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%
110.764479144961449484506044981449480.22
210.834468244856447690.28
单位质量响应值RSD%判断
4177.324133.800.75数据可信
供试品溶液-697902批-培哚普利-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147119-4711996.74592.465.0896.7592.465.08
248167-4816798.89798.90
345034-4503492.46492.46
442077-4207786.39386.39
544457-4445791.28091.28
643330-4333088.96688.97
10min149467-49467101.56698.173.60102.6499.193.61
250290-50290103.256104.35
347162-4716296.83397.86
446130-4613094.71595.67
546206-4620694.87195.88
647610-4761097.75398.74
15min148924-48924100.45198.762.56102.65100.882.58
249946-49946102.550104.80
347358-4735897.23699.34
446424-4642495.31897.33
547825-4782598.195100.26
648127-4812798.815100.89
20min148268-4826899.10497.722.34102.42100.932.38
249347-49347101.320104.71
346951-4695196.40099.58
446269-4626995.00098.07
546928-4692896.35399.51
647793-4779398.129101.30
30min148158-4815898.87897.782.71103.30102.082.73
249844-49844102.340106.85
347595-4759597.723101.98
446100-4610094.65398.78
546884-4688496.263100.49
647167-4716796.844101.11
45min147937-4793798.42597.092.62103.94102.482.63
249229-49229101.077106.73
346566-4656695.610100.95
446487-4648795.448100.63
545824-4582494.08699.39
647680-4768097.897103.24
极限146712-4671295.91095.120.54102.52101.590.60
246310-4631095.084101.86
346505-4650595.485101.89
446214-4621494.887101.13
546200-4620094.858101.20
646021-4602194.491100.92
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%
113.981633981638471642021631351633681635900.27
213.981639751634831637290.22
单位质量响应值RSD%判断
11701.7211711.660.07数据可信
供试品溶液-697902批-氨氯地平-醋酸盐缓冲液(pH4.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152451-15245184.41981.093.6784.4281.093.67
2152703-15270384.55884.56
3145472-14547280.55480.55
4140571-14057177.84077.84
5146729-14672981.25081.25
6140695-14069577.90977.91
10min1171635-17163595.04291.962.9595.9892.862.94
2172295-17229595.40796.35
3162174-16217489.80390.70
4163286-16328690.41991.28
5160916-16091689.10690.01
6166064-16606491.95792.82
15min1170369-17036994.34192.781.8896.3394.701.90
2171836-17183695.15397.15
3164437-16443791.05692.95
4163910-16391090.76492.63
5167380-16738092.68694.58
6167371-16737192.68194.57
20min1171168-17116894.78392.342.1697.8395.302.16
2170604-17060494.47197.53
3161846-16184689.62192.53
4164480-16448091.08093.96
5165875-16587591.85294.78
6166582-16658292.24495.16
30min1168981-16898193.57292.132.1297.6796.112.13
2172412-17241295.47299.58
3164493-16449391.08794.99
4164378-16437891.02394.91
5164226-16422690.93994.88
6163777-16377790.69194.63
45min1169227-16922793.70892.561.9998.8497.561.99
2172082-17208295.289100.46
3163419-16341990.49295.40
4166596-16659692.25297.15
5163759-16375990.68195.63
6167838-16783892.93997.89
极限1165527-16552791.66092.390.8197.8498.430.69
2166273-16627392.07398.30
3166447-16644792.16998.09
4169424-16942493.81899.74
5166558-16655892.23198.19
6166888-16688892.41398.40
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%
110.764461044900445274469244671446800.32
210.834463844778447080.23
单位质量响应值RSD%判断
4152.424128.160.42数据可信
供试品溶液-697902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%
5min140679-4067983.82992.815.4583.8392.815.45
243788-4378890.23690.24
346568-4656895.96595.96
446289-4628995.39095.39
545533-4553393.83293.83
647359-4735997.59597.59
10min144144-4414490.96997.203.8491.9098.233.85
246398-4639895.61496.62
348209-4820999.346100.41
447074-4707497.00798.07
547713-4771398.32499.37
649458-49458101.920103.00
15min147628-4762898.14996.731.33100.0998.841.26
246630-4663096.09298.16
347762-4776298.425100.60
446540-4654095.90798.04
546848-4684896.54298.68
646217-4621795.24197.46
20min147380-4738097.63897.611.52100.67100.801.52
246653-4665396.14099.27
347579-4757998.048101.31
446888-4688896.62499.83
547029-4702996.915100.12
648668-48668100.292103.57
