3000ppm

Benzene ≤2ppm

Ethyl acetate ≤5000ppm

Triethylamine ≤320ppm

Content

97.0～103.0%