培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411622941623331621401622301622601622510.05
216.471622231621911622070.02
单位质量响应值RSD%判断
9887.329848.630.28数据可信
加速6月-供试品溶液-2023110721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172662-7266245.92953.7818.7845.9353.7818.78
2112524-11252471.12671.13
366411-6641141.97841.98
483636-8363652.86652.87
589110-8911056.32656.33
686125-8612554.43954.44
10min1159495-159495100.81698.082.66101.0098.302.68
2157943-15794399.835100.12
3147660-14766093.33693.50
4156483-15648398.91299.12
5155008-15500897.98098.21
6154456-15445697.63197.85
15min1161156-161156101.86698.911.56102.4599.521.56
2157005-15700599.24299.93
3154561-15456197.69898.24
4154967-15496797.95498.56
5155841-15584198.50799.12
6155349-15534998.19698.80
20min1158290-158290100.05598.650.86101.0599.660.86
2156306-15630698.80199.88
3155707-15570798.42299.35
4154485-15448597.65098.65
5156559-15655998.96199.97
6155090-15509098.03299.03
30min1157181-15718199.35498.030.87100.7599.420.88
2156027-15602798.624100.10
3154796-15479697.84699.17
4154128-15412897.42498.81
5154926-15492697.92899.34
6153443-15344396.99198.38
45min1157126-15712699.31998.040.71101.1199.840.71
2155491-15549198.285100.16
3154251-15425197.50299.22
4154773-15477397.83299.61
5154765-15476597.82799.63
6154253-15425397.50399.28
60min1155698-15569898.41697.460.80100.6199.640.82
2155799-15579998.480100.74
3153175-15317596.82298.93
4153186-15318696.82899.00
5153461-15346197.00299.19
6153808-15380897.22299.39
极限1154632-15463297.74296.970.91100.3399.540.92
2155441-15544198.254100.91
3152753-15275396.55599.05
4151632-15163295.84698.40
5152994-15299496.70799.29
6153011-15301196.71899.28
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303024443024273022903022913024163023740.03
212.353022123020963021540.03
单位质量响应值RSD%判断
24583.2524465.910.34数据可信
加速6月-供试品溶液-2023110721批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149891-4989115.98218.5213.5415.9818.5213.54
267732-6773221.69721.70
347328-4732815.16115.16
458334-5833418.68618.69
563035-6303520.19220.19
660507-6050719.38219.38
10min1148649-14864947.61750.206.3147.6850.286.33
2165037-16503752.86752.95
3140428-14042844.98445.04
4163428-16342852.35152.43
5161880-16188051.85651.94
6160872-16087251.53351.61
15min1199439-19943963.88764.693.1864.1464.963.20
2205336-20533665.77666.07
3190032-19003260.87461.11
4207559-20755966.48866.77
5204405-20440565.47865.77
6204866-20486665.62565.91
20min1227680-22768072.93473.042.1173.4473.572.13
2228984-22898473.35173.91
3218811-21881170.09270.58
4232529-23252974.48775.04
5229369-22936973.47574.02
6230713-23071373.90574.45
30min1257651-25765182.53481.881.6783.3482.711.68
2254140-25414081.41082.26
3248158-24815879.49380.26
4260630-26063083.48984.34
5255699-25569981.90982.75
6257399-25739982.45483.30
45min1280236-28023689.76988.251.4890.9089.401.48
2272743-27274387.36988.55
3269761-26976186.41387.50
4279752-27975289.61490.80
5274396-27439687.89889.07
6276086-27608688.44089.61
60min1291233-29123393.29291.361.5594.7892.871.55
2281304-28130490.11191.64
3280184-28018489.75291.18
4288782-28878292.50794.05
5282870-28287090.61392.14
6286826-28682691.88093.41
极限1300267-30026796.18693.211.8498.0595.081.81
2285826-28582691.56093.45
3287583-28758392.12293.91
4292722-29272293.76995.68
5287276-28727692.02493.91
6292175-29217593.59395.49
