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%
110.354205541938420684197841994420070.13
210.354229442123422080.29
单位质量响应值RSD%判断
4058.654078.070.34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%
5min146445-4644597.40398.301.2697.4098.301.26
247018-4701898.60598.60
347962-47962100.585100.58
446750-4675098.04398.04
546324-4632497.14997.15
646730-4673098.00198.00
10min147198-4719898.982100.110.71100.06101.200.71
247533-4753399.685100.78
347971-47971100.603101.72
447892-47892100.438101.53
548127-48127100.931102.01
647683-4768399.999101.09
15min147098-4709898.77399.630.76100.95101.840.76
247009-4700998.586100.79
347865-47865100.381102.62
447649-4764999.928102.13
547681-4768199.995102.20
647748-47748100.136102.34
20min145182-4518294.75497.871.8498.03101.181.80
246195-4619596.879100.18
347404-4740499.414102.77
446958-4695898.479101.79
547422-4742299.452102.76
646842-4684298.236101.55
30min145037-4503794.45095.961.3198.78100.361.29
245536-4553695.49799.87
346813-4681398.175102.63
445968-4596896.403100.81
545567-4556795.56299.98
645621-4562195.675100.08
45min145077-4507794.53495.331.0699.92100.791.04
244977-4497794.32599.76
346027-4602796.527102.07
445282-4528294.964100.45
546084-4608496.646102.12
645288-4528894.977100.44
极限144949-4494994.26695.180.85100.70101.700.86
245126-4512694.637101.12
345985-4598596.438103.06
445470-4547095.358101.89
545628-4562895.690102.24
645152-4515294.692101.21
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%
114.301675671676121678111679491678381677550.10
214.331684001678781681390.22
单位质量响应值RSD%判断
11731.1211733.360.02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%
5min1120941-12094166.82563.587.4866.8263.587.48
2123312-12331268.13568.13
3120409-12040966.53166.53
4116341-11634164.28364.28
5108108-10810859.73459.73
6101323-10132355.98555.98
10min1150115-15011582.94480.622.8383.6981.332.87
2149398-14939882.54883.31
3146897-14689781.16681.91
4145662-14566280.48481.20
5144757-14475779.98480.65
6138635-13863576.60177.22
15min1158138-15813887.37785.831.8189.0487.431.86
2156947-15694786.71988.39
3157072-15707286.78888.43
4155426-15542685.87987.49
5153944-15394485.06086.61
6150452-15045283.13084.60
20min1155271-15527185.79386.731.9188.4389.291.93
2159273-15927388.00490.64
3159700-15970088.24090.85
4156828-15682886.65389.22
5158831-15883187.76090.26
6151900-15190083.93186.33
30min1157716-15771687.14487.401.9490.7390.921.98
2160750-16075088.82192.44
3162131-16213189.58493.17
4157992-15799287.29790.82
5157137-15713786.82490.30
6153331-15333184.72188.05
45min1162020-16202089.52288.821.7094.0893.311.73
2161835-16183589.42094.02
3163222-16322290.18694.77
4159423-15942388.08792.58
5162150-16215089.59494.03
6155798-15579886.08490.36
极限1165323-16532391.34791.391.3196.9096.861.36
2167523-16752392.56398.16
3166380-16638091.93197.51
4164748-16474891.03096.50
5166891-16689192.21497.65
6161511-16151189.24194.47
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%
110.354201142129422164208442060421000.19
210.354214242215421780.13
单位质量响应值RSD%判断
4067.634075.170.14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%
5min143511-4351191.18193.281.6391.1893.281.63
244646-4464693.56093.56
344043-4404392.29692.30
445679-4567995.72595.72
544594-4459493.45193.45
644594-4459493.45193.45
10min144459-4445993.16894.231.6794.1895.261.66
244189-4418992.60293.64
344638-4463893.54394.57
446288-4628897.00198.06
545249-4524994.82495.86
644970-4497094.23995.28
15min143826-4382691.84293.281.6093.8995.361.59
243816-4381691.82193.89
344710-4471093.69495.76
445662-4566295.68997.83
544842-4484293.97196.06
644205-4420592.63694.72
20min144428-4442893.10393.131.2596.1796.251.23
