培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524335614330394327784337614334014333080.10
210.384337264344044340650.12
单位质量响应值RSD%判断
41188.9741817.441.08数据可信
供试品溶液-2025072412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%
5min1309638-30963883.76865.0626.6483.7765.0626.64
2207015-20701556.00556.01
3212890-21289057.59557.59
4210770-21077057.02157.02
5171557-17155746.41246.41
6331143-33114389.58689.59
10min1347125-34712593.91095.171.4694.0595.281.47
2346938-34693893.85993.95
3352547-35254795.37795.47
4352583-35258395.38795.48
5350589-35058994.84794.92
6360916-36091697.64197.79
15min1346578-34657893.76295.661.7594.0695.931.75
2347739-34773994.07694.33
3354636-35463695.94296.20
4353987-35398795.76796.02
5354785-35478595.98296.22
6363798-36379898.42198.73
20min1345715-34571593.52995.421.7393.9895.851.73
2346771-34677193.81494.22
3353879-35387995.73796.15
4352593-35259395.38995.80
5355006-35500696.04296.44
6362372-36237298.03598.51
30min1345597-34559793.49795.491.8894.1096.081.89
2345139-34513993.37393.94
3353631-35363195.67096.24
4355249-35524996.10896.68
5355661-35566196.21996.77
6362540-36254098.08098.72
极限1346754-34675493.81095.871.9894.5796.611.98
2345263-34526393.40694.12
3358384-35838496.95697.69
4355013-35501396.04496.78
5357716-35771696.77597.49
6363100-36310098.23299.03
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524338924329864340954340794338774337860.11
210.384344034347014345520.05
单位质量响应值RSD%判断
41234.4141864.351.08数据可信
供试品溶液-2025072412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%
5min1337352-33735291.16575.2319.5091.1675.2319.50
2312099-31209984.34084.34
3330960-33096089.43789.44
4243110-24311065.69765.70
5218048-21804858.92458.92
6228756-22875661.81861.82
10min1362288-36228897.90394.432.1398.0694.562.13
2345134-34513493.26893.41
3343527-34352792.83392.98
4345067-34506793.25093.36
5346065-34606593.51993.62
6354611-35461195.82995.93
15min1362083-36208397.84894.531.9598.1694.811.95
2343543-34354392.83893.13
3347258-34725893.84294.15
4346274-34627493.57693.84
5346494-34649493.63593.89
6353112-35311295.42495.69
20min1362472-36247297.95394.642.0198.4395.082.02
2343820-34382092.91393.36
3349830-34983094.53795.00
4345733-34573393.43093.85
5345492-34549293.36493.77
6353953-35395395.65196.07
30min1361267-36126797.62794.392.0198.2794.992.01
2343442-34344292.81093.42
3347081-34708193.79494.41
4345148-34514893.27193.85
5344628-34462893.13193.70
6354107-35410795.69396.27
极限1361023-36102397.56194.202.1198.3794.962.12
2340617-34061792.04792.81
3346264-34626493.57394.35
4345003-34500393.23293.96
5345276-34527693.30694.03
6353322-35332295.48096.22
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524346514363444349554356514359494355100.17
210.384360414365694363050.09
单位质量响应值RSD%判断
41398.2942033.241.08数据可信
供试品溶液-2025072512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%
5min1310925-31092583.68876.0415.1083.6976.0415.10
2210300-21030056.60456.60
3258534-25853469.58769.59
4330433-33043388.93988.94
5294129-29412979.16779.17
6290773-29077378.26478.26
10min1351365-35136594.57395.201.2394.7195.321.23
2348823-34882393.88993.98
3361436-36143697.28497.40
4352084-35208494.76694.91
5353481-35348195.14295.27
6354933-35493395.53395.66
15min1355586-35558695.70995.921.0196.0196.211.01
2355201-35520195.60595.86
3363577-36357797.86098.14
4353651-35365195.18895.49
5355111-35511195.58195.87
6355160-35516095.59495.88
20min1355425-35542595.66696.040.9896.1296.490.98
2356018-35601895.82596.24
3363815-36381597.92498.37
4354131-35413195.31795.78
5355962-35596295.81096.26
6355642-35564295.72496.17
30min1357104-35710496.11896.091.0396.7396.691.02
2356980-35698096.08496.65
3363868-36386897.93898.54
4353134-35313495.04995.67
5355309-35530995.63496.24
6355621-35562195.71896.33
极限1359546-35954696.77596.421.0097.5597.190.98
2358502-35850296.49497.22
3363198-36319897.75898.53
4352202-35220294.79895.58
5357816-35781696.30997.08
6358146-35814696.39897.17
