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%
112.195044250332503905036150456503960.11
212.235061450750506820.19
单位质量响应值RSD%判断
4134.214144.070.17数据可信
中间条件3月-供试品溶液-24051503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%
5min148054-4805493.82593.811.5493.8393.801.54
247366-4736692.48292.48
347100-4710091.96391.96
448996-4899695.66595.66
548016-4801693.75193.75
648734-4873495.15395.15
10min151531-51531100.61498.801.85101.1499.321.85
250011-5001197.64698.16
349043-4904395.75696.27
451380-51380100.319100.85
550885-5088599.35399.87
650770-5077099.12899.66
15min150902-5090299.38697.991.68100.4799.071.67
250516-5051698.63299.69
348703-4870395.09396.14
450104-5010497.82898.92
549927-4992797.48298.56
650985-5098599.548100.63
20min150932-5093299.44598.621.24101.08100.231.24
250550-5055098.699100.30
349316-4931696.28997.86
450433-5043398.470100.10
551008-5100899.593101.21
650808-5080899.203100.84
30min150099-5009997.81897.592.16100.0099.752.14
249737-4973797.11199.26
347996-4799693.71295.82
450694-5069498.980101.16
550293-5029398.197100.36
651059-5105999.693101.88
45min149463-4946396.57795.860.7599.3098.560.77
248861-4886195.40198.09
348469-4846994.63697.26
449189-4918996.04298.77
549271-4927196.20298.91
649321-4932196.29999.04
60min149397-4939796.44895.761.0699.7198.991.06
248944-4894495.56398.79
348106-4810693.92797.08
449264-4926496.18899.45
549561-4956196.768100.02
648984-4898495.64198.91
极限149427-4942796.50695.591.36100.3199.361.36
248693-4869395.07398.83
347793-4779393.31696.99
449358-4935896.372100.17
549588-4958896.821100.61
648883-4888395.44499.25
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%
111.293909243918853919193917543912313915430.12
211.343933363909623921490.43
单位质量响应值RSD%判断
34680.5134581.040.21数据可信
中间条件3月-供试品溶液-24051503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%
5min13200-32000.8290.856.400.830.856.54
23241-32410.8400.84
33555-35550.9210.92
43432-34320.8890.89
52947-29470.7640.76
63353-33530.8690.87
10min110869-108692.8162.753.542.822.763.51
210980-109802.8452.85
310874-108742.8182.82
410488-104882.7172.72
59974-99742.5842.59
610510-105102.7232.73
15min116789-167894.3504.213.084.374.233.12
216675-166754.3214.34
316304-163044.2244.25
416105-161054.1734.19
515385-153853.9864.00
616292-162924.2214.24
20min121093-210935.4655.352.765.515.392.75
221113-211135.4705.51
320991-209915.4395.48
420075-200755.2025.24
519785-197855.1265.17
620786-207865.3865.43
30min126806-268066.9466.902.367.026.982.34
227455-274557.1147.19
327041-270417.0067.08
425989-259896.7346.81
525809-258096.6876.76
626690-266906.9166.99
45min133716-337168.7368.574.598.858.684.54
234150-341508.8488.96
335082-350829.0909.20
431296-312968.1098.22
531460-314608.1518.26
632728-327288.4808.59
60min139446-3944610.2219.894.7110.3810.054.68
239646-3964610.27210.44
340131-4013110.39810.56
437446-374469.7029.86
535850-358509.2899.44
636564-365649.4749.63
极限142910-4291011.11810.942.8011.3411.162.80
243296-4329611.21811.44
343327-4332711.22611.45
442168-4216810.92611.13
540570-4057010.51210.72
641041-4104110.63410.85
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%
112.195068950498502975044350696505250.34
212.235036250465504140.15
单位质量响应值RSD%判断
4144.794122.160.39数据可信
中间条件3月-供试品溶液-24051503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%
5min149661-4966197.09790.9218.9797.1090.9318.97
228629-2862955.97555.98
349093-4909395.98695.99
449937-4993797.63697.64
549586-4958696.95096.95
652119-52119101.902101.90
10min153802-53802105.193102.463.53105.73102.963.60
248943-4894395.69396.00
353844-53844105.275105.81
452646-52646102.933103.48
551923-51923101.519102.06
653264-53264104.141104.71
15min152221-52221102.102100.652.67103.23101.732.73
249301-4930196.39397.24
352873-52873103.377104.49
451683-51683101.050102.16
550375-5037598.49399.60
652428-52428102.507103.65
20min151260-51260100.22399.221.72101.91100.861.82
249153-4915396.10397.48
351463-51463100.620102.31
450586-5058698.905100.58
550620-5062098.972100.62
651414-51414100.524102.24
30min151476-51476100.64598.402.05102.89100.592.12
248664-4866495.14797.06
350221-5022198.192100.44
450685-5068599.099101.32
