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%
110.524388404400074397454401164396864396790.12
210.384391904399574395740.13
单位质量响应值RSD%判断
41794.5842348.170.94数据可信
供试品溶液-2025072412批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202203-20220353.96478.6116.8053.9678.6116.81
2304058-30405881.14781.15
3305129-30512981.43381.43
4284344-28434475.88675.89
5333697-33369789.05789.06
6337823-33782390.15890.16
10min1317063-31706384.61891.884.9884.7192.014.99
2358168-35816895.58895.72
3347098-34709892.63392.77
4329739-32973988.00188.13
5355610-35561094.90595.05
6357916-35791695.52095.67
15min1338980-33898090.46793.732.6890.7094.022.70
2360801-36080196.29096.58
3351771-35177193.88094.17
4340459-34045990.86291.13
5356411-35641195.11995.43
6358846-35884695.76996.08
20min1346099-34609992.36794.451.9092.7594.891.92
2362150-36215096.65097.11
3353200-35320094.26294.71
4346039-34603992.35192.78
5357194-35719495.32895.79
6358640-35864095.71496.18
30min1353994-35399494.47495.301.1095.0195.901.11
2363638-36363897.04897.66
3354962-35496294.73295.34
4353183-35318394.25794.84
5357994-35799495.54196.17
6358765-35876595.74796.38
极限1367730-36773098.14096.811.0398.8397.571.01
2367017-36701797.94998.73
3358581-35858195.69896.46
4361538-36153896.48797.22
5360362-36036296.17396.96
6361256-36125696.41297.20
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%
110.524381504381344387054391434386954385650.10
210.384389394384924387160.08
单位质量响应值RSD%判断
41688.6942265.510.98数据可信
供试品溶液-2025072412批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1340415-34041591.05486.745.4991.0586.745.49
2330934-33093488.51888.52
3326745-32674587.39887.40
4291087-29108777.86077.86
5336543-33654390.01890.02
6320013-32001385.59785.60
10min1357755-35775595.69294.401.6695.8494.541.66
2359401-35940196.13396.28
3350748-35074893.81893.96
4344285-34428592.08992.22
5349114-34911493.38193.53
6356252-35625295.29095.43
15min1359775-35977596.23395.711.4596.5496.011.44
2364465-36446597.48797.79
3355843-35584395.18195.48
4355134-35513494.99195.27
5350139-35013993.65593.96
6361669-36166996.73997.04
20min1360361-36036196.38996.381.5796.8696.841.57
2366246-36624697.96398.43
3359042-35904296.03796.50
4358844-35884495.98496.43
5351135-35113593.92294.38
6366368-36636897.99698.46
30min1362692-36269297.01396.871.6997.6597.491.68
2367857-36785798.39499.03
3360899-36089996.53397.15
4362223-36222396.88797.49
5351311-35131193.96994.59
6367962-36796298.42299.05
极限1371440-37144099.35397.982.07100.1598.762.05
2370564-37056499.11899.92
3364852-36485297.59198.37
4366554-36655498.04698.81
5352103-35210394.18094.96
6372331-37233199.591100.38
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%
110.524382704385294386094375384370874380070.16
210.384390034387254388640.05
单位质量响应值RSD%判断
41635.6542279.771.09数据可信
供试品溶液-2025072512批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108195-10819528.95436.0737.7728.9536.0637.77
2227624-22762460.91460.91
3160374-16037442.91742.92
497993-9799326.22426.22
5114178-11417830.55530.55
6100259-10025926.83026.83
10min1337159-33715990.22689.835.9290.2789.885.93
2347431-34743192.97593.08
3340563-34056391.13791.21
4344645-34464592.22992.27
5348148-34814893.16793.22
6296024-29602479.21879.26
15min1360283-36028396.41495.623.3096.6195.833.31
2358904-35890496.04596.30
3359193-35919396.12296.35
4363193-36319397.19397.39
5368001-36800198.48098.69
6334314-33431489.46589.64
20min1364273-36427397.48297.131.5897.8497.501.58
2360745-36074596.53896.95
3362460-36246096.99797.38
4364604-36460497.57097.93
5371551-37155199.43099.80
6354045-35404594.74595.07
30min1365946-36594697.93098.001.0698.4598.521.06
2363185-36318597.19197.77
3365604-36560497.83898.38
4364963-36496397.66798.19
5373784-373784100.027100.56
6363656-36365697.31797.80
极限1368673-36867398.65999.151.3699.3499.841.34
2367937-36793798.46299.20
3369898-36989898.98799.70
4363995-36399597.40798.09
5378087-378087101.179101.88
6374412-374412100.195100.84
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%