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411623911624961626591624881625081625080.06
216.471626811625011625910.08
单位质量响应值RSD%判断
9902.999871.950.23数据可信
长期6月-供试品溶液-2023110721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157571-5757136.31935.616.3036.3235.616.30
251118-5111832.24832.25
355639-5563935.10035.10
454774-5477434.55434.55
561740-6174038.94938.95
657871-5787136.50836.51
10min1158193-15819399.79698.801.0099.9498.951.00
2156781-15678198.90599.03
3156292-15629298.59798.74
4158561-158561100.028100.17
5155257-15525797.94498.10
6154632-15463297.55097.70
15min1159713-159713100.75599.221.25101.3099.761.24
2155594-15559498.15798.68
3155862-15586298.32698.86
4159822-159822100.824101.36
5156132-15613298.49699.04
6156573-15657398.77499.31
20min1160576-160576101.29999.471.19102.25100.411.19
2155894-15589498.34699.26
3155898-15589898.34899.28
4159124-159124100.383101.33
5156822-15682298.93199.87
6157783-15778399.538100.47
30min1159411-159411100.56598.801.25101.92100.141.25
2155671-15567198.20599.52
3155405-15540598.03799.36
4158654-158654100.087101.43
5154528-15452897.48498.82
6156030-15603098.43299.76
45min1158641-158641100.07998.721.13101.83100.451.13
2155238-15523897.93299.64
3155044-15504497.81099.52
4158646-158646100.082101.83
5154877-15487797.70499.43
6156463-15646398.705100.43
60min1157574-15757499.40698.051.13101.56100.171.12
2154450-15445097.43599.53
3153922-15392297.10299.21
4157677-15767799.471101.61
5153980-15398097.13899.26
6154952-15495297.75299.87
极限1157032-15703299.06497.631.23101.62100.151.23
2153314-15331496.71899.20
3153247-15324796.67699.17
4157357-15735799.269101.81
5153889-15388997.08199.59
6153740-15374096.98799.50
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303026243025613025713024783024843025440.03
212.353026753026553026650.01
单位质量响应值RSD%判断
24597.0724507.290.26数据可信
长期6月-供试品溶液-2023110721批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140001-4000112.79913.637.5212.8013.637.52
242321-4232113.54213.54
341981-4198113.43313.43
439428-3942812.61612.62
548367-4836715.47615.48
643399-4339913.88613.89
10min1145440-14544046.53747.092.8546.5947.152.85
2149184-14918447.73547.79
3149926-14992647.97248.03
4141122-14112245.15545.21
5152659-15265948.84748.91
6144722-14472246.30746.36
15min1198789-19878963.60764.401.3563.8464.651.36
2204554-20455465.45265.70
3200900-20090064.28364.53
4199763-19976363.91964.15
5204732-20473265.50965.77
6198932-19893263.65363.89
20min1227538-22753872.80673.721.2473.3074.221.24
2235244-23524475.27275.78
3228440-22844073.09573.60
4229128-22912873.31573.80
5232146-23214674.28074.80
6229951-22995173.57874.07
30min1257235-25723582.30883.041.4183.0983.831.40
2266334-26633485.22086.03
3256295-25629582.00782.80
4260418-26041883.32784.11
5259075-25907582.89783.71
6257756-25775682.47583.26
45min1276176-27617688.36989.581.4389.4890.711.42
2287097-28709791.86393.01
3276709-27670988.53989.66
4281507-28150790.07591.19
5278801-27880189.20990.36
6279480-27948089.42690.55
60min1284512-28451291.03692.251.5792.5093.731.57
2296584-29658494.89996.42
3285935-28593591.49192.97
4290417-29041792.92594.40
5286056-28605691.53093.03
6286257-28625791.59493.07
极限1291374-29137493.23294.311.5695.0696.171.55
2302320-30232096.73498.63
3292049-29204993.44895.29
4298601-29860195.54497.39
5292040-29204093.44595.32
6292128-29212893.47395.32
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411624331623951623151624421623551623880.04