243877-4387791.94895.04
343723-4372391.62694.73
444648-4464893.56496.77
544807-4480793.89797.03
645159-4515994.63597.75
30min142934-4293489.97291.591.7494.0895.741.72
242699-4269989.48093.59
343946-4394692.09396.22
444724-4472493.72397.97
543797-4379791.78195.96
644124-4412492.46696.63
45min142437-4243788.93192.652.8194.0397.822.73
243090-4309090.29995.40
344084-4408492.38297.53
445063-4506394.43499.72
544979-4497994.25899.46
645618-4561895.597100.79
极限143459-4345991.07293.761.8697.1699.961.84
244123-4412392.46498.57
344719-4471993.71399.89
445652-4565295.668102.00
545073-4507394.455100.70
645434-4543495.211101.47
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%
114.301676821678881680111678171679441678680.08
214.331677721677261677490.02
单位质量响应值RSD%判断
11739.0211706.140.20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%
5min194569-9456952.29654.453.8352.3054.453.83
2103839-10383957.42257.42
399913-9991355.25155.25
4101299-10129956.01856.02
595738-9573852.94352.94
695434-9543452.77452.77
10min1138736-13873676.72077.272.6577.3077.882.64
2138086-13808676.36177.00
3141663-14166378.33978.95
4145433-14543380.42481.05
5140054-14005477.44978.04
6134427-13442774.33774.92
15min1150905-15090583.45084.182.8184.8885.642.80
2149630-14963082.74584.23
3156495-15649586.54188.03
4157379-15737987.03088.55
5152822-15282284.51085.96
6146118-14611880.80282.21
20min1156937-15693786.78586.921.3189.1589.321.31
2154825-15482585.61788.02
3156846-15684686.73589.18
4159603-15960388.26090.74
5159610-15961088.26390.65
6155305-15530585.88388.19
30min1157504-15750487.09989.082.4090.4292.442.37
2156487-15648786.53689.89
3164205-16420590.80494.21
4165990-16599091.79295.26
5162975-16297590.12493.49
6159346-15934688.11791.38
45min1160079-16007988.52390.492.0692.8294.842.04
2161093-16109389.08493.40
3168573-16857393.22097.64
4165385-16538591.45795.94
5165551-16555191.54995.92
6161143-16114389.11193.35
极限1163268-16326890.28691.892.0395.5697.251.98
2161537-16153789.32994.64
3166367-16636792.00097.45
4169932-16993293.97199.47
5169681-16968193.83399.22
6166223-16622391.92097.15
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%
110.354220142354422474220542124422260.20
210.354229742245422710.09
单位质量响应值RSD%判断
4079.814084.150.08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%
5min145561-4556195.23097.672.5395.2397.672.53
248729-48729101.852101.85
345616-4561695.34595.34
447076-4707698.39698.40
547052-4705298.34698.35
646337-4633796.85296.85
10min145402-4540294.89899.362.4695.96100.442.46
248788-48788101.975103.11
347366-4736699.003100.06
448341-48341101.041102.13
547683-4768399.665100.76
647631-4763199.557100.63
15min145909-4590995.95799.222.5398.07101.412.53
249244-49244102.928105.19
346533-4653397.26299.42
448317-48317100.990103.21
547379-4737999.030101.23
647446-4744699.170101.35
20min146078-4607896.31198.382.4199.49101.682.40
249065-49065102.554105.96
345920-4592095.98099.22
446959-4695998.152101.49
547389-4738999.051102.35
647008-4700898.254101.54
30min145139-4513994.34897.492.7398.60101.882.71
248567-48567101.513106.06
345329-4532994.74599.05
446700-4670097.611102.04
547150-4715098.551102.95
646981-4698198.198102.57
45min144751-4475193.53795.932.8098.83101.402.78
248288-48288100.930106.61
344865-4486593.77599.13
446015-4601596.179101.69
545950-4595096.043101.54
645519-4551995.142100.61
极限144404-4440492.81296.463.4599.15103.003.37
248567-48567101.513108.31
344973-4497394.001100.40
447537-4753799.360105.94
545568-4556895.245101.81
645857-4585795.849102.37
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%
114.301677021677211678261677701678721677780.05
