培哚普利片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.844212942119422224225742225421900.15
29.874171841921418200.35
单位质量响应值RSD%判断
4287.604237.080.84数据可信
供试品溶液-736137批-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%
5min15877-587711.89732.1133.0311.9032.1133.03
218664-1866437.78337.78
316307-1630733.01233.01
420105-2010540.70040.70
519159-1915938.78538.79
615067-1506730.50130.50
10min121096-2109642.70676.3622.4942.8476.7222.54
242382-4238285.79786.22
338118-3811877.16577.53
441962-4196284.94785.40
544269-4426989.61790.05
638493-3849377.92478.26
15min134763-3476370.37494.6712.6970.9895.8812.83
249218-4921899.636101.01
348726-4872698.64099.86
448863-4886398.917100.31
548376-4837697.93199.36
650649-50649102.533103.74
20min144731-4473190.55396.833.6091.9499.093.89
248467-4846798.116100.60
347800-4780096.76599.09
448238-4823897.652100.15
547797-4779796.75999.27
649973-49973101.164103.51
30min149083-4908399.36398.632.02101.76101.961.91
248744-4874498.676102.25
347893-4789396.954100.35
448030-4803097.231100.81
548085-4808597.342100.93
650487-50487102.205105.67
45min149190-4919099.57997.571.71103.08102.001.44
247746-4774696.656101.32
347118-4711895.38599.86
448008-4800897.186101.85
547962-4796297.093101.76
649153-4915399.504104.11
极限147742-4774296.64895.611.68101.25101.131.53
247070-4707095.288101.03
346466-4646694.06599.60
447112-4711295.373101.11
546477-4647794.08799.84
648522-4852298.227103.94
培哚普利片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.844213741918418674185941807419180.31
29.874188941970419300.14
单位质量响应值RSD%判断
4259.964248.230.20数据可信
供试品溶液-736137批-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%
5min117617-1761735.73130.8219.2635.7330.8219.26
217005-1700534.49034.49
317718-1771835.93635.94
415285-1528531.00231.00
510387-1038721.06721.07
613155-1315526.68126.68
10min142139-4213985.46877.0711.6485.8677.4111.66
239405-3940579.92380.31
341410-4141083.98984.39
437526-3752676.11276.46
529841-2984160.52560.76
637656-3765676.37576.67
15min148070-4807097.49795.614.9898.8496.815.06
248665-4866598.70499.98
347531-4753196.40497.74
447900-4790097.15398.34
542418-4241886.03486.94
648256-4825697.87599.02
20min146855-4685595.03397.301.4097.4699.561.26
248594-4859498.560100.93
347684-4768496.71599.12
448304-4830497.972100.24
548595-4859598.562100.42
647799-4779996.94899.18
30min147386-4738696.11097.271.2899.60100.611.09
248020-4802097.396100.86
347515-4751596.37299.85
448422-4842298.211101.57
548914-4891499.209102.17
647484-4748496.30999.62
45min147113-4711395.55696.081.07100.11100.500.93
247457-4745796.254100.80
347087-4708795.504100.05
447803-4780396.956101.41
548058-4805897.473101.53
646696-4669694.71199.09
极限146656-4665694.63095.221.78100.25100.711.60
247275-4727595.885101.50
346267-4626793.84199.45
447566-4756696.475102.00
548067-4806797.491102.63
645860-4586093.01598.45
培哚普利片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.844203042171419334216042153420890.25
29.874186942086419780.37
单位质量响应值RSD%判断
4277.344253.090.41数据可信
供试品溶液-736137批-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%
5min115292-1529230.93538.4811.0630.9438.4811.05
219224-1922438.88938.89
318600-1860037.62737.63
421677-2167743.85243.85
519480-1948039.40739.41
619868-1986840.19240.19
10min139410-3941079.72586.305.3880.0786.735.40
241769-4176984.49784.93
342398-4239885.77086.19
446209-4620993.47993.97
542118-4211885.20385.64
644052-4405289.11689.56
15min149466-49466100.06899.591.48101.30100.981.45
248812-4881298.745100.12
348391-4839197.89399.26
448628-4862898.37399.90
549913-49913100.972102.36
650161-50161101.474102.91
20min148649-4864998.41598.831.33100.76101.321.33
248481-4848198.075100.54
348035-4803597.17399.63
448853-4885398.828101.45
549915-49915100.976103.48
649182-4918299.493102.06
30min147580-4758096.25398.011.3499.69101.601.37
248217-4821797.541101.10
348051-4805197.205100.74
448466-4846698.045101.76
549333-4933399.799103.43
649045-4904599.216102.89
45min147646-4764696.38695.853.14100.89100.533.04
247707-4770796.509101.15
344647-4464790.31994.94
448451-4845198.015102.82
547005-4700595.08999.83
648824-4882498.769103.54
极限147854-4785496.80796.681.59102.38102.431.45
248933-4893398.990104.70
347783-4778396.663102.29
446590-4659094.250100.15
547561-4756196.214102.01
648034-4803497.171103.04
培哚普利片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.844169441656416334162941712416650.09
29.874174641570416580.30
单位质量响应值RSD%判断
4234.254220.670.23数据可信
供试品溶液-736137批-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%
5min120526-2052641.89439.618.5841.8939.618.58
221537-2153743.95743.96
317001-1700134.69934.70
418240-1824037.22837.23
518917-1891738.61038.61
620219-2021941.26741.27
10min142748-4274887.24985.942.0987.7186.382.12
243072-4307287.91188.40
340570-4057082.80483.19
442342-4234286.42186.83
541787-4178785.28885.72
642134-4213485.99686.45
15min147749-4774997.45799.301.2398.89100.701.21
249393-49393100.812102.28
349240-49240100.500101.81
448484-4848498.957100.33
548474-4847498.936100.31
648586-4858699.165100.58
20min146725-4672595.36797.951.5097.88100.451.45
248485-4848598.959101.54
348651-4865199.298101.72
447728-4772897.41499.89
548450-4845098.887101.36
647911-4791197.787100.30
30min146618-4661895.14897.961.5798.73101.551.52
248503-4850398.996102.68
348519-4851999.028102.55
447678-4767897.312100.87
548504-4850498.998102.57
648151-4815198.277101.88
45min146214-4621494.32496.441.6798.96101.121.63
247896-4789697.757102.54
347175-4717596.285100.91
446404-4640494.71199.35
548009-4800997.987102.66
647807-4780797.575102.27
极限145758-4575893.39396.361.6999.08102.111.62
247079-4707996.089101.96
347867-4786797.697103.39
447079-4707996.089101.78
547867-4786797.697103.46
647626-4762697.206102.98
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