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%
110.464181941900418974194842100419330.25
210.474204841892419700.27
单位质量响应值RSD%判断
4008.894008.600.01数据可信
供试品溶液-2022081201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%
5min145141-4514196.07698.612.1796.0898.612.17
245040-4504095.86195.86
346886-4688699.79099.79
447487-47487101.069101.07
546675-4667599.34199.34
646766-4676699.53499.53
10min145820-4582097.52198.852.0798.5999.942.07
244968-4496895.70896.77
346633-4663399.251100.36
447219-47219100.498101.62
547620-47620101.352102.46
646402-4640298.76099.87
15min145582-4558297.01498.271.3999.17100.461.40
245214-4521496.23198.36
346714-4671499.424101.64
446774-4677499.551101.79
546524-4652499.019101.25
646224-4622498.381100.58
20min144728-4472895.19797.171.6198.43100.461.60
245189-4518996.17899.38
346252-4625298.440101.76
446707-4670799.409102.75
545767-4576797.408100.74
645296-4529696.40699.70
30min143779-4377993.17795.602.1297.4699.962.10
243679-4367992.96497.23
345388-4538896.601101.01
445811-4581197.502101.95
545686-4568697.236101.65
645155-4515596.106100.47
45min144130-4413093.92495.191.7799.25100.621.77
243488-4348892.55897.86
345179-4517996.157101.64
445697-4569797.259102.79
544942-4494295.652101.15
644925-4492595.616101.05
极限143648-4364892.89894.381.5499.26100.861.55
243385-4338592.33898.67
344940-4494095.648102.20
444603-4460394.931101.55
545035-4503595.850102.41
644441-4444194.586101.08
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%
113.811587591584301585521592131589561587820.20
213.891585291586121585700.04
单位质量响应值RSD%判断
11497.6111416.130.51数据可信
供试品溶液-2022081201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%
5min1123008-12300869.60170.462.0169.6070.462.01
2125088-12508870.77870.78
3126708-12670871.69571.69
4128027-12802772.44172.44
5122713-12271369.43469.43
6121655-12165568.83668.84
10min1150717-15071785.28085.881.9886.0586.671.97
2147827-14782783.64484.43
3154614-15461487.48588.28
4154173-15417387.23588.04
5154389-15438987.35788.13
6148987-14898784.30185.07
15min1156616-15661688.61788.862.4990.3490.592.47
2150539-15053985.17986.89
3161841-16184191.57493.34
4159195-15919590.07791.85
5158792-15879289.84991.59
6155261-15526187.85189.55
20min1156987-15698788.82790.511.8391.5393.241.81
2161627-16162791.45394.11
3164314-16431492.97395.76
4161364-16136491.30494.08
5158225-15822589.52892.27
6157297-15729789.00391.68
30min1156988-15698888.82891.101.5892.5294.831.57
2160584-16058490.86394.54
3164487-16448793.07196.89
4161986-16198691.65695.45
5162161-16216191.75595.49
6159769-15976990.40194.07
45min1161701-16170191.49592.161.1996.1796.911.21
2161291-16129191.26395.95
3165927-16592793.88698.74
4164663-16466393.17197.98
5162155-16215591.75196.51
6161571-16157191.42196.09
极限1162574-16257491.98993.031.3097.6898.791.29
2162006-16200691.66797.37
3166996-16699694.491100.39
4163734-16373492.64598.49
5166943-16694394.461100.23
6164192-16419292.90498.59
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%
110.464193741973420944223642105420690.29
210.474203842269421540.39
单位质量响应值RSD%判断
4021.894026.170.08数据可信
供试品溶液-2022081302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%
5min146172-4617297.89798.052.3597.9098.062.35
246464-4646498.51698.52
345212-4521295.86195.86
448252-48252102.307102.31
545895-4589597.30997.31
645480-4548096.43096.43
10min145500-4550096.47297.062.6897.5698.152.68
246157-4615797.86598.96
344602-4460294.56895.63
448018-48018101.811102.95
545501-4550196.47497.56
644885-4488595.16896.24
15min145249-4524995.94096.732.6098.1098.902.60
245884-4588497.28699.47
344719-4471994.81696.93
447896-47896101.552103.82
544878-4487895.15397.31
645115-4511595.65697.78
20min144578-4457894.51795.302.5497.7498.542.54
244697-4469794.76998.03
344145-4414593.59996.77
447239-47239100.159103.56
544587-4458794.53697.75
644434-4443494.21297.40
