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%
112.319966899601996209955599588996060.05
212.2910000399618998100.28
单位质量响应值RSD%判断
8091.478121.240.26数据可信
供试品溶液-STGY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%
5min178384-7838477.74376.234.8377.7476.234.82
269889-6988969.31769.32
379249-7924978.60178.60
479332-7933278.68378.68
575468-7546874.85174.85
678853-7885378.20878.21
10min194584-9458493.81090.513.3493.9390.633.34
285549-8554984.84984.95
391514-9151490.76590.88
492588-9258891.83091.95
592141-9214191.38791.50
691174-9117490.42890.55
15min198191-9819197.38893.932.7397.6494.182.73
290540-9054089.79990.03
393949-9394993.18093.43
496208-9620895.42195.68
595381-9538194.60194.85
693934-9393493.16593.42
20min199828-9982899.01195.662.3599.4196.052.35
293428-9342892.66493.03
395196-9519694.41794.81
497544-9754496.74697.14
597397-9739796.60096.99
695286-9528694.50694.90
30min1101192-101192100.36498.031.94100.9298.571.94
297082-9708296.28896.79
397162-9716296.36796.90
499056-9905698.24698.79
5101062-101062100.235100.77
697493-9749396.69597.23
45min1101410-101410100.58099.051.13101.2899.731.13
298591-9859197.78498.43
399008-9900898.19898.88
4100176-10017699.356100.05
5100841-100841100.016100.70
699160-9916098.34999.03
极限1101382-101382100.55299.581.16101.41100.411.16
299237-9923798.42599.22
399012-9901298.20299.03
4101232-101232100.404101.24
5101623-101623100.792101.63
699905-9990599.08899.91
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%
112.311007351007221005441006671006261006590.08
212.291007011007101007060.01
单位质量响应值RSD%判断
8177.018194.140.15数据可信
供试品溶液-STGY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%
5min177603-7760376.22368.498.4676.2268.498.46
262771-6277161.65561.65
371051-7105169.78769.79
470045-7004568.79968.80
563058-6305861.93761.94
673835-7383572.52272.52
10min185950-8595084.42284.165.9984.5484.275.99
280965-8096579.52579.62
389252-8925287.66587.77
487855-8785586.29386.40
578300-7830076.90877.00
691796-9179690.16490.27
15min188944-8894487.36289.133.8087.6089.363.81
287759-8775986.19886.41
393454-9345491.79292.03
492641-9264190.99491.23
586565-8656585.02685.23
695083-9508393.39293.64
20min191246-9124689.62391.782.6390.0092.142.64
291359-9135989.73490.08
395748-9574894.04594.42
494902-9490293.21493.58
591104-9110489.48489.82
696275-9627594.56394.95
30min193906-9390692.23695.162.4192.7495.662.41
296359-9635994.64595.12
398499-9849996.74797.26
499130-9913097.36797.88
594421-9442192.74293.21
698957-9895797.19797.72
45min196065-9606594.35797.352.2295.0097.992.22
299932-9993298.15598.77
3101047-10104799.25099.91
499948-9994898.17198.83
596658-9665894.93995.55
6101027-10102799.23099.90
极限198642-9864296.88899.171.4797.6799.961.46
2102630-102630100.805101.57
3102441-102441100.619101.43
4101001-10100199.205100.01
5100246-10024698.46399.21
6100829-10082999.03699.86
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%
112.311002961002951002351000381001801002090.11
212.291000461002201001330.13
单位质量响应值RSD%判断
8140.458147.520.07数据可信
供试品溶液-STGC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%
5min159381-5938158.62363.759.1158.6263.749.10
263857-6385763.04263.04
358862-5886258.11058.11
474515-7451573.56473.56
567890-6789067.02367.02
662928-6292862.12562.12
10min185029-8502983.94385.513.1184.0385.613.12
288033-8803386.90987.00
382696-8269681.64081.73
489106-8910687.96888.08
589529-8952988.38688.49
685331-8533184.24184.33
15min189683-8968388.53890.382.6188.7590.602.62
292971-9297191.78492.01
388464-8846487.33487.54
493057-9305791.86992.11
594695-9469593.48693.72
690397-9039789.24389.46
