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2000
标示量(mg)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%
110.058502585128850638514785056850840.07
210.038550685383854440.11
单位质量响应值RSD%判断
8466.078518.840.44数据可信
长期12月-供试品溶液-2024110221批-比索洛尔-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%
5min193886-9388699.299100.581.0299.30100.581.02
295971-95971101.504101.50
396264-96264101.814101.81
495226-95226100.716100.72
594066-9406699.48999.49
695175-95175100.662100.66
10min194457-9445799.903101.061.15100.07101.231.15
296373-96373101.929102.10
397168-97168102.770102.94
495180-95180100.668100.84
594400-9440099.843100.01
695713-95713101.231101.40
15min194447-9444799.892100.841.07100.22101.181.07
295871-95871101.398101.74
396830-96830102.413102.75
495292-95292100.786101.12
594007-9400799.42799.76
695623-95623101.136101.47
20min194244-9424499.678100.601.07100.18101.101.07
295620-95620101.133101.64
396742-96742102.320102.83
494956-94956100.431100.93
593931-9393199.34799.84
695197-95197100.686101.19
30min193911-9391199.325100.260.9799.99100.930.97
295372-95372100.871101.55
396204-96204101.751102.43
494637-94637100.093100.76
593760-9376099.16699.83
694868-94868100.338101.01
45min194014-9401499.434100.401.00100.26101.241.00
295999-95999101.534102.38
396050-96050101.588102.44
494622-94622100.077100.92
593878-9387899.291100.12
695002-95002100.479101.32
极限193887-9388799.30099.951.01100.30100.961.01
295006-95006100.484101.50
396003-96003101.538102.56
494346-9434699.785100.79
593235-9323598.61099.60
694540-9454099.991101.00
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.764929749362492744929249371493190.09
213.724954349532495380.02
单位质量响应值RSD%判断
3584.233610.640.52数据可信
长期12月-供试品溶液-2024110221批-左氨氯地平-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%
5min145812-4581279.74476.467.8579.7476.467.84
236978-3697864.36764.37
345484-4548479.17379.17
445302-4530278.85678.86
544313-4431377.13577.13
645666-4566679.49079.49
10min159397-59397103.391103.550.91103.52103.680.92
258774-58774102.306102.41
360083-60083104.585104.72
459799-59799104.091104.22
559939-59939104.334104.46
658951-58951102.615102.75
15min158781-58781102.319100.401.96102.62100.701.96
257337-5733799.805100.08
355577-5557796.74297.05
458242-58242101.380101.69
557995-57995100.950101.25
658134-58134101.192101.50
20min157978-57978100.921100.120.90101.40100.590.91
256731-5673198.75099.19
357933-57933100.843101.31
457377-5737799.875100.35
557940-57940100.855101.33
657158-5715899.49499.97
30min157260-5726099.67199.391.19100.32100.021.19
255859-5585997.23297.84
357823-57823100.651101.29
457068-5706899.33799.98
557535-57535100.150100.79
657034-5703499.27899.92
45min157278-5727899.70298.601.32100.5199.401.32
255888-5588897.28398.05
355827-5582797.17797.98
456489-5648998.32999.13
557697-57697100.432101.24
656691-5669198.68199.48
极限156671-5667198.64698.600.7999.6299.570.79
255853-5585397.22298.15
357130-5713099.445100.41
456531-5653198.40299.37
556941-5694199.116100.09
656758-5675898.79799.77
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2000
标示量(mg)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%
110.058495584923850218487984934849420.07
210.038507085087850780.02
单位质量响应值RSD%判断
8451.948482.350.26数据可信
长期12月-供试品溶液-2024110321批-比索洛尔-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%
5min192482-9248298.106100.122.0198.11100.122.01
295542-95542101.352101.35
396358-96358102.217102.22
496053-96053101.894101.89
591935-9193597.52697.53
693894-9389499.60499.60
10min193287-9328798.960100.681.9899.12100.841.98
295697-95697101.516101.69
396864-96864102.754102.92
496929-96929102.823102.99
592482-9248298.10698.27
694187-9418799.914100.08
15min193212-9321298.880100.541.8899.21100.871.88
295674-95674101.492101.83
396526-96526102.396102.74
496609-96609102.484102.82
592350-9235097.96698.29
694287-94287100.021100.35
20min193037-9303798.695100.152.0099.19100.652.00
295248-95248101.040101.55
396353-96353102.212102.72
496344-96344102.203102.71
591722-9172297.30097.79
693730-9373099.43099.93
30min192719-9271998.35799.991.9799.01100.661.97
295033-95033100.812101.49
396073-96073101.915102.60
496319-96319102.176102.86
591768-9176897.34898.00
693661-9366199.356100.02
45min192709-9270998.347100.391.5699.17101.231.56
295714-95714101.534102.38
395859-95859101.688102.54
496216-96216102.067102.92
593659-9365999.354100.17
693663-9366399.359100.19
极限192129-9212997.73199.532.0198.72100.542.01
294299-94299100.033101.05
395827-95827101.654102.68
495934-95934101.768102.79
