比索洛尔左氨氯地平片项目信息
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100711-202203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4000
标示量(mg)2.5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%
110.234301843047429214290542881429540.18
210.274306043041430500.04
单位质量响应值RSD%判断
4198.834191.820.12数据可信
供试品溶液-2024010321批-比索洛尔-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%
5min146094-4609498.68595.002.4498.6995.002.44
245243-4524396.86396.86
343998-4399894.19894.20
443427-4342792.97592.98
544106-4410694.42994.43
643359-4335992.83092.83
10min146427-4642799.39895.712.0899.5695.872.08
244883-4488396.09396.25
344637-4463795.56695.72
444042-4404294.29294.45
544440-4444095.14495.30
643808-4380893.79193.95
15min146160-4616098.82795.402.0299.1695.722.02
244843-4484396.00796.33
344623-4462395.53695.85
443801-4380193.77694.09
544195-4419594.62094.94
643734-4373493.63393.94
20min146112-4611298.72495.182.1399.2295.662.13
244818-4481895.95396.43
344447-4444795.15995.63
443702-4370293.56494.03
544184-4418494.59695.07
643489-4348993.10893.58
30min145893-4589398.25594.832.0498.9195.462.04
244653-4465395.60096.24
344298-4429894.84095.47
443546-4354693.23093.85
543886-4388693.95894.59
643489-4348993.10893.73
45min145892-4589298.25394.562.1699.0895.352.16
244546-4454695.37196.17
344055-4405594.32095.11
443423-4342392.96793.75
543692-4369293.54394.33
643384-4338492.88393.66
极限145666-4566697.76994.422.0198.7695.372.01
244444-4444495.15396.11
344077-4407794.36795.32
443358-4335892.82893.76
543800-4380093.77494.72
643268-4326892.63593.57
比索洛尔左氨氯地平片项目信息
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100711-202203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4000
标示量(mg)2.5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%
110.234307043120430874303043026430670.10
210.274298742858429220.22
单位质量响应值RSD%判断
4209.874179.360.52数据可信
供试品溶液-2024010321批-比索洛尔-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%
5min147151-47151100.96799.212.93100.9799.212.93
248509-48509103.875103.87
344919-4491996.18796.19
445031-4503196.42796.43
546000-4600098.50298.50
646367-4636799.28899.29
10min147261-47261101.20299.092.77101.3799.252.77
248044-48044102.879103.05
345116-4511696.60996.77
444763-4476395.85396.01
545769-4576998.00798.17
646692-4669299.984100.15
15min146996-46996100.63599.532.45100.9799.862.45
248135-48135103.074103.42
344795-4479595.92296.24
446612-4661299.812100.13
545720-4572097.90298.23
646622-4662299.834100.17
20min146589-4658999.76398.372.68100.2798.872.68
247813-47813102.384102.90
344738-4473895.80096.28
444571-4457195.44295.93
545575-4557597.59298.08
646346-4634699.24399.74
30min146643-4664399.87998.032.82100.5598.692.82
247630-47630101.992102.68
344560-4456095.41896.06
444362-4436294.99495.64
545188-4518896.76397.42
646300-4630099.14499.81
45min146221-4622198.97597.692.6499.8198.512.64
247471-47471101.652102.51
344553-4455395.40396.20
444312-4431294.88795.69
545034-4503496.43397.25
646123-4612398.76599.59
极限146191-4619198.91197.512.7499.9198.502.74
247390-47390101.478102.50
344300-4430094.86295.82
444178-4417894.60095.56
545080-4508096.53297.51
646089-4608998.69299.69
比索洛尔左氨氯地平片项目信息
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100711-202203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4000
标示量(mg)2.5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%
110.234296342916430404289142847429310.18
210.274291743108430120.32
单位质量响应值RSD%判断
4196.584188.120.15数据可信
供试品溶液-23122801批-比索洛尔-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%
5min144495-4449595.32995.761.7895.3395.761.78
244165-4416594.62294.62
345119-4511996.66696.67
444901-4490196.19996.20
543611-4361193.43693.44
645890-4589098.31898.32
10min144785-4478595.95196.531.8496.1196.691.84
244735-4473595.84496.00
345582-4558297.65897.82
445224-4522496.89197.05
543792-4379293.82393.98
646221-4622199.02799.19
15min145093-4509396.61196.941.8996.9397.261.89
244660-4466095.68396.00
