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%
19.954017839977399424022340150400940.32
29.984024339947400950.53
单位质量响应值RSD%判断
4029.554017.540.22数据可信
长期12月-供试品溶液-2022081302批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146239-4623998.05198.650.9198.0598.650.91
246416-4641698.42698.43
346073-4607397.69997.70
447271-47271100.239100.24
546461-4646198.52298.52
646677-4667798.98098.98
10min146059-4605997.66998.300.8198.7699.390.81
246652-4665298.927100.02
345992-4599297.52798.61
446954-4695499.567100.68
546191-4619197.94999.04
646283-4628398.14499.24
15min145863-4586397.25498.140.7799.43100.320.75
246790-4679099.219101.41
346524-4652498.655100.82
446143-4614397.847100.07
546397-4639798.386100.57
645960-4596097.45999.65
20min145503-4550396.49097.050.9299.75100.330.90
246496-4649698.596101.89
345897-4589797.326100.59
445553-4555396.59699.90
545307-4530796.07599.35
645848-4584897.222100.49
30min145162-4516295.76796.700.92100.09101.050.89
245696-4569696.899101.29
346029-4602997.606101.95
446103-4610397.763102.14
545143-4514395.727100.07
645470-4547096.420100.77
45min144240-4424093.81294.520.9899.2099.950.96
245192-4519295.831101.30
344297-4429793.93399.36
445049-4504995.528100.99
544208-4420893.74499.15
644457-4445794.27299.70
极限143984-4398493.26993.241.1899.7099.721.13
244307-4430793.954100.49
344334-4433494.011100.49
444423-4442394.200100.73
543078-4307891.34897.80
643687-4368792.63999.11
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4000
标示量(mg)5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%
113.958068080982806788050080774807230.22
214.018093780819808780.11
单位质量响应值RSD%判断
5786.595772.880.17数据可信
长期12月-供试品溶液-2022081302批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186298-8629896.79197.160.8796.7997.160.87
288053-8805398.76098.76
386239-8623996.72596.73
486814-8681497.37097.37
586408-8640896.91596.91
685957-8595796.40996.41
10min185764-8576496.19297.301.7097.2798.381.68
288450-8845099.205100.30
387665-8766598.32599.40
487393-8739398.02099.10
584377-8437794.63795.71
686866-8686697.42898.50
15min185515-8551595.91397.771.3098.0699.931.28
288450-8845099.205101.40
388252-8825298.983101.15
486705-8670597.24899.42
587577-8757798.226100.35
686512-8651297.03199.19
20min184746-8474695.05196.691.3398.2699.941.32
288012-8801298.714102.02
387002-8700297.581100.85
486017-8601796.47699.73
585734-8573496.15999.38
685719-8571996.14299.37
30min183500-8350093.65395.941.5997.92100.261.56
286062-8606296.527100.93
387671-8767198.331102.68
485538-8553895.939100.26
585404-8540495.789100.08
685062-8506295.40599.71
45min181802-8180291.74993.551.3497.0698.941.33
284955-8495595.285100.76
384158-8415894.39199.83
483680-8368093.85599.24
583195-8319593.31198.66
682667-8266792.71998.08
极限181647-8164791.57592.931.1397.9099.361.12
283273-8327393.39999.93
384196-8419694.434100.93
483039-8303993.13699.57
583016-8301693.11099.50
681947-8194791.91198.30
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%
19.953992540214397704025440133400590.52
29.983995340070400120.21
单位质量响应值RSD%判断
4026.034009.220.30数据可信
长期12月-供试品溶液-2022081401批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146125-4612597.95398.940.9597.9598.940.95
246449-4644998.64298.64
346448-4644898.63998.64
446408-4640898.55498.55
547410-47410100.682100.68
646707-4670799.18999.19
10min146345-4634598.421100.000.8499.51101.100.84
247221-47221100.281101.38
347316-47316100.483101.58
447173-47173100.179101.27
547456-47456100.780101.90
647012-4701299.837100.94
15min146086-4608697.87199.410.90100.05101.620.89
246884-4688499.565101.78
347182-47182100.198102.41
447068-4706899.956102.16
546564-4656498.886101.12
647089-47089100.001102.21
20min145551-4555196.73498.381.16100.00101.701.14
245987-4598797.660100.98
347111-47111100.047103.37
446588-4658898.937102.26
546457-4645798.659102.00
646269-4626998.259101.58
30min145024-4502495.61596.660.7999.96101.060.77
245297-4529796.195100.60
345422-4542296.461100.90
445985-4598597.656102.07
545502-4550296.630101.06
645854-4585497.378101.79
45min144651-4465194.82395.580.66100.23101.060.65
245247-4524796.089101.56
345033-4503395.634101.14
445365-4536596.339101.84
545090-4509095.755101.26
644665-4466594.853100.35
极限144523-4452394.55195.330.69101.01101.870.66
245057-4505795.685102.22
345007-4500795.579102.15
444829-4482995.201101.77
544579-4457994.670101.24
645330-4533096.265102.82
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4000