214.331681091683581682340.11
单位质量响应值RSD%判断
11732.7311739.990.05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%
5min183518-8351846.13145.802.3946.1345.802.39
281057-8105744.77144.77
383989-8398946.39146.39
483154-8315445.93045.93
585585-8558547.27247.27
680183-8018344.28944.29
10min1118519-11851965.46367.582.8965.9868.082.86
2127898-12789870.64471.14
3120506-12050666.56167.08
4125310-12531069.21469.72
5121406-12140667.05867.58
6120429-12042966.51867.01
15min1135945-13594575.08876.542.5876.3377.802.56
2144527-14452779.82981.11
3135057-13505774.59875.85
4140853-14085377.79979.08
5138399-13839976.44477.71
6136678-13667875.49376.72
20min1144982-14498280.08080.542.3382.1582.652.31
2151970-15197083.94086.11
3142228-14222878.55980.64
4144717-14471779.93482.08
5146979-14697981.18383.30
6143986-14398679.53081.60
30min1151493-15149383.67684.732.3286.6487.742.30
2159405-15940588.04691.15
3148898-14889882.24385.20
4152437-15243784.19887.23
5154933-15493385.57688.60
6153275-15327584.66187.61
45min1154628-15462885.40886.242.6689.3090.192.62
2164020-16402090.59694.68
3152163-15216384.04687.92
4156504-15650486.44490.41
5155586-15558685.93789.91
6153893-15389385.00288.90
极限1158999-15899987.82289.203.0092.6694.102.95
2169388-16938893.56198.65
3157539-15753987.01691.82
4165585-16558591.46096.39
5159273-15927387.97492.90
6158154-15815487.35592.19
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%
110.354232442189423624230542438423240.22
210.354235042352423510.01
单位质量响应值RSD%判断
4089.284091.880.05数据可信
供试品溶液-2022081901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%
5min147328-4732898.71598.211.3598.7298.211.35
247745-4774599.58599.59
347056-4705698.14898.15
447390-4739098.84598.84
547085-4708598.20898.21
645897-4589795.73195.73
10min149295-49295102.81899.951.93103.91101.041.92
247732-4773299.558100.66
347812-4781299.725100.82
447549-4754999.176100.27
548553-48553101.270102.36
646582-4658297.15998.22
15min149345-49345102.92299.262.24105.16101.462.22
247120-4712098.281100.49
347461-4746198.993101.19
447198-4719898.444100.64
548180-48180100.492102.71
646232-4623296.42998.57
20min147821-4782199.74498.531.17103.13101.831.18
246821-4682197.658100.96
347071-4707198.179101.48
447229-4722998.509101.80
547938-4793899.988103.32
646542-4654297.076100.29
30min146644-4664497.28996.481.63101.78100.881.61
245758-4575895.44199.83
346130-4613096.216100.61
446533-4653397.057101.45
547313-4731398.684103.13
645150-4515094.17298.47
45min146472-4647296.93095.821.77102.50101.291.72
245115-4511594.09999.55
347032-4703298.098103.56
446231-4623196.427101.89
545861-4586195.655101.20
644917-4491793.68699.03
极限146564-4656497.12294.821.80103.77101.361.76
245401-4540194.696101.19
344744-4474493.32699.87
445707-4570795.334101.87
546007-4600795.960102.56
644346-4434692.49598.88
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%
114.301680831682251682041681771682231681820.04
214.331682851683001682920.01
单位质量响应值RSD%判断
11760.9811744.030.11数据可信
供试品溶液-2022081901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%
5min193159-9315951.38552.406.1851.3952.406.17
295514-9551452.68452.68
3101785-10178556.14356.14
4101076-10107655.75255.75
586185-8618547.53847.54
692267-9226750.89350.89
10min1138031-13803176.13675.232.4776.7175.812.50
2136600-13660075.34775.93
3140439-14043977.46478.09
4138572-13857276.43477.05
5132026-13202672.82473.35
6132686-13268673.18873.75
15min1154856-15485685.41683.522.0086.8384.942.01
2151887-15188783.77985.20
3153860-15386084.86786.35
4151766-15176683.71285.18
5149661-14966182.55183.89
6146472-14647280.79282.17
20min1156143-15614386.12686.660.8288.4989.000.86
