Vonoprazan Fumarate; CAS 881681-01-2

Appearance

White to off-white crystals or crystalline powder

Identification

IR: the infrared absorption spectrum of the sample shall be consistent with that of the reference substance

UV: the UV absorption spectrum of the test solution should be consistent with that of the reference solution.

HPLC: the retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay.

Solubility

Soluble in dimethyl sulfoxide, sparingly soluble in N,N-dimethylacetamide, slightly soluble in methanol and in water, practically insoluble in isopropanol and in acetonitrile

Moisture

≤ 0.4%

Residue on Ignition

≤ 0.1%

Fluoride (F^-)

3.9%~4.3%

Chloride (Cl^-)

≤ 0.05%

Ammonium (NH4⁺)

≤ 0.05%

Sulfate (SO₄^2-)

≤ 0.05%

Single impurity ≤ 0.15%

Total impurities ≤ 1.0%

Heavy Metals

≤ 20ppm

Residual Solvents

Methanol ≤ 0.3%

Ethanol ≤ 0.5%

Ethyl acetate ≤ 0.5%

Dichloromethane ≤ 0.06%

Acetonitrile ≤ 0.041%

Tetrahydrofuran ≤ 0.072%

Benzene ≤ 0.0002%

Pyridine ≤ 0.02%

N, N-Diisopropylethylamine ≤ 0.1%

N, N-Dimethylacetamide ≤ 0.109%

Methylamine  ≤ 0.1%

Acetic acid ≤ 0.5%

Fumaric Acid

23.9%~26.4%

Purity

(C₁₇H₁₆FN₃O₂S-C₄H₄O₄,

on anhydrous basis)

98.0%~102.0%