比索洛尔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10071-202203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%
110.178481485018845678470884873847960.21
210.108476384899848310.12
单位质量响应值RSD%判断
8337.868399.110.52数据可信
长期36月-供试品溶液-2022110111批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188484-8848494.97297.511.8494.9797.511.84
289830-8983096.41796.42
393085-9308599.91199.91
490544-9054497.18397.18
590790-9079097.44797.45
692341-9234199.11299.11
10min189004-8900495.53098.401.9295.6998.561.92
290761-9076197.41697.58
393515-93515100.372100.54
491054-9105497.73197.89
592201-9220198.96299.12
693503-93503100.359100.52
15min189037-8903795.56698.362.0095.8898.692.00
290550-9055097.19097.51
393383-93383100.231100.56
491034-9103497.70998.03
591931-9193198.67299.00
693923-93923100.810101.14
20min188954-8895495.47797.981.9495.9598.471.94
290023-9002396.62497.11
393367-93367100.213100.71
490710-9071097.36297.85
591435-9143598.14098.63
693251-93251100.089100.59
30min188710-8871095.21597.811.9195.8598.461.91
289936-8993696.53197.18
392938-9293899.753100.42
490732-9073297.38598.04
591236-9123697.92698.58
693212-93212100.047100.71
45min188167-8816794.63297.852.0495.4398.662.04
290833-9083397.49498.30
393082-9308299.907100.74
490622-9062297.26798.08
591074-9107497.75298.57
693198-93198100.032100.87
极限188071-8807194.52997.442.0495.4898.422.04
289917-8991796.51097.48
392877-9287799.687100.69
490231-9023196.84797.82
590768-9076897.42498.41
692840-9284099.648100.65
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921075311075471070891075841072191073940.21
213.901066941072241069590.36
单位质量响应值RSD%判断
7715.097694.890.19数据可信
长期36月-供试品溶液-2022110111批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104732-10473288.12885.884.2588.1385.884.25
2108318-10831891.14591.14
399240-9924083.50683.51
4103966-10396687.48387.48
599471-9947183.70183.70
696635-9663581.31481.31
10min1116647-11664798.15397.762.4298.3097.912.43
2121189-121189101.975102.13
3116521-11652198.04798.19
4114451-11445196.30696.45
5115350-11535097.06297.20
6112951-11295195.04395.18
15min1115418-11541897.11996.142.2497.4396.442.25
2118422-11842299.64799.97
3113720-11372095.69195.99
4114625-11462596.45296.76
5111761-11176194.04294.34
6111552-11155293.86694.16
20min1115384-11538497.09195.782.2897.5696.252.28
2118134-11813499.40599.89
3113196-11319695.25095.71
4113314-11331495.34995.82
5112159-11215994.37794.84
6110796-11079693.23093.68
30min1114515-11451596.36095.232.4096.9995.862.40
2117988-11798899.28299.94
3111416-11141693.75294.37
4112899-11289995.00095.63
5111217-11121793.58494.20
6110989-11098993.39394.00
45min1113765-11376595.72895.072.2596.5295.862.25
2117405-11740598.79199.61
3112064-11206494.29795.07
4113337-11333795.36896.15
5110257-11025792.77793.55
6111100-11110093.48694.25
极限1113868-11386895.81594.652.4796.7795.602.47
2117277-11727798.68499.67
3111817-11181794.08995.02
4112064-11206494.29795.24
5110125-11012592.66693.59
6109776-10977692.37293.29
比索洛尔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10071-202203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%
110.178470784709847818467484803847350.07
210.108479585149849720.30
单位质量响应值RSD%判断
8331.868413.070.69数据可信
长期36月-供试品溶液-2022110211批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189542-8954296.06396.612.1396.0696.612.13
292074-9207498.78098.78
386819-8681993.14293.14
489830-8983096.37296.37
590172-9017296.73996.74
691898-9189898.59198.59
10min190308-9030896.88597.621.9797.0597.791.97
293315-93315100.111100.28
388234-8823494.66094.82
490665-9066597.26897.43
590906-9090697.52697.69
692558-9255899.29999.46
15min189988-8998896.54297.712.1296.8698.032.12
293275-93275100.068100.40
388053-8805394.46694.78
490579-9057997.17697.50
591848-9184898.53798.86
692695-9269599.44699.78
20min189597-8959796.12297.562.4996.6098.052.49
293024-9302499.799100.30
387823-8782394.21994.69
490461-9046197.04997.53
590721-9072197.32897.82
694000-94000100.846101.34
30min189529-8952996.04997.102.1596.6997.752.15
