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%
1 10.304354243406433414349143359434280.20
2 10.294337843397433880.04
单位质量响应值RSD%判断
4216.314216.520.01数据可信
供试品溶液-2022082001批-培哚普利-磷酸盐缓冲液(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%
5min149071-4907199.29699.010.9699.3099.020.96
248299-4829997.73497.73
348475-4847598.09098.09
449201-4920199.55999.56
549547-49547100.259100.26
648997-4899799.14699.15
10min149796-49796100.763100.051.01101.87101.160.99
249602-49602100.371101.46
349142-4914299.440100.53
450114-50114101.407102.51
548729-4872998.60499.72
649291-4929199.741100.84
15min148487-4848798.11498.571.18100.34100.781.16
249120-4912099.395101.60
348718-4871898.582100.78
449349-4934999.859102.09
547721-4772196.56498.77
648867-4886798.883101.09
20min148072-4807297.27596.881.10100.59100.191.09
247508-4750896.13399.44
348002-4800297.133100.42
448788-4878898.723102.07
547406-4740695.92799.21
647499-4749996.11599.42
30min146945-4694594.99495.111.1099.3999.501.08
247252-4725295.61599.99
346567-4656794.22998.60
447903-4790396.933101.37
546839-4683994.78099.13
646520-4652094.13498.51
45min146378-4637893.84794.350.6099.3099.790.59
247040-4704095.186100.62
346335-4633593.76099.18
446863-4686394.828100.34
546633-4663394.36399.76
646502-4650294.09899.52
极限146440-4644093.97293.991.12100.46100.481.08
246199-4619993.48599.98
346201-4620193.48999.95
447434-4743495.984102.55
545962-4596293.00599.45
646461-4646194.015100.48
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%
114.121668671664621663401661221660151663610.21
214.211663801665191664500.06
单位质量响应值RSD%判断
11781.9411713.580.42数据可信
供试品溶液-2022082001批-氨氯地平-磷酸盐缓冲液(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%
5min1115891-11589163.95062.874.0463.9562.874.04
2105632-10563258.28958.29
3113606-11360662.68962.69
4114686-11468663.28563.29
5119601-11960165.99766.00
6114188-11418863.01063.01
10min1157231-15723186.76285.721.2487.4786.421.24
2153376-15337684.63585.28
3155242-15524285.66586.36
4157770-15777087.06087.76
5155337-15533785.71786.45
6153092-15309284.47885.18
15min1161294-16129489.00489.270.9490.6890.920.91
2162563-16256389.70491.29
3161072-16107288.88290.53
4163515-16351590.23091.90
5159356-15935687.93589.62
6162879-16287989.87991.52
20min1163317-16331790.12090.021.1892.7892.661.17
2160576-16057688.60891.19
3163814-16381490.39593.03
4166343-16634391.79094.46
5162484-16248489.66192.32
6162329-16232989.57592.21
30min1163734-16373490.35190.800.9094.0294.450.87
2165234-16523491.17894.75
3162592-16259289.72093.36
4166805-16680592.04595.74
5165102-16510291.10594.76
6163873-16387390.42794.06
45min1164486-16448690.76591.760.7795.4396.410.75
2166598-16659891.93196.51
3165148-16514891.13195.77
4167902-16790292.65097.37
5167149-16714992.23596.91
6166458-16645891.85496.49
极限1166517-16651791.88692.681.2697.5698.361.23
2166201-16620191.71297.32
3167520-16752092.44098.09
4171926-17192694.871100.62
5167018-16701892.16397.86
6168582-16858293.02698.68
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%
1 10.304318643220434984326743158432660.32
2 10.294335743192432740.27
单位质量响应值RSD%判断
4200.584205.440.09数据可信
供试品溶液-2022082001批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147956-4795697.34997.861.6097.3597.861.60
247462-4746296.34796.35
347459-4745996.34196.34
448511-4851198.47698.48
548351-4835198.15198.15
649493-49493100.469100.47
10min148831-4883199.12698.621.62100.2199.711.62
248172-4817297.78898.86
347290-4729095.99797.07
448532-4853298.51999.61
549172-4917299.818100.91
649496-49496100.476101.59
15min148035-4803597.51097.251.6999.6999.441.69
247193-4719395.80197.96
347073-4707395.55797.69
447468-4746896.35998.55
548599-4859998.655100.85
649083-4908399.637101.87
20min147326-4732696.07196.151.5999.3499.421.59
246697-4669794.79498.02
346946-4694695.29998.50
446712-4671294.82498.08
547956-4795697.349100.65
