盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992116812119112118832118972123542119450.12
216.002114272113912114090.02
单位质量响应值RSD%判断
13254.8513213.060.23数据可信
供试品溶液-2024042421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118636-186369.4369.2146.149.449.2146.13
225585-2558512.95412.95
311875-118756.0126.01
46695-66953.3903.39
529337-2933714.85414.85
617061-170618.6388.64
10min1164306-16430683.19080.797.0083.2480.847.00
2145269-14526973.55273.62
3147635-14763574.74974.78
4159475-15947580.74480.76
5173549-17354987.87087.95
6167175-16717584.64384.69
15min1182710-18271092.50892.742.0593.0293.242.08
2181665-18166591.97992.46
3177446-17744689.84390.29
4183048-18304892.67993.15
5188605-18860595.49396.06
6185491-18549193.91694.43
20min1180779-18077991.53193.782.4892.5694.792.47
2186791-18679194.57595.57
3178784-17878490.52191.47
4191175-19117596.79497.78
5187379-18737994.87295.97
6186393-18639394.37395.41
30min1184633-18463393.48295.271.6195.0296.811.59
2189142-18914295.76597.28
3187546-18754694.95796.41
4192875-19287597.65599.18
5189456-18945695.92497.55
6185335-18533593.83795.40
45min1185850-18585094.09896.151.6696.1598.221.62
2193324-19332497.88299.93
3190744-19074496.57698.55
4192974-19297497.70599.77
5189994-18999496.19698.36
6186560-18656094.45896.54
极限1186600-18660094.47896.341.6797.0698.941.62
2194191-19419198.321100.91
3191190-19119096.80299.32
4193267-19326797.853100.46
5189498-18949895.94598.64
6186942-18694294.65197.26
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992119072114362109612118452119502116200.20
216.002111682118982115330.25
单位质量响应值RSD%判断
13234.5213220.810.08数据可信
供试品溶液-2024042421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169073-6907334.98928.4219.2234.9928.4219.22
241522-4152221.03321.03
356171-5617128.45428.45
460603-6060330.69930.70
545264-4526422.92922.93
664026-6402632.43332.43
10min1170587-17058786.41190.148.5886.6190.308.54
2189428-18942895.95596.07
3184847-18484793.63593.79
4180949-18094991.66091.83
5191262-19126296.88497.01
6150643-15064376.30976.49
15min1192285-19228597.40297.231.4398.0897.891.40
2192501-19250197.51298.16
3190444-19044496.47097.15
4187437-18743794.94795.63
5195304-19530498.93299.60
6193681-19368198.11098.71
20min1190280-19028096.38796.171.8297.6097.371.78
2187956-18795695.20996.40
3188207-18820795.33796.55
4185153-18515393.79095.00
5193971-19397198.25699.47
6193541-19354198.03999.19
30min1188123-18812395.29496.272.2497.0598.002.19
2187377-18737794.91696.64
3188533-18853395.50297.25
4185527-18552793.97995.71
5195042-19504298.799100.56
6195654-19565499.109100.80
45min1188894-18889495.68595.921.1897.9798.191.16
2190539-19053996.51898.77
3186242-18624294.34196.62
4187478-18747894.96797.22
5192051-19205197.28499.59
6190984-19098496.74398.99
极限1186337-18633794.38995.881.8797.2098.681.83
2192105-19210597.311100.10
3184074-18407493.24396.04
4188572-18857295.52298.30
5192396-19239697.459100.31
6192210-19221097.364100.15
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.992120672122572120382119852121182120930.05
216.002137822140572139200.10
单位质量响应值RSD%判断
13264.1013370.000.57数据可信
供试品溶液-2024042421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min173606-7360637.03630.2234.3837.0430.2234.39
259077-5907729.72529.73
341820-4182021.04221.04
429661-2966114.92414.92
573597-7359737.03137.03
682549-8254941.53541.54
10min1175198-17519888.15390.392.2888.3690.562.30
2184259-18425992.71292.88
3174729-17472987.91788.03
4179322-17932290.22890.31
5180565-18056590.85391.06
6183821-18382192.49192.72
15min1193464-19346497.34397.702.0798.0498.372.08
2201628-201628101.451102.13
3190196-19019695.69996.30
4191969-19196996.59197.18
5195294-19529498.26498.97
6192528-19252896.87297.62
20min1195689-19568998.46398.291.4899.7099.501.52
2197126-19712699.186100.43
3194585-19458597.90799.04
4190497-19049795.85096.97
5195051-19505198.14299.40
6199110-199110100.184101.47
30min1190584-19058495.89497.752.2997.6899.512.27
2202387-202387101.833103.63
3195319-19531998.27799.96
4190676-19067695.94197.59
5192075-19207596.64498.45
6194569-19456997.89999.74
45min1192044-19204496.62996.411.6098.9498.711.59
2195296-19529698.265100.63
3188736-18873694.96497.19
4191586-19158696.39898.58
5187569-18756994.37796.72
6194451-19445197.840100.22
极限1189919-18991995.56096.311.1998.4199.151.19
2195605-19560598.421101.33
3190783-19078395.99498.75
4190901-19090196.05498.78
5189191-18919195.19398.06
6192062-19206296.63899.56
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