30min143600-4360092.44393.563.1096.7297.863.07
244096-4409693.49597.81
342979-4297991.12795.34
446694-4669499.004103.51
544322-4432293.97498.24
643070-4307091.32095.56
45min143598-4359892.43993.032.4097.7498.372.41
244249-4424993.81999.17
342936-4293691.03696.26
445828-4582897.167102.78
543235-4323591.67096.97
643403-4340392.02697.28
极限142926-4292691.01492.012.8597.3498.392.83
243442-4344292.10898.51
342496-4249690.10396.34
445836-4583697.184103.87
542837-4283790.82697.15
642847-4284790.84797.12
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%
113.818000880306804178046179835802050.34
213.897998979325796570.59
单位质量响应值RSD%判断
5807.755734.850.90数据可信
供试品溶液-2022081302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%
5min157726-5772664.84267.193.7064.8467.193.70
260588-6058868.05768.06
358590-5859065.81365.81
463563-6356371.39971.40
560496-6049667.95467.95
657953-5795365.09765.10
10min174169-7416983.31283.852.7284.0384.602.72
274596-7459683.79284.55
373179-7317982.20082.93
478660-7866088.35789.15
573618-7361882.69383.45
673670-7367082.75283.48
15min177303-7730386.83388.503.0988.4890.183.08
278988-7898888.72590.41
378365-7836588.02689.67
483389-8338993.66995.44
576414-7641485.83487.51
678274-7827487.92389.57
20min179257-7925789.02889.563.3191.6492.223.29
278269-7826987.91890.59
378926-7892688.65691.28
484991-8499195.46998.28
577831-7783187.42690.05
679125-7912588.87991.50
30min178286-7828687.93789.453.2191.5493.103.20
279448-7944889.24292.89
378907-7890788.63492.24
484680-8468095.11999.00
577611-7761187.17990.78
678842-7884288.56192.17
45min179831-7983189.67290.513.0494.2595.163.04
280470-8047090.39095.03
379395-7939589.18393.78
485303-8530395.819100.75
578231-7823187.87592.44
680245-8024590.13794.73
极限179517-7951789.32090.022.5194.8995.682.54
280669-8066990.61496.26
378980-7898088.71694.30
483984-8398494.337100.34
578723-7872388.42893.97
678961-7896188.69594.29
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%
110.464200742161419734198442131420510.21
210.474217342069421210.18
单位质量响应值RSD%判断
4020.174023.020.06数据可信
供试品溶液-2022081201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%
5min146034-4603497.66396.641.0897.6696.641.08
245446-4544696.41696.42
346188-4618897.99097.99
445283-4528396.07096.07
545487-4548796.50396.50
644864-4486495.18195.18
10min147284-47284100.31598.681.20101.4099.761.19
246049-4604997.69598.77
346856-4685699.407100.50
445752-4575297.06598.13
546463-4646398.57399.65
646676-4667699.025100.08
15min146327-4632798.28597.700.98100.4899.870.95
246812-4681299.314101.47
345576-4557696.69298.88
445872-4587297.32099.47
545972-4597297.53299.70
645761-4576197.08499.24
20min145845-4584597.26296.510.54100.5599.760.54
245665-4566596.880100.14
345452-4545296.42999.70
445168-4516895.82699.05
545299-4529996.10499.36
645506-4550696.54399.78
30min145502-4550296.53595.710.45100.91100.040.45
244926-4492695.31399.65
345063-4506395.60399.94
445024-4502495.52199.81
545128-4512895.741100.06
645027-4502795.52799.84
45min145474-4547496.47595.120.81101.92100.520.78
244638-4463894.702100.10
344668-4466894.765100.17
445049-4504995.574100.93
544648-4464894.723100.11
644537-4453794.48799.86
极限144831-4483195.11194.051.10101.63100.501.05
244836-4483695.122101.57
344420-4442094.239100.69
444190-4419093.751100.17
543549-4354992.39198.83
644151-4415193.668100.09
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%
113.811588651586991588961592041594021590130.18
213.891591401593871592640.11
单位质量响应值RSD%判断
11514.3411466.090.30数据可信
供试品溶液-2022081201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%
5min185600-8560048.29447.162.1148.2947.162.11
281145-8114545.78045.78
383814-8381447.28647.29
484757-8475747.81847.82
584424-8442447.63047.63
681754-8175446.12446.12
10min1122070-12207068.86967.821.2869.4168.351.28
2117978-11797866.56167.07
3121805-12180568.72069.25
