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%
111.634667946651466414655846791466640.19
211.704680146831468160.05
单位质量响应值RSD%判断
4012.384001.370.20数据可信
供试品溶液-24042401批-左氨氯地平-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%
5min18252-825216.64443.9370.6516.6443.9370.66
26243-624312.59212.59
335678-3567871.96171.96
48777-877717.70317.70
535455-3545571.51171.51
636275-3627573.16573.16
10min143929-4392988.60388.338.1288.7088.578.25
237013-3701374.65374.72
346087-4608792.95593.36
443456-4345687.64987.75
546777-4677794.34794.74
645494-4549491.75992.17
15min146533-4653393.85593.421.4794.4494.161.62
245432-4543291.63492.12
347065-4706594.92895.84
445766-4576692.30892.89
547054-4705494.90695.83
646057-4605792.89593.81
20min147450-4745095.70494.521.5196.8195.781.58
245632-4563292.03893.03
347092-4709294.98296.43
447161-4716195.12196.22
547420-4742095.64497.09
646431-4643193.64995.08
30min147907-4790796.62694.722.3298.2696.502.36
244983-4498390.72992.23
346615-4661594.02095.99
447616-4761696.03997.67
547697-4769796.20398.18
646952-4695294.70096.65
45min148894-4889498.61795.211.95100.7997.511.89
246251-4625193.28695.30
346710-4671094.21296.71
447295-4729595.39297.55
547309-4730995.42097.93
646765-4676594.32396.80
60min146521-4652193.83195.711.6896.5598.541.75
246633-4663394.05796.58
348340-4834097.499100.52
448336-4833697.491100.18
547632-4763296.07199.12
647258-4725895.31798.32
极限148889-4888998.60796.211.70101.8599.581.61
247253-4725395.30798.36
347951-4795196.715100.27
447912-4791296.63699.87
547745-4774596.29999.88
646460-4646093.70897.24
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(%)99.7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%
110.963802483797263808883794313807583802100.17
211.043806943805533806240.03
单位质量响应值RSD%判断
34690.6934476.810.44数据可信
供试品溶液-24042401批-阿齐沙坦-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%
5min171715-7171518.60712.7035.4718.6112.7035.48
255424-5542414.38014.38
332423-324238.4128.41
461712-6171216.01216.01
526554-265546.8906.89
645882-4588211.90511.90
10min1226574-22657458.78755.954.2058.8956.024.21
2208959-20895954.21654.30
3216312-21631256.12456.17
4207100-20710053.73453.82
5208307-20830754.04754.09
6226488-22648858.76458.83
15min1327585-32758584.99583.507.1485.4383.887.11
2344448-34444889.37089.75
3309746-30974680.36780.73
4281267-28126772.97773.36
5331767-33176786.08086.42
6336109-33610987.20787.60
20min1338933-33893387.93989.977.2588.8490.827.20
2360771-36077193.60594.48
3340674-34067488.39189.20
4303671-30367178.79079.58
5374581-37458197.18998.01
6361907-36190793.90094.78
30min1347314-34731490.11492.517.3291.5093.867.26
2367495-36749595.35096.75
3354514-35451491.98293.28
4311091-31109180.71681.95
5385523-385523100.028101.38
6373349-37334996.86998.27
45min1352767-35276791.52992.976.8193.4294.836.77
2365865-36586594.92796.85
3356791-35679192.57394.38
4314751-31475181.66583.34
5385103-38510399.919101.83
6374656-37465697.20899.15
60min1347057-34705790.04793.426.7392.4595.796.69
2368218-36821895.53897.99
3362205-36220593.97896.30
4319408-31940882.87385.01
5388948-388948100.916103.38
6374434-37443497.15099.63
极限1387239-387239100.473102.092.27103.37104.982.18
2379606-37960698.492101.48
3393712-393712102.152105.00
4399796-399796103.731106.32
5404379-404379104.920107.95
6396076-396076102.766105.78
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%
111.634735947439474614733147415474010.12
211.704700046555467780.68
单位质量响应值RSD%判断
4075.753998.121.36数据可信
供试品溶液-24042401SP批-左氨氯地平-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%
5min129315-2931558.69262.9417.4558.6962.9417.45
239511-3951179.10679.11
327864-2786455.78755.79
427848-2784855.75555.75
537258-3725874.59574.59
626834-2683453.72553.72
10min145596-4559691.28891.922.3191.6192.272.36
247271-4727194.64295.08
345346-4534690.78891.10
445974-4597492.04592.35
546904-4690493.90794.32
644384-4438488.86289.16
15min147256-4725694.61294.841.2295.4595.701.28
248358-4835896.81897.78
346745-4674593.58994.40
447050-4705094.19995.02
547709-4770995.51996.45