216.471623851621311622580.12
单位质量响应值RSD%判断
9895.679851.730.32数据可信
加速6月-供试品溶液-2023110721批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100481-10048163.47764.4728.6663.4864.4828.66
257608-5760836.39336.39
392919-9291958.70058.70
4125126-12512679.04679.05
593958-9395859.35659.36
6142264-14226489.87389.87
10min1149076-14907694.17695.542.4894.4395.802.51
2150296-15029694.94795.09
3145657-14565792.01692.25
4156281-15628198.72899.04
5153879-15387997.21097.45
6152259-15225996.18796.55
15min1156486-15648698.85797.501.8899.4998.141.86
2156780-15678099.04399.57
3149537-14953794.46795.07
4156466-15646698.84599.56
5154341-15434197.50298.13
6152384-15238496.26697.01
20min1156217-15621798.68796.831.4699.7197.861.46
2152897-15289796.59097.51
3150141-15014194.84995.83
4154985-15498597.90999.02
5153872-15387297.20698.22
6151591-15159195.76596.89
30min1155534-15553498.25696.541.3299.6897.961.31
2152735-15273596.48897.80
3150040-15004094.78596.15
4154200-15420097.41398.91
5153269-15326996.82598.23
6151118-15111895.46696.98
45min1155185-15518598.03596.931.8899.8598.741.83
2156843-15684399.083100.78
3150069-15006994.80396.54
4155584-15558498.287100.18
5152707-15270796.47098.26
6150271-15027194.93196.83
60min1154889-15488997.84896.732.02100.0598.921.99
2148734-14873493.96096.05
3156660-15666098.967101.09
4155245-15524598.073100.35
5152887-15288796.58498.76
6150272-15027294.93297.21
极限1155296-15529698.10596.272.31100.7098.852.23
2156074-15607498.597101.06
3149199-14919994.25496.77
4154612-15461297.673100.35
5151672-15167295.81698.38
6147506-14750693.18495.84
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.303002933001353002113003263002083002350.03
212.352989372988152988760.03
单位质量响应值RSD%判断
24409.3524200.490.61数据可信
加速6月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156559-5655918.28218.7020.5918.2818.7020.60
238160-3816012.33512.33
355146-5514617.82517.82
467098-6709821.68821.69
557320-5732018.52818.53
672910-7291023.56723.57
10min1143713-14371346.45350.726.3846.5350.806.36
2170105-17010554.98455.03
3146507-14650747.35647.43
4162395-16239552.49152.58
5158420-15842051.20751.28
6160370-16037051.83751.93
15min1191860-19186062.01564.173.5562.2764.453.55
2204208-20420866.00766.28
3189230-18923061.16561.43
4204968-20496866.25266.55
5204626-20462666.14266.42
6196234-19623463.42963.73
20min1220614-22061471.31072.142.5071.8272.682.50
2223846-22384672.35472.89
3217015-21701570.14670.65
4229393-22939374.14774.71
5230007-23000774.34674.89
6218211-21821170.53371.09
30min1249158-24915880.53681.621.6281.3382.451.63
2251802-25180281.39182.21
3248221-24822180.23381.02
4257246-25724683.15084.01
5257784-25778483.32484.17
6250912-25091281.10381.94
45min1272185-27218587.97988.571.7389.0989.721.74
2270710-27071087.50288.65
3272155-27215587.96989.08
4280900-28090090.79691.99
5278945-27894590.16491.34
6269236-26923687.02688.19
60min1290351-29035193.85193.632.7295.3295.132.68
2292858-29285894.66196.16
3292578-29257894.57196.03
4299658-29965896.85998.41
5286168-28616892.49994.03
6276327-27632789.31890.83
极限1291459-29145994.20995.024.5396.0596.904.47
2293846-29384694.98196.86
3294832-29483295.29997.14
4317624-317624102.666104.61
5289368-28936893.53395.44
6276679-27667989.43291.30
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.411628231625371626671626521624981626350.08
