培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.884220442177420804215642171421580.12
29.944220742215422110.02
单位质量响应值RSD%判断
4267.004246.580.34数据可信
供试品溶液-2022081401批-培哚普利-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%
5min148992-4899298.19798.881.0298.2098.881.02
249817-4981799.85099.85
349151-4915198.51598.52
449755-4975599.72699.73
548586-4858697.38397.38
649692-4969299.60099.60
10min149018-4901898.24999.061.1899.34100.161.18
250237-50237100.692101.80
348810-4881097.83298.93
450031-50031100.279101.39
549079-4907998.37199.45
649374-4937498.962100.07
15min148781-4878197.77498.811.1999.96101.011.18
249721-4972199.658101.89
348549-4854997.30999.49
449785-4978599.786102.01
549026-4902698.265100.44
649920-49920100.057102.26
20min147956-4795696.12097.320.9899.39100.610.98
249159-4915998.531101.87
348173-4817396.55599.82
448770-4877097.752101.08
548319-4831996.848100.11
648937-4893798.086101.40
30min148009-4800996.22696.350.76100.56100.730.75
248385-4838596.980101.41
347540-4754095.28699.62
448307-4830796.824101.24
548427-4842797.064101.41
647767-4776795.741100.15
45min147442-4744295.09095.521.10100.50100.971.08
248263-4826396.735102.24
347065-4706594.33499.73
447586-4758695.378100.87
547272-4727294.749100.17
648322-4832296.854102.33
极限146379-4637992.95994.421.4599.42100.931.40
247110-4711094.424101.01
346475-4647593.15299.59
447991-4799196.190102.74
546859-4685993.921100.40
647841-4784195.890102.44
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858457884539846148445884446845270.09
214.898439384207843000.16
单位质量响应值RSD%判断
5692.055661.520.39数据可信
供试品溶液-2022081401批-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%
5min139911-3991145.57646.753.5245.5846.753.52
242022-4202247.98747.99
342934-4293449.02849.03
441414-4141447.29247.29
539061-3906144.60544.61
640294-4029446.01346.01
10min157876-5787666.09166.992.1166.6067.512.12
260498-6049869.08569.62
359211-5921167.61668.16
459314-5931467.73368.26
557971-5797166.19966.70
657099-5709965.20465.71
15min166110-6611075.49476.321.3176.7377.581.31
268024-6802477.67978.98
366374-6637475.79577.09
467297-6729776.84978.13
565786-6578675.12476.35
667412-6741276.98178.22
20min169343-6934379.18680.020.9881.2782.130.99
270827-7082780.88083.04
370326-7032680.30882.45
470395-7039580.38782.52
569114-6911478.92480.99
670425-7042580.42182.51
30min173653-7365384.10784.041.2187.0787.041.18
274516-7451685.09388.16
373185-7318583.57386.60
473946-7394684.44287.47
574222-7422284.75787.70
672052-7205282.27985.26
45min175674-7567486.41586.661.4990.3190.601.45
277027-7702787.96091.97
375609-7560986.34190.30
476074-7607486.87290.84
573971-7397184.47188.36
676991-7699187.91991.82
极限176252-7625287.07588.082.1891.9392.982.11
277966-7796689.03394.02
376012-7601286.80191.72
479592-7959290.88995.82
574996-7499685.64190.46
677991-7799189.06193.94
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.884231742316423704232342359423370.07
29.944244142397424190.08
单位质量响应值RSD%判断
4285.124267.510.30数据可信
供试品溶液-2022081501批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147467-4746794.70596.081.8794.7196.081.86
249817-4981799.39499.39
347547-4754794.86594.87
448532-4853296.83096.83
547750-4775095.27095.27
647832-4783295.43495.43
10min149725-4972599.21196.951.29100.2698.021.28
248851-4885197.46798.57
347985-4798595.73996.79
448484-4848496.73597.81
548216-4821696.20097.26
648292-4829296.35197.41
15min148876-4887697.51796.561.5699.6798.711.55
249616-4961698.993101.18
347821-4782195.41297.53
448030-4803095.82997.98
548449-4844996.66598.79
647594-4759494.95997.09
20min148486-4848696.73995.062.2899.9898.272.25
249429-4942998.620101.91
347056-4705693.88597.06
447357-4735794.48697.70
546884-4688493.54296.74
646646-4664693.06796.25
30min147339-4733994.45094.521.5598.7698.791.54
248798-4879897.361101.74
346817-4681793.40997.63
446921-4692193.61697.88
547340-4734094.45298.69
647019-4701993.81298.03
45min147153-4715394.07993.061.4799.4498.391.47
247781-4778195.332100.80
346079-4607991.93697.20
446520-4652092.81698.12
546136-4613692.05097.34
646191-4619192.16097.42
极限146606-4660692.98891.851.5899.4098.201.57
247098-4709893.969100.49
345024-4502489.83196.11
445810-4581091.39997.74
545955-4595591.68998.00
645713-4571391.20697.49
