托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.373979913978683968213980623978033977090.13
216.343997163992893995020.08
单位质量响应值RSD%判断
24294.9924449.330.45数据可信
供试品溶液-2025032921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141534-4153410.22510.281.3510.2310.281.33
242326-4232610.42010.42
341553-4155310.23010.23
441765-4176510.28210.28
540976-4097610.08810.09
642506-4250610.46410.46
10min184917-8491720.90521.000.9920.9221.010.99
285003-8500320.92620.94
385187-8518720.97220.99
486875-8687521.38721.40
584395-8439520.77720.79
685395-8539521.02321.04
15min1116078-11607828.57728.740.8928.6328.790.89
2115420-11542028.41528.47
3116154-11615428.59528.65
4118262-11826229.11429.17
5117351-11735128.89028.94
6117142-11714228.83928.89
20min1140333-14033334.54834.980.8534.6535.080.86
2141247-14124734.77334.87
3142191-14219135.00535.10
4143819-14381935.40635.51
5142244-14224435.01835.12
6142761-14276135.14635.25
30min1177473-17747343.69144.141.0643.8544.301.05
2178855-17885544.03144.19
3179117-17911744.09644.25
4182942-18294245.03845.20
5178516-17851643.94844.11
6178770-17877044.01044.17
45min1215132-21513252.96253.340.7053.1953.580.70
2217985-21798553.66553.90
3215151-21515152.96753.20
4218843-21884353.87654.11
5216878-21687853.39253.62
6216108-21610853.20353.44
60min1243242-24324259.88360.340.6360.2060.660.63
2246606-24660660.71161.03
3244769-24476960.25860.58
4247056-24705660.82161.15
5245175-24517560.35860.68
6243656-24365659.98460.31
90min1279146-27914668.72269.210.6569.1469.630.65
2282475-28247569.54169.96
3281947-28194769.41169.83
4283427-28342769.77570.20
5280875-28087569.14769.57
6278951-27895168.67469.09
120min1301890-30189074.32174.951.0274.8575.491.02
2303168-30316874.63575.17
3305594-30559475.23375.77
4309904-30990476.29476.84
5304601-30460174.98875.52
6301545-30154574.23674.77
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1313653-31365377.21778.121.1777.8778.781.17
2318664-31866478.45079.11
3317350-31735078.12778.79
4323742-32374279.70080.37
5316689-31668977.96478.63
6313873-31387377.27177.93
240min1-0.0000.00-0.790.790.52
2-0.0000.79
3-0.0000.79
4-0.0000.80
5-0.0000.79
6-0.0000.79
极限1-0.0000.00-0.790.790.52
2-0.0000.79
3-0.0000.79
4-0.0000.80
5-0.0000.79
6-0.0000.79
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.373992054002764004124003493999104000300.13
216.343994454007014000730.23
单位质量响应值RSD%判断
24436.7724484.270.14数据可信
供试品溶液-2025032921批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143387-4338710.64310.073.3510.6410.073.33
240976-4097610.05110.05
339905-399059.7889.79
441903-4190310.27910.28
540274-402749.8799.88
639895-398959.7869.79
10min187602-8760221.48821.243.7821.5121.253.78
285496-8549620.97220.99
384461-8446120.71820.73
484888-8488820.82220.84
592762-9276222.75422.77
684218-8421820.65820.67
15min1116520-11652028.58228.142.2028.6428.192.21
2115713-11571328.38428.44
3110796-11079627.17827.23
4117349-11734928.78528.84
5112506-11250627.59727.65
6115322-11532228.28828.34
20min1141835-14183534.79134.361.4234.8934.461.42
2139833-13983334.30034.40
3136357-13635733.44733.54
4141643-14164334.74434.84
5140200-14020034.39034.49
6140592-14059234.48634.58
30min1178268-17826843.72843.201.8043.8943.361.80
2177091-17709143.43943.60
3169932-16993241.68341.84
4178050-17805043.67443.83
5175735-17573543.10743.26
6177667-17766743.58143.74
45min1216281-21628153.05252.242.5353.2852.462.52
2214924-21492452.71952.95
3202170-20217049.59149.81
4215227-21522752.79453.02
