达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.691061821059721062371059101061041060810.14
212.851073101073241073170.01
单位质量响应值RSD%判断
8359.428351.520.07数据可信
供试品溶液-2025080621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%
5min187840-8784084.52485.821.2084.5285.821.20
290057-9005786.65786.66
389891-8989186.49786.50
487806-8780684.49184.49
589728-8972886.34086.34
689832-8983286.44086.44
10min192611-9261189.11490.801.4689.2490.931.46
295913-9591392.29292.42
395196-9519691.60291.73
492739-9273989.23889.36
595162-9516291.56991.70
694558-9455890.98891.12
15min194237-9423790.67992.451.3590.9492.721.35
297241-9724193.57093.84
396726-9672693.07493.34
494698-9469891.12391.38
597138-9713893.47093.74
696449-9644992.80893.07
20min195303-9530391.70593.301.2892.1093.701.28
298617-9861794.89495.30
397431-9743193.75294.16
495742-9574292.12792.52
597595-9759593.91094.32
697086-9708693.42093.83
30min196346-9634692.70894.251.3093.2494.791.30
299610-9961095.84996.40
398499-9849994.78095.33
496567-9656792.92193.46
598661-9866194.93695.48
697982-9798294.28394.83
45min196585-9658592.93894.621.3493.6195.311.34
299965-9996596.19196.89
399113-9911395.37196.06
496960-9696093.29993.97
598907-9890795.17395.86
698485-9848594.76795.45
极限196678-9667893.02894.701.2293.8495.531.23
299952-9995296.17897.02
398840-9884095.10895.94
497314-9731493.64094.45
598947-9894795.21196.04
698790-9879095.06095.89
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.691063331064251064201064151063491063880.05
212.851070571069251069910.09
单位质量响应值RSD%判断
8383.618326.150.49数据可信
供试品溶液-2025080621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%
5min191510-9151088.06286.491.3788.0686.491.37
290612-9061287.19887.20
390666-9066687.25087.25
488614-8861485.27585.28
588514-8851485.17985.18
689354-8935485.98785.99
10min196914-9691493.26391.221.5593.3991.351.55
295509-9550991.91192.04
395649-9564992.04592.18
493181-9318189.67089.80
593469-9346989.94790.08
694016-9401690.47490.60
15min199507-9950795.75893.351.7096.0393.621.70
297392-9739293.72393.99
398182-9818294.48394.75
495335-9533591.74392.01
595641-9564192.03892.30
695989-9598992.37292.64
20min1101008-10100897.20294.361.8397.6294.771.83
298086-9808694.39094.80
399180-9918095.44395.85
496359-9635992.72993.13
596477-9647792.84293.24
697242-9724293.57893.98
30min1102474-10247498.61395.302.0599.1795.842.05
299355-9935595.61296.16
399899-9989996.13596.69
497097-9709793.43993.98
597227-9722793.56494.10
698111-9811194.41594.96
45min1103483-10348399.58495.822.21100.2996.512.20
299740-9974095.98296.68
3100357-10035796.57697.27
497657-9765793.97894.66
597906-9790694.21794.90
698294-9829494.59195.28
极限1103221-10322199.33295.742.18100.1996.582.18
299689-9968995.93396.77
3100489-10048996.70397.55
497627-9762793.94994.77
597547-9754793.87294.69
698360-9836094.65495.48
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.691054791056261056411054911054711055420.08
212.851054391053021053700.10
单位质量响应值RSD%判断
8316.948200.001.01数据可信
供试品溶液-2025080721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%
5min189393-8939387.03387.080.7587.0387.080.75
290353-9035387.96787.97
389967-8996787.59187.59
489046-8904686.69586.69
589428-8942887.06787.07
688471-8847186.13586.13
10min195301-9530192.78592.880.4192.9293.010.41
296064-9606493.52793.66
395338-9533892.82192.95
494994-9499492.48692.62
595580-9558093.05693.19
695110-9511092.59992.73
15min197056-9705694.49394.790.4994.7695.050.49
298184-9818495.59195.86
397487-9748794.91395.18
496789-9678994.23394.50
597266-9726694.69894.97
697354-9735494.78395.05
20min197743-9774395.16295.880.6295.5796.290.62
299437-9943796.81197.23
398484-9848495.88396.30
497954-9795495.36795.78
598511-9851195.91096.32
698753-9875396.14596.56
30min198926-9892696.31497.020.7596.8797.580.75
2100788-10078898.12798.69
399621-9962196.99097.55
498913-9891396.30196.85
599437-9943796.81197.37
6100233-10023397.58698.14
45min199254-9925496.63397.380.6997.3398.080.69
2101192-10119298.52099.23
399667-9966797.03597.74
499574-9957496.94597.64
5100170-10017097.52598.23
6100265-10026597.61798.32
极限199298-9929896.67697.360.6597.5298.210.65
2100973-10097398.30799.16
399801-9980197.16698.01
499443-9944396.81797.66
5100531-10053197.87698.72
699967-9996797.32798.17
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.691073251072471072641072431072761072710.04
212.851064111063701063900.03
单位质量响应值RSD%判断
8453.198279.381.47数据可信
供试品溶液-2025080621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%
5min189896-8989686.39985.900.9086.4085.900.90
290289-9028986.77786.78
389722-8972286.23286.23
488721-8872185.27085.27
588134-8813484.70684.71
689503-8950386.02286.02
10min195355-9535591.64691.600.7591.7891.730.75
296065-9606592.32892.46
396057-9605792.32192.45
494254-9425490.58890.72
594758-9475891.07291.20
695364-9536491.65591.78
15min197731-9773193.93093.560.9994.2093.830.99
297312-9731293.52793.80
398261-9826194.43994.71
495647-9564791.92792.19
597003-9700393.23093.49
698120-9812094.30494.57
20min198893-9889395.04694.630.9895.4595.040.97
298052-9805294.23894.65
399191-9919195.33395.74
497090-9709093.31493.72
597876-9787694.06994.47
699673-9967395.79696.20
30min1100047-10004796.15695.611.2096.7196.161.19
298756-9875694.91595.47
399787-9978795.90696.46
497658-9765893.85994.40
599465-9946595.59696.14
6101146-10114697.21297.76
45min1100067-10006796.17595.941.4996.8796.631.49
298429-9842994.60095.29
3100447-10044796.54097.24
498006-9800694.19494.88
599838-9983895.95596.64
6102137-10213798.16498.86
极限1100270-10027096.37096.131.5497.2196.971.53
298688-9868894.84995.68
3100681-10068196.76597.61
497930-9793094.12194.94
5100315-10031596.41397.25
6102256-10225698.27999.12
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