648561-4856198.578101.92
30min146702-4670294.80494.711.4099.1499.041.40
245793-4579392.95997.23
346073-4607393.52797.78
446631-4663194.66098.97
547304-4730496.026100.40
647430-4743096.282100.72
45min146826-4682695.05694.341.35100.4499.731.36
245942-4594293.26198.57
345657-4565792.68297.98
446254-4625493.89499.26
546866-4686695.137100.58
647303-4730396.024101.53
极限191295-91295185.326108.5834.66191.77115.0232.73
244711-4471190.76297.11
345437-4543792.23698.56
446009-4600993.39799.81
546997-4699795.403101.90
646488-4648894.369100.94
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%
114.121657061661151661661659981659941659960.11
214.211658111658861658480.04
单位质量响应值RSD%判断
11756.0911671.220.52数据可信
供试品溶液-2022082001批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114851-11485163.56163.522.8763.5663.522.86
2112051-11205162.01262.01
3112637-11263762.33662.34
4112712-11271262.37762.38
5115525-11552563.93463.93
6120871-12087166.89366.89
10min1153514-15351484.95884.972.2185.6685.672.21
2151746-15174683.98084.67
3148654-14865482.26882.96
4152785-15278584.55585.25
5156264-15626486.48087.19
6158232-15823287.56988.31
15min1159639-15963988.34888.242.0690.0089.892.07
2157525-15752587.17888.80
3155012-15501285.78787.39
4158063-15806387.47689.11
5162810-16281090.10391.77
6163588-16358890.53392.25
20min1161736-16173689.50889.292.0292.1491.922.02
2158489-15848987.71190.30
3158311-15831187.61390.17
4159377-15937788.20390.81
5163820-16382090.66293.33
6166367-16636792.07194.79
30min1163001-16300190.20889.912.2093.8393.542.19
2159130-15913088.06691.63
3157532-15753287.18290.72
4163083-16308390.25493.84
5165117-16511791.37995.06
6166961-16696192.40096.15
45min1166429-16642992.10691.321.9696.7395.941.97
2162396-16239689.87494.42
3160422-16042288.78193.28
4164251-16425190.90095.49
5167712-16771292.81697.51
6168809-16880993.42398.19
极限1317957-317957175.964105.4832.80181.62111.1231.15
2159812-15981288.44493.99
3162357-16235789.85295.34
4165292-16529291.47697.07
5169362-16936293.72999.46
6168814-16881493.42599.24
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%
1 10.304315843334432304331843266432610.17
2 10.294327543270432720.01
单位质量响应值RSD%判断
4200.104205.250.09数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147769-4776996.97897.811.3896.9897.811.38
247363-4736396.15396.15
348140-4814097.73197.73
448979-4897999.43499.43
548958-4895899.39199.39
647857-4785797.15697.16
10min148616-4861698.69799.111.0099.77100.201.00
248336-4833698.12999.20
348739-4873998.947100.03
449618-49618100.731101.84
549171-4917199.824100.93
648448-4844898.35699.44
15min149002-4900299.48198.281.32101.65100.471.31
247522-4752296.47698.63
348357-4835798.171100.36
448933-4893399.341101.56
548871-4887199.215101.43
647780-4778097.00099.17
20min147769-4776996.97896.821.30100.26100.101.29
246715-4671594.83898.07
347500-4750096.43299.71
448423-4842398.305101.63
548257-4825797.968101.28
647474-4747496.37999.63
30min147020-4702095.45795.370.9999.8199.731.00
246290-4629093.97598.26
346877-4687795.16799.51
447601-4760196.637101.06
547353-4735396.133100.54
646734-4673494.87699.20
45min146459-4645994.31894.171.1499.7499.581.13
245538-4553892.44897.78
346190-4619093.77299.18
447055-4705595.528101.02
546785-4678594.980100.45
646278-4627893.95199.33
极限147040-4704095.49894.041.28101.96100.501.24
245947-4594793.27999.63
346550-4655094.503100.95
446766-4676694.941101.50
546231-4623193.855100.38
645410-4541092.18998.61
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%
114.121662391656041661351663871659881660710.18
214.211656451657961657200.07
单位质量响应值RSD%判断
11761.4011662.210.60数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123825-12382568.53968.472.4468.5468.472.44
2120526-12052666.71366.71
3120844-12084466.88966.89
4128598-12859871.18171.18
5125326-12532669.36969.37
6123074-12307468.12368.12
10min1151326-15132683.76184.401.8984.5285.161.89