标示量(mg)5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%
113.958098680826810518091581263810080.21
214.018078880844808160.05
单位质量响应值RSD%判断
5807.035768.450.48数据可信
长期12月-供试品溶液-2022081401批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184969-8496995.17095.091.7495.1795.091.74
283734-8373493.78793.79
383331-8333193.33593.34
484070-8407094.16394.16
587035-8703597.48497.48
686228-8622896.58096.58
10min185842-8584296.14897.501.0497.2198.561.03
286075-8607596.40997.45
387190-8719097.65898.69
487831-8783198.37699.42
588008-8800898.57499.66
687351-8735197.83898.91
15min185770-8577096.06796.850.5098.1998.990.50
286345-8634596.71198.82
386665-8666597.07099.19
486496-8649696.88099.02
586466-8646696.84799.03
687065-8706597.51899.68
20min184001-8400194.08695.981.2097.2899.191.18
285006-8500695.21198.40
386239-8623996.59299.79
485733-8573396.02699.24
586512-8651296.898100.15
686640-8664097.042100.29
30min183930-8393094.00693.780.6898.2498.060.67
282903-8290392.85697.10
383846-8384693.91298.19
483187-8318793.17497.46
584398-8439894.53098.86
684078-8407894.17298.49
45min182306-8230692.18792.891.0897.4798.211.04
282117-8211791.97697.25
383133-8313393.11498.43
483965-8396594.04599.36
583981-8398194.06399.44
682098-8209891.95497.32
极限182454-8245492.35392.440.5698.6698.790.53
282530-8253092.43898.74
382458-8245892.35798.71
482108-8210891.96598.33
582216-8221692.08698.51
683399-8339993.41199.80
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%
19.954008240324399874018540307401770.37
29.984019140221402060.06
单位质量响应值RSD%判断
4037.894028.660.17数据可信
长期12月-供试品溶液-2022081501批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147414-47414100.30097.701.57100.3097.711.57
245980-4598097.26697.27
346076-4607697.46997.47
446600-4660098.57898.58
545564-4556496.38696.39
645488-4548896.22696.23
10min146582-4658298.54098.461.1199.6599.541.11
246769-4676998.935100.02
347086-4708699.606100.69
446382-4638298.11799.21
546839-4683999.084100.15
645611-4561196.48697.55
15min145936-4593697.17397.971.4199.38100.151.39
246270-4627097.880100.06
347561-47561100.611102.80
446207-4620797.74799.93
546237-4623797.81099.98
645670-4567096.61198.75
20min145151-4515195.51396.521.4698.8099.781.43
245685-4568596.64299.91
346446-4644698.252101.56
445329-4532995.88999.16
546348-4634898.045101.30
644794-4479494.75897.97
30min145093-4509395.39095.651.2399.7499.991.21
245460-4546096.166100.51
345283-4528395.792100.19
445242-4524295.705100.04
545955-4595597.213101.56
644260-4426093.62897.90
45min144862-4486294.90194.561.15100.3199.961.14
244909-4490995.001100.41
345353-4535395.940101.40
444518-4451894.17499.57
544751-4475194.667100.09
643816-4381692.68998.00
极限144021-4402193.12293.641.3599.59100.101.31
243861-4386192.78499.25
345097-4509795.398101.93
443812-4381292.68099.13
544963-4496395.115101.60
643844-4384492.74899.09
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4000
标示量(mg)5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%
113.958091980222806018061180872806450.35
214.018066980783807260.10
单位质量响应值RSD%判断
5781.005762.030.24数据可信
长期12月-供试品溶液-2022081501批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185907-8590796.49093.861.9496.4993.861.94
283086-8308693.32293.32
383963-8396394.30794.31
484549-8454994.96594.96
582620-8262092.79892.80
681254-8125491.26491.26
10min186239-8623996.86396.111.7097.9497.161.68
285962-8596296.55297.59
386429-8642997.07698.12
484266-8426694.64795.70
587174-8717497.91398.94
683362-8336293.63294.65
15min185339-8533995.85295.832.2198.0097.942.18
284245-8424594.62396.73
388016-8801698.859100.99
483975-8397594.32096.43
587107-8710797.83899.96
683247-8324793.50295.56
20min183747-8374794.06494.391.7997.2897.571.77
284310-8431094.69697.86
385653-8565396.20599.43
483234-8323493.48896.64
585585-8558596.12999.33
681713-8171391.78094.87
30min183363-8336393.63393.371.5997.8997.601.58
283787-8378794.10998.32
383910-8391094.24798.54
482354-8235492.49996.69
584505-8450594.91599.19
680870-8087090.83394.95
45min182842-8284293.04892.241.7498.3597.501.73
283002-8300293.22798.49
383494-8349493.78099.12
481130-8113091.12596.35
582565-8256592.73698.07
679705-7970589.52494.65
极限181812-8181291.89191.282.2898.2297.562.23
281319-8131991.33797.63
383368-8336893.638100.02
479165-7916588.91895.15
582942-8294293.16099.52
678981-7898188.71194.83
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