氨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%
114.613359053356063358353362543360863359370.08
214.603367633365213366420.06
单位质量响应值RSD%判断
22993.6323057.670.20数据可信
供试品溶液-2025011421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%
5min1141237-14123735.59438.156.3835.5938.146.38
2157162-15716239.60739.61
3159753-15975340.26040.26
4147902-14790237.27337.27
5139955-13995535.27135.27
6162170-16217040.86940.87
10min1312983-31298378.87680.492.7778.9480.552.77
2331763-33176383.60983.67
3321857-32185781.11281.18
4308690-30869077.79477.86
5314484-31448479.25479.31
6326552-32655282.29582.36
15min1389037-38903798.04397.501.7598.2397.701.75
2399131-399131100.586100.79
3383991-38399196.77196.97
4381558-38155896.15896.35
5380768-38076895.95996.15
6386936-38693697.51397.72
20min1394722-39472299.47599.001.4099.8399.361.40
2401375-401375101.152101.52
3395763-39576399.738100.10
4390246-39024698.34798.70
5387408-38740897.63297.98
6387406-38740697.63298.00
30min1393991-39399199.29198.771.4299.8199.291.42
2401073-401073101.076101.62
3393790-39379099.24099.77
4389361-38936198.12498.64
5386558-38655897.41897.93
6386737-38673797.46397.99
45min1396071-39607199.81598.631.48100.5099.321.48
2399386-399386100.651101.36
3393436-39343699.15199.85
4387928-38792897.76398.44
5385991-38599197.27597.95
6385464-38546497.14297.84
极限1392553-39255398.92998.351.3699.7899.211.36
2398469-398469100.420101.30
3392533-39253398.92499.78
4388302-38830297.85798.70
5384883-38488396.99697.83
6384883-38488396.99697.85
氨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%
114.613362643362743363923360073360553361980.05
214.603350583357913354240.16
单位质量响应值RSD%判断
23011.5022974.250.12数据可信
供试品溶液-2025011421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%
5min1161975-16197540.87840.504.7040.8840.504.70
2159703-15970340.30540.30
3146114-14611436.87536.88
4167618-16761842.30242.30
5164921-16492141.62241.62
6162612-16261241.03941.04
10min1337435-33743585.15981.757.0385.2381.827.03
2326581-32658182.42082.49
3278283-27828370.23170.29
4336745-33674584.98585.06
5334860-33486084.50984.58
6329765-32976583.22483.29
15min1410669-410669103.64298.845.17103.8599.045.17
2391449-39144998.79199.00
3352981-35298189.08389.26
4401478-401478101.322101.53
5401136-401136101.236101.45
6392158-39215898.97099.18
20min1410318-410318103.553101.242.02103.94101.612.03
2404801-404801102.161102.53
3386415-38641597.52097.85
4404205-404205102.010102.39
5401218-401218101.256101.64
6400046-400046100.961101.33
30min1409555-409555103.360101.301.66103.92101.841.68
2404377-404377102.054102.59
3389681-38968198.34598.83
4403934-403934101.942102.49
5400613-400613101.104101.65
6400203-400203101.000101.54
45min1408837-408837103.179100.781.60103.91101.491.62
2396943-396943100.177100.89
3389396-38939698.27398.93
4402348-402348101.542102.26
5399552-399552100.836101.55
6398895-398895100.670101.38
极限1408742-408742103.155100.991.78104.05101.871.79
2405497-405497102.336103.21
3388242-38824297.98298.80
4401391-401391101.300102.19
5399613-399613100.851101.74
6397544-397544100.329101.21
氨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%
114.613360433357913361613361603362643360840.06
214.603358533353923356220.10
单位质量响应值RSD%判断
23003.7022987.810.05数据可信
供试品溶液-2025011521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%
5min1179269-17926945.23741.059.9945.2441.059.99
2165268-16526841.70441.70
3139877-13987735.29735.30
4165070-16507041.65441.65
5147295-14729537.16937.17
6179294-17929445.24345.24
10min1339148-33914885.58182.094.6785.6682.164.67
2333239-33323984.09084.16
3320182-32018280.79580.85
4325727-32572782.19482.26
5297712-29771275.12575.19
6335779-33577984.73184.81
15min1387091-38709197.67997.511.4097.9097.711.41
2384493-38449397.02397.23
3385340-38534097.23797.43
4390135-39013598.44798.65
5377812-37781295.33795.52
6393598-39359899.32199.54
20min1390817-39081798.61998.880.9199.0099.240.91
2387278-38727897.72698.10
3397156-397156100.219100.57
4391983-39198398.91399.28
5389303-38930398.23798.58
6394457-39445799.53899.92
30min1389902-38990298.38898.990.7698.9399.520.76
2394720-39472099.604100.14
3395961-39596199.917100.44
4391510-39151098.79499.33
5388199-38819997.95898.47
6393348-39334899.25899.81
45min1389912-38991298.39198.520.9399.1099.220.93
2385398-38539897.25297.95
3395500-39550099.801100.49
4390762-39076298.60599.31
5387871-38787197.87698.55
6393100-39310099.19599.91
极限1388872-38887298.12898.210.8799.0099.060.86
2385431-38543197.26098.12
3394608-39460899.576100.43
4387756-38775697.84798.71
5386881-38688197.62698.46
6391509-39150998.79499.67
氨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%
114.613359803363223361543359583359443360720.05
214.603357373356333356850.03
单位质量响应值RSD%判断
23002.8722992.120.04数据可信
供试品溶液-2025011521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%
5min1168231-16823142.44840.995.5842.4540.995.58
2156996-15699639.61339.61
3172051-17205143.41243.41
4147824-14782437.29937.30
5168671-16867142.55942.56
6160875-16087540.59240.59
10min1330317-33031783.34681.923.6883.4281.993.69
2316218-31621879.78979.85
3336421-33642184.88684.96
4304457-30445776.82176.88
5330410-33041083.37083.44
6330148-33014883.30383.37
15min1390237-39023798.46598.402.0598.6798.602.05
2385467-38546797.26297.46
3391519-39151998.78999.00
4383162-38316296.68096.87
5384559-38455997.03297.24
6404811-404811102.143102.35
20min1395424-39542499.77499.531.35100.1599.901.35
2389528-38952898.28698.65
3395965-39596599.910100.29
4391781-39178198.85599.21
5390232-39023298.46498.84
6403879-403879101.907102.28
30min1395705-39570599.84599.151.36100.3899.681.36
2388428-38842898.00998.53
3391000-39100098.65899.20
4391121-39112198.68899.20
5389051-38905198.16698.70
6402462-402462101.550102.10
45min1394865-39486599.63398.901.47100.3499.601.46
2387980-38798097.89698.58
3389524-38952498.28598.99
4388928-38892898.13598.82
5388038-38803897.91098.61
6402402-402402101.535102.25
极限1393838-39383899.37498.611.41100.2599.471.41
2385678-38567897.31598.17
3388340-38834097.98798.86
4389283-38928398.22499.07
5387178-38717897.69398.56
6400463-400463101.045101.93
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