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%
110.214182241893417124164141661417460.26
210.164171541743417290.05
单位质量响应值RSD%判断
4088.744107.190.32数据可信
供试品溶液-2022081302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%
5min146343-4634396.48797.590.8596.4997.600.85
247377-4737798.64098.64
346891-4689197.62897.63
446617-4661797.05897.06
547281-4728198.44098.44
646736-4673697.30597.31
10min147328-4732898.53898.081.4199.6199.171.39
247393-4739398.67399.77
348065-48065100.072101.16
446252-4625296.29897.38
547147-4714798.16199.25
646476-4647696.76497.85
15min146499-4649996.81297.411.4098.9899.581.39
247839-4783999.602101.79
347138-4713898.142100.34
446335-4633596.47098.62
546899-4689997.64599.83
646004-4600495.78197.94
20min145959-4595995.68895.900.8098.9399.160.81
246626-4662697.076100.38
346279-4627996.35499.64
446001-4600195.77599.00
545972-4597295.71598.98
645529-4552994.79298.01
30min145778-4577895.31194.840.7799.6299.160.76
245989-4598995.750100.13
345573-4557394.88499.24
445685-4568595.11799.40
545197-4519794.10198.43
645089-4508993.87698.15
45min145596-4559694.93294.321.08100.3099.701.06
245439-4543994.605100.05
346015-4601595.804101.22
444675-4467593.01498.36
545216-4521694.14199.52
644876-4487693.43398.75
极限144779-4477993.23193.090.9699.6599.510.94
245434-4543494.595101.09
344844-4484493.36699.84
444521-4452192.69499.07
544501-4450192.65299.08
644181-4418191.98698.34
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%
114.128346083508836068325783619834900.18
214.128344283477834600.03
单位质量响应值RSD%判断
5912.895910.760.03数据可信
供试品溶液-2022081302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%
5min147542-4754252.13150.496.4652.1350.496.46
247305-4730551.87151.87
348453-4845353.13053.13
448414-4841453.08853.09
541796-4179645.83145.83
642753-4275346.88046.88
10min163842-6384270.00569.492.7070.5870.052.68
262117-6211768.11368.69
364005-6400570.18470.77
462568-6256868.60869.20
561470-6147067.40467.91
666230-6623072.62373.14
15min170699-7069977.52478.473.2078.8879.813.13
270866-7086677.70779.04
369893-6989376.64078.01
470417-7041777.21578.57
571399-7139978.29179.55
676116-7611683.46484.79
20min172641-7264179.65380.073.9481.8782.283.87
272208-7220879.17881.37
370073-7007376.83779.06
473266-7326680.33982.55
571498-7149878.40080.53
678452-7845286.02588.28
30min174722-7472281.93582.323.9485.0485.423.87
273337-7333780.41683.49
372113-7211379.07482.15
475610-7561082.90986.01
574086-7408681.23884.24
680596-8059688.37691.59
45min176430-7643083.80883.453.5087.8287.463.44
273778-7377880.90084.87
374343-7434381.52085.47
475277-7527782.54486.57
575598-7559882.89686.80
681194-8119489.03293.22
极限178968-7896886.59187.951.6691.5492.881.65
281524-8152489.39494.26
378615-7861586.20491.06
480481-8048188.25093.19
579798-7979887.50192.32
681860-8186089.76294.94
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%
110.214167341851417014163941698417120.20
210.164156041663416120.18
单位质量响应值RSD%判断
4085.414095.670.18数据可信
供试品溶液-2022081401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%
5min146916-4691697.85797.690.7097.8697.690.70
247051-4705198.13998.14
346755-4675597.52197.52
447264-4726498.58398.58
546318-4631896.61096.61
646711-4671197.42997.43
10min147117-4711798.27698.090.3699.3699.180.36
246942-4694297.91199.00
347177-4717798.40199.49
447138-4713898.32099.42
547071-4707198.18099.25
646729-4672997.46798.55
15min146800-4680097.61596.920.8899.7999.100.86
246085-4608596.12498.30
346400-4640096.78198.96
447016-4701698.066100.25
546544-4654497.08199.25
645966-4596695.87698.04