292988-9298899.760100.42
387579-8757993.95794.58
490332-9033296.91197.56
590393-9039396.97697.63
692255-9225598.97499.64
45min189558-8955896.08097.072.1196.8897.882.11
292616-9261699.361100.19
387429-8742993.79694.58
490214-9021496.78497.59
590798-9079897.41198.22
692274-9227498.99499.82
极限189353-8935395.86096.802.0296.8297.772.02
292572-9257299.314100.31
387455-8745593.82494.76
489943-8994396.49397.46
590258-9025896.83197.81
691790-9179098.47599.47
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921074821065691065181068831071021069110.38
213.901067411072021069720.31
单位质量响应值RSD%判断
7680.397695.830.15数据可信
长期36月-供试品溶液-2022110211批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101685-10168585.75184.193.5685.7584.193.56
2103562-10356287.33487.33
393905-9390579.19179.19
498317-9831782.91182.91
5102578-10257886.50586.50
698954-9895483.44883.45
10min1117384-11738498.99097.361.6799.1397.501.67
2115818-11581897.67097.82
3115495-11549597.39797.53
4113324-11332495.56795.70
5117560-11756099.13999.28
6113091-11309195.37095.51
15min1114311-11431196.39995.771.6596.7196.071.65
2115423-11542397.33797.65
3112309-11230994.71195.01
4111615-11161594.12594.42
5115848-11584897.69598.00
6111860-11186094.33294.63
20min1112873-11287395.18694.671.6295.6595.131.62
2113952-11395296.09696.57
3112165-11216594.58995.04
4111173-11117393.75394.21
5114072-11407296.19796.67
6109312-10931292.18392.64
30min1112675-11267595.01994.251.3195.6594.871.31
2113321-11332195.56496.19
3111693-11169394.19194.80
4110357-11035793.06593.68
5112807-11280795.13195.76
6109695-10969592.50693.12
45min1112272-11227294.67994.011.6495.4794.791.64
2112533-11253394.90095.69
3111177-11117793.75694.52
4109974-10997492.74293.51
5113958-11395896.10196.89
6108951-10895191.87992.64
极限1112237-11223794.65093.361.8695.5994.291.86
2112849-11284995.16696.11
3109627-10962792.44993.37
4109568-10956892.39993.32
5112283-11228394.68995.64
6107663-10766390.79391.71
比索洛尔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10071-202203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%
110.178550085556853678560485232854520.18
210.108491585124850200.18
单位质量响应值RSD%判断
8402.368417.820.13数据可信
长期36月-供试品溶液-2022110311批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189796-8979695.90296.401.9495.9096.401.94
287413-8741393.35793.36
390844-9084497.02297.02
491767-9176798.00798.01
589547-8954795.63795.64
692212-9221298.48398.48
10min191934-9193498.18699.142.2598.3599.302.25
289076-8907695.13395.29
393922-93922100.309100.47
494045-94045100.440100.60
593158-9315899.49399.65
694825-94825101.273101.44
15min191667-9166797.90199.232.2898.2299.562.28
289206-8920695.27295.59
393957-93957100.346100.68
493981-93981100.372100.70
593677-93677100.047100.37
694985-94985101.444101.78
20min191566-9156697.79399.082.0498.2899.572.05
289615-8961595.70996.18
393721-93721100.094100.59
494017-94017100.410100.91
592936-9293699.25699.75
694774-94774101.219101.72
30min191708-9170897.94499.012.0698.5999.672.06
289394-8939495.47396.11
393498-9349899.856100.52
493874-93874100.258100.92
593050-9305099.378100.04
694716-94716101.157101.83
45min191805-9180598.04899.071.8598.8699.891.85
289874-8987495.98696.78
393587-9358799.951100.78
493588-9358899.952100.78
592946-9294699.267100.09
694757-94757101.201102.04
极限190936-9093697.12098.692.4098.1099.682.40
288870-8887094.91395.87
393237-9323799.577100.57
493595-9359599.960100.96
592600-9260098.89799.89
695185-95185101.658102.67
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921080601080871076051083011080841080270.24
213.901076811078501077660.12
单位质量响应值RSD%判断
7760.567752.950.07数据可信
长期36月-供试品溶液-2022110311批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199512-9951283.17683.033.4783.1883.033.47
2105718-10571888.36388.36
395868-9586880.13080.13
498686-9868682.48682.49
596894-9689480.98880.99
699324-9932483.01983.02
10min1108085-10808590.34291.701.9890.4891.841.98
2113363-11336394.75394.90
3110213-11021392.12192.25
