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%
19.673959339829400203984040016398600.44
29.703983439904398690.13
单位质量响应值RSD%判断
4122.034110.210.21数据可信
长期18月-供试品溶液-2022081302批-培哚普利-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%
5min146478-4647896.34198.492.2496.3498.502.24
246399-4639996.17796.18
346849-4684997.11097.11
448626-48626100.794100.79
548658-48658100.860100.86
648092-4809299.68799.69
10min148063-4806399.62798.851.35100.7099.951.35
246925-4692597.26898.34
346859-4685997.13198.21
448417-48417100.360101.48
547953-4795399.399100.52
647924-4792499.338100.45
15min147454-4745498.36497.891.10100.54100.091.11
246648-4664896.69398.84
346720-4672096.84399.00
448041-4804199.581101.82
547128-4712897.68899.91
647373-4737398.196100.41
20min146476-4647696.33796.881.2599.61100.161.25
246515-4651596.41899.64
345947-4594795.24098.47
447679-4767998.831102.17
546818-4681897.046100.36
646990-4699097.402100.70
30min145983-4598395.31595.251.4799.6699.611.46
245021-4502193.32197.62
345316-4531693.93298.22
446829-4682997.069101.51
546278-4627895.927100.32
646282-4628295.935100.32
45min145619-4561994.56194.101.8499.9699.521.81
244493-4449392.22797.56
344529-4452992.30197.64
446745-4674596.895102.41
545413-4541394.13499.59
645583-4558394.48699.94
极限144906-4490693.08393.151.4099.5399.611.37
243859-4385990.91297.27
345274-4527493.845100.21
445761-4576194.855101.45
545005-4500593.28899.79
644819-4481992.90299.40
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%
114.018261382853823928254582713826230.22
214.068272782476826020.22
单位质量响应值RSD%判断
5897.435874.960.27数据可信
长期18月-供试品溶液-2022081302批-氨氯地平-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%
5min182190-8219090.51792.581.3690.5292.581.36
283865-8386592.36192.36
384511-8451193.07393.07
484417-8441792.96992.97
583729-8372992.21292.21
685658-8565894.33694.34
10min189683-8968398.76997.610.7299.7798.640.70
288203-8820397.13998.17
387838-8783896.73797.77
488541-8854197.51198.54
588868-8886897.87198.90
688649-8864997.63098.68
15min188550-8855097.52196.860.3999.6298.980.38
288027-8802796.94599.05
387586-8758696.45998.57
488005-8800596.92199.04
587664-8766496.54598.66
687884-8788496.78898.92
20min187127-8712795.95496.220.5199.1499.410.50
287914-8791496.821100.00
386707-8670795.49198.67
487790-8779096.68499.88
587257-8725796.09799.28
687429-8742996.28799.49
30min186047-8604794.76594.520.7199.0298.780.69
285306-8530693.94898.21
384940-8494093.54597.79
485866-8586694.56598.83
586245-8624594.98399.24
686566-8656695.33699.61
45min185109-8510993.73193.290.9799.0498.600.92
284312-8431292.85498.16
383584-8358492.05297.33
486011-8601194.725100.04
584533-8453393.09798.40
684691-8469193.27198.61
极限184001-8400192.51192.310.4398.8698.650.40
283140-8314091.56397.90
384044-8404492.55998.86
484073-8407392.59198.96
583899-8389992.39998.74
683726-8372692.20898.58
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%
19.673978339959398463998639757398660.26
29.703991839873398960.08
单位质量响应值RSD%判断
4122.654112.990.17数据可信
长期18月-供试品溶液-2022081401批-培哚普利-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%
5min148001-4800199.45797.881.9899.4697.881.98
246554-4655496.45996.46
347747-4774798.93198.93
445843-4584394.98594.99
548264-48264100.002100.00
647021-4702197.42697.43
10min148879-48879101.27699.281.26102.38100.361.26
248079-4807999.618100.69
348167-4816799.801100.90
447145-4714597.68398.74
547578-4757898.58099.69
647639-4763998.70799.79
15min149116-49116101.76798.981.76104.00101.171.75
247256-4725697.913100.09
348322-48322100.122102.33
446916-4691697.20999.35
547877-4787799.200101.41