647114-4711494.32895.12
20min147636-4763695.37394.761.3796.7396.141.40
248050-4805096.20297.70
346217-4621792.53293.87
446960-4696094.01995.36
547573-4757395.24796.71
647539-4753995.17996.49
30min147542-4754295.18594.761.2297.0796.681.22
247955-4795596.01198.05
346476-4647693.05094.90
447417-4741794.93496.80
546806-4680693.71195.71
647785-4778595.67197.52
45min147280-4728094.66095.021.6797.0897.461.70
248902-4890297.907100.48
346472-4647293.04295.41
447432-4743294.96497.36
547378-4737894.85697.37
647286-4728694.67297.05
60min146166-4616692.43093.371.5795.3796.331.56
246635-4663593.36996.48
345478-4547891.05293.93
446784-4678493.66796.59
547445-4744594.99098.03
647293-4729394.68697.59
极限148660-4866097.423108.7829.56100.88112.2628.68
247820-4782095.74199.37
346792-4679293.68397.07
447283-4728394.66698.11
587082-87082174.348177.92
648349-4834996.800100.23
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(%)99.7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%
110.963854313853073857223859453858803856570.08
211.043801743806863804300.10
单位质量响应值RSD%判断
35187.6834459.241.48数据可信
供试品溶液-24042401SP批-阿齐沙坦-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%
5min157060-5706014.70419.2037.7514.7019.2037.76
2129563-12956333.38833.39
364048-6404816.50516.51
459907-5990715.43815.44
578689-7868920.27820.28
657777-5777714.88914.89
10min1216647-21664755.83062.7422.2855.9162.8522.29
2325325-32532583.83684.02
3274929-27492970.84970.94
4225251-22525158.04758.13
5251918-25191864.91965.03
6166745-16674542.97043.05
15min1318090-31809081.97286.308.0582.3686.758.11
2357938-35793892.24092.89
3337149-33714986.88387.37
4330114-33011485.07085.48
5370243-37024395.41195.88
6295680-29568076.19776.52
20min1332825-33282585.76989.086.7286.6290.016.78
2360040-36004092.78293.95
3342990-34299088.38889.36
4340483-34048387.74288.62
5382539-38253998.58099.58
6315133-31513381.21081.95
30min1335733-33573386.51890.105.9887.8491.536.03
2358366-35836692.35194.03
3348729-34872989.86791.33
4345678-34567889.08190.45
5384996-38499699.213100.76
6324231-32423183.55484.75
45min1336878-33687886.81390.185.8188.6292.115.87
2360319-36031992.85495.05
3349036-34903689.94691.90
4345297-34529788.98390.85
5383440-38344098.812100.91
6324620-32462083.65485.31
60min1333688-33368885.99189.535.9788.2891.966.04
2360267-36026792.84195.55
3346294-34629489.24091.70
4339805-33980587.56889.93
5381299-38129998.260100.91
6323148-32314883.27585.40
极限1374821-37482196.591114.6237.0299.36117.5536.20
2374266-37426696.44899.67
3377562-37756297.297100.25
4367705-36770594.75797.60
5780329-780329201.090204.29
6393982-393982101.529104.12
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%
111.634683546728467954683446807468000.10
211.704678146757467690.04
单位质量响应值RSD%判断
4024.083997.350.48数据可信
供试品溶液-24042401批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148517-4851797.76486.3830.3397.7686.3830.33
249215-4921599.17099.17
349780-49780100.309100.31
448798-4879898.33098.33
544269-4426989.20489.20
616641-1664133.53233.53
10min151082-51082102.932101.651.06103.48102.131.07
250392-50392101.542102.09
350864-50864102.493103.05
449539-4953999.823100.37
550408-50408101.574102.07
650400-50400101.558101.74
15min150821-50821102.406101.101.94103.52102.151.86
250108-50108100.970102.08
350637-50637102.036103.16
449317-4931799.376100.48
548792-4879298.31899.38
651372-51372103.517104.27
20min150602-50602101.965100.561.35103.65102.171.27
249552-4955299.849101.53
350087-50087100.927102.62
449145-4914599.029100.68
549313-4931399.368100.97
650732-50732102.227103.55
30min152153-52153105.090101.352.96107.34103.512.85
249806-49806100.361102.59
350327-50327101.411103.67
448802-4880298.338100.54
548741-4874198.215100.37
651939-51939104.659106.55
45min148424-4842497.57699.361.17100.41102.091.06
249681-49681100.109102.90
349399-4939999.541102.36
449036-4903698.810101.56
549208-4920899.156101.86
650114-50114100.982103.46
60min149269-4926999.27999.352.51102.66102.632.35
248893-4889398.521101.87
349916-49916100.583103.95
447540-4754095.79599.09
548958-4895898.652101.91