549753-4975397.27699.48
651177-51177100.061102.33
45min149243-4924396.27996.771.1899.0999.501.27
248437-4843794.70397.14
349680-4968097.13499.93
450054-5005497.865100.64
549799-4979997.366100.11
649752-4975297.275100.10
60min148683-4868395.18495.541.9698.5398.812.01
247559-4755992.98795.95
349567-4956796.913100.25
449546-4954696.872100.19
547960-4796093.77197.05
649885-4988597.535100.90
极限149360-4936096.50896.251.91100.38100.051.97
247852-4785293.56097.04
350516-5051698.768102.64
449247-4924796.287100.14
548547-4854794.91998.72
649845-4984597.456101.37
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%
111.293909103923323908593924853905833914340.23
211.343907143919353913240.23
单位质量响应值RSD%判断
34670.8634508.290.34数据可信
中间条件3月-供试品溶液-24051503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%
5min14655-46551.2081.1914.441.211.1914.33
23535-35350.9170.92
35405-54051.4021.40
44335-43351.1251.12
55180-51801.3441.34
64487-44871.1641.16
10min112010-120103.1163.185.683.123.185.72
211148-111482.8922.90
313145-131453.4103.42
412164-121643.1563.16
512829-128293.3283.34
612182-121823.1603.17
15min117300-173004.4884.623.524.514.643.55
216925-169254.3914.41
318103-181034.6964.72
417948-179484.6564.68
517779-177794.6124.64
618713-187134.8544.88
20min121091-210915.4715.611.965.525.661.95
221336-213365.5355.58
321770-217705.6475.70
421553-215535.5915.64
522322-223225.7915.84
621714-217145.6335.68
30min127627-276277.1677.161.507.257.241.46
227137-271377.0407.12
327148-271487.0437.13
428226-282267.3227.40
527802-278027.2127.30
627619-276197.1657.25
45min132338-323388.3898.662.128.518.782.10
233129-331298.5948.71
332915-329158.5398.66
434271-342718.8909.01
533789-337898.7658.89
633781-337818.7638.89
60min136780-367809.5419.701.709.719.871.68
237384-373849.6989.86
336808-368089.5499.72
438429-384299.96910.14
537111-371119.6279.80
637773-377739.7999.97
极限141212-4121210.69110.961.5810.9111.181.58
241873-4187310.86211.08
342377-4237710.99311.22
442986-4298611.15111.38
542113-4211310.92511.15
642903-4290311.13011.35
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%
112.195071350549507375061950562506360.17
212.235020950539503740.47
单位质量响应值RSD%判断
4153.904118.890.60数据可信
中间条件3月-供试品溶液-2024052421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%
5min148622-4862294.99994.651.8795.0094.651.87
249462-4946296.64096.64
349237-4923796.20196.20
448612-4861294.98094.98
547442-4744292.69492.69
647279-4727992.37592.38
10min150500-5050098.66897.083.2199.2097.613.19
250044-5004497.77798.31
350639-5063998.94099.47
450316-5031698.30998.84
546473-4647390.80091.32
650159-5015998.00298.52
15min150494-5049498.65795.994.7899.7397.064.75
250312-5031298.30199.38
351264-51264100.161101.25
446919-4691991.67292.75
545464-4546488.82989.85
650328-5032898.33299.39
20min150085-5008597.85897.412.9499.4899.002.93
250424-5042498.520100.15
350361-5036198.397100.04
450695-5069599.049100.63
546903-4690391.64093.15
650653-5065398.967100.57
30min149960-4996097.61397.442.8499.7899.582.83
250581-5058198.827101.00
351445-51445100.515102.70
450420-5042098.512100.65
547308-4730892.43294.45
649523-4952396.75998.91
45min149008-4900895.75396.412.7998.4699.102.78
249467-4946796.65099.37
351131-5113199.901102.65
449777-4977797.25699.94
546944-4694491.72194.26
649748-4974897.19999.89
60min149085-4908595.90496.473.0599.1599.693.03
249618-4961896.945100.20
351419-51419100.464103.76
449617-4961796.943100.16
546773-4677391.38694.43
649748-4974897.199100.43
极限148983-4898395.70497.103.4799.48100.853.43
250563-5056398.791102.59
351354-51354100.337104.20
449526-4952696.765100.52
546706-4670691.25694.81
651048-5104899.739103.51
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%
111.293935593932723933703933073933793933770.03
211.343921983900403911190.40
单位质量响应值RSD%判断
34842.9634490.210.72数据可信
中间条件3月-供试品溶液-2024052421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%
5min15707-57071.4771.4211.441.481.4211.41
25648-56481.4621.46
35420-54201.4031.40
46451-64511.6701.67
55023-50231.3001.30
64629-46291.1981.20
10min113186-131863.4133.158.463.423.168.45
212745-127453.2993.31
311767-117673.0463.05
413094-130943.3893.40
