苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.299717497095970789665496120968240.46
219.319652296627965740.08
单位质量响应值RSD%判断
5019.395001.240.26数据可信
加速6月-供试品溶液-2025042321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%
5min196564-9656498.448100.131.7198.45100.121.71
298508-98508100.430100.43
3101101-101101103.074103.07
498285-98285100.203100.20
596513-9651398.39698.40
698282-98282100.200100.20
10min197674-9767499.580100.671.4499.74100.831.44
299011-99011100.943101.11
3100923-100923102.892103.06
499184-99184101.120101.29
596769-9676998.65798.82
698871-98871100.800100.97
15min197240-9724099.138100.381.5599.47100.711.55
298484-98484100.406100.74
3100728-100728102.694103.04
498844-98844100.773101.11
596356-9635698.23698.56
699093-99093101.027101.36
20min197930-9793099.841101.031.44100.34101.531.44
299102-99102101.036101.54
3101255-101255103.231103.75
499543-99543101.486101.99
597172-9717299.06899.56
699550-99550101.493102.00
30min197651-9765199.557100.691.54100.22101.361.54
298665-98665100.590101.26
3101187-101187103.162103.85
499013-99013100.945101.62
596765-9676598.65399.31
699295-99295101.233101.91
45min196743-9674398.631100.271.6899.46101.101.68
298552-98552100.475101.31
3101093-101093103.066103.92
498657-98657100.582101.42
596520-9652098.40499.23
698525-98525100.448101.29
极限197026-9702698.919100.021.4599.91101.031.45
298087-98087100.001101.01
3100377-100377102.336103.37
498364-98364100.284101.29
596248-9624898.12699.11
698557-98557100.480101.49
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.299646396326963679650596295963910.10
219.319645796498964780.04
单位质量响应值RSD%判断
4996.944996.270.01数据可信
加速6月-供试品溶液-2025042322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%
5min197102-9710299.26899.201.5699.2799.201.56
297299-9729999.47099.47
396179-9617998.32598.32
499840-99840102.067102.07
595706-9570697.84197.84
696100-9610098.24498.24
10min197085-9708599.25199.511.9099.4299.681.89
297961-97961100.146100.31
396750-9675098.90899.07
4100463-100463102.704102.87
594844-9484496.96097.12
696944-9694499.10799.27
15min197506-9750699.68199.701.75100.01100.041.75
297977-97977100.163100.50
397064-9706499.22999.56
4100505-100505102.747103.09
595401-9540197.52997.85
696723-9672398.88199.21
20min197394-9739499.56799.481.71100.0699.981.71
297717-9771799.897100.40
396716-9671698.87499.37
4100271-100271102.508103.02
595390-9539097.51898.01
696381-9638198.53199.02
30min197289-9728999.45999.481.75100.12100.151.75
297684-9768499.863100.53
397060-9706099.22599.88
4100336-100336102.574103.26
595368-9536897.49698.15
696139-9613998.28498.94
45min196939-9693999.10299.231.7199.93100.061.71
297807-9780799.989100.82
396582-9658298.73799.56
499883-99883102.111102.97
595065-9506597.18698.00
696092-9609298.23699.06
极限196752-9675298.91099.011.6199.90100.001.61
297256-9725699.426100.42
396433-9643398.58499.57
499539-99539101.760102.78
594782-9478296.89697.87
696313-9631398.46299.45
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.299647296219965639636096545964320.15
219.319599096087960380.08
单位质量响应值RSD%判断
4999.074973.490.37数据可信
加速6月-供试品溶液-2025042421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%
5min196294-9629498.64799.382.5898.6599.382.58
296938-9693899.30799.31
393170-9317095.44695.45
4100102-100102102.548102.55
599394-99394101.823101.82
696160-9616098.50998.51
10min198226-98226100.626100.462.21100.79100.632.21
297024-9702499.39599.56
394931-9493197.25097.41
4101091-101091103.561103.73
599748-99748102.185102.35
697382-9738299.76199.93
15min198097-98097100.494100.312.28100.83100.642.28
296762-9676299.12699.46
394690-9469097.00497.32
4101015-101015103.483103.83
599638-99638102.072102.41
697282-9728299.65999.99
20min198514-98514100.921100.972.23101.42101.472.22
297575-9757599.959100.46
395138-9513897.46397.95
4101477-101477103.956104.47
5100215-100215102.664103.17
698446-98446100.851101.35
30min197988-97988100.382100.602.15101.05101.272.16
297077-9707799.449100.11
395267-9526797.59598.24
4101126-101126103.597104.29
5100081-100081102.526103.21
697686-97686100.073100.74
45min197759-97759100.148100.342.20100.98101.182.20
296974-9697499.343100.17
394762-9476297.07797.89
4100801-100801103.264104.13
599863-99863102.303103.16
697519-9751999.902100.73
极限197843-97843100.234100.152.11101.24101.162.11
296807-9680799.172100.17
394721-9472197.03598.01
4100704-100704103.165104.20
599240-99240101.665102.69
697272-9727299.649100.65
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.00对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.299617896120963959587696085961310.20
219.319578695671957280.09
单位质量响应值RSD%判断
4983.464957.430.38数据可信
加速6月-供试品溶液-YAB2147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%
5min177319-7731979.46075.206.9279.4675.206.92
270713-7071372.67172.67
381495-8149583.75283.75
470800-7080072.76172.76
568754-6875470.65870.66
669966-6996671.90471.90
10min198978-98978101.719101.501.03101.85101.621.03
297366-97366100.063100.18
399772-99772102.535102.67
497643-97643100.347100.47
599576-99576102.334102.45
699228-99228101.976102.10
15min199560-99560102.317102.141.17102.62102.441.17
297544-97544100.246100.53
3100520-100520103.304103.61
498492-98492101.220101.51
5100348-100348103.127103.42
699889-99889102.656102.95
20min199360-99360102.112101.921.09102.58102.381.09
297609-97609100.312100.77
3100325-100325103.104103.59
498106-98106100.823101.28
599729-99729102.491102.95
699896-99896102.663103.12
30min198625-98625101.357101.811.30102.00102.441.30
297111-9711199.801100.42
3100256-100256103.033103.69
498235-98235100.956101.58
599877-99877102.643103.27
6100270-100270103.047103.68
45min198920-98920101.660101.681.03102.47102.491.03
297536-97536100.237101.03
3100088-100088102.860103.69
497951-97951100.664101.46
599475-99475102.230103.03
699679-99679102.440103.24
极限198702-98702101.436101.451.14102.42102.421.14
297115-9711599.805100.76
399878-99878102.644103.64
497626-97626100.330101.29
599457-99457102.212103.18
699506-99506102.262103.24
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