216.471622771620791621780.09
单位质量响应值RSD%判断
9910.739846.870.46数据可信
长期6月-供试品溶液-2023110721批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141675-14167589.45590.464.7889.4590.464.78
2153277-15327796.78196.78
3133430-13343084.24984.25
4139228-13922887.91087.91
5147274-14727492.99092.99
6144726-14472691.38191.38
10min1153487-15348796.91397.871.5297.2798.231.53
2157562-15756299.48699.87
3154510-15451097.55997.90
4151649-15164995.75396.10
5157708-15770899.57899.95
6155106-15510697.93598.30
15min1152448-15244896.25797.511.5797.0098.261.57
2156964-15696499.10999.89
3154591-15459197.61098.34
4151103-15110395.40896.14
5157190-15719099.251100.02
6154304-15430497.42998.19
20min1152480-15248096.27797.101.7397.4198.241.73
2154937-15493797.82999.01
3153724-15372497.06398.18
4150065-15006594.75295.87
5158034-15803499.784100.95
6153430-15343096.87798.02
30min1152407-15240796.23197.281.7597.7598.811.75
2156601-15660198.879100.45
3153880-15388097.16198.67
4150010-15001094.71896.21
5157305-15730599.324100.89
6154205-15420597.36698.90
45min1151233-15123395.49096.961.6597.3998.881.65
2155915-15591598.446100.41
3153025-15302596.62198.52
4150079-15007994.76196.64
5156076-15607698.548100.51
6155051-15505197.90199.82
60min1151588-15158895.71496.691.7898.0099.001.79
2155345-15534598.086100.45
3152279-15227996.15098.43
4149803-14980394.58796.84
5157330-15733099.340101.70
6152475-15247596.27498.59
极限1151184-15118495.45996.441.5198.1299.131.51
2154001-15400197.23899.99
3151994-15199495.97098.64
4149833-14983394.60697.24
5156374-15637498.736101.49
6153025-15302596.62199.32
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.302985352985112984012983552982982984200.04
212.352990492989562990020.03
单位质量响应值RSD%判断
24261.7924210.690.15数据可信
长期6月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177540-7754025.13426.046.3425.1326.046.35
282940-8294026.88426.88
371587-7158723.20423.20
481332-8133226.36326.36
586040-8604027.88927.89
682511-8251126.74526.75
10min1161674-16167452.40653.072.3952.5153.172.39
2166813-16681354.07154.18
3159584-15958451.72851.82
4160388-16038851.98952.09
5169519-16951954.94855.06
6164362-16436253.27753.38
15min1199071-19907164.52765.402.1864.8465.722.19
2206065-20606566.79567.12
3198661-19866164.39564.69
4198425-19842564.31864.63
5208538-20853867.59667.93
6199815-19981564.76965.09
20min1221861-22186171.91573.072.6872.4873.652.68
2230787-23078774.80875.40
3220461-22046171.46172.02
4219562-21956271.17071.74
5234460-23446075.99976.60
6225382-22538273.05673.64
30min1246768-24676879.98881.262.4380.8482.132.44
2254012-25401282.33683.23
3246382-24638279.86380.71
4244180-24418079.14980.00
5260458-26045884.42685.33
6252285-25228581.77682.65
45min1263283-26328385.34187.853.0686.5289.053.06
2279156-27915690.48691.71
3264337-26433785.68386.85
4263046-26304685.26586.44
5280142-28014290.80692.05
6276154-27615489.51390.71
60min1274605-27460589.01190.683.1490.5392.223.14
2286619-28661992.90694.49
3273796-27379688.74990.25
4272440-27244088.31089.82
5294353-29435395.41297.02
6276638-27663889.67091.23
极限1281410-28141091.21793.392.9293.0995.302.92
2294076-29407695.32397.28
3282111-28211191.44493.30
4280319-28031990.86392.73
5301302-30130297.66599.65
6289525-28952593.84895.76
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-05-21 15:28:29 完成)
生成报告数据部分下载报告(谢鑫慧 于 2024-05-21 15:29:10 完成)
Current page cost:889 ms