5213430-21343052.35352.58
6215690-21569052.90753.14
60min1244626-24462660.00559.033.0060.3359.352.99
2242083-24208359.38159.70
3226106-22610655.46255.77
4244692-24469260.02160.34
5242701-24270159.53359.85
6243778-24377859.79760.11
90min1281927-28192769.15567.334.0569.5867.754.04
2278550-27855068.32668.74
3252100-25210061.83862.23
4279211-27921168.48968.91
5277064-27706467.96268.38
6278127-27812768.22368.64
120min1304265-30426574.63473.014.1575.1773.534.14
2301503-30150373.95774.49
3272575-27257566.86167.36
4303496-30349674.44674.98
5300732-30073273.76874.30
6303208-30320874.37574.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1312875-31287576.74675.963.8777.4176.613.86
2312955-31295576.76677.42
3285526-28552670.03870.65
4316771-31677177.70278.36
5313607-31360776.92677.58
6316365-31636577.60278.26
240min1-0.0000.00-0.790.782.92
2-0.0000.78
3-0.0000.73
4-0.0000.79
5-0.0000.78
6-0.0000.78
极限1-0.0000.00-0.790.782.92
2-0.0000.78
3-0.0000.73
4-0.0000.79
5-0.0000.78
6-0.0000.78
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.374004154006524012974005153996784005110.15
216.344076754069554073150.13
单位质量响应值RSD%判断
24466.1624927.481.33数据可信
供试品溶液-2025032921批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141501-4150110.08310.162.0010.0810.161.99
241546-4154610.09410.09
343357-4335710.53410.53
440934-409349.9469.95
542076-4207610.22310.22
641501-4150110.08310.08
10min178376-7837619.04319.072.2119.0619.092.20
278549-7854919.08519.10
381424-8142419.78319.80
476018-7601818.47018.49
578569-7856919.09019.11
678019-7801918.95618.97
15min1106749-10674925.93725.741.0925.9925.791.09
2106238-10623825.81225.86
3107507-10750726.12126.17
4104462-10446225.38125.43
5105917-10591725.73425.78
6104816-10481625.46725.52
20min1128809-12880931.29631.221.2931.3931.311.29
2128749-12874931.28231.37
3131105-13110531.85431.95
4126130-12613030.64530.74
5128686-12868631.26731.36
6127451-12745130.96631.06
30min1162474-16247439.47639.381.0039.6239.531.01
2161919-16191939.34139.48
3164715-16471540.02040.17
4160456-16045638.98639.13
5162659-16265939.52139.66
6160352-16035238.96039.10
45min1197847-19784748.07048.010.7548.2848.220.75
2198459-19845948.21948.43
3199970-19997048.58648.80
4196918-19691847.84548.05
5196526-19652647.74947.96
6195907-19590747.59947.81
60min1222545-22254554.07154.160.6954.3654.460.70
2224217-22421754.47754.77
3225384-22538454.76155.06
4221880-22188053.91054.20
5222095-22209553.96254.25
6221445-22144553.80454.09
90min1258661-25866162.84662.400.8663.2362.780.86
2259264-25926462.99363.37
3258324-25832462.76463.15
4255132-25513261.98962.36
5254060-25406061.72862.11
6255413-25541362.05762.43
120min1281673-28167368.43768.200.6968.9268.690.69
2282712-28271268.69069.18
3282240-28224068.57569.07
4279753-27975367.97168.45
5277549-27754967.43567.92
6280368-28036868.12068.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1308848-30884875.04074.780.5275.6475.380.52
2309689-30968975.24475.84
3308864-30886475.04475.65
4307199-30719974.63975.23
5306737-30673774.52775.12
6305452-30545274.21574.81
240min1325714-32571479.13878.690.5779.8679.420.57
2325114-32511478.99279.72
3325554-32555479.09979.83
4322994-32299478.47779.19
5322730-32273078.41379.13
6321209-32120978.04378.76
极限1328577-32857779.83479.540.3180.6980.390.32
2327238-32723879.50880.37
3328164-32816479.73380.60
4326091-32609179.23080.08
5327821-32782179.65080.50
6326276-32627679.27480.12
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