30min146015-4601594.82594.591.8598.9498.861.81
245873-4587394.53298.73
346154-4615495.11299.46
444509-4450991.72296.00
545709-4570994.19598.48
647146-4714697.156101.55
45min145629-4562994.03093.711.7199.2099.031.69
244788-4478892.29797.55
345611-4561193.99399.40
444702-4470292.11997.42
545274-4527493.29898.63
646843-4684396.531102.00
极限145216-4521693.17992.471.5299.3998.831.49
244423-4442391.54497.82
344637-4463791.98598.44
444247-4424791.18297.50
544611-4461191.93298.30
646093-4609394.986101.53
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%
113.981629481635771640011629461634451633830.28
213.981637221634791636000.11
单位质量响应值RSD%判断
11686.9111702.430.10数据可信
供试品溶液-697902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%
5min1141934-14193478.67683.894.1578.6883.904.15
2148155-14815582.12482.12
3155682-15568286.29786.30
4152889-15288984.74884.75
5149493-14949382.86682.87
6159932-15993288.65288.65
10min1155968-15596886.45591.733.7887.3392.663.78
2161731-16173189.65090.56
3169267-16926793.82794.79
4167903-16790393.07194.01
5164299-16429991.07391.99
6173765-17376596.32097.31
15min1166484-16648492.28491.161.3394.1293.111.29
2161925-16192589.75791.67
3167068-16706892.60894.61
4165505-16550591.74293.72
5162660-16266090.16592.10
6163038-16303890.37492.43
20min1165027-16502791.47791.992.1594.3494.952.15
2162374-16237490.00692.91
3166803-16680392.46195.49
4166948-16694892.54295.54
5162558-16255890.10893.04
6171982-17198295.33298.39
30min1162236-16223689.93089.481.5893.8193.461.57
2159771-15977188.56392.47
3162124-16212489.86893.93
4159157-15915788.22392.25
5159403-15940388.35992.29
6165815-16581591.91396.03
45min1162003-16200389.80089.132.1394.6894.112.10
2157394-15739487.24692.14
3161023-16102389.25794.31
4159364-15936488.33893.34
5158169-15816987.67592.59
6166839-16683992.48197.62
极限1161801-16180189.68889.071.7495.5695.041.72
2157897-15789787.52493.38
3159007-15900788.14094.19
4162028-16202889.81495.80
5158281-15828187.73793.63
6165078-16507891.50597.67
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%
110.764482745105448744479344922449040.28
210.834484244737447900.17
单位质量响应值RSD%判断
4173.234135.730.64数据可信
供试品溶液-719406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%
5min145298-4529893.03093.195.1393.0393.195.13
247580-4758097.71697.72
346098-4609894.67394.67
440902-4090284.00284.00
546615-4661595.73495.73
645758-4575893.97493.97
10min147841-4784198.25297.902.2999.2998.932.32
248852-48852100.329101.41
347954-4795498.48499.54
445596-4559693.64294.58
548051-4805198.68499.75
647709-4770997.98199.03
15min148033-4803398.64798.131.24100.77100.251.28
248233-4823399.057101.26
348203-4820398.996101.14
446716-4671695.94297.92
548025-4802598.630100.79
647472-4747297.49599.63
20min147551-4755197.65797.940.99100.88101.161.02
248412-4841299.425102.73
348129-4812998.844102.09
447273-4727397.086100.13
547446-4744697.441100.70
647329-4732997.201100.42
30min147590-4759097.73798.021.46102.04102.321.46
248143-4814398.873103.28
348896-48896100.419104.76
446934-4693496.390100.51
547419-4741997.386101.72
647377-4737797.299101.60
45min148243-4824399.07897.741.35104.47103.131.34
248101-4810198.786104.29
348172-4817298.932104.39
447152-4715296.837102.03
547017-4701796.560101.98
646872-4687296.262101.64
极限147841-4784198.25297.230.71104.75103.710.76
247468-4746897.486104.09
347391-4739197.328103.89
446811-4681196.137102.40
547281-4728197.102103.60
647261-4726197.061103.51
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%
113.981640201632411635021641971627551635430.36
213.981635231639641637440.20
单位质量响应值RSD%判断
11698.3511712.730.09数据可信
供试品溶液-719406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%
5min1144910-14491080.25183.143.7080.2583.143.70
2157298-15729887.11187.11
3150743-15074383.48183.48
4142651-14265179.00079.00
5154480-15448085.55185.55
6150676-15067683.44483.44
10min1163005-16300590.27292.221.8691.1693.141.88
