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%
110.444302243339434464289643223431850.53
210.434259842852427250.43
单位质量响应值RSD%判断
4136.494096.360.69数据可信
供试品溶液-2022081001批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136540-3654075.73785.597.6875.7485.597.68
242509-4250988.10988.11
338907-3890780.64380.64
445693-4569394.70994.71
542103-4210387.26887.27
641997-4199787.04887.05
10min146074-4607495.49995.361.2196.3496.311.22
246517-4651796.41797.40
345056-4505693.38994.28
445672-4567294.66595.72
546296-4629695.95996.93
646429-4642996.23497.20
15min145257-4525793.80594.992.3295.7197.002.33
246989-4698997.39599.45
344621-4462192.48794.42
447105-4710597.63699.74
544925-4492593.11795.15
646069-4606995.48897.52
20min145198-4519893.68395.141.6196.6398.211.62
245536-4553694.38397.52
345708-4570894.74097.70
446439-4643996.25599.44
545395-4539594.09197.16
647133-4713397.694100.79
30min144923-4492393.11393.791.3797.1097.911.36
246068-4606895.48699.67
345137-4513793.55697.57
445837-4583795.00799.27
545139-4513993.56197.68
644383-4438391.99496.18
45min144241-4424191.69993.861.6996.7299.031.70
246071-4607195.492100.73
345062-4506293.40198.45
446283-4628395.932101.25
544937-4493793.14298.30
645113-4511393.50798.71
极限144284-4428491.78893.022.7497.8399.232.60
242934-4293488.99095.29
344365-4436591.95698.05
445968-4596895.279101.66
545889-4588995.115101.31
645841-4584195.016101.26
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%
113.981612521615001608731605601605191609410.27
213.991585981599391592680.60
单位质量响应值RSD%判断
11512.2311384.420.79数据可信
供试品溶液-2022081001批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123611-12361169.99675.866.8670.0075.866.86
2139122-13912278.77978.78
3124522-12452270.51270.51
4147904-14790483.75283.75
5135762-13576276.87676.88
6132857-13285775.23175.23
10min1154250-15425087.34586.922.2188.1287.762.21
2156640-15664088.69989.57
3147368-14736883.44884.23
4152353-15235386.27187.20
5156161-15616188.42889.28
6154271-15427187.35788.19
15min1153336-15333686.82886.823.3088.5888.633.29
2157562-15756289.22191.08
3148075-14807583.84985.56
4160854-16085491.08592.97
5151427-15142785.74787.58
6148673-14867384.18785.99
20min1151693-15169385.89786.621.9988.6189.392.02
2153449-15344986.89289.74
3148203-14820383.92186.56
4157518-15751889.19692.10
5153195-15319586.74889.54
6153707-15370787.03889.78
30min1146103-14610382.73284.762.5586.4088.492.55
2153385-15338586.85690.67
3147212-14721283.36086.93
4154775-15477587.64391.53
5150547-15054785.24989.00
6146070-14607082.71386.42
45min1147896-14789683.74785.412.6688.3390.092.66
2151731-15173185.91990.70
3146472-14647282.94187.44
4157992-15799289.46494.33
5149982-14998284.92989.63
6150943-15094385.47390.10
极限1157962-15796289.44789.472.7094.9695.102.52
2150625-15062585.29391.03
3157031-15703188.92094.34
4158270-15827089.62295.48
5163090-16309092.35198.00
6161035-16103591.18796.77
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%
110.444260643043432144335043079430580.66
210.434377743752437640.05
单位质量响应值RSD%判断
4124.334195.971.22数据可信
供试品溶液-2022081001批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140679-4067983.43486.402.8383.4386.392.83
243837-4383789.91189.91
342439-4243987.04487.04
441569-4156985.26085.26
543013-4301388.22188.22
641199-4119984.50184.50
10min146704-4670495.79296.081.0396.7297.041.02
246400-4640095.16896.17
347196-4719696.80197.77
446197-4619794.75295.70
547307-4730797.02998.01
647259-4725996.93097.87
15min145938-4593894.22196.101.6496.2198.131.61
246975-4697596.34898.40
345968-4596894.28296.32
447723-4772397.88299.88
547581-4758197.59099.65
646949-4694996.29498.31
20min146808-4680896.00596.241.0099.0499.330.98
246502-4650295.37798.50
346392-4639295.15298.24
446952-4695296.30099.39
547651-4765197.734100.88
647216-4721696.84299.93
30min146594-4659495.56696.041.1299.67100.201.08