2156694-15669486.43088.78
3158458-15845887.40389.83
4158744-15874487.56189.96
5157128-15712886.67088.92
6155470-15547085.75588.03
30min1158296-15829687.31488.241.2290.6491.551.19
2160209-16020988.36991.68
3160322-16032288.43191.83
4161363-16136389.00692.38
5162450-16245089.60592.82
6157181-15718186.69989.93
45min1162024-16202489.37089.841.4493.6694.131.43
2160778-16077888.68392.98
3166627-16662791.90996.29
4163856-16385690.38194.74
5163628-16362890.25594.47
6160306-16030688.42292.62
极限1165871-16587191.49290.801.1596.7896.091.08
2165068-16506891.04996.33
3162518-16251889.64395.05
4165152-16515291.09596.46
5166901-16690192.06097.28
6162162-16216289.44694.62
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%
110.354251242554425714264042591425740.12
210.354249742482424900.03
单位质量响应值RSD%判断
4113.434105.310.14数据可信
供试品溶液-2022081901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%
5min146581-4658196.71397.711.5596.7197.711.55
247660-4766098.95398.95
348260-48260100.199100.20
446692-4669296.94396.94
546475-4647596.49396.49
646708-4670896.97796.98
10min146850-4685097.27199.881.9398.35100.961.92
248729-48729101.173102.27
349202-49202102.155103.27
447133-4713397.85998.94
548492-48492100.681101.75
648227-48227100.130101.21
15min146676-4667696.91098.231.3299.07100.421.32
247523-4752398.669100.89
348329-48329100.342102.59
446973-4697397.52799.69
546796-4679697.15999.35
647573-4757398.773100.96
20min146566-4656696.68297.770.8999.91101.060.90
247275-4727598.154101.47
347586-4758698.800102.16
446594-4659496.74099.99
547293-4729398.191101.46
647224-4722498.048101.34
30min145403-4540394.26797.492.7598.57101.872.67
246839-4683997.249101.66
348883-48883101.492105.95
448051-4805199.765104.09
546503-4650396.551100.91
646066-4606695.644100.02
45min145405-4540594.27195.841.4099.63101.291.40
246147-4614795.812101.30
347278-4727898.160103.75
445701-4570194.886100.32
546350-4635096.233101.67
646068-4606895.648101.09
极限145301-4530194.05595.101.19100.46101.621.17
245328-4532894.111100.67
346593-4659396.738103.42
445385-4538594.230100.72
546147-4614795.812102.32
646063-4606395.637102.14
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%
114.301690671692331692431690381689601691080.08
214.331691441692161691800.04
单位质量响应值RSD%判断
11825.7311806.000.12数据可信
供试品溶液-2022081901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%
5min191443-9144350.16851.386.7850.1751.386.78
298120-9812053.83153.83
3102048-10204855.98655.99
496781-9678153.09753.10
586000-8600047.18247.18
687535-8753548.02448.02
10min1130162-13016271.41173.752.9871.9774.323.00
2136781-13678175.04275.64
3141304-14130477.52378.15
4132529-13252972.70973.30
5132211-13221172.53573.06
6133598-13359873.29673.83
15min1145550-14555079.85381.072.4381.2082.462.44
2149969-14996982.27783.71
3152677-15267783.76385.25
4145474-14547479.81181.21
5143171-14317178.54879.88
6149717-14971782.13983.49
20min1152324-15232483.56984.711.5085.8187.001.52
2155606-15560685.37087.72
3157111-15711186.19588.61
4151502-15150283.11885.40
5153425-15342584.17386.38
6156439-15643985.82788.09
30min1152627-15262783.73587.453.1786.9090.683.13
2160098-16009887.83491.13
3167043-16704391.64495.02
4162634-16263489.22692.43
5157209-15720986.24989.39
6156748-15674885.99689.21
45min1158512-15851286.96488.571.7391.0692.781.72
2161026-16102688.34392.61
3164567-16456790.28694.68
4158971-15897187.21691.42
5160496-16049688.05392.15
6165083-16508390.56994.74
极限1161682-16168288.70389.541.7193.7794.731.64
2160794-16079488.21693.47
3165273-16527390.67396.07
4159746-15974687.64192.81
5165481-16548190.78895.86
6166244-16624491.20696.38
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