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OBJECTIVE:To establish a method for the determination of ethanol,acetonitrile,dichloromethane,ethyl acetate, pyridine in vidarabine monophosphate. METHODS:Headspace GC was performed on the column of Agilent DB-624,programmed temperature,inlet temperature was 200 ℃,the detector was flame ionization detector,detecting temperature was 250 ℃,nitrogen was carrier gas,flow rate was 3 ml/min,split ratio was 1∶1,the top bottles equilibrium temperature was 100 ℃,and equilibrium time was 45 min,injection volume was 1 ml. external standard was used for quantitative analysis. RESULTS:The peaks of five re-sidual solvents could be completely separated from the other peaks respectively,The linear rang was 24.7-296.3 μg/ml for ethanol (r=0.999 6)、1.9-23.2 μg/ml for acetonitrile(r=0.999 0),2.8-33.6 μg/ml for dichloromethane(r=0.998 0),24.7-295.9 μg/ml for ethyl acetate(r=0.999 5),1.0-11.9 μg/ml for pyridine(r=0.998 6);RSDs of precision and reproducibility tests were lower than 4.35%;recoveries were 102.4%(RSD=2.0%,n=9)、102.1%(RSD=3.4%,n=9)、105.5%(RSD=4.8%,n=9)、100.3%(RSD=4.8%, n=9)、98.3%(RSD=4.0%,n=9). The minimum quantifation limit was 0.304 4-0.988 0 μg/ml and the minimum detection limit was 0.101 5-0.329 3 μg/ml. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for the determination of residual solvents in vidarabine monophosphate.
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Objective To establish a HPLC method for the determination of preservative in iron maltose syrup.Methods A Kromasil 100-5 C18 column was used with acetonitrile-sodium acetate buffer solution(40 ︰60) as the mobile phase at the flow rate of 1.0 mL/min and 254 nm as the detection wavelength.The column temperature was set at 30 ℃.Results The calibration curve was linear within the range of 0.62 ~3.72 μg/mL for methyl parahydroxybenzoate, 0.18~1.07μg/mL for propyl parahydroxybenzoate, and the linear equation was Y=228494X-2512.5,Y=203351X-3471.4, respectively.The average recovery of methyl parahydroxybenzoate, propyl parahydroxybenzoate was 100.9%(RSD=1.5%),99.6%(RSD=0.5%), respectively.Conclusion The established method is simple, rapid and accurate, which could be used in the determination of preservative in iron maltose syrup.
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Objective To establish a method for determining the molecular weight (Mw) and molecular weight distribution of Iron Maltose Syrup. Methods HPGPC was used; PSS HEMA was used as column.Detector was differential refraction detector.Mobile phase was phosphate buffer solution (pH6.8) at 0.5 mL/min, column temperature was 45℃.Results The Mw of 3 batches of Iron Maltose Syrup were 45000-47000 Da with good linearity, precision and reproducibility.Conclusion The method is simple, reliable and accepted by the specification for controlling the molecular weight and weight distribution of Iron Maltose Syrup.
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Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.
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<p><b>OBJECTIVE</b>To find an inhibitor to reduce the volatilization of formalin.</p><p><b>METHOD</b>The saturated solution of sodium hydrosulphite (SHS) was sprayed on the surface of the anatomy specimens, then the concentration of formaldehyde in the air was tested.</p><p><b>RESULTS</b>The concentration of formaldehyde in the air of SHS sprayed group [(3.10 +/- 1.22) mg/m3] was significantly lower than that of the control group [(8.36 +/- 4.11) mg/m3, P < 0.01].</p><p><b>CONCLUSION</b>SHS may be a volatilization inhibitor for formalin, which could reduce the concentration of formaldehyde in the air.</p>