4107270-10727089.66189.80
5108850-10885090.98191.12
6110473-11047392.33892.48
15min1109507-10950791.53093.702.0191.8293.992.01
2115647-11564796.66296.97
3112440-11244093.98294.27
4109969-10996991.91792.20
5111802-11180293.44993.74
6113222-11322294.63694.93
20min1109195-10919591.27093.802.1091.7194.252.10
2116102-11610297.04397.51
3111004-11100492.78293.23
4111210-11121092.95493.39
5112837-11283794.31494.76
6112980-11298094.43394.88
30min1109410-10941091.44994.482.3392.0495.082.33
2116974-11697497.77298.40
3111722-11172293.38293.98
4111800-11180093.44794.04
5114279-11427995.51996.12
6114046-11404695.32495.93
45min1109179-10917991.25694.462.5192.0095.222.51
2117383-11738398.11398.90
3111517-11151793.21093.96
4111776-11177693.42794.18
5114360-11436095.58796.35
6113863-11386395.17195.94
极限1108567-10856790.74594.132.5491.6495.042.53
2117311-11731198.05399.01
3111657-11165793.32794.24
4112005-11200593.61894.52
5113591-11359194.94495.86
6112557-11255794.08095.00
比索洛尔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10071-202203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%
110.178497185218849628503485111850590.13
210.108519384961850770.20
单位质量响应值RSD%判断
8363.728423.470.51数据可信
长期36月-供试品溶液-5543C0421批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189444-8944495.71596.271.8995.7296.271.89
290622-9062296.97696.98
393094-9309499.62199.62
488390-8839094.58894.59
589222-8922295.47895.48
689010-8901095.25195.25
10min191593-9159398.01598.831.9898.1798.991.98
292926-9292699.44299.60
395773-95773102.488102.65
490663-9066397.02097.18
591437-9143797.84898.01
691749-9174998.18298.34
15min191718-9171898.14998.661.7298.4798.991.73
293138-9313899.668100.00
394991-94991101.651101.99
490892-9089297.26597.58
591358-9135897.76498.09
691084-9108497.47097.79
20min191606-9160698.02998.341.7998.5298.831.79
292595-9259599.08799.58
394834-94834101.483101.99
490256-9025696.58497.07
590776-9077697.14197.63
691294-9129497.69598.18
30min192537-9253799.02598.881.9199.6899.531.91
293412-9341299.962100.62
395125-95125101.795102.47
490243-9024396.57097.21
592219-9221998.68599.33
690874-9087497.24697.89
45min191610-9161098.03398.321.7398.8599.141.73
292429-9242998.91099.73
394612-94612101.246102.09
489948-8994896.25597.06
591732-9173298.16498.98
690918-9091897.29398.10
极限190956-9095697.33397.711.6298.3198.701.62
292051-9205198.50599.50
393894-93894100.477101.49
489854-8985496.15497.12
590206-9020696.53197.51
690905-9090597.27998.25
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.921072391073341072061073731074551073210.10
213.901070761071591071180.06
单位质量响应值RSD%判断
7709.847706.330.04数据可信
长期36月-供试品溶液-5543C0421批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100462-10046284.50083.450.9384.5083.450.93
299967-9996784.08484.08
399129-9912983.37983.38
498417-9841782.78082.78
599272-9927283.49983.50
698012-9801282.44082.44
10min1111981-11198194.18992.091.6294.3392.221.62
2110458-11045892.90893.05
3108984-10898491.66891.81
4106637-10663789.69489.83
5109598-10959892.18592.32
6109222-10922291.86992.01
15min1113921-11392195.82193.911.6596.1294.201.65
2113077-11307795.11195.41
3111596-11159693.86594.16
4108702-10870291.43191.72
5111946-11194694.16094.45
6110656-11065693.07593.37
20min1112761-11276194.84594.181.5595.3094.631.56
2114790-11479096.55297.01
3111664-11166493.92394.37
4109537-10953792.13492.57
5111320-11132093.63394.08
6111764-11176494.00794.45
30min1112675-11267594.77393.841.5595.3994.441.55
2114003-11400395.89096.50
3111038-11103893.39694.00
4108877-10887791.57892.17
5111590-11159093.86094.47
6111183-11118393.51894.12
45min1112380-11238094.52593.911.5995.3094.671.59
2114253-11425396.10096.87
3111009-11100993.37294.13
4108838-10883891.54692.29
5111705-11170593.95794.72
6111678-11167893.93494.69
极限1112728-11272894.81893.411.5895.7594.331.58
2113139-11313995.16396.10
3110202-11020292.69393.61
4108342-10834291.12892.03
5110815-11081593.20894.13
6111090-11109093.44094.35
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