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%
110.214154341518414894143541428414830.13
210.164127941266412720.03
单位质量响应值RSD%判断
4062.984062.200.02数据可信
供试品溶液-2022081001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%
5min146948-4694898.59798.231.2598.6098.231.25
246230-4623097.08997.09
347293-4729399.32299.32
446804-4680498.29598.29
547424-4742499.59799.60
645947-4594796.49596.50
10min147733-47733100.24699.600.96101.34100.690.96
246926-4692698.55199.63
348159-48159101.141102.24
447237-4723799.204100.30
547418-4741899.584100.69
647084-4708498.88399.96
15min146859-4685998.41098.410.81100.62100.610.81
246544-4654497.74999.92
347553-4755399.868102.10
446858-4685898.408100.60
546847-4684798.385100.60
646506-4650697.66999.84
20min145599-4559995.76496.271.6499.0799.561.61
244853-4485394.19797.46
347168-4716899.059102.40
445760-4576096.10299.39
545889-4588996.37399.68
645758-4575896.09899.35
30min146004-4600496.61595.351.35100.9899.711.31
245237-4523795.00499.31
346088-4608896.791101.23
445398-4539895.34299.70
544410-4441093.26797.64
645273-4527395.08099.40
45min144981-4498194.46694.530.9099.9199.950.90
244686-4468693.84799.21
345771-4577196.125101.64
444682-4468293.83899.25
544867-4486794.22799.64
645073-4507394.659100.04
极限144787-4478794.05993.981.03100.55100.441.03
244268-4426892.96999.37
345601-4560195.768102.35
444632-4463293.733100.19
544732-4473293.943100.40
644464-4446493.38199.81
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%
114.121654391652071657891656571652241654630.16
214.121653781653201653490.03
单位质量响应值RSD%判断
11718.3411710.270.05数据可信
供试品溶液-2022081001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%
5min195402-9540252.79451.796.0152.7951.796.01
287424-8742448.37948.38
394845-9484552.48652.49
495953-9595353.09953.10
5101324-10132456.07156.07
686544-8654447.89247.89
10min1132485-13248573.31573.643.3973.9074.213.40
2126360-12636069.92670.46
3136296-13629675.42476.01
4136436-13643675.50276.09
5137523-13752376.10376.73
6129283-12928371.54372.08
15min1151032-15103283.57984.842.5284.9886.242.54
2147845-14784581.81583.13
3155661-15566186.14087.56
4157426-15742687.11788.55
5156762-15676286.75088.22
6151149-15114983.64384.97
20min1152718-15271884.51286.783.1486.8489.123.13
2149079-14907982.49884.72
3161342-16134289.28491.66
4160625-16062588.88791.28
5159814-15981488.43990.87
6157331-15733187.06489.32
30min1159637-15963788.34188.441.4691.6191.741.49
2156496-15649686.60289.74
3161735-16173589.50292.87
4163091-16309190.25293.64
5158697-15869787.82091.24
6159227-15922788.11491.34
45min1158407-15840787.66088.741.5391.9193.021.56
2156971-15697186.86590.97
3162134-16213489.72294.09
4163694-16369490.58694.97
5160153-16015388.62693.02
6160780-16078088.97393.18
极限1160682-16068288.91989.561.5994.1494.841.64
2158291-15829187.59692.66
3164378-16437890.96496.33
4163962-16396290.73496.13
5163882-16388290.69096.07
6159902-15990288.48793.68
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%
110.214148841310415164157441506414790.25
210.164144641470414580.05
单位质量响应值RSD%判断
4062.594080.510.32数据可信
供试品溶液-2022081101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%
5min146276-4627696.97395.891.1596.9795.891.15
246074-4607496.54996.55
345119-4511994.54894.55
446222-4622296.85996.86
545714-4571495.79595.79
645149-4514994.61194.61
10min146833-4683398.14097.280.8299.2298.340.82
246903-4690398.28799.36
346272-4627296.96498.01
446429-4642997.29398.37
545954-4595496.29897.36
646147-4614796.70297.75
15min146088-4608896.57996.491.5498.7598.631.52
247230-4723098.972101.14
346113-4611396.63198.76
446076-4607696.55498.71
545077-4507794.46096.59
645677-4567795.71797.84
