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%
114.913417683420553419333420413424093420410.07
214.983493413492263492840.03
单位质量响应值RSD%判断
22940.3823316.691.16数据可信
供试品溶液-第1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%
5min1125944-12594431.60030.1815.4531.6030.1815.45
296045-9604524.09924.10
3112660-11266028.26728.27
4108497-10849727.22327.22
5129576-12957632.51232.51
6148984-14898437.38137.38
10min1280358-28035870.34468.854.5470.4068.904.55
2264879-26487966.46066.50
3268951-26895167.48267.53
4262733-26273365.92265.97
5273118-27311868.52868.58
6296345-29634574.35574.42
15min1369297-36929792.66091.822.8892.8391.992.88
2365561-36556191.72291.87
3361393-36139390.67790.84
4355573-35557389.21689.37
5358898-35889890.05190.22
6385024-38502496.60696.79
20min1398134-39813499.895100.180.96100.22100.500.97
2401779-401779100.810101.11
3401368-401368100.707101.02
4396994-39699499.60999.91
5393393-39339398.70699.02
6403911-403911101.345101.69
30min1397931-39793199.844100.080.94100.34100.560.94
2399994-399994100.362100.83
3401950-401950100.853101.33
4397356-39735699.700100.17
5392794-39279498.55599.04
6403159-403159101.156101.67
45min1396665-39666599.52799.910.92100.18100.560.93
2398903-398903100.088100.73
3400709-400709100.541101.19
4397236-39723699.670100.31
5392549-39254998.49499.14
6403155-403155101.155101.84
极限1396845-39684599.57299.680.99100.39100.501.00
2398472-39847299.980100.79
3399330-399330100.195101.01
4396008-39600899.362100.16
5390705-39070598.03198.84
6402419-402419100.970101.82
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%
114.916878426866566862366864596859996866380.11
214.986862566865286863920.03
单位质量响应值RSD%判断
46052.1845820.560.36数据可信
供试品溶液-第2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%
5min1192689-19268924.34126.728.8724.3426.728.87
2200890-20089025.37725.38
3205538-20553825.96425.96
4202961-20296125.63925.64
5223333-22333328.21228.21
6243810-24381030.79930.80
10min1465056-46505658.74757.716.5458.7957.766.54
2428131-42813154.08354.12
3452776-45277657.19657.24
4419121-41912152.94452.99
5497319-49731962.82362.87
6478895-47889560.49560.55
15min1648965-64896581.97980.562.9282.1280.702.92
2621792-62179278.54678.68
3624309-62430978.86479.00
4618665-61866578.15178.28
5663531-66353183.81983.97
6649297-64929782.02182.17
20min1759797-75979795.97995.441.8396.2595.711.84
2739299-73929993.39093.65
3745390-74539094.16094.43
4746914-74691494.35294.61
5774414-77441497.82698.12
6767293-76729396.92697.22
30min1786864-78686499.399100.020.9799.83100.450.95
2794489-794489100.362100.78
3792813-792813100.150100.58
4804234-804234101.593102.01
5781770-78177098.75599.21
6790450-79045099.852100.30
45min1786219-78621999.31799.851.0999.92100.451.07
2793144-793144100.192100.78
3789547-78954799.738100.33
4805707-805707101.779102.37
5780581-78058198.60599.22
6787201-78720199.441100.06
极限1783242-78324298.94199.641.0999.71100.401.07
2792793-792793100.148100.90
3789585-78958599.742100.50
4803053-803053101.444102.20
5778649-77864998.36199.14
6785143-78514399.18199.96
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%
114.916861846864416859906858646850676859090.08
214.986845416851446848420.07
单位质量响应值RSD%判断
46003.2945717.090.45数据可信
供试品溶液-第1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%
5min1306418-30641838.77238.0413.3138.7738.0413.30
2221509-22150928.02828.03
3304518-30451838.53238.53
4319025-31902540.36740.37
5331174-33117441.90441.90
6321060-32106040.62540.62
10min1595488-59548875.34972.9010.3275.4172.9610.33
2456705-45670557.78857.83
3584631-58463173.97574.04
4598203-59820375.69275.76
5615696-61569677.90677.98
6606210-60621076.70576.77
15min1766071-76607196.93394.278.0597.1294.458.05
2624718-62471879.04779.19
3752728-75272895.24595.43
4764512-76451296.73696.93
5781540-78154098.89099.09
6780386-78038698.74498.94
