氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.59 6799756786766820396816556790716802830.23
214.56 6768416779586774000.12
单位质量响应值RSD%判断
46626.6646524.730.16数据可信
供试品溶液-H042批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227895-22789528.39326.0121.7528.3926.0221.74
2233725-23372529.11929.12
3238867-23886729.76029.76
4123658-12365815.40615.41
5190839-19083923.77623.78
6237797-23779729.62729.63
10min1470553-47055358.62555.506.6558.6755.556.65
2455613-45561356.76456.81
3474229-47422959.08359.13
4396432-39643249.39149.42
5425750-42575053.04353.08
6450445-45044556.12056.17
15min1645901-64590180.47177.653.2980.6277.783.30
2630398-63039878.54078.68
3646589-64658980.55780.71
4600762-60076274.84874.96
5607661-60766175.70775.84
6608004-60800475.75075.89
20min1754818-75481894.04192.591.8994.3292.861.90
2749146-74914693.33593.61
3762070-76207094.94595.23
4731439-73143991.12891.36
5733494-73349491.38491.64
6728141-72814190.71890.99
30min1821350-821350102.330102.110.47102.77102.540.49
2820324-820324102.202102.63
3824724-824724102.751103.19
4814983-814983101.537101.92
5815259-815259101.571101.98
6821067-821067102.295102.72
45min1820394-820394102.211101.930.45102.82102.520.46
2816500-816500101.726102.33
3821289-821289102.323102.93
4815029-815029101.543102.10
5813526-813526101.356101.93
6822310-822310102.450103.04
极限1816971-816971101.785101.680.51102.56102.440.52
2815154-815154101.558102.33
3822086-822086102.422103.20
4811518-811518101.105101.83
5812032-812032101.169101.91
6819053-819053102.044102.81
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.59 6748686751426751696761216758946754390.08
214.56 6742516749696746100.08
单位质量响应值RSD%判断
46294.6546333.100.06数据可信
供试品溶液-H042批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194675-19467524.39127.7413.3824.3927.7413.37
2175006-17500621.92721.93
3235296-23529629.48129.48
4237120-23712029.70929.71
5251285-25128531.48431.48
6234831-23483129.42229.42
10min1410633-41063351.44955.235.9351.4955.285.93
2422466-42246652.93252.97
3476895-47689559.75159.80
4441322-44132255.29455.34
5466705-46670558.47458.53
6426939-42693953.49253.54
15min1598032-59803274.92977.572.5975.0677.712.59
2619445-61944577.61277.74
3642918-64291880.55380.70
4620170-62017077.70277.84
5628543-62854378.75178.90
6605657-60565775.88476.02
20min1728829-72882991.31792.551.4391.5792.821.44
2735342-73534292.13392.39
3753472-75347294.40494.69
4743043-74304393.09793.37
5745483-74548393.40393.68
6725870-72587090.94691.21
30min1827133-827133103.633102.730.59104.04103.150.58
2815116-815116102.128102.54
3814349-814349102.031102.47
4822621-822621103.068103.49
5819942-819942102.732103.17
6820381-820381102.787103.20
45min1828998-828998103.867102.700.64104.44103.300.63
2816150-816150102.257102.84
3814880-814880102.098102.71
4821908-821908102.979103.58
5816502-816502102.301102.91
6819892-819892102.726103.31
极限1826199-826199103.516102.450.71104.27103.220.70
2814764-814764102.083102.83
3809353-809353101.406102.19
4821318-821318102.905103.67
5816507-816507102.302103.08
6818110-818110102.503103.26
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.59 6828576832886834526827366829426830550.05
214.56 6810286803196806740.08
单位质量响应值RSD%判断
46816.6646749.590.11数据可信
供试品溶液-H042批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213383-21338326.46726.3314.2526.4726.3314.25
2229952-22995228.52228.52
3154244-15424419.13219.13
4238426-23842629.57329.57
5211114-21111426.18626.19
6226688-22668828.11728.12
10min1470141-47014158.31456.134.8858.3656.174.89
2462636-46263657.38357.43
3431572-43157253.53053.56
4480250-48025059.56859.62
5424852-42485252.69752.74
6445528-44552855.26155.31
15min1612695-61269575.99676.073.3676.1476.223.36
2633789-63378978.61278.76
3588414-58841472.98473.11
4639845-63984579.36379.51
5594056-59405673.68473.82
6611172-61117275.80775.95
20min1744999-74499992.40691.251.7792.6791.521.78
2747247-74724792.68592.96
3725751-72575190.01990.26
4747179-74717992.67792.96
5716103-71610388.82289.08
6732775-73277590.89091.16
30min1813924-813924100.955100.420.63101.38100.840.63
2810114-810114100.483100.91
3812621-812621100.794101.19
4803972-80397299.721100.16
5802742-80274299.56899.97
6814321-814321101.005101.42
45min1814389-814389101.013100.110.94101.60100.690.94
2804195-80419599.749100.34
3811563-811563100.663101.22
4806576-806576100.044100.65
5793691-79369198.44699.01
6812086-812086100.727101.31
极限1812220-812220100.74499.960.49101.50100.710.49
2807056-807056100.104100.87
3802927-80292799.591100.32
4803846-80384699.705100.47
5801710-80171099.440100.17
6807785-807785100.194100.95
氢溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.59 6823526824386820356825346828756824470.05
214.56 6790816792146791480.02
单位质量响应值RSD%判断
46774.9846644.780.20数据可信
供试品溶液-H042批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117352-11735214.57920.9125.1614.5820.9125.16
2174147-17414721.63421.63
3155819-15581919.35719.36
4231963-23196328.81728.82
5132782-13278216.49616.50
6197686-19768624.55924.56
10min1326519-32651940.56349.8412.7140.5949.8712.72
2402300-40230049.97850.01
3406065-40606550.44550.48
4468882-46888258.24958.30
5364204-36420445.24545.27
6439093-43909354.54954.59
15min1527905-52790565.58272.536.3965.6772.656.41
2584952-58495272.66972.79
3599452-59945274.47074.59
4633583-63358378.71078.86
5555621-55562169.02569.13
6601357-60135774.70774.84
20min1679051-67905184.35987.733.1084.5687.963.12
2709078-70907888.08988.33
3709524-70952488.14488.38
4740592-74059292.00492.28
5686023-68602385.22585.44
6712742-71274288.54488.80
30min1804749-80474999.974100.090.61100.32100.480.58
2810797-810797100.725101.11
3806905-806905100.242100.63
4797781-79778199.10899.54
5810354-810354100.670101.03
6803545-80354599.824100.23
45min1807037-807037100.258100.350.46100.77100.910.45
2809482-809482100.562101.12
3804664-80466499.963100.52
4811150-811150100.769101.36
5811797-811797100.850101.38
6802700-80270099.720100.29
极限1805669-805669100.08899.890.56100.76100.600.54
2800243-80024399.414100.14
3803487-80348799.817100.54
4805253-805253100.037100.80
5811142-811142100.768101.46
6798488-79848899.19699.93
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