651259-51259103.289106.32
极限148848-4884898.43198.801.95102.36102.641.85
249108-4910898.955102.85
349853-49853100.456104.39
447966-4796696.653100.48
548062-4806296.847100.65
650364-50364101.486105.10
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(%)99.7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%
110.963831053830103833283826783824183829080.10
211.043806883808973807920.04
单位质量响应值RSD%判断
34936.8634492.030.91数据可信
供试品溶液-24042401批-阿齐沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15159-51591.3341.3119.941.331.3119.87
25616-56161.4521.45
36309-63091.6311.63
45687-56871.4701.47
53817-38170.9870.99
63913-39131.0111.01
10min19411-94112.4332.478.602.442.488.64
28265-82652.1362.14
310077-100772.6052.61
410723-107232.7722.78
59635-96352.4912.50
69320-93202.4092.41
15min117510-175104.5264.554.914.554.574.90
216240-162404.1984.22
318545-185454.7944.82
418534-185344.7914.81
517368-173684.4894.51
617383-173834.4934.51
20min124542-245426.3446.283.436.396.333.42
223080-230805.9666.01
324999-249996.4626.51
425357-253576.5556.60
523846-238466.1646.21
623979-239796.1986.24
30min134892-348929.0198.683.189.108.763.18
232700-327008.4538.53
334344-343448.8788.96
434115-341158.8188.91
532105-321058.2998.38
633203-332038.5838.66
45min140439-4043910.45310.520.9110.5810.650.90
240741-4074110.53110.65
340444-4044410.45410.59
441177-4117710.64410.78
541148-4114810.63610.76
640355-4035510.43110.56
60min145098-4509811.65711.671.2911.8511.851.26
244779-4477911.57511.76
345807-4580711.84112.03
444334-4433411.46011.65
544962-4496211.62211.81
645791-4579111.83712.02
极限147450-4745012.26512.300.9412.5212.560.92
247735-4773512.33912.59
348194-4819412.45812.72
446952-4695212.13712.40
547296-4729612.22612.47
647904-4790412.38312.63
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%
111.634686746822469214669746983468580.24
211.704659446415465040.28
单位质量响应值RSD%判断
4029.063974.700.97数据可信
供试品溶液-24042401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%
5min145528-4552891.94668.2550.7891.9568.2550.78
27486-748615.11815.12
345388-4538891.66491.66
445447-4544791.78391.78
542398-4239885.62585.63
616529-1652933.38133.38
10min147557-4755796.04494.561.5596.5594.941.60
247336-4733695.59895.68
347072-4707295.06595.57
446285-4628593.47593.99
547040-4704095.00095.48
645636-4563692.16592.35
15min148018-4801896.97591.3113.4398.0292.2113.25
248121-4812197.18397.80
346640-4664094.19295.23
433022-3302266.69067.72
549245-4924599.453100.46
646217-4621793.33894.04
20min147295-4729595.51594.513.1997.1095.923.18
247686-4768696.30597.46
346786-4678694.48796.05
444167-4416789.19890.60
548514-4851497.97799.53
646327-4632793.56094.78
30min146480-4648093.86993.572.4395.9895.502.36
247578-4757896.08797.78
344756-4475690.38792.47
445556-4555692.00393.90
547588-4758896.10798.21
646020-4602092.94094.68
45min147408-4740895.74394.863.2198.3897.323.26
245408-4540891.70493.93
347560-4756096.05098.64
448963-4896398.884101.29
547531-4753195.99298.63
644959-4495990.79793.05
60min148169-4816997.28094.722.74100.4597.702.82
245837-4583792.57095.30
347107-4710795.13598.26
448050-4805097.040100.00
547328-4732895.58298.75
644916-4491690.71093.47
极限147204-4720495.33194.443.3799.0497.943.36
246953-4695394.82498.07
346842-4684294.60098.25
448583-4858398.116101.61
547162-4716295.24698.94
643820-4382088.49791.76
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(%)99.7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%
110.963840913846933847003841133840713843340.09
211.043799223801993800600.06
单位质量响应值RSD%判断
35066.9734425.721.31数据可信
供试品溶液-24042401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%
5min11363-13630.3520.4327.920.350.4328.38
22430-24300.6280.63
31800-18000.4650.46
41811-18110.4680.47
51093-10930.2820.28
61485-14850.3840.38
10min111900-119003.0732.858.803.082.858.89
212018-120183.1043.11
39600-96002.4792.48
410964-109642.8322.83
510195-101952.6332.63
611496-114962.9692.97
15min125198-251986.5085.986.236.536.006.26
223104-231045.9675.99
320900-209005.3985.41
422423-224235.7915.81
523359-233596.0336.05