20min145213-4521394.74595.181.5497.9998.401.51
246211-4621196.836100.10
344519-4451993.29196.49
446215-4621596.845100.07
545487-4548795.31998.50
644873-4487394.03397.22
30min145316-4531694.96193.891.4399.2598.161.41
245732-4573295.833100.17
344144-4414492.50596.74
444958-4495894.21198.52
544274-4427492.77797.02
644394-4439493.02997.26
45min144523-4452393.29992.570.8898.6597.890.89
244715-4471593.70299.11
343664-4366491.49996.77
444111-4411192.43697.79
543906-4390692.00697.28
644130-4413092.47697.74
极限143865-4386591.92091.311.0698.3197.661.05
244054-4405492.31698.76
342857-4285789.80896.09
443861-4386191.91298.29
543206-4320690.53996.84
643589-4358991.34297.64
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%
114.121656151654061654301654461655261654850.06
214.121660461655821658140.20
单位质量响应值RSD%判断
11719.9011743.200.15数据可信
供试品溶液-2022081101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%
5min196277-9627753.20052.092.1253.2052.092.12
291984-9198450.82850.83
391890-9189050.77650.78
494927-9492752.45452.45
594149-9414952.02452.02
696406-9640653.27153.27
10min1129437-12943771.52371.690.9872.1172.260.98
2129107-12910771.34171.91
3128810-12881071.17771.74
4131671-13167172.75873.34
5128465-12846570.98671.56
6130901-13090172.33272.92
15min1147531-14753181.52182.531.8982.9183.901.85
2154733-15473385.50186.86
3148026-14802681.79583.15
4149741-14974182.74384.13
5147064-14706481.26382.63
6149026-14902682.34783.74
20min1151604-15160483.77284.872.3786.0687.162.33
2158906-15890687.80790.11
3148375-14837581.98884.25
4155967-15596786.18388.49
5154043-15404385.12087.39
6152644-15264484.34786.66
30min1154799-15479985.53785.921.4888.7689.161.46
2159731-15973188.26391.55
3153449-15344984.79287.97
4155720-15572086.04689.31
5153610-15361084.88088.10
6155691-15569186.03089.28
45min1155186-15518685.75186.011.1389.9290.201.12
2158657-15865787.66991.93
3153560-15356084.85388.97
4154813-15481385.54589.77
5155208-15520885.76389.92
6156500-15650086.47790.68
极限1156398-15639886.42186.461.0191.5591.601.01
2159128-15912887.93093.17
3154621-15462185.43990.50
4157143-15714386.83392.01
5156094-15609486.25391.36
6155376-15537685.85691.02
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%
110.214152741534416854163541659416080.18
210.164129841517414080.38
单位质量响应值RSD%判断
4075.224075.590.01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%
5min146122-4612296.55896.661.0296.5696.661.02
246458-4645897.26197.26
346628-4662897.61797.62
445462-4546295.17695.18
545789-4578995.86195.86
646569-4656997.49497.49
10min146834-4683498.04997.231.0599.1298.301.05
245981-4598196.26397.34
347019-4701998.43699.52
446238-4623896.80197.86
545842-4584295.97297.04
646735-4673597.84198.92
15min146730-4673097.83197.600.5599.9999.750.54
246576-4657697.50899.66
346384-4638497.10699.28
446273-4627396.87499.01
546841-4684198.063100.19
646918-4691898.224100.39
20min145801-4580195.88695.941.1499.1499.181.12
245930-4593096.15699.39
346090-4609096.49199.75
445624-4562495.51598.72
544976-4497694.15997.38
646534-4653497.421100.68
30min145691-4569195.65695.510.7399.9799.820.72
245247-4524794.72699.03
345864-4586496.018100.35
445300-4530094.83799.11
545533-4553395.32599.59
646099-4609996.510100.85
45min145020-4502094.25193.470.9999.6398.830.96
244539-4453993.24498.60
344521-4452193.20698.60
444852-4485293.89999.22
543880-4388091.86497.19
645061-4506194.33799.75
极限144110-4411092.34692.101.0198.7798.510.99
243667-4366791.41897.81
344192-4419292.51798.95
443670-4367091.42597.79
543592-4359291.26197.61
644738-4473893.661100.13
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%
114.121655921657741655191657661653941656090.10
