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%
110.524321384315854315494320014319794318500.07
210.384313324310624311970.05
单位质量响应值RSD%判断
41050.3841541.140.85数据可信
供试品溶液-2025072412批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1161974-16197444.03946.3112.7444.0446.3112.74
2176086-17608647.87647.88
3149912-14991240.76040.76
4164469-16446944.71744.72
5158471-15847143.08743.09
6211040-21104057.38057.38
10min1342701-34270193.17794.162.1393.2594.242.12
2351778-35177895.64595.72
3349541-34954195.03795.10
4333392-33339290.64690.72
5353310-35331096.06196.13
6347183-34718394.39694.49
15min1369240-369240100.39398.671.57100.6298.901.57
2364871-36487199.20599.44
3363076-36307698.71798.94
4352665-35266595.88696.11
5366175-36617599.55999.79
6361467-36146798.27998.53
20min1367118-36711899.81698.401.37100.2198.801.37
2359244-35924497.67598.08
3361281-36128198.22998.62
4353765-35376596.18596.57
5365803-36580399.45899.86
6364216-36421699.02799.44
30min1367178-36717899.83298.291.36100.3998.851.36
2362548-36254898.57399.14
3360191-36019197.93298.49
4352614-35261495.87296.42
5363061-36306198.71399.28
6363348-36334898.79199.37
极限1366737-36673799.71298.421.10100.4499.141.11
2362891-36289198.66699.40
3358109-35810997.36698.08
4356421-35642196.90797.61
5364979-36497999.23499.96
6362787-36278798.63899.38
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%
110.524302834303354297404303164302354301820.06
210.384288514283734286120.08
单位质量响应值RSD%判断
40891.8341292.100.69数据可信
供试品溶液-2025072412批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201243-20124354.98749.9612.0754.9949.9612.07
2214663-21466358.65358.65
3158114-15811443.20243.20
4161332-16133244.08244.08
5181379-18137949.55949.56
6180362-18036249.28149.28
10min1351571-35157196.06293.793.7496.1593.873.74
2343286-34328693.79893.90
3322982-32298288.25088.32
4360014-36001498.36898.44
5345733-34573394.46694.55
6335910-33591091.78291.86
15min1367413-367413100.39098.751.36100.6498.991.37
2360819-36081998.58898.84
3354053-35405396.74096.96
4360572-36057298.52198.76
5366365-366365100.104100.34
6359274-35927498.16698.40
20min1360725-36072598.56398.320.9498.9898.720.94
2361289-36128998.71799.14
3353235-35323596.51696.90
4362149-36214998.95299.35
5361943-36194398.89699.30
6359628-35962898.26398.66
30min1359770-35977098.30298.420.4398.8998.990.44
2361214-36121498.69699.28
3357686-35768697.73298.27
4359704-35970498.28498.85
5362199-36219998.96599.54
6360595-36059598.52799.09
极限1361757-36175798.84599.060.5699.5999.800.55
2361815-36181598.86199.61
3361859-36185998.87399.58
4366483-366483100.136100.87
5362623-36262399.08199.82
6360821-36082198.58999.32
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%
110.524328004328414328554326244326624327560.03
210.384339764337764338760.04
单位质量响应值RSD%判断
41136.5041799.231.14数据可信
供试品溶液-2025072512批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153096-15309641.45444.5322.6441.4544.5222.64
2174542-17454247.26147.26
3109181-10918129.56329.56
4224672-22467260.83460.83
5164460-16446044.53144.53
6160740-16074043.52343.52
10min1348906-34890694.47394.412.3194.5494.492.30
2351699-35169995.22995.31
3356858-35685896.62696.68
4333621-33362190.33490.44
5353195-35319595.63495.71
6347763-34776394.16394.24
15min1362204-36220498.07498.221.5498.3098.451.52
2363990-36399098.55798.79
3368963-36896399.904100.11
4352801-35280195.52895.78
5366608-36660899.26699.50
6361882-36188297.98698.22
20min1361606-36160697.91298.091.2898.3098.481.26
2361603-36160397.91198.31
3368058-36805899.659100.04
4354382-35438295.95696.37
5365300-36530098.91299.31
6362568-36256898.17298.57
30min1360438-36043897.59597.901.3098.1598.461.28
2362549-36254998.16798.73
3367947-36794799.629100.17
4353580-35358095.73996.31
5363118-36311898.32198.89
6361651-36165197.92498.48
极限1359012-35901297.20998.090.9697.9398.810.94
2363467-36346798.41699.14
3367359-36735999.469100.18
4357763-35776396.87197.60
5362956-36295698.27799.01
6363047-36304798.30299.02