511635-116353.0123.02
610550-105502.7312.74
15min118310-183104.7394.544.244.774.564.26
218482-184824.7844.81
317539-175394.5404.56
417352-173524.4914.52
516689-166894.3204.34
616820-168204.3544.38
20min122536-225365.8335.623.245.895.673.27
222092-220925.7185.77
321211-212115.4905.54
422267-222675.7645.82
521423-214235.5455.59
620716-207165.3625.41
30min127820-278207.2017.192.657.297.272.68
228904-289047.4827.57
328051-280517.2617.34
427851-278517.2097.29
527150-271507.0287.11
626802-268026.9387.01
45min133713-337138.7268.721.888.858.841.88
234470-344708.9229.05
334267-342678.8708.99
433459-334598.6618.79
533565-335658.6888.81
632697-326978.4638.58
60min138255-382559.9029.992.1010.0810.162.09
239560-3956010.24010.42
339579-3957910.24510.41
438173-381739.88110.05
538426-384269.94610.11
637572-375729.7259.89
极限142764-4276411.06911.251.7911.3011.481.76
244687-4468711.56711.80
344073-4407311.40811.63
442720-4272011.05811.29
543293-4329311.20611.43
643213-4321311.18511.40
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%
112.195031650160502945048850153502820.28
212.235030850661504840.50
单位质量响应值RSD%判断
4124.864127.880.06数据可信
中间条件3月-供试品溶液-2024052421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%
5min149025-4902596.01790.6114.0496.0290.6114.04
233147-3314764.92064.92
349452-4945296.85496.85
449132-4913296.22796.23
547107-4710792.26192.26
649727-4972797.39297.39
10min150730-5073099.35798.702.7699.8999.202.80
248517-4851795.02395.38
350973-5097399.833100.37
452401-52401102.629103.16
549123-4912396.20996.72
650614-5061499.13099.67
15min151099-51099100.07998.612.38101.1699.662.38
250314-5031498.54299.43
351674-51674101.206102.30
450567-5056799.038100.14
548159-4815994.32195.37
650283-5028398.48199.57
20min149479-4947996.90798.213.1098.5599.813.12
248433-4843394.85896.29
351852-51852101.554103.21
451714-51714101.284102.94
548490-4849094.97096.54
650891-5089199.672101.31
30min150987-5098799.86098.763.11102.04100.903.10
250143-5014398.207100.17
352015-52015101.873104.09
450803-5080399.500101.72
547471-4747192.97495.07
651127-51127100.134102.33
45min149904-4990497.73998.522.66100.47101.212.65
250024-5002497.974100.48
352028-52028101.899104.68
451130-51130100.140102.91
548089-4808994.18496.80
650635-5063599.171101.92
60min150787-5078799.46898.373.02102.75101.613.01
249904-4990497.739100.79
351588-51588101.037104.39
451364-51364100.598103.93
547421-4742192.87696.01
650292-5029298.499101.80
极限150683-5068399.26597.702.44103.09101.482.44
249786-4978697.508101.10
351062-51062100.007103.92
449988-4998897.904101.79
547593-4759393.21396.87
650177-5017798.274102.12
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%
111.293901903913903912793900783904023906680.16
211.343902753923823913280.39
单位质量响应值RSD%判断
34603.0134508.640.20数据可信
中间条件3月-供试品溶液-2024052421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%
5min15367-53671.3941.415.561.391.405.61
25428-54281.4091.41
35744-57441.4921.49
45207-52071.3521.35
55755-57551.4941.49
64987-49871.2951.29
10min112079-120793.1373.203.293.143.203.28
212759-127593.3133.32
312153-121533.1563.16
412186-121863.1643.17
512876-128763.3433.35
611859-118593.0793.09
15min117723-177234.6024.644.454.634.664.41
218479-184794.7984.82
317940-179404.6584.68
416654-166544.3244.35
518926-189264.9144.94
617471-174714.5374.56
20min121040-210405.4635.633.245.515.683.25
221445-214455.5695.62
321742-217425.6465.70
421087-210875.4765.52
522945-229455.9586.01
621880-218805.6825.73
30min127340-273407.0997.202.987.187.282.96
227706-277067.1947.28
327911-279117.2487.33
426564-265646.8986.98
529095-290957.5557.64
627803-278037.2207.30
45min134191-341918.8789.063.749.009.183.71
234830-348309.0449.17
334200-342008.8819.00
434036-340368.8388.96
537491-374919.7359.86
634669-346699.0029.12
60min139602-3960210.28310.251.2110.4510.431.24
239367-3936710.22210.40
338812-3881210.07810.25
439152-3915210.16610.33
540103-4010310.41310.60
639889-3988910.35810.53
极限143476-4347611.28911.302.1511.5211.532.15
243662-4366211.33811.57
342920-4292011.14511.37
442167-4216710.94911.17
544841-4484111.64411.88
644134-4413411.46011.69
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