20min1822396-822396104.060101.674.11104.41102.024.13
2736795-73679593.22993.50
3808804-808804102.340102.69
4819671-819671103.715104.07
5816960-816960103.372103.74
6816593-816593103.326103.69
30min1825836-825836104.495103.640.84105.02104.150.84
2819555-819555103.701104.13
3805833-805833101.964102.48
4820663-820663103.841104.37
5821800-821800103.985104.52
6820800-820800103.858104.39
45min1822848-822848104.117103.410.77104.82104.100.75
2822015-822015104.012104.61
3805573-805573101.931102.62
4818131-818131103.520104.22
5816278-816278103.286104.00
6818705-818705103.593104.30
极限1823311-823311104.176103.340.87105.05104.190.85
2822182-822182104.033104.81
3803632-803632101.686102.54
4817624-817624103.456104.33
5815517-815517103.190104.07
6817748-817748103.472104.35
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%
114.916817606816746813546817816813226815780.04
214.986882656881506882080.02
单位质量响应值RSD%判断
45712.8145941.790.36数据可信
供试品溶液-第2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%
5min1282054-28205435.71532.3818.6435.7132.3818.64
2159080-15908020.14320.14
3275102-27510234.83434.83
4265366-26536633.60133.60
5275812-27581234.92434.92
6276803-27680335.05035.05
10min1545627-54562769.08963.9614.0169.1564.0114.01
2361808-36180845.81345.85
3535229-53522967.77267.83
4521335-52133566.01366.07
5526624-52662466.68366.74
6540029-54002968.38068.44
15min1714613-71461390.48784.7111.4190.6684.8811.42
2515595-51559565.28665.40
3699068-69906888.51888.69
4689455-68945587.30187.47
5681227-68122786.25986.43
6714187-71418790.43390.61
20min1782387-78238799.06894.788.0699.3995.088.08
2627912-62791279.50879.73
3769795-76979597.47497.79
4767769-76776997.21797.53
5754447-75444795.53095.84
6788852-78885299.887100.21
30min1781704-78170498.98297.842.2099.4798.302.23
2751295-75129595.13195.48
3772377-77237797.80198.28
4775868-77586898.24398.72
5756959-75695995.84996.32
6797927-797927101.036101.53
45min1782666-78266699.10497.911.6099.7698.531.62
2764498-76449896.80397.31
3769348-76934897.41798.06
4773904-77390497.99498.63
5757554-75755495.92496.56
6791432-791432100.214100.87
极限1779473-77947398.69997.911.4799.5298.701.48
2770734-77073497.59398.26
3766765-76676597.09097.90
4769857-76985797.48298.28
5760062-76006296.24197.03
6792545-792545100.355101.18
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%
114.916864026857176862046856566860096859980.05
214.986865396864736865060.01
单位质量响应值RSD%判断
46009.2645828.170.28数据可信
供试品溶液-第3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%
5min1256113-25611332.36532.964.9732.3732.974.97
2283419-28341935.81635.82
3252577-25257731.91831.92
4247438-24743831.26931.27
5257709-25770932.56732.57
6267824-26782433.84533.85
10min1510090-51009064.46065.014.2764.5165.074.27
2555537-55553770.20470.26
3493327-49332762.34262.40
4498404-49840462.98463.04
5515353-51535365.12665.18
6514059-51405964.96265.02
15min1696092-69609287.96686.883.8488.1387.043.84
2731318-73131892.41792.59
3655471-65547182.83282.99
4668202-66820284.44184.60
5693457-69345787.63387.80
6680475-68047585.99286.16
20min1790323-79032399.87497.963.54100.1898.263.54
2813470-813470102.799103.13
3739105-73910593.40193.70
4761431-76143196.22396.52
5790181-79018199.856100.16
6756424-75642495.59095.90
30min1794083-794083100.34998.863.25100.8299.343.24
2814979-814979102.990103.49
3748651-74865194.60895.06
4773687-77368797.77198.23
5801287-801287101.259101.73
6761343-76134396.21296.68
45min1798328-798328100.88598.803.39101.5399.443.38
2813865-813865102.849103.52
3745337-74533794.18994.80
4773657-77365797.76898.39
5799837-799837101.076101.72
6760048-76004896.04896.68
极限1793924-793924100.32998.473.46101.1499.283.46
2812057-812057102.620103.47
3741228-74122893.67094.44
4771262-77126297.46598.25
5798723-798723100.935101.75
6758318-75831895.82996.62
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