2169719-16971993.99094.96
3167066-16706692.52193.45
4162420-16242089.94890.83
5167972-16797293.02393.97
6168952-16895293.56594.49
15min1165127-16512791.44792.730.7693.3494.680.77
2168617-16861793.38095.39
3166967-16696792.46694.42
4168165-16816593.13095.01
5168056-16805693.06995.05
6167721-16772192.88494.85
20min1164309-16430990.99492.541.0093.9095.520.99
2168694-16869493.42296.47
3167869-16786992.96695.95
4168599-16859993.37096.28
5166531-16653192.22595.24
6166654-16665492.29395.29
30min1167985-16798593.03093.170.8196.9597.170.79
2168764-16876493.46197.55
3170262-17026294.29198.31
4167843-16784392.95196.90
5166084-16608491.97796.02
6168448-16844893.28697.31
45min1169688-16968893.97393.590.6898.9398.630.63
2169454-16945493.84398.97
3169709-16970993.98599.05
4169596-16959693.92298.90
5166802-16680292.37597.44
6168679-16867993.41498.47
极限1170823-17082394.60294.760.96100.60100.840.94
2171512-17151294.983101.15
3171897-17189795.196101.30
4168097-16809793.09299.12
5171364-17136494.901100.99
6172927-17292795.767101.87
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%
110.764458844820445324466744871446960.33
210.834470544734447200.05
单位质量响应值RSD%判断
4153.904129.270.43数据可信
供试品溶液-719406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%
5min144852-4485292.40091.443.6792.4091.443.66
241987-4198786.49786.50
342714-4271487.99588.00
445674-4567494.09394.09
545733-4573394.21494.21
645364-4536493.45493.45
10min147131-4713197.09498.051.5098.1299.061.49
246545-4654595.88796.85
348582-48582100.084101.06
447556-4755697.97099.02
548064-4806499.017100.06
647686-4768698.23899.28
15min147481-4748197.81698.160.9499.92100.270.93
247194-4719497.22499.25
348502-4850299.919102.01
447519-4751997.894100.03
547672-4767298.209100.36
647534-4753497.925100.05
20min147368-4736897.58398.151.57100.78101.351.52
247570-4757097.999101.11
349114-49114101.180104.38
446984-4698496.792100.01
547436-4743697.723100.96
647397-4739797.642100.86
30min147497-4749797.84898.501.69102.13102.791.61
248243-4824399.385103.58
349234-49234101.427105.75
447408-4740897.665101.96
546981-4698196.785101.11
647519-4751997.894102.20
45min148252-4825299.40497.971.97104.77103.361.87
247933-4793398.747104.05
348555-48555100.028105.48
445969-4596994.701100.08
547086-4708697.002102.40
647549-4754997.956103.35
极限147101-4710197.03397.752.65103.50104.222.48
249499-49499101.973108.37
348440-4844099.791106.35
446395-4639595.578102.01
546911-4691196.641103.12
646359-4635995.504101.98
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%
113.981637611629611634331631661636001633840.20
213.981635951633161634560.13
单位质量响应值RSD%判断
11686.9811692.130.04数据可信
供试品溶液-719406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%
5min1148467-14846782.33380.675.3282.3380.675.31
2133739-13373974.16674.17
3139454-13945477.33577.34
4155536-15553686.25386.25
5146528-14652881.25881.26
6149101-14910182.68582.68
10min1163791-16379190.83191.273.3891.7592.173.39
2153905-15390585.34986.17
3168131-16813193.23894.10
4168780-16878093.59894.56
5165322-16532291.68092.58
6167552-16755292.91793.84
15min1166270-16627092.20691.573.4494.1393.483.44
2153795-15379585.28887.06
3168252-16825293.30595.20
4169192-16919293.82695.82
5166728-16672892.46094.38
6166489-16648992.32794.28
20min1166088-16608892.10591.393.0695.0594.323.06
2155975-15597586.49789.22
3170977-17097794.81697.75
4167555-16755592.91995.96
5163556-16355690.70193.65
6164631-16463191.29794.27
30min1167233-16723392.74092.292.4896.7196.232.51
2159055-15905588.20591.89
3170664-17066494.64398.63
4169694-16969494.10598.18
5165349-16534991.69595.65
6166531-16653192.35196.34
45min1169861-16986194.19792.592.0499.2097.562.08
2160783-16078389.16393.82
3170213-17021394.39399.43
4167602-16760292.94598.06
5166845-16684592.52597.50
6166478-16647892.32197.34
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