647144-4714497.68199.86
20min147752-4775298.94197.402.14102.30100.692.11
247696-4769698.825102.09
347732-4773298.899102.22
445258-4525893.77396.99
547208-4720897.814101.12
646399-4639996.13899.40
30min147608-4760898.64395.152.60103.1099.522.53
246256-4625695.841100.21
344733-4473392.68697.11
444449-4444992.09796.36
546660-4666096.678101.07
645820-4582094.93899.27
45min146617-4661796.58994.521.53102.1599.951.52
245573-4557394.42699.86
346218-4621895.762101.21
444836-4483692.89998.19
544952-4495293.13998.61
645503-4550394.28199.67
极限146032-4603295.37793.751.89102.01100.241.86
244668-4466892.55199.03
345992-4599295.294101.81
443834-4383490.82397.14
545586-4558694.453100.96
645381-4538194.028100.46
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%
114.018229782336824338223282684823960.22
214.068234082267823040.07
单位质量响应值RSD%判断
5881.235853.770.34数据可信
长期18月-供试品溶液-2022081401批-氨氯地平-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%
5min184326-8432693.16593.061.5393.1793.061.53
282746-8274691.42091.42
383848-8384892.63792.64
483637-8363792.40492.40
586588-8658895.66495.66
684226-8422693.05593.05
10min189590-8959098.98198.061.04100.0299.101.02
287830-8783097.03798.05
388704-8870498.00299.03
489927-8992799.353100.38
587627-8762796.81297.88
688884-8888498.20199.24
15min190031-9003199.46898.071.51101.60100.201.49
286704-8670495.79397.89
389728-8972899.134101.25
489896-8989699.319101.45
587915-8791597.13099.27
688333-8833397.59299.72
20min187664-8766496.85396.660.61100.0999.870.58
287828-8782897.034100.19
388289-8828997.544100.76
486892-8689296.00099.23
587091-8709196.22099.44
687154-8715496.29099.50
30min186821-8682195.92294.021.42100.2498.301.37
284893-8489393.79298.03
383113-8311391.82596.13
485431-8543194.38698.69
584836-8483693.72998.02
685482-8548294.44298.72
45min186001-8600195.01693.671.35100.4099.001.30
283588-8358892.35097.63
385009-8500993.92099.24
485771-8577194.762100.11
583213-8321391.93697.26
685091-8509194.01099.34
极限184419-8441993.26892.931.1699.7199.301.11
282402-8240291.04097.34
385268-8526894.206100.57
484105-8410592.92199.32
583847-8384792.63698.99
684627-8462793.49899.87
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%
19.674002639878398814019040261400470.44
29.703989139957399240.12
单位质量响应值RSD%判断
4141.374115.880.44数据可信
长期18月-供试品溶液-2022081401批-培哚普利-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%
5min146378-4637895.84394.632.4695.8494.642.46
243720-4372090.35090.35
346210-4621095.49695.50
445357-4535793.73393.73
546264-4626495.60895.61
646830-4683096.77796.78
10min146859-4685996.83798.781.4797.9099.831.46
247846-4784698.87799.88
348511-48511100.251101.31
447020-4702097.17098.21
548225-4822599.660100.72
648323-4832399.863100.94
15min146118-4611895.30697.252.0097.4599.401.97
247527-4752798.218100.32
347917-4791799.024101.20
445656-4565694.35196.47
547387-4738797.929100.10
647743-4774398.664100.85
20min146613-4661396.32997.071.1899.53100.301.18
246840-4684096.79899.99
347361-4736197.875101.15
446195-4619595.46598.63
547754-4775498.687101.94
647072-4707297.278100.56
30min145257-4525793.52794.851.9297.8099.161.89
245863-4586394.77999.05
345941-4594194.94099.30
444720-4472092.41796.65
546321-4632195.726100.08
647277-4727797.701102.06
45min144523-4452392.01093.551.1497.3298.911.14
245119-4511993.24298.56
345880-4588094.814100.23
444973-4497392.94098.20
545315-4531593.64799.06
645802-4580294.653100.10
极限144930-4493092.85192.461.2499.1898.861.22
244816-4481692.61598.97
344603-4460392.17598.65
443758-4375890.42996.72
544914-4491492.81899.28
645431-4543193.886100.39