214.121652931654281653600.06
单位质量响应值RSD%判断
11728.6811711.050.11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%
5min190728-9072850.18453.173.8550.1853.173.85
297960-9796054.18454.18
398343-9834354.39654.40
494551-9455152.29852.30
594143-9414352.07352.07
6101084-10108455.91255.91
10min1126930-12693070.20871.962.4370.7772.552.44
2129821-12982171.80772.41
3130717-13071772.30272.91
4130244-13024472.04172.62
5127189-12718970.35170.93
6135655-13565575.03475.66
15min1149145-14914582.49583.842.3083.8385.232.30
2150651-15065183.32884.73
3150043-15004382.99284.40
4151005-15100583.52484.91
5150051-15005182.99684.36
6158542-15854287.69389.15
20min1152952-15295284.60186.522.9586.8688.842.94
2155718-15571886.13188.46
3155943-15594386.25588.59
4156035-15603586.30688.62
5152565-15256584.38786.67
6165275-16527591.41793.85
30min1156304-15630486.45588.092.8189.6591.382.80
2155868-15586886.21489.50
3158873-15887387.87691.16
4158255-15825587.53490.80
5158252-15825287.53390.75
6168047-16804792.95096.40
45min1158153-15815387.47887.962.3391.6392.222.34
2157281-15728186.99691.24
3157252-15725286.98091.24
4159346-15934688.13892.38
5155873-15587386.21790.41
6166203-16620391.93196.41
极限1157419-15741987.07288.132.3892.2093.372.38
2156692-15669286.67091.88
3158429-15842987.63192.86
4158839-15883987.85793.08
5157707-15770787.23192.38
6166890-16689092.31197.81
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%
110.214161741771415194147741699416170.30
210.164157741691416340.20
单位质量响应值RSD%判断
4076.104097.830.38数据可信
供试品溶液-697902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%
5min147376-4737698.90398.581.2098.9098.571.20
247175-4717598.48498.48
347906-47906100.010100.01
447299-4729998.74398.74
547367-4736798.88598.88
646189-4618996.42596.43
10min148181-48181100.584100.250.84101.68101.340.84
248184-48184100.590101.68
347673-4767399.523100.63
448340-48340100.916102.01
548359-48359100.955102.05
647380-4738098.91299.98
15min147826-4782699.84399.612.02102.06101.821.99
248036-48036100.281102.49
347595-4759599.361101.58
447949-47949100.100102.32
548901-48901102.087104.31
645974-4597495.97798.15
20min147368-4736898.88798.632.42102.21101.942.36
247059-4705998.242101.57
346767-4676797.632100.95
449220-49220102.753106.08
547331-4733198.809102.16
645728-4572895.46398.70
30min146192-4619296.43296.561.07100.86100.971.07
246195-4619596.438100.86
345726-4572695.45999.86
447088-4708898.302102.77
546489-4648997.052101.50
645831-4583195.67899.98
45min146151-4615196.34695.480.71101.84100.960.72
245587-4558795.169100.66
345322-4532294.615100.08
445950-4595095.926101.49
545928-4592895.880101.41
645467-4546794.918100.28
极限145547-4554795.08594.141.05101.65100.681.05
244922-4492293.780100.33
345101-4510194.154100.67
445558-4555895.108101.74
545146-4514694.248100.84
644285-4428592.45198.87
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%
114.121654451654211652381653681657021654350.11
214.121653501654381653940.04
单位质量响应值RSD%判断
11716.3611713.460.02数据可信
供试品溶液-697902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%
5min1138171-13817176.45874.762.1076.4674.762.10
2134742-13474274.56074.56
3138141-13814176.44176.44
4133253-13325373.73673.74
5135477-13547774.96774.97
6130873-13087372.41972.42
10min1164038-16403890.77189.461.0991.6290.291.10
2163326-16332690.37791.21
3161075-16107589.13289.98
4160413-16041388.76589.58
5161777-16177789.52090.35
6159406-15940688.20889.01
15min1168259-16825993.10793.061.3594.9794.881.34
2169210-16921093.63395.47
3167626-16762692.75794.60
4168018-16801892.97494.78
5171404-17140494.84796.68
6164472-16447291.01292.80
20min1167570-16757092.72692.651.6495.6295.511.59
2168154-16815493.04995.92
