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%
110.444222842264422724217542066422010.21
210.434232641942421340.65
单位质量响应值RSD%判断
4042.244039.690.05数据可信
供试品溶液-2022081302批-培哚普利-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%
5min142311-4231189.33488.884.4189.3388.884.42
238555-3855581.40481.40
341753-4175388.15688.16
443398-4339891.62991.63
543179-4317991.16791.17
643382-4338291.59691.60
10min144076-4407693.06194.001.9694.0594.991.98
243330-4333091.48692.39
344639-4463994.25095.23
445977-4597797.07598.09
544722-4472294.42595.44
644394-4439493.73294.75
15min143392-4339291.61795.132.3393.6497.162.30
245193-4519395.41997.34
344626-4462694.22296.25
446613-4661398.418100.51
545207-4520795.44997.51
645296-4529695.63797.70
20min142889-4288990.55593.021.5393.6096.111.53
243667-4366792.19795.18
344297-4429793.52896.60
444350-4435093.64096.83
544359-4435993.65996.78
644776-4477694.53997.66
30min143484-4348491.81193.482.0295.8697.601.97
243774-4377492.42396.43
345686-4568696.460100.57
445073-4507395.16699.40
543969-4396992.83597.00
643654-4365492.17096.34
45min143358-4335891.54592.502.6096.6297.662.51
242733-4273390.22595.26
345490-4549096.046101.23
444552-4455294.06699.35
542555-4255589.85095.04
644180-4418093.28198.48
极限143559-4355991.96992.662.3198.0698.852.24
242852-4285290.47796.51
344991-4499194.993101.24
444664-4466494.302100.64
542632-4263290.01296.21
644621-4462194.212100.44
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2000
标示量(mg)10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%
113.988070780203806307960779705801700.64
213.997988079922799010.04
单位质量响应值RSD%判断
5734.625711.290.29数据可信
供试品溶液-2022081302批-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%
5min171356-7135680.82782.134.0580.8382.134.05
267277-6727776.20676.21
373115-7311582.81982.82
473460-7346083.21083.21
575768-7576885.82485.82
674048-7404883.87683.88
10min178518-7851888.93989.360.9989.8490.270.99
278853-7885389.31990.17
379191-7919189.70290.62
479498-7949890.04990.97
579694-7969490.27191.23
677562-7756287.85688.79
15min177364-7736487.63290.251.6889.5292.161.64
281305-8130592.09693.94
379399-7939989.93791.85
480551-8055191.24293.17
579937-7993790.54792.50
679498-7949890.04991.96
20min176923-7692387.13388.261.1389.9991.161.10
278839-7883989.30392.17
377720-7772088.03590.95
476947-7694787.16090.10
578880-7888089.34992.31
678184-7818488.56191.47
30min177768-7776888.09088.681.5591.9292.571.49
278490-7849088.90892.76
380438-8043891.11495.01
477680-7768087.99091.90
578488-7848888.90592.86
676874-7687487.07790.97
45min178123-7812388.49287.491.4193.3092.361.32
276299-7629986.42691.27
378611-7861189.04593.95
477838-7783888.16993.05
576008-7600886.09691.04
676559-7655986.72091.58
极限178656-7865689.09689.481.6294.8995.331.52
278082-7808288.44594.25
380214-8021490.86096.76
479096-7909689.59495.46
577280-7728087.53793.44
680654-8065491.35997.18
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%
110.444199341871426264235342287422260.72
210.434241142168422900.41
单位质量响应值RSD%判断
4044.644054.650.18数据可信
供试品溶液-2022081302批-培哚普利-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%
5min140512-4051285.35389.693.7885.3589.693.78
243954-4395492.60592.60
343179-4317990.97290.97
443800-4380092.28092.28
540547-4054785.42785.43
643443-4344391.52891.53
10min144140-4414092.99795.201.4393.9496.191.45
245734-4573496.35597.38
345599-4559996.07197.08
445455-4545595.76796.79
544629-4462994.02794.98
645550-4555095.96796.98
15min145382-4538295.61396.210.6397.5998.260.65
246141-4614197.21299.31
345828-4582896.55398.63
445498-4549895.85897.95
545466-4546695.79097.78
645681-4568196.24398.33
20min144008-4400892.71994.381.4795.7697.501.47
245466-4546695.79098.97
344575-4457593.91397.06
444800-4480094.38797.54
544272-4427293.27596.33
645662-4566296.20399.36
30min144378-4437893.49894.371.3997.5798.541.38
245745-4574596.378100.62