4120112-12011267.76568.30
5119432-11943267.38167.91
6119891-11989167.64068.15
15min1136865-13686577.21676.790.8378.5278.070.83
2135106-13510676.22477.47
3136109-13610976.79078.08
4137498-13749877.57478.86
5136587-13658777.06078.34
6134519-13451975.89377.16
20min1143549-14354980.98780.740.6783.1582.870.68
2141799-14179980.00082.10
3143224-14322480.80482.95
4143813-14381381.13683.28
5144146-14414681.32483.46
6142080-14208080.15982.27
30min1150361-15036184.83184.831.1187.8987.861.10
2148434-14843483.74386.73
3151179-15117985.29288.33
4152393-15239385.97789.02
5151489-15148985.46788.50
6148345-14834583.69386.69
45min1154318-15431887.06386.861.2091.0790.831.19
2151881-15188185.68889.60
3155182-15518287.55091.54
4155671-15567187.82691.83
5155242-15524287.58491.57
6151420-15142085.42889.36
极限1154771-15477187.31987.800.8592.2992.740.84
2154242-15424287.02091.89
3157352-15735288.77593.74
4156495-15649588.29193.27
5156481-15648188.28393.24
6154426-15442687.12492.00
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%
110.464209142244422664208842211421800.21
210.474227642041421580.40
单位质量响应值RSD%判断
4032.504026.550.11数据可信
供试品溶液-2022081302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%
5min145967-4596797.32997.581.2497.3397.581.24
247139-4713999.81199.81
345758-4575896.88796.89
445814-4581497.00597.01
545556-4555696.45996.46
646289-4628998.01198.01
10min145417-4541796.16597.311.6497.2598.401.63
246884-4688499.271100.38
345756-4575696.88297.96
446138-4613897.69198.77
544903-4490395.07696.15
646647-4664798.76999.86
15min145215-4521595.73796.691.2297.8998.861.22
246448-4644898.348100.56
345358-4535896.04098.19
445845-4584597.07199.23
545031-4503195.34797.48
646094-4609497.59899.78
20min144746-4474694.74495.721.2397.9698.961.23
246134-4613497.683100.99
344934-4493495.14298.36
445139-4513995.57698.82
544715-4471594.67897.87
645578-4557896.50699.78
30min144686-4468694.61794.291.1998.8898.601.19
245292-4529295.900100.29
343977-4397793.11697.39
444213-4421393.61597.92
544074-4407493.32197.56
644957-4495795.19199.53
45min143038-4303891.12792.721.1496.4598.081.12
244241-4424193.67599.13
343839-4383992.82398.14
443602-4360292.32297.67
543615-4361592.34997.63
644412-4441294.03799.44
极限143296-4329691.67492.721.1398.0099.101.13
244509-4450994.242100.74
343195-4319591.46097.80
443998-4399893.16099.53
543707-4370792.54498.85
644027-4402793.22199.67
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%
113.818038180326805878051480524804660.14
213.898008780527803070.39
单位质量响应值RSD%判断
5826.655781.640.55数据可信
供试品溶液-2022081302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%
5min144408-4440849.59950.471.5249.6050.461.52
246137-4613751.53051.53
344636-4463649.85449.85
444802-4480250.03950.04
545324-4532450.62250.62
645800-4580051.15451.15
10min158804-5880465.67867.241.7766.2367.801.76
261760-6176068.97969.55
359627-5962766.59767.15
459631-5963166.60167.16
560470-6047067.53968.10
660920-6092068.04168.61
15min166826-6682674.63776.612.1775.9277.922.15
269018-6901877.08678.42
367010-6701074.84376.14
468438-6843876.43877.73
570602-7060278.85580.17
669660-6966077.80379.13
20min170640-7064078.89781.352.6181.0183.512.58
273467-7346782.05584.25
370973-7097379.26981.39
472345-7234580.80282.95
575643-7564384.48586.67
673938-7393882.58184.77
30min174806-7480683.55084.742.5786.5487.802.54
276133-7613385.03288.14
373772-7377282.39585.40
474314-7431483.00186.04
578779-7877987.98891.12
677412-7741286.46189.57
45min174343-7434383.03386.333.1686.9590.343.09
275951-7595184.82988.88
377448-7744886.50190.42
475878-7587884.74888.71
581002-8100290.47194.58
679154-7915488.40792.47
极限177397-7739786.44488.372.1491.2893.342.13
278962-7896288.19293.19
377524-7752486.58691.47
478980-7898088.21293.12
581964-8196491.54596.66
679897-7989789.23694.29
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