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858456084572846988460884468845810.10
214.898467584690846820.02
单位质量响应值RSD%判断
5695.695687.170.11数据可信
供试品溶液-2022081501批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138098-3809843.39346.954.7543.3946.954.75
242153-4215348.01248.01
341632-4163247.41947.42
444015-4401550.13350.13
540600-4060046.24346.24
640821-4082146.49546.49
10min160280-6028068.65968.170.9369.1468.690.92
260219-6021968.58969.12
360436-6043668.83669.36
459746-5974668.05068.61
559110-5911067.32667.84
659290-5929067.53168.05
15min167368-6736876.73277.240.8077.9878.520.80
267825-6782577.25278.55
367952-6795277.39778.69
468228-6822877.71179.02
568476-6847677.99479.26
667024-6702476.34077.61
20min172730-7273082.83980.821.6084.9482.961.56
271827-7182781.81183.96
370495-7049580.29382.45
470813-7081380.65682.83
570269-7026980.03682.16
669613-6961379.28981.40
30min174860-7486085.26584.491.0288.2887.520.98
274536-7453684.89687.96
372814-7281482.93585.98
474173-7417384.48387.56
574756-7475685.14788.16
673938-7393884.21587.21
45min177455-7745588.22186.551.3592.1990.521.30
276108-7610886.68790.69
374307-7430784.63588.60
476134-7613486.71690.73
576289-7628986.89390.86
675622-7562286.13390.07
极限178293-7829389.17587.641.4494.1292.571.38
277044-7704487.75392.72
374932-7493285.34790.25
476958-7695887.65592.63
577450-7745088.21593.14
676968-7696887.66692.56
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.884225342278422764225042261422640.04
29.944247742427424520.09
单位质量响应值RSD%判断
4277.734270.820.12数据可信
供试品溶液-2022081501批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148806-4880697.42395.851.4797.4295.841.47
247958-4795895.73095.73
348159-4815996.13296.13
446745-4674593.30993.31
548474-4847496.76096.76
647953-4795395.72095.72
10min149239-4923998.28797.231.4999.3798.291.49
248639-4863997.09098.15
348050-4805095.91496.98
447716-4771695.24796.28
549621-4962199.050100.12
648987-4898797.78498.85
15min148371-4837196.55595.971.5198.7398.121.51
247651-4765195.11797.26
348460-4846096.73298.87
446839-4683993.49795.59
548882-4888297.57599.75
648270-4827096.35398.50
20min148158-4815896.13094.941.6999.3898.151.68
247090-4709093.99897.20
347838-4783895.49198.70
446506-4650692.83295.97
548672-4867297.156100.42
647103-4710394.02497.24
30min147563-4756394.94293.761.7399.2698.021.71
246453-4645392.72696.97
346987-4698793.79298.06
445845-4584591.51295.68
548138-4813896.090100.43
646829-4682993.47797.74
45min147037-4703793.89292.421.9999.2697.731.96
246123-4612392.06797.34
346603-4660393.02698.34
444744-4474489.31594.50
547308-4730894.43399.84
645980-4598091.78297.09
极限146677-4667793.17391.811.5199.5998.141.52
245640-4564091.10397.40
346031-4603191.88498.23
445039-4503989.90496.08
546891-4689193.600100.06
645678-4567891.17997.50
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.858434384434843828445184394844010.06
214.898474484807847760.06
单位质量响应值RSD%判断
5683.575693.490.13数据可信
供试品溶液-2022081501批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139224-3922444.69947.124.7244.7047.124.71
239380-3938044.87744.88
343230-4323049.26449.26
441395-4139547.17347.17
540883-4088346.58946.59
643960-4396050.09650.10
10min159589-5958967.90667.742.7468.4068.272.74
257030-5703064.99065.49
358903-5890367.12567.67
458966-5896667.19667.72
560260-6026068.67169.19
661930-6193070.57471.13
15min168212-6821277.73376.322.1178.9877.592.10
265305-6530574.42075.64
366728-6672876.04277.33
465333-6533374.45275.72
567805-6780577.26978.55
668434-6843477.98679.33
20min172071-7207182.13080.321.6884.2582.441.66
269405-6940579.09281.14
370682-7068280.54882.69
469066-6906678.70680.80
571541-7154181.52683.67
670107-7010779.89282.10
30min175483-7548386.01983.961.9189.0586.971.88
273048-7304883.24486.17
373150-7315083.36086.39
471714-7171481.72484.70
575108-7510885.59188.64
673529-7352983.79286.89
45min176943-7694387.68285.452.4791.6789.402.40
274893-7489385.34689.20
374596-7459685.00888.97
472231-7223182.31386.19
577164-7716487.93491.93
674099-7409984.44288.47
极限179503-7950390.60087.922.3095.5692.822.23
277358-7735888.15592.96
376204-7620486.84091.74
475131-7513185.61890.41
578960-7896089.98194.95
675775-7577586.35191.32
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