345817-4581798.16298.49
445435-4543597.34397.67
544030-4403094.33394.65
646439-4643999.49499.82
20min144732-4473295.83796.521.8096.3297.011.81
244523-4452395.38995.87
345785-4578598.09398.58
445309-4530997.07397.56
543914-4391494.08594.55
646055-4605598.67299.17
30min144664-4466495.69296.161.6796.3396.801.67
244471-4447195.27895.91
345289-4528997.03197.68
445097-4509796.61997.27
543797-4379793.83494.46
645972-4597298.49499.15
45min144462-4446295.25995.821.7496.0696.621.74
244367-4436795.05595.85
345333-4533397.12597.94
445020-4502096.45497.26
543502-4350293.20293.98
645656-4565697.81798.64
极限144423-4442395.17595.611.9096.1396.581.89
244204-4420494.70695.66
345225-4522596.89397.87
444911-4491196.22197.19
543305-4330592.78093.72
645701-4570197.91398.90
比索洛尔左氨氯地平片项目信息
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100711-202203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4000
标示量(mg)2.5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%
110.234355943482434734345443501434940.10
210.274311343164431380.09
单位质量响应值RSD%判断
4251.614200.390.86数据可信
供试品溶液-23122801批-比索洛尔-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%
5min145164-4516495.99694.422.1196.0094.422.11
244215-4421593.97993.98
345644-4564497.01697.02
443329-4332992.09592.10
544759-4475995.13595.13
643425-4342592.29992.30
10min145697-4569797.12995.342.3897.2995.492.38
244241-4424194.03494.19
346064-4606497.90998.07
443533-4353392.52992.68
545622-4562296.96997.13
643965-4396593.44793.60
15min145671-4567197.07395.542.1397.4095.862.13
244592-4459294.78095.09
346242-4624298.28798.61
443895-4389593.29893.61
545333-4533396.35596.68
643958-4395893.43293.74
20min145628-4562896.98295.472.0097.4795.952.00
244619-4461994.83795.31
345905-4590597.57198.06
443771-4377193.03593.50
545532-4553296.77897.26
644054-4405493.63694.10
30min145305-4530596.29595.142.0796.9495.772.07
244389-4438994.34894.98
346030-4603097.83698.49
443631-4363192.73793.36
545268-4526896.21796.86
643932-4393293.37794.00
45min145337-4533796.36394.922.0797.1795.722.07
244315-4431594.19194.98
345792-4579297.33198.14
443523-4352392.50893.28
545227-4522796.13096.93
643766-4376693.02493.80
极限145439-4543996.58094.962.0697.5595.922.06
244319-4431994.20095.14
345768-4576897.27998.26
443624-4362492.72293.65
545201-4520196.07497.04
643720-4372092.92693.86
比索洛尔左氨氯地平片项目信息
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100711-202203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4000
标示量(mg)2.5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%
110.234313743261432604327043273432400.14
210.274315343268432100.19
单位质量响应值RSD%判断
4226.784207.400.33数据可信
供试品溶液-23122802批-比索洛尔-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%
5min143158-4315891.92395.002.0991.9295.002.09
245285-4528596.45396.45
344814-4481495.45095.45
443796-4379693.28293.28
545037-4503795.92595.92
645537-4553796.99096.99
10min143440-4344092.52495.402.0492.6895.562.03
244788-4478895.39595.56
345267-4526796.41596.57
444022-4402293.76393.92
545347-4534796.58596.75
645880-4588097.72097.88
15min143513-4351392.67995.751.9192.9996.071.91
245364-4536496.62196.94
345042-4504295.93696.26
444469-4446994.71595.03
545402-4540296.70297.02
645953-4595397.87698.20
20min143302-4330292.23095.492.0192.6995.972.01
245142-4514296.14996.63
344838-4483895.50195.98
444430-4443094.63295.10
545400-4540096.69897.18
645884-4588497.72998.22
30min143398-4339892.43495.591.8293.0596.231.82
245141-4514196.14696.79
345052-4505295.95796.60
444618-4461895.03395.66
545296-4529696.47797.12
645771-4577197.48898.14
45min143451-4345192.54794.862.7793.3295.652.76
245212-4521296.29897.10
344929-4492995.69596.49
442581-4258190.69491.48
545364-4536496.62197.43
645674-4567497.28298.09
极限143447-4344792.53895.371.7493.4696.321.74
245097-4509796.05397.01
344931-4493195.69996.66
444376-4437694.51795.45
545114-4511496.08997.05
645692-4569297.32098.30
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