20min191530-9153090.36192.482.2490.7192.842.25
294816-9481693.60593.97
391197-9119790.03390.37
494851-9485193.64094.02
596539-9653995.30695.68
693098-9309891.90992.26
30min195398-9539894.18095.081.5594.6695.581.56
297207-9720795.96696.47
393967-9396792.76793.24
496492-9649295.26095.78
598261-9826197.00697.52
696557-9655795.32495.82
45min197607-9760796.36196.791.1096.9897.431.10
298373-9837397.11797.76
396951-9695195.71396.33
496857-9685795.62096.28
599223-9922397.95698.62
699261-9926197.99498.63
极限197886-9788696.63697.511.1997.4098.301.18
298609-9860997.35098.14
399537-9953798.26699.02
497052-9705295.81396.62
599290-9929098.02298.83
6100272-10027298.99299.77
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%
112.311001711002031003231002301003141002480.07
212.291007301004891006100.17
单位质量响应值RSD%判断
8143.628186.330.37数据可信
供试品溶液-STGC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%
5min169011-6901167.95564.1012.7767.9664.1012.77
266977-6697765.95265.95
349515-4951548.75748.76
469452-6945268.38968.39
572813-7281371.69971.70
662814-6281461.85361.85
10min184403-8440383.11284.336.0983.2184.426.09
282822-8282281.55581.65
385558-8555884.24984.32
491508-9150890.10890.21
591479-9147990.07990.19
678052-7805276.85876.95
15min188142-8814286.79388.784.8987.0289.014.89
287770-8777086.42786.65
391909-9190990.50390.70
494999-9499993.54693.78
594479-9447993.03393.28
683686-8368682.40682.61
20min190812-9081289.42391.183.9689.7891.543.96
290722-9072289.33489.68
394570-9457093.12393.46
496726-9672695.24695.62
595655-9565594.19294.57
687116-8711685.78386.11
30min193379-9337991.95094.012.6492.4494.512.65
293366-9336691.93892.42
397251-9725195.76396.24
499044-9904497.52998.05
596689-9668995.21095.73
693120-9312091.69592.16
45min195442-9544293.98296.162.1794.6196.792.17
294909-9490993.45794.08
398704-9870497.19497.81
4100325-10032598.79099.46
597567-9756796.07496.74
698979-9897997.46598.06
极限197529-9752996.03796.661.6996.8197.441.69
296111-9611194.64195.40
399973-9997398.44399.21
4100382-10038298.84699.66
597481-9748195.99096.80
697485-9748595.99496.74
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%
112.312021092021522021682023662020922021770.06
212.292020362021422020890.04
单位质量响应值RSD%判断
16423.8016443.370.09数据可信
供试品溶液-2025041711批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148559-14855972.68167.724.5172.6867.724.51
2137029-13702967.04067.04
3134228-13422865.67065.67
4140091-14009168.53868.54
5140338-14033868.65968.66
6130294-13029463.74563.75
10min1167799-16779982.09479.282.2782.2079.382.27
2157973-15797377.28777.39
3159154-15915477.86577.96
4160019-16001978.28878.39
5163634-16363480.05780.16
6163711-16371180.09480.19
15min1176548-17654886.37584.611.4886.6184.831.48
2171935-17193584.11884.33
3171574-17157483.94184.16
4169569-16956982.96083.18
5172773-17277384.52884.75
6175224-17522485.72785.94
20min1180920-18092088.51487.351.1388.8887.701.13
2178612-17861287.38587.73
3178369-17836987.26687.61
4175268-17526885.74886.09
5177810-17781086.99287.34
6180313-18031388.21788.56
30min1187087-18708791.53190.771.3392.0391.251.32
2186872-18687291.42691.90
3186257-18625791.12591.60
4181332-18133288.71589.19
5183849-18384989.94790.43
6187749-18774991.85592.33
45min1190570-19057093.23593.201.5393.8793.821.53
2191632-19163293.75494.37
3192200-19220094.03294.64
4186443-18644391.21691.82
5187839-18783991.89992.51
6194333-19433395.07695.69
极限1200088-20008897.89198.961.1498.6699.711.13
2200508-20050898.09798.85
3204959-204959100.275101.02
4200098-20009897.89698.64
5203379-20337999.502100.25
6204572-204572100.085100.84
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