591381-9138196.93897.92
693397-9339799.076100.07
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.764947349404492854906249458493360.35
213.724941549050492320.53
单位质量响应值RSD%判断
3585.473588.340.06数据可信
长期12月-供试品溶液-2024110321批-左氨氯地平-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%
5min145640-4564079.67776.325.5179.6876.325.51
243569-4356976.06176.06
343950-4395076.72676.73
439454-3945468.87768.88
543339-4333975.66075.66
646340-4634080.89980.90
10min157498-57498100.378100.071.19100.51100.201.20
258021-58021101.291101.42
357064-5706499.62099.75
456604-5660498.81798.93
556589-5658998.79198.92
658142-58142101.502101.64
15min156952-5695299.42598.281.9399.7298.581.93
256715-5671599.01199.31
355050-5505096.10496.40
455216-5521696.39496.67
555997-5599797.75898.05
657860-57860101.010101.31
20min156507-5650798.64897.192.0499.1197.652.04
256567-5656798.75399.21
354634-5463495.37895.83
454652-5465295.41095.85
554664-5466495.43095.88
657016-5701699.537100.01
30min155887-5588797.56696.891.8498.2097.521.85
256274-5627498.24198.87
354561-5456195.25195.86
454555-5455595.24095.84
554769-5476995.61496.23
656968-5696899.453100.09
45min155577-5557797.02496.031.7597.8296.811.75
254984-5498495.98996.78
353965-5396594.21094.98
453933-5393394.15494.91
555172-5517296.31797.09
656422-5642298.50099.30
极限154826-5482695.71394.951.2796.6795.891.27
254160-5416094.55195.50
354091-5409194.43095.36
453759-5375993.85194.77
553924-5392494.13995.07
655575-5557597.02197.99
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2000
标示量(mg)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%
110.058502885009851668513485082850840.08
210.038517885307852420.11
单位质量响应值RSD%判断
8466.078498.700.28数据可信
长期12月-供试品溶液-2024110421批-比索洛尔-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%
5min193816-9381699.34297.771.2999.3497.771.29
293386-9338698.88798.89
392199-9219997.63097.63
490969-9096996.32796.33
592610-9261098.06598.07
690990-9099096.35096.35
10min195060-95060100.65998.201.38100.8298.361.38
292172-9217297.60197.77
392735-9273598.19798.36
491492-9149296.88197.04
593091-9309198.57498.74
691855-9185597.26697.43
15min194888-94888100.47798.421.40100.8198.751.40
293863-9386399.39299.72
392658-9265898.11698.44
491537-9153796.92997.25
593109-9310998.59398.92
691640-9164097.03897.36
20min194553-94553100.12398.191.33100.6298.681.33
293535-9353599.04599.54
392435-9243597.88098.37
491484-9148496.87397.36
592999-9299998.47798.97
691378-9137896.76197.24
30min194241-9424199.79297.911.29100.4698.571.29
293096-9309698.58099.24
392426-9242697.87098.52
491116-9111696.48397.13
592735-9273598.19798.85
691189-9118996.56097.21
45min193891-9389199.42297.661.31100.2698.481.32
293187-9318798.67699.50
392049-9204997.47198.29
490752-9075296.09896.90
592414-9241497.85898.68
691059-9105996.42397.23
极限193690-9369099.20997.401.39100.2198.381.39
292911-9291198.38499.37
391885-9188597.29798.28
490331-9033195.65296.62
592323-9232397.76198.74
690745-9074596.09097.06
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100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.764938449272494714933149501493920.20
213.724918349402492920.32
单位质量响应值RSD%判断
3589.533592.710.07数据可信
长期12月-供试品溶液-2024110421批-左氨氯地平-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%
5min154966-5496695.84594.684.5195.8494.684.51
249787-4978786.81486.81
356576-5657698.65298.65
453574-5357493.41893.42
556087-5608797.80097.80
654802-5480295.55995.56
10min155905-5590597.48296.012.1697.6496.172.16
253794-5379493.80193.95
356477-5647798.48098.64
453604-5360493.47093.63
555796-5579697.29297.46
654791-5479195.54095.70
15min156116-5611697.85096.792.0698.1797.102.06
255490-5549096.75997.06
356500-5650098.52098.85
453450-5345093.20193.51
556364-5636498.28398.61
655114-5511496.10396.42
20min155880-5588097.43996.572.1297.9297.052.12
255942-5594297.54798.01
356295-5629598.16298.66
453265-5326592.87993.35
556159-5615997.92598.41
654762-5476295.48995.97
30min155608-5560896.96496.362.0997.6197.002.08
255791-5579197.28397.91
356400-5640098.34599.00
453137-5313792.65693.28
555765-5576597.23897.89
654856-5485695.65396.29
45min155393-5539396.58996.002.2297.4096.802.21
255895-5589597.46598.25
356126-5612697.86898.69
453002-5300292.42093.20
555741-5574197.19698.01
654182-5418294.47895.28
极限154907-5490795.74295.662.1496.7196.622.13
255068-5506896.02396.97
356082-5608297.79198.77
452880-5288092.20893.14
555901-5590197.47598.45
654325-5432594.72795.68
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