344409-4440993.56397.76
444455-4445593.66097.86
544343-4434393.42497.52
645409-4540995.67099.89
45min143682-4368292.03294.381.7697.1499.601.75
245967-4596796.846102.16
344406-4440693.55798.79
444929-4492994.65999.90
544516-4451693.78998.92
645289-4528995.417100.70
极限144043-4404392.79294.081.7098.93100.351.67
245357-4535795.561101.95
344281-4428193.29499.57
444527-4452793.812100.11
543919-4391992.53198.71
645789-4578996.471102.82
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2000
标示量(mg)10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%
113.988040479964797707999880312800900.33
213.998030280465803840.15
单位质量响应值RSD%判断
5728.905745.820.21数据可信
供试品溶液-2022081302批-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%
5min168830-6883077.77082.013.3177.7782.003.31
274723-7472384.42884.43
374679-7467984.37884.38
472817-7281782.27482.27
570568-7056879.73379.73
673859-7385983.45283.45
10min179161-7916189.44289.850.3590.3190.760.37
279537-7953789.86790.81
380002-8000290.39391.33
479572-7957289.90790.82
579414-7941489.72890.61
679455-7945589.77590.70
15min179935-7993590.31790.490.7392.1792.400.71
279708-7970890.06092.00
380525-8052590.98492.93
479265-7926589.56091.47
580879-8087991.38493.27
680197-8019790.61392.54
20min178411-7841188.59588.481.2291.4691.391.19
277755-7775587.85490.79
378699-7869988.92091.87
476737-7673786.70489.61
578717-7871788.94191.84
679510-7951089.83792.77
30min178656-7865688.87288.720.3692.7292.620.36
278519-7851988.71792.63
378498-7849888.69392.63
477981-7798188.10991.98
578728-7872888.95392.84
678735-7873588.96192.89
45min178221-7822188.38088.520.7593.2193.400.69
279163-7916389.44594.34
377710-7771087.80392.73
478760-7876088.98993.84
578508-7850888.70593.58
677707-7770787.80092.72
极限180898-8089891.40590.831.0897.2296.701.03
280591-8059191.05896.95
380210-8021090.62896.53
479123-7912389.39995.24
579870-7987090.24396.10
681633-8163392.23598.13
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%
110.444208742146423054235842350422490.30
210.434256142546425540.03
单位质量响应值RSD%判断
4046.844079.960.58数据可信
供试品溶液-2022081401批-培哚普利-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%
5min138857-3885781.59084.926.5681.5984.926.56
236903-3690377.48777.49
339190-3919082.28982.29
443244-4324490.80290.80
540757-4075785.58085.58
643702-4370291.76391.76
10min144176-4417692.75994.841.5893.6795.781.62
244608-4460893.66694.53
344893-4489394.26495.18
445917-4591796.41497.42
545612-4561295.77496.72
645802-4580296.17397.19
15min145099-4509994.69795.040.6296.6397.040.63
245346-4534695.21597.12
344989-4498994.46696.43
445663-4566395.88197.96
545495-4549595.52897.54
644997-4499794.48396.57
20min144111-4411192.62294.191.3695.6197.241.38
244374-4437493.17496.13
344531-4453193.50496.52
445282-4528295.08198.23
545666-4566695.88798.96
645180-4518094.86798.00
30min143221-4322190.75392.961.6794.7797.061.69
243919-4391992.21996.21
343785-4378591.93895.99
445084-4508494.66598.87
544732-4473293.92698.07
644885-4488594.24798.44
45min143688-4368891.73493.281.2796.7698.411.26
244402-4440293.23398.25
344106-4410692.61297.68
444365-4436593.15698.41
545366-4536695.257100.44
644605-4460593.66098.90
极限144392-4439293.21293.440.9299.2699.610.87
245143-4514394.789100.84
343886-4388692.15098.25
444443-4444393.31999.61
544669-4466993.794100.04
644462-4446293.35999.64
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2000
标示量(mg)10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%
113.988027980406808548031580357804420.30
213.998026080603804320.31
单位质量响应值RSD%判断
5754.085749.250.06数据可信
供试品溶液-2022081401批-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%
5min166997-6699775.51078.696.2075.5178.696.20
264308-6430872.47972.48
368051-6805176.69876.70
470904-7090479.91479.91
572048-7204881.20381.20
676597-7659786.33086.33
10min174746-7474684.24488.873.2285.0889.743.24
277238-7723887.05287.86