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524342284345644337354346554346534343670.10
210.384344264353584348920.16
单位质量响应值RSD%判断
41289.6441897.111.04数据可信
供试品溶液-2025072512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%
5min1238554-23855464.39771.5621.4264.4071.5621.42
2337146-33714691.01291.01
3329876-32987689.05089.05
4197664-19766453.35953.36
5226983-22698361.27461.27
6260248-26024870.25470.25
10min1352683-35268395.20695.641.3195.3195.761.33
2358825-35882596.86597.02
3361225-36122597.51297.66
4351275-35127594.82694.92
5349653-34965394.38994.49
6352008-35200895.02495.14
15min1355642-35564296.00596.650.8596.2796.930.88
2362366-36236697.82098.13
3361274-36127497.52697.84
4357571-35757196.52696.77
5355307-35530795.91596.17
6356121-35612196.13596.41
20min1354816-35481695.78296.670.8696.2197.110.88
2362890-36289097.96298.44
3360657-36065797.35997.83
4357686-35768696.55796.96
5356777-35677796.31296.73
6355890-35589096.07296.51
30min1354097-35409795.58896.570.9696.1797.170.98
2363757-36375798.19698.84
3358979-35897996.90697.54
4356450-35645096.22396.79
5357584-35758496.53097.11
6355484-35548495.96396.56
极限1354496-35449695.69696.800.8096.4497.560.81
2362790-36279097.93598.74
3358666-35866696.82297.62
4357540-35754096.51897.25
5360535-36053597.32698.07
6357469-35746996.49897.25
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524345344341024342904345114350124344900.08
210.384318274316684317480.03
单位质量响应值RSD%判断
41301.3341594.220.50数据可信
供试品溶液-2025072612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%
5min1179647-17964748.66458.6921.2048.6658.6921.21
2204920-20492055.51055.51
3210942-21094257.14157.14
4298321-29832180.81180.81
5171707-17170746.51346.51
6234522-23452263.52963.53
10min1357225-35722596.76796.901.2096.8596.991.20
2353390-35339095.72995.82
3356266-35626696.50896.60
4358032-35803296.98697.12
5355511-35551196.30396.38
6365771-36577199.08299.19
15min1361900-36190098.03498.131.0098.2898.401.00
2358322-35832297.06597.32
3360089-36008997.54397.80
4361961-36196198.05098.35
5362399-36239998.16998.41
6368950-36895099.944100.21
20min1361989-36198998.05898.010.7398.4698.430.74
2359318-35931897.33497.75
3359431-35943197.36597.78
4361249-36124997.85798.32
5362297-36229798.14198.54
6366539-36653999.29099.73
30min1362933-36293398.31497.950.8398.8898.540.84
2358419-35841997.09197.67
3359079-35907997.27097.85
4361470-36147097.91798.54
5360932-36093297.77298.34
6366711-36671199.33799.94
极限1363267-36326798.40497.941.0799.1498.691.07
2359889-35988997.48998.23
3356653-35665396.61297.36
4359982-35998297.51498.30
5361468-36146897.91798.64
6368058-36805899.702100.47
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.524342104325144330424338654331434333550.16
210.384339674327254333460.21
单位质量响应值RSD%判断
41193.4441748.170.95数据可信
供试品溶液-2025072612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%
5min1297059-29705980.42771.1822.3980.4371.1822.39
2311272-31127284.27584.28
3219157-21915759.33659.34
4178415-17841548.30548.30
5242710-24271065.71265.71
6328855-32885589.03689.04
10min1361542-36154297.88698.280.5498.0298.390.53
2361481-36148197.86998.01
3365561-36556198.97499.07
4364239-36423998.61698.70
5360825-36082597.69197.80
6364237-36423798.61598.76
15min1361995-36199598.00898.920.7998.3199.200.77
2362375-36237598.11198.41
3367926-36792699.61499.88
4368868-36886899.869100.11
5366561-36656199.24499.52
6364512-36451298.69099.00
20min1363452-36345298.40399.030.7698.8699.480.74
2361745-36174597.94198.41
3368770-36877099.843100.27
4368372-36837299.735100.15
5365869-36586999.05799.49
6366377-36637799.19599.67
30min1364915-36491598.79998.930.5199.4299.540.49
2363334-36333498.37199.00
3367081-36708199.38599.98
4366987-36698799.36099.94
5366950-36695099.35099.95
6363147-36314798.32098.96
极限1363026-36302698.28798.820.4899.0899.600.45
2363728-36372898.47799.27
3366567-36656799.246100.01
4366991-36699199.361100.10
5366012-36601299.09699.86
6363664-36366498.46099.27
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