磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543341833342203341163339323342633341430.04
212.473336793328983332880.17
单位质量响应值RSD%判断
26646.1726727.190.22数据可信
供试品溶液-2025041011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%
5min1336848-33684888.18687.391.3488.1987.391.34
2338342-33834288.57788.58
3327475-32747585.73285.73
4331335-33133586.74286.74
5331083-33108386.67686.68
6337727-33772788.41688.42
10min1351865-35186592.11791.731.1492.2691.881.14
2350680-35068091.80791.95
3351812-35181292.10392.25
4355168-35516892.98293.13
5343252-34325289.86290.01
6349590-34959091.52291.67
15min1356071-35607193.21893.241.0593.5293.541.05
2355554-35555493.08393.38
3358805-35880593.93494.23
4361099-36109994.53594.83
5350085-35008591.65191.95
6355346-35534693.02893.33
20min1359702-35970294.16994.181.0894.6294.641.08
2360363-36036394.34294.80
3362670-36267094.94695.40
4363687-36368795.21295.67
5352626-35262692.31692.76
6359455-35945594.10494.56
30min1363782-36378295.23795.441.2395.8596.061.23
2366111-36611195.84796.46
3368284-36828496.41697.03
4368894-36889496.57597.19
5356597-35659793.35693.96
6363749-36374995.22895.84
45min1366510-36651095.95196.321.1096.7297.091.10
2368794-36879496.54997.32
3372764-37276497.58898.36
4371116-37111697.15797.93
5361237-36123794.57195.33
6367206-36720696.13396.90
极限1370157-37015796.90697.151.0697.8498.081.05
2371901-37190197.36298.30
3376481-37648198.56199.50
4372901-37290197.62498.56
5364623-36462395.45796.37
6370470-37047096.98897.92
磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543333773332743329553329873332343331650.06
212.473320263322043321150.04
单位质量响应值RSD%判断
26568.1826633.120.18数据可信
供试品溶液-2025041011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%
5min1334056-33405687.73884.7010.9287.7484.7010.92
2363259-36325995.40795.41
3262648-26264868.98368.98
4305805-30580580.31880.32
5345691-34569190.79390.79
6323513-32351384.96884.97
10min1364365-36436595.69893.764.5895.8493.904.58
2369001-36900196.91697.07
3324855-32485585.32185.44
4363499-36349995.47195.60
5364470-36447095.72695.88
6355792-35579293.44693.59
15min1364483-36448395.72995.272.0396.0395.572.04
2370341-37034197.26897.59
3351145-35114592.22692.48
4369155-36915596.95697.25
5364180-36418095.64995.96
6357185-35718593.81294.11
20min1364067-36406795.62095.821.3396.0896.281.33
2370050-37005097.19197.67
3362043-36204395.08895.50
4370515-37051597.31397.77
5364539-36453995.74496.21
6357840-35784093.98494.44
30min1364554-36455495.74896.231.3396.3796.841.33
2370953-37095397.42898.07
3367251-36725196.45697.03
4371631-37163197.60698.22
5365570-36557096.01496.64
6358288-35828894.10294.71
45min1364304-36430495.68296.421.4996.4797.201.48
2372510-37251097.83798.64
3368608-36860896.81297.54
4372759-37275997.90398.68
5366176-36617696.17496.96
6358407-35840794.13394.90
极限1369313-36931396.99897.221.3597.9498.161.35
2375875-37587598.72199.69
3369128-36912896.94997.84
4374580-37458098.38199.32
5370345-37034597.26998.22
6361804-36180495.02595.95
磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543322053319833316803316663319043318880.07
212.473315423315263315340.01
单位质量响应值RSD%判断
26466.3526586.530.33数据可信
供试品溶液-2025041111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%
5min1320820-32082084.49786.642.3684.5086.642.36
2337825-33782588.97688.98
3332827-33282787.66087.66
4325278-32527885.67185.67
5320557-32055784.42884.43
6336379-33637988.59588.60
10min1339027-33902789.29391.681.6989.4391.821.70
2352218-35221892.76792.92
3346785-34678591.33691.48
4351937-35193792.69392.84
5344011-34401190.60590.75
6354458-35445893.35793.50
15min1342929-34292990.32092.961.7790.6193.261.77
2356504-35650493.89694.20
3352866-35286692.93793.24
4358441-35844194.40694.70
5348478-34847891.78292.07
6358452-35845294.40994.71
20min1347057-34705791.40793.851.6591.8594.301.65
2358666-35866694.46594.92
3356374-35637493.86194.31
4361960-36196095.33395.79
5352134-35213492.74593.19
6361872-36187295.30995.77
30min1348990-34899091.91794.821.9692.5195.431.96
2363150-36315095.64696.26
3358983-35898394.54995.16
4365532-36553296.27396.89
5355448-35544893.61894.22
6368001-36800196.92497.54
45min1352450-35245092.82896.051.9993.5796.811.99
2367420-36742096.77197.55
3365058-36505896.14996.92
4369449-36944997.30598.08
5360793-36079395.02595.78
6372859-37285998.20398.98
极限1358393-35839394.39397.091.9195.2998.021.91
2371370-37137097.81198.75
3367939-36793996.90797.83
4374329-37432998.59099.53
5362909-36290995.58396.50
6376877-37687799.261100.21
磷酸西格列汀片项目信息
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101546-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.543322683321653323683326613325473324020.07
212.473309013308693308850.01
单位质量响应值RSD%判断
26507.3426534.480.08数据可信
供试品溶液-2025041111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%
5min1316741-31674183.44082.054.9883.4482.044.98
2291164-29116476.70276.70
3325598-32559885.77385.77
4292565-29256577.07177.07
5319007-31900784.03784.04
6323624-32362485.25385.25
10min1342542-34254290.23790.881.2190.3891.021.20
2349736-34973692.13292.26
3349450-34945092.05792.20
4342286-34228690.16990.30
5346291-34629191.22491.36
6339624-33962489.46889.61
15min1349567-34956792.08792.481.4892.3892.771.48
2356373-35637393.88094.16
3355195-35519593.57093.87
4349620-34962092.10192.38
5353468-35346893.11593.41
6342184-34218490.14290.43
20min1351307-35130792.54693.401.5792.9993.841.57
2359730-35973094.76595.20
3359491-35949194.70295.15
4352013-35201392.73293.16
5358585-35858594.46394.91
6346163-34616391.19191.63
30min1356833-35683394.00194.201.2894.6094.801.28
2362056-36205695.37795.97
3361658-36165895.27295.88
4353286-35328693.06793.65
5360532-36053294.97695.58
6351272-35127292.53693.13
45min1362086-36208695.38595.211.5696.1495.971.56
2364676-36467696.06896.82
3366418-36641896.52697.30
4354862-35486293.48294.22
5366487-36648796.54597.31
6354091-35409193.27994.03
极限1368020-36802096.94896.951.3997.8697.871.38
2374217-37421798.58199.50
3371510-37151097.86898.80
4367148-36714896.71997.62
5368076-36807696.96397.89
6359197-35919794.62495.53
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