20min146684-4668497.37395.661.10100.6498.911.08
245481-4548194.86498.11
346030-4603096.00999.26
446036-4603696.02299.30
545677-4567795.27398.52
645266-4526694.41597.65
30min145235-4523594.35193.580.7898.7097.890.76
245089-4508994.04698.35
345168-4516894.21198.53
444571-4457192.96697.31
544734-4473493.30697.61
644386-4438692.58096.86
45min145046-4504693.95793.530.4599.3598.890.44
244770-4477093.38198.73
344532-4453292.88598.25
444991-4499193.84299.22
544724-4472493.28598.62
644998-4499893.85699.17
极限144788-4478893.41891.651.0299.8698.050.98
243722-4372291.19597.58
344092-4409291.96798.36
443613-4361390.96897.39
543648-4364891.04197.42
643790-4379091.33797.69
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%
114.128361083383832918323982953832950.29
214.128338083141832600.21
单位质量响应值RSD%判断
5899.085896.600.03数据可信
供试品溶液-2022081401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%
5min147367-4736752.06351.726.4752.0651.726.47
251073-5107356.13656.14
347212-4721251.89251.89
449441-4944154.34254.34
543013-4301347.27747.28
644227-4422748.61148.61
10min166642-6664273.24872.852.6173.8373.422.63
266925-6692573.55974.18
366866-6686673.49574.07
468675-6867575.48376.09
564603-6460371.00771.53
663943-6394370.28270.82
15min176720-7672084.32583.782.7685.7285.172.77
276338-7633883.90685.35
376357-7635783.92785.32
479438-7943887.31388.76
572889-7288980.11581.43
675620-7562083.11684.44
20min179879-7987987.79887.491.4590.1389.801.49
279262-7926287.11989.49
379723-7972387.62689.95
481595-8159589.68492.10
578956-7895686.78388.99
678166-7816685.91588.16
30min178735-7873586.54087.740.8489.8591.030.85
280213-8021388.16591.51
380319-8031988.28191.58
480468-8046888.44591.85
579862-7986287.77990.95
679378-7937887.24790.45
45min180898-8089888.91889.030.7693.1893.290.77
280792-8079288.80193.12
380298-8029888.25892.54
482008-8200890.13894.53
580621-8062188.61392.76
681381-8138189.44993.62
极限182281-8228190.43888.751.2495.6994.001.23
280510-8051088.49193.80
381316-8131689.37794.64
480959-8095988.98594.38
579511-7951187.39392.52
679909-7990987.83192.99
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%
110.214192841632417394173841661417400.28
210.164181341542416780.46
单位质量响应值RSD%判断
4088.154102.170.25数据可信
供试品溶液-2022081501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%
5min147244-4724498.43098.991.0698.4398.991.05
247999-47999100.003100.00
347189-4718998.31698.32
446921-4692197.75797.76
548211-48211100.445100.44
647523-4752399.01199.01
10min148069-48069100.14999.691.18101.24100.791.17
247503-4750398.970100.08
347116-4711698.16399.26
447483-4748398.928100.01
548449-48449100.941102.06
648469-48469100.982102.08
15min148003-48003100.011100.190.85102.22102.400.82
247930-4793099.859102.07
348261-48261100.549102.73
448694-48694101.451103.64
548171-48171100.362102.60
647471-4747198.903101.13
20min146394-4639496.65996.660.5399.9899.980.52
246716-4671697.330100.65
346101-4610196.04999.35
446157-4615796.16599.48
546610-4661097.109100.46
646399-4639996.67099.99
30min146751-4675197.40396.291.06101.79100.681.01
246639-4663997.170101.57
345481-4548194.75799.12
446461-4646196.799101.18
545987-4598795.811100.24
645972-4597295.780100.18
45min145556-4555694.91395.080.51100.39100.540.50
245617-4561795.040100.52
345264-4526494.30599.73
445726-4572695.267100.72
545967-4596795.770101.27
645682-4568295.176100.64
极限145401-4540194.59093.741.16101.12100.261.12
245150-4515094.067100.60
344101-4410191.88298.35
445034-4503493.826100.34
545539-4553994.878101.44
644732-4473293.19799.71