2152017-15201784.14384.88
3150215-15021583.14683.89
4157832-15783287.36288.15
5150191-15019183.13383.90
6153278-15327884.84185.60
15min1161590-16159089.44288.971.3591.1390.671.36
2158725-15872587.85689.53
3158451-15845187.70589.37
4163668-16366890.59292.35
5162535-16253589.96591.66
6159454-15945488.26089.96
20min1160428-16042888.79989.701.8691.4892.391.85
2158689-15868987.83690.49
3159955-15995588.53791.18
4166662-16666292.24995.02
5164410-16441091.00393.70
6162237-16223789.80092.48
30min1162529-16252989.96290.781.3693.6394.461.37
2162319-16231989.84693.47
3161811-16181189.56493.19
4167240-16724092.56996.36
5166120-16612091.94995.65
6164029-16402990.79294.47
45min1164249-16424990.91491.281.3595.5995.971.36
2161628-16162889.46394.09
3163735-16373590.62995.25
4168036-16803693.01097.83
5166303-16630392.05196.78
6165469-16546991.58996.28
极限1168328-16832893.17292.471.2798.8598.181.26
2165543-16554391.63097.25
3166847-16684792.35297.98
4170341-17034194.286100.14
5167073-16707392.47798.23
6164271-16427190.92696.63
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%
1 10.304339643295433224328443317433230.11
2 10.294331643299433080.03
单位质量响应值RSD%判断
4206.124208.750.05数据可信
供试品溶液-2022082101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147818-4781896.96797.540.9396.9797.540.94
248050-4805097.43897.44
347865-4786597.06397.06
448991-4899199.34699.35
548036-4803697.40997.41
647851-4785197.03497.03
10min148561-4856198.474100.472.0999.55101.562.07
248931-4893199.224100.31
348405-4840598.15899.24
450346-50346102.094103.20
550772-50772102.958104.04
650267-50267101.933103.01
15min148312-4831297.96999.741.59100.14101.941.57
248562-4856298.476100.66
349297-4929799.966102.14
449436-49436100.248102.49
550516-50516102.438104.66
648994-4899499.352101.56
20min147151-4715195.61597.652.1898.87100.962.13
246614-4661494.52697.81
349028-4902899.421102.70
449191-4919199.752103.10
548625-4862598.604101.97
648330-4833098.006101.32
30min147764-4776496.85897.121.53101.18101.511.50
247144-4714495.60199.93
347206-4720695.726100.11
447904-4790497.142101.60
549116-4911699.599104.06
648228-4822897.799102.20
45min146651-4665194.60195.221.30100.00100.691.29
246024-4602493.32998.72
346769-4676994.840100.29
447103-4710395.517101.06
547674-4767496.675102.24
647514-4751496.351101.84
极限145262-4526291.78493.852.1898.23100.382.11
245491-4549192.24998.68
346292-4629293.873100.37
446051-4605193.38499.99
548099-4809997.537104.18
646502-4650294.299100.86
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%
114.121664951663121665521661951659231662950.16
214.211659481656701658090.12
单位质量响应值RSD%判断
11777.2711668.470.66数据可信
供试品溶液-2022082101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124230-12423068.69869.763.1968.7069.763.19
2128540-12854071.08271.08
3125267-12526769.27269.27
4133117-13311773.61373.61
5123349-12334968.21168.21
6122403-12240367.68867.69
10min1152850-15285084.52586.222.6985.2986.992.68
2153690-15369084.98985.78
3151142-15114283.58084.35
4162562-16256289.89590.71
5158260-15826087.51688.27
6156938-15693886.78587.54
15min1157898-15789887.31689.342.0689.0291.072.05
2159379-15937988.13589.87
3162342-16234289.77491.47
4165307-16530791.41393.23
5165484-16548491.51193.24
6158927-15892787.88589.60
20min1157443-15744387.06588.952.2789.7491.682.25
2156140-15614086.34489.06
3163334-16333490.32293.02
4165948-16594891.76894.60
5161582-16158289.35492.10
6160677-16067788.85391.55
30min1160953-16095389.00689.862.1992.6593.572.15
2157184-15718486.92190.59
3160979-16097989.02092.72
4165282-16528291.40095.25
5167134-16713492.42496.16
6163426-16342690.37394.05
45min1160869-16086988.95989.741.7293.5994.451.70
2157597-15759787.15091.79
3161858-16185889.50694.19
4164480-16448090.95695.82
5164769-16476991.11695.88
6164121-16412190.75895.44
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