3166039-16603991.87994.75
4172351-17235195.37198.21
5165992-16599291.85394.73
6164496-16449691.02593.82
30min1164281-16428190.90691.070.9294.8394.960.88
2165064-16506491.33995.25
3162512-16251289.92793.82
4167060-16706092.44496.34
5163843-16384390.66394.57
6164711-16471191.14494.95
45min1165457-16545791.55790.380.8596.4995.280.82
2163385-16338590.41095.33
3161163-16116389.18094.07
4163322-16332290.37595.30
5162925-16292590.15595.06
6163727-16372790.59995.42
极限1163876-16387690.68289.940.6496.6395.840.64
2162631-16263189.99395.92
3162197-16219789.75395.63
4163542-16354290.49796.43
5161650-16165089.45095.36
6161282-16128289.24695.07
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%
110.214168141497417454158841503416030.27
210.164136741310413380.10
单位质量响应值RSD%判断
4074.734068.700.11数据可信
供试品溶液-719406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%
5min149683-49683104.107100.632.11104.11100.632.11
248507-48507101.643101.64
347592-4759299.72699.73
447435-4743599.39799.40
548148-48148100.891100.89
646775-4677598.01498.01
10min149437-49437103.592102.191.96104.75103.311.96
249604-49604103.942105.07
347971-47971100.520101.63
448764-48764102.182103.29
549537-49537103.801104.92
647292-4729299.097100.19
15min149440-49440103.598101.481.34105.91103.731.35
248988-48988102.651104.94
347862-47862100.292102.52
448330-48330101.272103.51
548044-48044100.673102.95
647906-47906100.384102.57
20min148283-48283101.17499.491.68104.63102.881.67
248355-48355101.325104.75
346334-4633497.090100.43
447782-47782100.124103.49
547116-4711698.728102.12
647019-4701998.525101.83
30min147827-47827100.21898.850.95104.80103.340.98
247601-4760199.745104.30
346912-4691298.301102.72
447019-4701998.525103.00
547049-4704998.588103.08
646648-4664897.748102.15
45min147456-4745699.44196.861.69105.14102.441.67
246823-4682398.114103.77
345284-4528494.890100.40
445936-4593696.256101.83
545986-4598696.361101.95
645856-4585696.088101.57
极限146805-4680598.07796.051.43104.88102.721.43
246357-4635797.138103.89
345543-4554395.432102.00
445940-4594096.264102.91
545294-4529494.911101.57
645099-4509994.502101.06
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%
114.121655941654761656221656121657361656080.06
214.121656561653791655180.12
单位质量响应值RSD%判断
11728.6111722.240.04数据可信
供试品溶液-719406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%
5min1134047-13404774.10971.822.1074.1171.822.10
2131163-13116372.51572.51
3129084-12908471.36571.37
4127985-12798570.75870.76
5130887-13088772.36272.36
6126280-12628069.81569.82
10min1163060-16306090.14989.601.1590.9790.401.15
2161481-16148189.27690.08
3161837-16183789.47390.27
4163847-16384790.58491.37
5163426-16342690.35291.16
6158785-15878587.78688.56
15min1170765-17076594.40993.990.9596.2395.780.93
2169261-16926193.57895.38
3170270-17027094.13595.92
4172353-17235395.28797.08
5167499-16749992.60394.41
6169882-16988293.92195.67
20min1167319-16731992.50493.021.0995.3895.851.07
2169200-16920093.54496.38
3167293-16729392.49095.32
4171567-17156794.85297.70
5166799-16679992.21695.05
6167283-16728392.48495.28
30min1168093-16809392.93293.050.7596.8396.920.73
2167433-16743392.56796.44
3169587-16958793.75897.62
4169693-16969393.81697.72
5166434-16643492.01595.88
6168548-16854893.18397.01
45min1166955-16695592.30391.450.8697.2496.360.84
2165835-16583591.68396.59
3163878-16387890.60195.50
4166678-16667892.15097.10
5163529-16352990.40995.29
6165604-16560491.55696.41
极限1165626-16562691.56891.311.3197.5397.231.26
2165701-16570191.60997.53
3166564-16656492.08698.00
4167873-16787392.81098.78
5162398-16239889.78395.67
6162776-16277689.99295.87
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