379168-7916889.22890.08
479391-7939189.47990.37
580757-8075791.01991.92
681786-8178692.17893.14
15min177664-7766487.53389.241.8389.3191.101.87
278483-7848388.45690.23
378422-7842288.38790.23
478661-7866188.65690.54
580314-8031490.51992.43
681528-8152891.88893.87
20min175883-7588385.52588.702.8588.2791.562.86
276899-7689986.67089.43
377984-7798487.89390.72
479052-7905289.09791.96
581804-8180492.19995.12
680591-8059190.83193.84
30min175705-7570585.32587.922.8689.0291.762.88
276380-7638086.08589.80
376858-7685886.62490.43
477883-7788387.77991.64
579581-7958189.69393.64
681629-8162992.00196.02
45min175583-7558385.18788.532.9189.8393.342.92
277219-7721987.03191.71
378586-7858688.57293.34
477434-7743487.27392.11
581190-8119091.50796.45
681256-8125691.58196.62
极限179676-7967689.80089.260.6495.3995.050.63
278798-7879888.81194.45
378610-7861088.59994.35
479401-7940189.49095.29
579815-7981589.95795.91
678856-7885688.87694.93
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%
110.444203742325421284233842250422160.31
210.434247042329424000.24
单位质量响应值RSD%判断
4043.684065.200.38数据可信
供试品溶液-2022081401批-培哚普利-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%
5min137610-3761079.14685.364.6479.1585.364.64
241186-4118686.67186.67
342169-4216988.73988.74
441816-4181687.99788.00
538836-3883681.72681.73
641758-4175887.87587.87
10min143979-4397992.54895.832.2593.4396.782.25
245854-4585496.49497.46
346715-4671598.30699.29
444632-4463293.92394.90
546015-4601596.83397.74
646031-4603196.86797.84
15min145137-4513794.98596.330.8096.8998.340.83
245609-4560995.97898.01
346111-4611197.03599.11
445784-4578496.34798.37
546000-4600096.80198.79
646017-4601796.83798.89
20min144603-4460393.86195.131.2196.8298.211.22
245170-4517095.05598.16
346124-4612497.062100.22
445077-4507794.85997.95
545486-4548695.72098.78
644768-4476894.20997.34
30min144215-4421593.04594.631.7097.0598.781.70
244777-4477794.22898.39
346133-4613397.081101.32
444361-4436193.35297.50
544663-4466393.98898.11
645671-4567196.109100.28
45min144386-4438693.40595.021.2898.44100.211.28
245041-4504194.78399.99
345934-4593496.662101.98
444893-4489394.47299.65
545721-4572196.214101.38
644935-4493594.56099.80
极限145105-4510594.91894.550.27101.00100.800.25
244872-4487294.428100.69
345023-4502394.745101.13
444762-4476294.196100.43
544913-4491394.514100.75
644915-4491594.518100.81
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2000
标示量(mg)10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%
113.988068980804805958055380984807250.22
213.998045080069802600.34
单位质量响应值RSD%判断
5774.325736.950.46数据可信
供试品溶液-2022081401批-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%
5min164833-6483373.02178.164.6573.0278.164.65
269412-6941278.17978.18
373522-7352282.80882.81
468836-6883677.53077.53
567322-6732275.82575.82
672467-7246781.62081.62
10min175618-7561885.16988.883.2485.9889.753.24
278730-7873088.67489.54
382512-8251292.93393.85
476486-7648686.14687.01
579802-7980289.88190.72
680357-8035790.50691.41
15min178417-7841788.32189.701.7990.0891.551.82
279338-7933889.35891.21
381512-8151291.80793.76
478034-7803487.89089.71
579365-7936589.38991.23
681163-8116391.41493.33
20min175399-7539984.92289.052.6587.6691.902.65
279001-7900188.97991.83
381770-8177092.09895.07
478807-7880788.76091.56
580073-8007390.18693.02
679316-7931689.33492.26
30min177384-7738487.15888.972.3890.8492.812.39
278183-7818388.05891.89
381698-8169892.01796.01
476979-7697986.70290.48
578999-7899988.97792.81
680706-8070690.89994.82
45min176740-7674086.43288.972.5191.0893.802.51
278471-7847188.38293.20
382022-8202292.38197.40
477142-7714286.88591.63
579425-7942589.45694.28
680164-8016490.28995.22
极限181220-8122091.47891.511.5297.0997.331.55
280622-8062290.80596.60
383591-8359194.149100.19
480358-8035890.50796.22
580292-8029290.43396.25
681399-8139991.68097.61
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