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%
114.018224582362819188249682308822660.27
214.068261282301824560.27
单位质量响应值RSD%判断
5871.955864.580.09数据可信
长期18月-供试品溶液-2022081401批-氨氯地平-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%
5min181346-8134689.86189.832.3489.8689.832.34
278355-7835586.55786.56
382296-8229690.91090.91
479890-7989088.25288.25
582480-8248091.11391.11
683526-8352692.26992.27
10min185594-8559494.55397.672.0095.5598.662.00
288293-8829397.53598.50
389707-8970799.097100.11
487120-8712096.23997.22
589857-8985799.263100.27
689901-8990199.311100.34
15min184703-8470393.56996.902.5795.6298.982.55
288549-8854997.81899.86
389896-8989699.306101.42
485042-8504293.94495.99
588893-8889398.198100.31
689239-8923998.580100.71
20min185025-8502593.92596.431.6997.0199.591.70
287170-8717096.29499.43
388084-8808497.304100.52
486272-8627295.30298.40
589157-8915798.489101.70
688042-8804297.258100.48
30min183205-8320591.91494.452.3896.0598.682.35
285520-8552094.47298.67
385751-8575194.72799.02
483278-8327891.99596.15
586846-8684695.936100.24
688423-8842397.679101.98
45min181101-8110189.59093.162.0594.7498.442.03
284573-8457393.42698.68
385528-8552894.48099.83
483837-8383792.61297.79
585386-8538694.32499.69
685570-8557094.52799.92
极限182168-8216890.76991.961.9096.9298.271.89
283506-8350692.24798.54
382933-8293391.61498.01
480957-8095789.43195.63
584666-8466693.52899.94
685226-8522694.147100.59
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%
19.673979839922402073991240011399700.39
29.704028940347403180.11
单位质量响应值RSD%判断
4133.404156.490.40数据可信
长期18月-供试品溶液-2022081501批-培哚普利-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%
5min146212-4621295.12491.013.0195.1291.013.01
243992-4399290.55490.55
343171-4317188.86488.86
442785-4278588.07088.07
543713-4371389.98089.98
645407-4540793.46793.47
10min147683-4768398.15297.602.1699.2198.612.13
247580-4758097.94098.95
349140-49140101.151102.14
447305-4730597.37498.35
546561-4656195.84296.84
646222-4622295.14596.18
15min146524-4652495.76696.811.8797.9198.901.83
247269-4726997.30099.39
348453-4845399.737101.85
447449-4744997.67099.73
546433-4643395.57997.64
646049-4604994.78896.88
20min146168-4616895.03396.172.2198.2499.342.16
246387-4638795.48498.66
348648-48648100.138103.36
446874-4687496.48799.63
546578-4657895.87799.00
645668-4566894.00497.15
30min145759-4575994.19194.772.3498.4699.012.28
246712-4671296.153100.39
347750-4775098.290102.62
445620-4562093.90598.12
545788-4578894.25198.44
644604-4460491.81496.01
45min144662-4466291.93393.122.0397.2598.411.98
245436-4543693.52798.83
346734-4673496.198101.62
445742-4574294.15699.42
544512-4451291.62596.86
644345-4434591.28196.49
极限144461-4446191.52092.391.2097.8698.721.19
245477-4547793.61199.95
345616-4561693.897100.39
444505-4450591.61097.92
544813-4481392.24498.50
644421-4442191.43797.67
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%
114.018240782549822888251782233823990.17
214.068271682766827410.05
单位质量响应值RSD%判断
5881.445884.850.05数据可信
长期18月-供试品溶液-2022081501批-氨氯地平-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%
5min181534-8153489.84186.503.1489.8486.503.14
277575-7757585.47885.48
375222-7522282.88582.89
477106-7710684.96184.96
578363-7836386.34686.35
681233-8123389.50989.51
10min187473-8747396.38596.641.6897.3897.601.65
287274-8727496.16597.12
390605-9060599.836100.76
487242-8724296.13097.07
586417-8641795.22196.18
687220-8722096.10697.10
15min186152-8615294.92996.371.6397.0098.401.59
287472-8747296.38498.40
389993-8999399.161101.19
487961-8796196.92298.93
586223-8622395.00797.02