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%
114.128362583571834008335083586835060.15
214.128345183374834120.07
单位质量响应值RSD%判断
5914.025907.370.08数据可信
供试品溶液-2022081501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%
5min148315-4831552.98952.854.0252.9952.854.02
250101-5010154.94854.95
347938-4793852.57652.58
444935-4493549.28249.28
550201-5020155.05855.06
647616-4761652.22352.22
10min165831-6583172.20072.113.0372.7972.703.02
265181-6518171.48772.10
364638-6463870.89171.48
462905-6290568.99169.54
568301-6830174.90975.52
667644-6764474.18874.77
15min176437-7643783.83283.981.0085.2285.371.00
275535-7553582.84284.25
375984-7598483.33584.71
476707-7670784.12885.44
577622-7762285.13186.58
677160-7716084.62586.03
20min175962-7596283.31184.101.8485.6386.421.84
277398-7739884.88687.21
375859-7585983.19885.50
474683-7468381.90884.16
577723-7772385.24287.63
678451-7845186.04188.39
30min180349-8034988.12287.131.2591.3790.381.21
279637-7963787.34190.61
377790-7779085.31688.54
479635-7963587.33990.50
578853-7885386.48189.82
680384-8038488.16191.46
45min180686-8068688.49287.711.6992.7291.931.65
278765-7876586.38590.62
378147-7814785.70789.88
479745-7974587.46091.59
580756-8075688.56992.87
681736-8173689.64393.92
极限180925-8092588.75488.101.4093.9693.291.37
279830-7983087.55392.75
378253-7825385.82390.95
480741-8074188.55293.65
581190-8119089.04594.33
681011-8101188.84894.12
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%
110.214179541740418134168041614417280.20
210.164176541689417270.13
单位质量响应值RSD%判断
4086.974106.990.35数据可信
供试品溶液-322765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%
5min148354-48354100.69897.392.17100.7097.392.17
246417-4641796.66496.66
346104-4610496.01396.01
447407-4740798.72698.73
546829-4682997.52297.52
645488-4548894.73094.73
10min149028-49028102.10298.642.48103.2299.722.48
246472-4647296.77997.85
347582-4758299.091100.16
448360-48360100.711101.81
546771-4677197.40298.49
645973-4597395.74096.79
15min148617-48617101.24697.871.92103.50100.041.92
247171-4717198.235100.38
346288-4628896.39698.56
447191-4719198.276100.49
546395-4639596.61998.78
646304-4630496.42998.55
20min147965-4796599.88896.761.68103.27100.021.68
246482-4648296.800100.04
345948-4594895.68898.93
446438-4643896.708100.02
545899-4589995.58698.83
646035-4603595.86999.06
30min147407-4740798.72695.731.83103.21100.081.82
245824-4582495.42999.75
344814-4481493.32697.63
446157-4615796.123100.51
545769-4576995.31599.62
645848-4584895.47999.73
45min147250-4725098.39994.642.26103.98100.052.24
245447-4544794.644100.02
344386-4438692.43597.77
445875-4587595.536100.99
544978-4497893.66899.03
644744-4474493.18098.49
极限146517-4651796.87392.962.87103.5599.422.79
244638-4463892.96099.39
343206-4320689.97796.34
445590-4559094.942101.45
543343-4334390.26396.66
644549-4454992.77499.12
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%
114.128341783540834038373683372834940.18
214.128342683269833480.14
单位质量响应值RSD%判断
5913.175902.830.13数据可信
供试品溶液-322765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%
5min162381-6238168.44768.302.4368.4568.302.43
260022-6002265.85965.86
363620-6362069.80769.81
463147-6314769.28869.29
563497-6349769.67269.67
660788-6078866.69966.70
10min179233-7923386.93884.662.8087.7085.422.79
275112-7511282.41683.15
379374-7937487.09387.87
478154-7815485.75486.52
576832-7683284.30385.08
674211-7421181.42882.17
15min183414-8341491.52588.641.8393.2590.341.80
281582-8158289.51591.16
379684-7968487.43389.18
480443-8044388.26689.99
580019-8001987.80089.51
679576-7957687.31488.96
