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%
114.616714316718476724576714806718516718130.07
214.606700456714516707480.15
单位质量响应值RSD%判断
45983.0945941.640.07数据可信
供试品溶液-2025011021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%
5min1250673-25067331.64829.975.2531.6529.975.25
2230354-23035429.08229.08
3227609-22760928.73628.74
4252492-25249231.87731.88
5240538-24053830.36830.37
6222736-22273628.12028.12
10min1530199-53019966.93865.083.6166.9965.133.61
2531358-53135867.08467.13
3499205-49920563.02563.07
4529532-52953266.85466.91
5515503-51550365.08265.13
6487224-48722461.51261.56
15min1719899-71989990.88789.382.5991.0589.542.59
2725894-72589491.64491.80
3695616-69561687.82287.97
4716190-71619090.41990.58
5713227-71322790.04590.20
6676979-67697985.46985.62
20min1788250-78825099.51798.682.3399.8398.992.33
2796752-796752100.590100.90
3766658-76665896.79197.09
4787797-78779799.46099.77
5797982-797982100.745101.05
6752372-75237294.98795.28
30min1787414-78741499.41199.271.7599.8999.741.75
2796256-796256100.528101.01
3776544-77654498.03998.50
4793264-793264100.150100.63
5800310-800310101.039101.52
6763988-76398896.45496.90
45min1785622-78562299.18599.001.7399.8399.641.73
2793747-793747100.211100.86
3775553-77555397.91498.54
4791369-79136999.911100.56
5797370-797370100.668101.31
6761310-76131096.11696.73
极限1782988-78298898.85298.811.7399.6799.611.74
2793133-793133100.133100.95
3773867-77386797.70198.49
4789910-78991099.726100.54
5795664-795664100.453101.27
6760235-76023595.98096.75
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%
114.616707106701096712826708606708006707520.07
214.606699196700166699680.02
单位质量响应值RSD%判断
45910.4745888.220.04数据可信
供试品溶液-2025011021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%
5min1227042-22704228.70329.495.8628.7029.495.86
2256450-25645032.42132.42
3233522-23352229.52329.52
4218670-21867027.64527.65
5223644-22364428.27428.27
6240379-24037930.39030.39
10min1495203-49520362.60565.573.5962.6565.623.59
2551515-55151569.72569.78
3523992-52399266.24566.29
4514343-51434365.02565.07
5514159-51415965.00265.05
6512854-51285464.83764.89
15min1688722-68872287.07189.812.1287.2289.972.12
2730993-73099392.41592.59
3719325-71932590.94091.10
4716533-71653390.58790.74
5706116-70611689.27089.43
6700686-70068688.58388.74
20min1762877-76287796.44699.061.5596.7499.361.55
2792639-792639100.208100.53
3795528-795528100.574100.88
4782347-78234798.90799.21
5790258-79025899.907100.21
6777614-77761498.30998.62
30min1782211-78221198.89099.750.9499.35100.220.95
2793724-793724100.345100.84
3797795-797795100.860101.34
4783660-78366099.07399.54
5795337-795337100.549101.02
6781352-78135298.78199.25
45min1782390-78239098.91399.601.0599.54100.241.05
2793117-793117100.269100.93
3797969-797969100.882101.53
4781474-78147498.79799.43
5794060-794060100.388101.03
6777836-77783698.33798.97
极限1786202-78620299.39599.440.89100.18100.250.89
2789460-78946099.806100.63
3793870-793870100.364101.18
4780519-78051998.67699.48
5792976-792976100.251101.06
6776446-77644698.16198.96
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%
114.616712816716326715736710376711876713420.04
214.606710126704256707180.07
单位质量响应值RSD%判断
45950.8645939.590.02数据可信
供试品溶液-2025011121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%
5min1256838-25683832.43830.683.9232.4430.683.92
2231188-23118829.19829.20
3234526-23452629.62029.62
4240511-24051130.37630.38
5248972-24897231.44531.44
6245654-24565431.02531.03
10min1535013-53501367.57165.723.8867.6265.773.88
2512147-51214764.68364.73
3535792-53579267.66967.72
4533711-53371167.40667.46
5521537-52153765.86965.92
6483859-48385961.11061.16
15min1720301-72030190.97289.603.4191.1489.763.41
2710028-71002889.67589.83
3730893-73089392.31092.47
4726198-72619891.71791.88
5704706-70470689.00389.16
6664292-66429283.89884.05
20min1787775-78777599.49499.381.6799.8199.681.67
2787647-78764799.47899.78
3795468-795468100.466100.78
4796958-796958100.654100.97
5791888-791888100.013100.32
6761291-76129196.14996.44
30min1794027-794027100.284100.541.22100.77101.011.22
2790825-79082599.879100.35
3796471-796471100.592101.08
4800469-800469101.097101.58
5811556-811556102.497102.97
6782843-78284398.87199.32
45min1791995-791995100.027100.111.31100.68100.761.31
2783498-78349898.95499.59
3792591-792591100.102100.75
4797134-797134100.676101.33
5809822-809822102.278102.93
6781101-78110198.65199.27
极限1796668-796668100.617100.211.34101.44101.021.34
2783954-78395499.01199.81
3793369-793369100.200101.02
4796952-796952100.653101.47
5809629-809629102.254103.07
6779945-77994598.50599.29
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%
114.616704346705506699276700476695216700960.07
214.606696346696396696360.01
单位质量响应值RSD%判断
45865.5745865.480.01数据可信
供试品溶液-2025011121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%
5min1226396-22639628.64328.789.3328.6428.789.33
2228766-22876628.94328.94
3245730-24573031.08931.09
4186776-18677623.63023.63
5240756-24075630.46030.46
6236441-23644129.91429.91
10min1505976-50597664.01464.096.2164.0664.136.21
2523368-52336866.21566.26
3534106-53410667.57367.63
4445315-44531556.34056.38
5515701-51570165.24565.30
6514745-51474565.12465.17
15min1720921-72092191.20988.923.2791.3689.073.27
2723793-72379391.57291.73
3719283-71928391.00191.17
4665744-66574484.22884.36
5688935-68893587.16287.32
6698208-69820888.33588.49
20min1794951-794951100.57598.682.05100.8898.992.05
2790571-790571100.021100.33
3793659-793659100.411100.73
4774745-77474598.01898.29
5754563-75456395.46595.77
6771520-77152097.61097.92
30min1796224-796224100.73699.611.83101.21100.081.81
2798045-798045100.966101.44
3789774-78977499.920100.40
4801050-801050101.346101.78
5768055-76805597.17297.64
6770934-77093497.53698.00
45min1794747-794747100.54999.431.90101.19100.061.89
2793575-793575100.401101.05
3786234-78623499.472100.12
4804337-804337101.762102.37
5765901-76590196.89997.53
6770600-77060097.49498.12
极限1796705-796705100.79799.291.74101.61100.091.73
2791386-791386100.124100.94
3787105-78710599.582100.40
4797644-797644100.915101.69
5766884-76688497.02497.81
6768996-76899697.29198.08
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