623892-238926.1706.19
20min132738-327388.4558.164.448.518.224.45
232107-321078.2928.35
330200-302007.8007.85
429476-294767.6137.66
532549-325498.4068.46
632567-325678.4118.46
30min144029-4402911.37111.132.6511.4711.232.65
243847-4384711.32411.42
341734-4173410.77810.87
441564-4156410.73510.83
543957-4395711.35311.45
643456-4345611.22311.32
45min155822-5582214.41714.442.5714.5814.602.52
254612-5461214.10414.27
354989-5498914.20214.35
458653-5865315.14815.30
555985-5598514.45914.62
655431-5543114.31614.48
60min163088-6308816.29315.891.8816.5416.131.87
260869-6086915.72015.96
360200-6020015.54815.78
462818-6281816.22416.46
561274-6127415.82516.06
660971-6097115.74715.99
极限165420-6542016.89616.971.4917.2317.291.46
265567-6556716.93417.26
364748-6474816.72217.04
467550-6755017.44617.77
565729-6572916.97517.30
665137-6513716.82317.15
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%
111.634673846870467884689746763468110.15
211.704682446831468280.02
单位质量响应值RSD%判断
4025.024002.390.40数据可信
供试品溶液-24042401SP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%
5min142413-4241385.40085.9810.5985.4085.9810.59
234026-3402668.51268.51
344241-4424189.08189.08
443921-4392188.43688.44
547157-4715794.95294.95
644452-4445289.50589.51
10min148393-4839397.44195.933.1397.9296.413.15
245238-4523891.08891.47
348649-4864997.95698.45
449102-4910298.86899.36
548047-4804796.74497.27
646439-4643993.50694.00
15min148531-4853197.71995.562.8898.7396.572.89
245874-4587492.36993.26
347467-4746795.57696.62
449074-4907498.81299.85
548001-4800196.65297.72
645799-4579992.21893.23
20min148612-4861297.88295.922.5199.4497.472.52
246340-4634093.30794.71
348256-4825697.16598.74
448432-4843297.51999.11
548298-4829897.25098.85
645900-4590092.42193.95
30min147942-4794296.53394.842.4198.6496.922.42
245889-4588992.39994.32
347681-4768196.00798.12
448063-4806396.77698.91
547583-4758395.81097.95
645449-4544991.51393.56
45min145050-4505090.71094.112.6393.3596.712.52
248003-4800396.65699.09
346893-4689394.42197.06
445584-4558491.78594.45
548055-4805596.76099.43
646854-4685494.34296.89
60min147456-4745695.55494.991.9098.7098.121.78
248458-4845897.572100.54
346614-4661493.85997.03
445873-4587392.36795.55
547644-4764495.93399.14
647021-4702194.67897.75
极限145701-4570192.02092.942.3195.6996.602.18
247224-4722495.08798.60
345287-4528791.18794.88
444721-4472190.04793.74
546834-4683494.30298.05
647184-4718495.00698.61
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(%)99.7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%
110.963818423817683819563819643818043818670.03
211.043834263829863832060.09
单位质量响应值RSD%判断
34841.8834710.690.27数据可信
供试品溶液-24042401SP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%
5min12225-22250.5740.7821.490.570.7821.71
22817-28170.7270.73
32422-24220.6250.62
43888-38881.0031.00
53553-35530.9170.92
63204-32040.8270.83
10min111458-114582.9563.4213.402.963.4313.40
212614-126143.2553.26
311842-118423.0553.06
416370-163704.2244.23
513380-133803.4523.46
613882-138823.5823.59
15min124172-241726.2376.517.156.266.547.15
224645-246456.3596.38
323611-236116.0926.11
428700-287007.4057.43
524908-249086.4276.45
625429-254296.5616.59
20min133378-333788.6128.793.868.678.853.91
234050-340508.7868.84
332956-329568.5038.56
436605-366059.4459.52
534068-340688.7908.85
633385-333858.6148.67
30min145308-4530811.69011.652.5811.7911.762.62
244766-4476611.55111.66
344208-4420811.40711.51
447414-4741412.23412.36
544536-4453611.49111.60
644701-4470111.53411.64
45min152347-5234713.50713.862.3713.6714.042.32
255262-5526214.25914.43
353331-5333113.76113.93
452266-5226613.48613.68
554629-5462914.09514.27
654556-5455614.07714.25
60min161172-6117215.78415.402.1416.0315.652.08
261021-6102115.74515.99
358420-5842015.07415.31
458106-5810614.99315.26
559553-5955315.36615.62
659757-5975715.41915.67
极限163897-6389716.48716.162.3116.8216.502.25
264176-6417616.55916.90
361017-6101715.74416.07
460760-6076015.67716.03
562828-6282816.21116.55
663128-6312816.28816.63
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