246276-4627694.91499.10
346474-4647495.32099.47
446796-4679695.980100.14
547086-4708696.575100.80
647727-4772797.890102.05
45min146476-4647695.32496.531.17100.49101.761.14
246461-4646195.293100.53
347330-4733097.076102.28
447116-4711696.637101.86
547907-4790798.259103.56
647090-4709096.583101.83
极限146635-4663595.65096.321.37101.88102.621.32
245954-4595494.253100.55
347432-4743297.285103.57
447104-4710496.612102.91
547786-4778698.011104.40
646845-4684596.081102.40
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%
113.981596921605751613561601941610051605640.41
213.991637461622541630000.65
单位质量响应值RSD%判断
11485.2611651.181.02数据可信
供试品溶液-2022081001批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132232-13223274.10375.372.8474.1075.372.85
2139948-13994878.42778.43
3134234-13423475.22575.22
4133229-13322974.66274.66
5137863-13786377.25977.26
6129497-12949772.57072.57
10min1153324-15332485.92386.221.5486.7587.061.52
2150096-15009684.11484.99
3155888-15588887.36088.20
4153695-15369586.13186.96
5156855-15685587.90288.76
6153278-15327885.89786.70
15min1153207-15320785.85787.292.2887.6489.092.25
2155539-15553987.16488.97
3152657-15265785.54987.36
4160678-16067890.04491.83
5159569-15956989.42391.26
6152918-15291885.69587.46
20min1155712-15571287.26187.171.1989.9989.941.18
2153809-15380986.19588.97
3155527-15552787.15889.91
4157370-15737088.19090.98
5157747-15774788.40291.23
6153165-15316585.83488.55
30min1152883-15288385.67686.441.4589.3890.181.42
2153536-15353686.04289.77
3153634-15363486.09789.82
4152608-15260885.52289.29
5158659-15865988.91392.72
6154183-15418386.40490.07
45min1154082-15408286.34887.591.8991.0092.281.85
2154583-15458386.62891.32
3157647-15764788.34693.03
4158900-15890089.04893.76
5159936-15993689.62894.43
6152604-15260485.51990.15
极限1163097-16309791.40092.441.1697.0198.101.15
2162510-16251091.07196.72
3165914-16591492.97898.64
4165597-16559792.80198.51
5167698-16769893.97899.77
6164859-16485992.38797.96
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%
110.444399944529440024418044240441900.50
210.434457144601445860.05
单位质量响应值RSD%判断
4232.764274.780.70数据可信
供试品溶液-2022081101批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139156-3915678.53976.356.1878.5476.356.18
242190-4219084.62584.62
335990-3599072.18972.19
438126-3812676.47376.47
536505-3650573.22273.22
636423-3642373.05773.06
10min146454-4645493.17793.002.3694.0593.852.33
245536-4553691.33692.28
346342-4634292.95393.75
447543-4754395.36296.21
544779-4477989.81890.63
647536-4753695.34896.16
15min145850-4585091.96693.721.9493.8795.601.88
245574-4557491.41293.37
347600-4760095.47697.31
447834-4783495.94597.85
546652-4665293.57595.39
646827-4682793.92695.80
20min146617-4661793.50493.952.5396.4396.882.45
245576-4557691.41694.39
348352-4835296.98499.88
447157-4715794.58797.56
545472-4547291.20894.06
647872-4787296.02298.94
30min145800-4580091.86692.302.3595.8396.272.25
244238-4423888.73392.72
345784-4578491.83395.81
446678-4667893.62797.65
546138-4613892.54496.41
647463-4746395.20199.18
45min145325-4532590.91392.841.7895.9097.831.71
245448-4544891.16096.13
346637-4663793.54498.54
447549-4754995.374100.44
546418-4641893.10598.00
646323-4632392.91597.95
极限144995-4499590.25192.833.5296.2598.863.35
243880-4388088.01494.00
347561-4756195.398101.43
446969-4696994.210100.34
546090-4609092.44798.37
648196-4819696.671102.74
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%
113.981643581640771633221641951646441641190.31
213.991650161649491649820.03
单位质量响应值RSD%判断
11739.5611792.850.33数据可信
供试品溶液-2022081101批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128258-12825870.66366.637.2170.6666.637.21
2134976-13497674.36474.36
3116172-11617264.00564.00
4117212-11721264.57764.58
5116664-11666464.27664.28
6112315-11231561.88061.88
10min1155051-15505185.42583.362.1586.2184.102.13
