The standard of UTP is as follow:
TestsSpecificationsResultsAppearanceWhite or almost white loose mass or powderWhite loose powderIdentificationHave the largest absorption at λ=262±2nm
262±2nm
A250/A260=0.70-0.80
A280/A260=0.33-0.43263.0nm
A250/A260=0.73
A280/A260=0.37 The retention time of the principal peak of the substance being examined in the chromatogram obtained in the Assay is identical with that of the principal peak obtained in the chromatogram of the reference solution.
,CompliesThe infrared absorption spectrum is concordant with the reference spectrum of working standard.CompliesClarity and Color
of solution
The solutions are clear and colourless;any opalescence produced is not more pronounced than that of reference suspension ;any colour produced is not more intense than that of reference solution Y1.
;,1,;,1,:<1
:<1pH()3.0-7.04.90Water content(Karl Fischer)
()≤15.0%9.40%Chloride≤0.2%<0.2%ProteinNo turbidity is producedCompliesPurity(HPLC)≥90.0%97.84%Assay(on dried basis)
()≥90.0%99.11%ConclusionMeets the requirements of Q/CHBTT001-2018.
Q/CHBTT001-2018,.
Storage: The product is heat-labile.Preserve in a cool(-20±5)ºC and dry place , and away from light
:,(-20±5)ºC.