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%
110.524316334314404313254315774314494314850.03
210.384313534310814312170.05
单位质量响应值RSD%判断
41015.6841543.060.91数据可信
供试品溶液-2025072512批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1235159-23515963.96355.9321.3163.9655.9321.31
2143116-14311638.92738.93
3181964-18196449.49449.49
4265427-26542772.19672.20
5185749-18574950.52450.52
6222438-22243860.50360.50
10min1353230-35323096.07893.253.3396.1893.343.33
2346991-34699194.38194.45
3322879-32287987.82387.91
4344247-34424793.63593.76
5352471-35247195.87295.96
6337176-33717691.71291.81
15min1366667-36666799.73398.441.39100.0098.681.39
2361973-36197398.45698.68
3354500-35450096.42496.65
4360818-36081898.14298.42
5368195-368195100.149100.39
6359224-35922497.70997.96
20min1361451-36145198.31498.241.1198.7598.651.12
2363828-36382898.96199.35
3353225-35322596.07796.47
4363169-36316998.78299.22
5363468-36346898.86399.27
6361874-36187498.42998.85
30min1360333-36033398.01098.430.7398.6199.010.73
2364417-36441799.12199.67
3357411-35741197.21697.77
4363214-36321498.79499.40
5363878-36387898.97599.55
6362045-36204598.47699.06
极限1361032-36103298.20098.610.5998.9699.350.59
2364110-36411099.03899.75
3359136-35913697.68598.40
4364820-36482099.231100.00
5363365-36336598.83599.58
6362806-36280698.68399.43
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%
110.524304454304954305134301884308054304890.06
210.384324514330444327480.10
单位质量响应值RSD%判断
40921.0141690.561.32数据可信
供试品溶液-2025072612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327683-32768389.07749.6350.5789.0849.6350.57
2121752-12175233.09733.10
3145576-14557639.57339.57
4113329-11332930.80730.81
5269210-26921073.18173.18
6117835-11783532.03232.03
10min1355558-35555896.65493.733.5596.8093.823.58
2337179-33717991.65891.71
3346443-34644394.17694.24
4341380-34138092.80092.85
5360860-36086098.09598.22
6327459-32745989.01689.07
15min1356245-35624596.84197.531.1897.1597.771.19
2352681-35268195.87296.08
3359435-35943597.70897.93
4360195-36019597.91598.12
5365264-36526499.29399.58
6358901-35890197.56397.76
20min1356615-35661596.94197.440.9197.4197.840.92
2354561-35456196.38396.75
3356925-35692597.02697.41
4361651-36165198.31098.68
5363016-36301698.68199.13
6357898-35789897.29097.65
30min1356313-35631396.85997.560.8497.4998.130.85
2355802-35580296.72097.25
3357782-35778297.25997.81
4360677-36067798.04698.58
5363841-36384198.90699.52
6358985-35898597.58698.11
极限1355936-35593696.75797.570.8097.5598.300.81
2356077-35607796.79597.48
3359058-35905897.60698.32
4359589-35958997.75098.45
5363748-36374898.88099.66
6359165-35916597.63598.32
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%
110.524322524324464325404322634320554323110.05
210.384311354315864313600.08
单位质量响应值RSD%判断
41094.2041556.840.80数据可信
供试品溶液-2025072612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1130415-13041535.43334.0731.0335.4334.0731.04
2201877-20187754.84954.85
3101890-10189027.68327.68
4109070-10907029.63429.63
5107319-10731929.15829.16
6101915-10191527.69027.69
10min1327410-32741088.95586.623.6889.0186.683.67
2312207-31220784.82484.92
3310463-31046384.35184.40
4313030-31303085.04885.10
5311005-31100584.49884.55
6338888-33888892.07392.12
15min1361612-36161298.24796.471.4598.4596.671.46
2359066-35906697.55697.79
3351114-35111495.39595.58
4357511-35751197.13397.32
5348188-34818894.60094.79
6352983-35298395.90396.10
20min1367924-36792499.96297.681.53100.3398.041.54
2360862-36086298.04498.44
3356646-35664696.89897.24
4363313-36331398.71099.06
5354473-35447396.30896.65
6354018-35401896.18496.54
30min1367614-36761499.87897.991.38100.4298.521.38
2361861-36186198.31598.87
3359415-35941597.65198.16
4364255-36425598.96699.48
5356909-35690996.97097.48
6354032-35403296.18896.71
极限1366616-36661699.60797.981.24100.3198.671.24
2360729-36072998.00898.73
3359082-35908297.56098.23
4364205-36420598.95299.63
5359253-35925397.60698.28
6353837-35383796.13596.82
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