110.524394744391434392694390564393784392640.04
210.384389054386684387860.04
单位质量响应值RSD%判断
41755.1342272.250.88数据可信
供试品溶液-2025072512批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233836-23383662.49142.1153.4262.4942.1153.41
2292515-29251578.17378.17
394561-9456125.27125.27
4102027-10202727.26627.27
5107262-10726228.66528.67
6115137-11513730.77030.77
10min1331764-33176488.66290.133.8288.7790.203.83
2356057-35605795.15495.28
3340871-34087191.09691.14
4346480-34648092.59592.64
5325255-32525586.92386.97
6323116-32311686.35186.40
15min1347096-34709692.75994.781.9793.0195.001.97
2360361-36036196.30496.59
3358296-35829695.75395.95
4362245-36224596.80897.01
5354336-35433694.69494.89
6345570-34557092.35292.55
20min1352066-35206694.08895.781.4094.4996.161.41
2362952-36295296.99797.45
3361440-36144096.59396.95
4363468-36346897.13597.50
5357525-35752595.54795.90
6353011-35301194.34094.69
30min1357692-35769295.59196.520.7196.1597.050.70
2362311-36231196.82697.44
3362890-36289096.98097.49
4364314-36431497.36197.88
5360966-36096696.46696.98
6358749-35874995.87496.38
极限1364331-36433197.36597.420.4198.0998.120.41
2364668-36466897.45598.23
3364523-36452397.41798.09
4366650-36665097.98598.67
5364891-36489197.51598.19
6362088-36208896.76697.43
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%
110.524389164391954389544387174387814389130.05
210.384395314396284395800.02
单位质量响应值RSD%判断
41721.7742348.751.06数据可信
供试品溶液-2025072612批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159970-15997042.73049.6634.4042.7349.6634.40
2169736-16973645.33945.34
3237176-23717663.35363.35
4165673-16567344.25344.25
5100884-10088426.94726.95
6282075-28207575.34675.35
10min1332323-33232388.76788.416.6888.8488.506.69
2354698-35469894.74494.82
3327425-32742587.45987.56
4339858-33985890.78090.85
5290067-29006777.48077.53
6341641-34164191.25691.38
15min1349548-34954893.36894.112.4593.5994.342.46
2361755-36175596.62996.86
3349303-34930393.30393.55
4361762-36176296.63196.86
5339091-33909190.57590.75
6352570-35257094.17694.45
20min1360919-36091996.40696.331.6896.7896.721.68
2364638-36463897.39997.79
3362271-36227196.76797.17
4368450-36845098.41798.80
5351815-35181593.97494.30
6355738-35573895.02295.46
30min1367352-36735298.12497.881.4198.6698.431.41
2369046-36904698.57799.13
3370229-37022998.89399.46
4371849-37184999.32599.88
5359938-35993896.14496.63
6360248-36024896.22796.82
极限1369265-36926598.63599.321.4799.33100.031.46
2376534-376534100.577101.30
3374882-374882100.136100.87
4377620-377620100.867101.58
5369101-36910198.59199.23
6363523-36352397.10197.85
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%
110.524355884361744354924358934360844358460.07
210.384387364383084385220.07
单位质量响应值RSD%判断
41430.2342246.821.39数据可信
供试品溶液-2025072612批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116254-11625431.20031.6926.9931.2031.6926.99
2104125-10412527.94527.94
3107990-10799028.98228.98
4101658-10165827.28327.28
5181734-18173448.77448.77
696738-9673825.96225.96
10min1300810-30081080.73174.7314.2280.7874.7814.22
2281818-28181875.63475.68
3295721-29572179.36579.41
4259630-25963069.67969.72
5322860-32286086.64986.73
6209906-20990656.33456.38
15min1349121-34912193.69788.628.3293.8888.808.33
2322402-32240286.52686.70
3347253-34725393.19593.38
4334214-33421489.69689.86
5349658-34965893.84194.07
6278613-27861374.77474.91
20min1364072-36407297.70993.126.9598.0593.446.96
2338485-33848590.84291.16
3359521-35952196.48896.82
4360941-36094196.86997.18
5357376-35737695.91296.29
6301384-30138480.88581.15
30min1372097-37209799.86396.304.16100.3796.784.19
2356268-35626895.61596.08
3366627-36662798.39598.89
4364235-36423597.75398.23
5363444-36344497.54198.08
6330212-33021288.62289.02
极限1377431-377431101.29499.691.03101.97100.331.02
2369319-36931999.11799.74
3370675-37067599.481100.14
4366526-36652698.36899.00
5370724-37072499.494100.20
6374085-374085100.396100.94
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