20min183789-8378991.93789.041.7594.6891.721.74
281303-8130389.20991.85
381244-8124489.14491.86
480513-8051388.34291.05
580189-8018987.98790.67
679836-7983687.60090.22
30min183392-8339291.50188.911.5295.2792.581.51
280803-8080388.66192.29
380323-8032388.13491.84
480744-8074488.59692.28
581011-8101188.88992.55
679886-7988687.65491.24
45min183334-8333491.43888.122.0596.2292.782.01
280141-8014187.93492.55
379201-7920186.90391.59
480530-8053088.36193.03
580024-8002487.80692.46
678607-7860786.25190.81
极限183115-8311591.19787.512.6996.9993.152.59
280150-8015087.94493.54
378683-7868386.33491.98
480819-8081988.67894.33
576820-7682084.29089.92
678947-7894786.62492.15
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%
110.214168241775417454173741795417470.11
210.164161441819417160.35
单位质量响应值RSD%判断
4088.834105.910.30数据可信
供试品溶液-2021561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%
5min145724-4572495.21297.871.8495.2197.871.84
247461-4746198.82998.83
347969-4796999.88799.89
446464-4646496.75396.75
546671-4667197.18497.18
647725-4772599.37999.38
10min145232-4523294.18897.701.9295.2598.791.92
247277-4727798.44699.54
347375-4737598.65099.76
447115-4711598.10999.18
546713-4671397.27198.35
647810-4781099.556100.66
15min144912-4491293.52197.062.1495.6399.232.12
245913-4591395.60697.80
347442-4744298.789101.00
447173-4717398.229100.39
546917-4691797.69699.86
647301-4730198.496100.71
20min144090-4409091.81096.302.6994.9599.552.66
245944-4594495.67098.92
347494-4749498.898102.20
446977-4697797.821101.08
545856-4585695.48798.73
647108-4710898.094101.40
30min143556-4355690.69894.242.1594.8698.562.14
245584-4558494.92099.24
346494-4649496.815101.22
445528-4552894.80499.15
544961-4496193.62397.93
645408-4540894.55498.95
45min143882-4388291.37693.781.8896.5599.151.87
245970-4597095.724101.10
345963-4596395.710101.19
445091-4509193.89499.29
544322-4432292.29397.64
644979-4497993.66199.11
极限143375-4337590.32192.911.8096.5199.321.78
245403-4540394.544100.98
344612-4461292.89699.44
444656-4465692.98899.43
544145-4414591.92498.30
645523-4552394.793101.28
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%
114.128351983310833038307883521833460.23
214.128321983280832500.06
单位质量响应值RSD%判断
5902.695895.890.09数据可信
供试品溶液-2021561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%
5min165361-6536171.82373.451.9171.8273.451.91
268754-6875475.55175.55
366032-6603272.56072.56
465975-6597572.49772.50
567674-6767474.36474.36
667257-6725773.90673.91
10min175041-7504182.46085.962.0583.2686.772.04
278467-7846786.22487.06
378524-7852486.28787.09
479244-7924487.07887.88
578742-7874286.52787.35
679315-7931587.15687.98
15min177647-7764785.32389.072.5387.0490.842.51
279696-7969687.57589.37
381690-8169089.76691.53
483407-8340791.65393.43
581995-8199590.10191.89
681918-8191890.01791.81
20min178259-7825985.99690.663.8988.6693.423.80
280496-8049688.45491.22
387682-8768296.35199.11
483722-8372291.99994.79
581749-8174989.83192.62
683094-8309491.30994.10
30min176411-7641183.96587.692.1887.5891.462.17
280190-8019088.11891.87
381452-8145289.50593.34
480244-8024488.17791.99
580386-8038688.33392.12
680113-8011388.03391.84
45min176957-7695784.56587.551.8389.1292.301.83
281123-8112389.14393.88
380381-8038188.32893.16
480410-8041088.36093.15
579793-7979387.68292.45
679386-7938687.23492.02
极限177592-7759285.26387.772.1490.7593.492.09
279834-7983487.72793.45
378175-7817585.90491.71
481916-8191690.01495.79
580465-8046588.42094.16
681280-8128089.31695.07
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