阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.814729647252472944729447291472850.04
211.874732547351473380.04
单位质量响应值RSD%判断
4003.813988.040.28数据可信
供试品溶液-24042903批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min151519-51519104.196103.650.97104.20103.650.97
250904-50904102.953102.95
350788-50788102.718102.72
450776-50776102.694102.69
551562-51562104.283104.28
651948-51948105.064105.06
10min152633-52633106.449104.811.05107.03105.381.04
250989-50989103.124103.70
351745-51745104.653105.22
451607-51607104.374104.94
552022-52022105.214105.79
651930-51930105.028105.61
15min151376-51376103.907103.420.75105.08104.580.75
250523-50523102.182103.33
350825-50825102.793103.94
451340-51340103.834104.98
551515-51515104.188105.35
651229-51229103.610104.78
20min150878-50878102.900102.480.95104.65104.220.94
249829-49829100.778102.49
350605-50605102.348104.07
450803-50803102.748104.48
551272-51272103.697105.44
650649-50649102.437104.18
30min151330-51330103.814102.662.05106.13104.962.02
249441-4944199.994102.27
349760-49760100.639102.93
450623-50623102.384104.68
551181-51181103.513105.83
652227-52227105.628107.94
45min150383-50383101.899101.571.12104.79104.441.11
249204-4920499.514102.34
349972-49972101.068103.92
450640-50640102.419105.29
550683-50683102.506105.40
650440-50440102.014104.91
60min149862-49862100.84599.791.18104.31103.231.17
248740-4874098.576101.96
348947-4894798.995102.41
448912-4891298.924102.36
550185-50185101.498104.96
649390-4939099.890103.36
极限149611-49611100.33799.191.35104.36103.181.33
247738-4773896.549100.48
349159-4915999.423103.39
449269-4926999.646103.63
549219-4921999.545103.57
649266-4926699.640103.66
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.963813433812153812883814003813313813150.02
210.983816593815843816220.02
单位质量响应值RSD%判断
34791.5134756.100.08数据可信
供试品溶液-24042903批-阿齐沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15060-50601.3061.267.651.311.267.58
25008-50081.2921.29
34986-49861.2871.29
45365-53651.3841.38
54512-45121.1641.16
64365-43651.1261.13
10min117290-172904.4614.324.024.474.324.01
217445-174454.5014.51
316860-168604.3514.36
416940-169404.3714.38
516052-160524.1424.15
615778-157784.0714.08
15min125284-252846.5246.492.786.566.522.79
226348-263486.7996.83
324774-247746.3936.42
425398-253986.5546.59
524373-243736.2896.32
624736-247366.3836.41
20min130863-308637.9647.972.478.038.042.50
232305-323058.3368.41
330290-302907.8167.88
430953-309537.9878.06
530183-301837.7887.85
630743-307437.9338.00
30min139215-3921510.11910.052.6610.2310.162.66
240493-4049310.44910.57
337472-374729.6699.78
438847-3884710.02410.14
538254-382549.8719.98
639418-3941810.17110.28
45min145995-4599511.86912.052.5312.0412.222.54
248720-4872012.57212.75
345604-4560411.76811.93
446795-4679512.07512.24
545771-4577111.81111.97
647266-4726612.19612.36
60min150827-5082713.11513.182.8813.3513.422.87
253808-5380813.88514.13
349730-4973012.83213.06
450144-5014412.93913.17
550513-5051313.03413.26
651558-5155813.30413.54
极限157748-5774814.90114.921.5215.2115.231.52
259443-5944315.33915.66
357337-5733714.79515.10
457314-5731414.78915.10
557032-5703214.71615.02
658077-5807714.98615.29
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.814743347406474434740447420474210.04
211.874738447337473600.08
单位质量响应值RSD%判断
4015.333989.890.45数据可信
供试品溶液-24042903批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148313-4831397.550100.331.4697.55100.331.46
250117-50117101.192101.19
349467-4946799.88099.88
450157-50157101.273101.27
549972-49972100.899100.90
650122-50122101.202101.20
10min151602-51602104.191103.411.54104.73103.961.53
251302-51302103.585104.15
351105-51105103.187103.74
452084-52084105.164105.73
549761-49761100.473101.03
651424-51424103.831104.39
15min151023-51023103.022102.531.46104.14103.661.45
251651-51651104.290105.43
350559-50559102.085103.21
451122-51122103.221104.37
549462-4946299.870100.99
650861-50861102.694103.83
20min150144-50144101.247102.081.28102.94103.781.27
251112-51112103.201104.92
350576-50576102.119103.81
450843-50843102.658104.38
549495-4949599.936101.61
651170-51170103.318105.03
30min150190-50190101.340100.981.90103.60103.251.88
249950-49950100.855103.15
349975-49975100.905103.17
450429-50429101.822104.11
548321-4832197.56699.79
651212-51212103.403105.69
45min150392-50392101.74799.762.07104.57102.592.04
250070-50070101.097103.95
349392-4939299.728102.55
449666-49666100.282103.14
547474-4747495.85698.63
649459-4945999.864102.72
60min149784-49784100.52098.411.92103.90101.791.89
248991-4899198.919102.33
348855-4885598.644102.02
448839-4883998.612102.03
546968-4696894.83498.14
648985-4898598.907102.32
极限148491-4849197.90998.011.62101.85101.951.61
248985-4898598.907102.87
348334-4833497.592101.52
449175-4917599.290103.25
547108-4710895.11798.95
649167-4916799.274103.24
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.963826013823423825283824183823773824530.03
210.983820953821083821020.01
单位质量响应值RSD%判断
34895.3534799.820.20数据可信
供试品溶液-24042903批-阿齐沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15878-58781.5141.6610.881.511.6611.04
27371-73711.8981.90
36894-68941.7751.78
46986-69861.7991.80
55827-58271.5001.50
65802-58021.4941.49
10min117063-170634.3944.645.284.404.655.30
219691-196915.0705.08
318261-182614.7024.71
418124-181244.6674.68
517824-178244.5904.60
617176-171764.4234.43
15min125474-254746.5596.764.086.596.804.09
227840-278407.1697.21
326636-266366.8596.89
425380-253806.5356.57
527066-270666.9697.00
625240-252406.4996.53
20min131066-310667.9998.274.028.078.344.01
233520-335208.6318.71
332609-326098.3978.47
430714-307147.9097.98
533602-336028.6528.72
631196-311968.0338.10
30min139343-3934310.13110.292.9510.2410.412.95
240848-4084810.51810.64
340461-4046110.41810.54
438181-381819.8319.95
541431-4143110.66810.79
639520-3952010.17610.29
45min147449-4744912.21812.142.9812.3912.322.99
248614-4861412.51812.70
347725-4772512.28912.47
445013-4501311.59111.76
548263-4826312.42712.61
645920-4592011.82411.99
60min152233-5223313.45013.302.6513.6913.552.63
252446-5244613.50413.76
352415-5241513.49713.74
449405-4940512.72112.96
552899-5289913.62113.87
650567-5056713.02113.26
极限157556-5755614.82015.031.5615.1315.351.59
259242-5924215.25415.58
358916-5891615.17015.49
457414-5741414.78415.09
559433-5943315.30415.63
657754-5775414.87115.18
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