686959-8695995.81897.88
20min184995-8499593.65495.802.0896.7898.902.02
286292-8629295.08398.17
390298-9029899.497102.63
487287-8728796.18099.27
586209-8620994.99298.06
686551-8655195.36998.50
30min184694-8469493.32294.261.8197.4998.431.76
286148-8614894.92599.07
388409-8840997.416101.65
484503-8450393.11297.27
585148-8514893.82397.95
684372-8437292.96897.15
45min182562-8256290.97392.791.6296.1798.011.58
284197-8419792.77597.98
386512-8651295.326100.65
484790-8479093.42898.62
583345-8334591.83697.01
683884-8388492.43097.65
极限182396-8239690.79092.171.0997.0098.421.07
284350-8435092.94399.17
384797-8479793.43699.82
482919-8291991.36797.60
583420-8342091.91998.11
684029-8402992.59098.84
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%
19.674019940162401814033640188402130.18
29.704001240003400080.02
单位质量响应值RSD%判断
4158.534124.540.59数据可信
长期18月-供试品溶液-2022081501批-培哚普利-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%
5min144159-4415990.97494.273.0190.9794.273.01
246120-4612095.01495.01
347917-4791798.71698.72
446556-4655695.91295.91
544853-4485392.40492.40
644951-4495192.60592.61
10min147896-4789698.67397.191.8699.6898.231.85
247177-4717797.19198.25
347834-4783498.54599.64
447923-4792398.72899.79
545978-4597894.72195.75
646239-4623995.25996.29
15min146997-4699796.82096.731.0798.9398.861.07
247230-4723097.30099.44
347213-4721397.26599.46
447300-4730097.44599.61
547008-4700896.84398.92
645967-4596794.69996.79
20min146849-4684996.51695.231.2999.7098.431.28
246578-4657895.95799.17
346777-4677796.36799.64
445909-4590994.57997.82
545836-4583694.42997.58
645390-4539093.51096.65
30min146363-4636395.51494.051.5499.7798.311.53
245724-4572494.19898.48
346343-4634395.47399.82
445870-4587094.49998.79
544841-4484192.37996.58
644780-4478092.25396.43
45min145461-4546193.65693.101.3498.9798.401.34
245409-4540993.54998.88
345881-4588194.52199.93
445457-4545793.64898.99
544685-4468592.05797.29
644242-4424291.14596.35
极限145219-4521993.15892.321.7599.5198.661.71
245579-4557993.899100.27
345676-4567694.099100.55
444446-4444691.56597.95
544085-4408590.82197.08
643867-4386790.37296.59
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%
114.018285482703826958230782240825600.33
214.068260582456825300.13
单位质量响应值RSD%判断
5892.935869.840.28数据可信
长期18月-供试品溶液-2022081501批-氨氯地平-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%
5min179693-7969387.83988.752.5787.8488.762.57
281117-8111789.40889.41
384322-8432292.94192.94
480309-8030988.51888.52
578516-7851686.54186.54
679187-7918787.28187.28
10min190305-9030599.53595.922.39100.5196.912.38
286822-8682295.69696.69
388502-8850297.54898.58
486572-8657295.42196.40
584839-8483993.51194.47
685131-8513193.83294.80
15min188442-8844297.48295.771.5199.5697.821.50
287020-8702095.91497.97
387588-8758896.54198.66
486350-8635095.17697.22
587301-8730196.22498.22
684616-8461693.26595.28
20min188128-8812897.13694.301.97100.3097.411.95
286161-8616194.96898.09
386487-8648795.32798.52
484073-8407392.66695.77
584746-8474693.40896.48
683709-8370992.26595.31
30min187271-8727196.19193.082.05100.4497.252.04
284294-8429492.91097.09
385570-8557094.31698.56
483959-8395992.54196.67
582990-8299091.47395.58
682623-8262391.06895.14
45min185555-8555594.30092.331.8199.6197.531.80
284335-8433592.95598.16
385301-8530194.02099.32
482704-8270491.15796.32
582806-8280691.27096.39
681902-8190290.27395.36
极限185506-8550694.24691.572.33100.6197.792.29
284106-8410692.70398.95
384740-8474093.40199.74
481041-8104189.32495.50
581650-8165089.99696.13
681405-8140589.72695.81
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