2149754-14975482.50683.33
3151636-15163683.54384.25
4153449-15344984.54285.26
5145769-14576980.31181.03
6152197-15219783.85284.54
15min1156078-15607885.99184.941.6587.7286.601.62
2151910-15191083.69485.44
3158142-15814287.12888.77
4154372-15437285.05186.71
5152240-15224083.87685.48
6152244-15224483.87885.50
20min1158254-15825487.18985.272.0289.8887.882.00
2153193-15319384.40187.07
3158777-15877787.47890.09
4153579-15357984.61487.22
5150784-15078483.07485.61
6153987-15398784.83987.39
30min1154977-15497785.38483.551.5989.0487.111.57
2148572-14857281.85585.47
3153399-15339984.51588.09
4151641-15164183.54687.09
5149359-14935982.28985.75
6151951-15195183.71787.21
45min1154874-15487485.32784.321.6989.9388.801.67
2152396-15239683.96288.48
3156138-15613886.02490.54
4154638-15463885.19789.67
5150049-15004982.66987.04
6150170-15017082.73687.16
极限1159311-15931187.77290.132.9993.3395.552.78
2156277-15627786.10091.55
3169252-16925293.24998.72
4165373-16537391.11296.53
5164278-16427890.50895.80
6167011-16701192.01497.36
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%
110.444423344966447584456944678446410.61
210.434517244682449270.78
单位质量响应值RSD%判断
4275.964307.480.52数据可信
供试品溶液-2022081101批-培哚普利-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142020-4202083.53877.665.4183.5477.665.41
237868-3786875.28375.28
336851-3685173.26173.26
439908-3990879.33979.34
540656-4065680.82680.83
637076-3707673.70973.71
10min147500-4750094.43294.350.8495.3695.210.82
247741-4774194.91195.75
347239-4723993.91394.73
447767-4776794.96395.84
546765-4676592.97193.87
647741-4774194.91195.73
15min146909-4690993.25794.821.5695.2396.731.51
248420-4842096.26198.15
347705-4770594.84096.70
448361-4836196.14498.08
546686-4668692.81494.74
648090-4809095.60597.48
20min146686-4668692.81494.872.1995.8397.842.11
248683-4868396.78499.74
347585-4758594.60197.51
448084-4808495.59398.60
546367-4636792.18095.14
648927-4892797.269100.20
30min146689-4668992.82093.520.9396.8697.540.89
247228-4722893.89197.93
347371-4737194.17698.14
446862-4686293.16497.23
546473-4647392.39096.38
647613-4761394.65798.67
45min146034-4603491.51893.811.4596.5998.871.37
247701-4770194.83299.91
347477-4747794.38699.40
446703-4670392.84897.95
547408-4740894.24999.26
647803-4780395.034100.10
极限145959-4595991.36894.402.5897.46100.502.42
248266-4826695.955102.09
348649-4864996.716102.77
446817-4681793.07499.21
546446-4644692.33798.40
648761-4876196.939103.06
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%
113.981662751659161655771655391658471658310.18
213.991674131674651674390.03
单位质量响应值RSD%判断
11862.0211968.480.64数据可信
供试品溶液-2022081101批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1134177-13417773.00167.016.2973.0067.016.29
2119401-11940164.96264.96
3114673-11467362.38962.39
4125541-12554168.30268.30
5129163-12916370.27370.27
6116044-11604463.13563.14
10min1156944-15694485.38783.801.4886.2084.541.51
2154023-15402383.79884.52
3151234-15123482.28182.97
4156483-15648385.13785.90
5152384-15238482.90683.69
6153083-15308383.28783.99
15min1156843-15684385.33285.181.1987.0986.861.18
2158406-15840686.18387.84
3154640-15464084.13485.74
4158739-15873986.36488.07
5154282-15428283.93985.64
6156462-15646285.12586.75
20min1157100-15710085.47285.271.5488.1887.891.53
2158276-15827686.11288.72
3153150-15315083.32385.87
4159413-15941386.73189.40
5154469-15446984.04186.68
6157913-15791385.91588.49
30min1156047-15604784.89983.831.0388.5687.401.05
2152614-15261483.03286.60
3152773-15277383.11886.59
4155525-15552584.61588.24
5152625-15262583.03886.61
6154891-15489184.27087.80
45min1155973-15597384.85984.330.9789.4688.830.98
2155694-15569484.70789.20
3152325-15232582.87487.27
4155422-15542284.55989.13
5154210-15421083.90088.39
6156348-15634885.06389.53
极限1162930-16293088.64491.201.8094.1996.641.64
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