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%
19.954171041678416864163241645416700.08
29.994177041729417500.07
单位质量响应值RSD%判断
4187.944179.180.15数据可信
供试品溶液-2022081001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%
5min131405-3140564.04877.5511.6664.0577.5511.66
240308-4030882.20582.20
343288-4328888.28288.28
434903-3490371.18271.18
536969-3696975.39575.40
641290-4129084.20784.21
10min142363-4236386.39690.263.4287.1191.123.48
243742-4374289.20890.12
346979-4697995.81096.79
444031-4403189.79790.59
543996-4399689.72690.56
644437-4443790.62591.56
15min143302-4330288.31191.222.7489.9893.082.79
243854-4385489.43691.34
346868-4686895.58397.63
445026-4502691.82793.62
544664-4466491.08892.92
644644-4464491.04892.99
20min143324-4332488.35690.912.3391.0193.792.41
244266-4426690.27793.18
346473-4647394.77897.89
444707-4470791.17693.99
544337-4433790.42193.27
644356-4435690.46093.41
30min142889-4288987.46890.672.2391.1094.562.29
243844-4384489.41693.32
345671-4567193.14297.30
445180-4518092.14195.96
544440-4444090.63294.48
644726-4472691.21595.17
45min143646-4364689.01290.481.9593.6295.381.99
243650-4365089.02093.92
345768-4576893.34098.54
445026-4502691.82796.67
544274-4427490.29395.15
643824-4382489.37594.35
极限145466-4546692.72492.731.4498.3298.631.39
244984-4498491.74197.63
345946-4594693.70399.94
446427-4642794.684100.55
545374-4537492.53698.40
644615-4461590.98896.95
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%
113.931618491618731616011615951616651617170.09
214.001615881617231616560.06
单位质量响应值RSD%判断
11609.2611546.860.39数据可信
供试品溶液-2022081001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%
5min140230-4023022.52527.2419.2422.5227.2419.25
254819-5481930.69330.69
359451-5945133.28733.29
436121-3612120.22420.22
545766-4576625.62425.62
655493-5549331.07131.07
10min186085-8608548.19951.615.4448.4551.915.48
289113-8911349.89450.24
3100495-10049556.26756.64
490745-9074550.80851.03
591712-9171251.35051.63
694896-9489653.13253.48
15min1104373-10437358.43862.295.1259.2263.165.13
2104739-10473958.64359.54
3119031-11903166.64567.64
4113166-11316663.36264.15
5112211-11221162.82763.68
6113956-11395663.80464.74
20min1114874-11487464.31868.064.0465.7569.634.09
2117912-11791266.01967.57
3128919-12891972.18273.92
4122228-12222868.43569.93
5121095-12109567.80169.35
6124338-12433869.61771.26
30min1123242-12324269.00373.814.2971.1576.144.32
2127592-12759271.43973.72
3138345-13834577.45980.00
4133786-13378674.90777.16
5131563-13156373.66275.97
6136476-13647676.41378.83
45min1131879-13187973.83976.812.9876.7679.963.05
2134240-13424075.16178.24
3143221-14322180.18983.59
4139356-13935678.02581.11
5135574-13557475.90879.03
6138858-13885877.74781.01
极限1154062-15406286.25987.451.8890.0091.451.89
2152815-15281585.56189.47
3158246-15824688.60292.89
4160639-16063989.94293.89
5156833-15683387.81191.78
6154544-15454486.52990.66
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%
19.954167441724417354164641677416910.09
29.994177641668417220.19
单位质量响应值RSD%判断
4190.054176.380.24数据可信
供试品溶液-2022081001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%
5min137698-3769876.88877.983.0476.8977.983.03
239651-3965180.87280.87
337669-3766976.82976.83
438668-3866878.86778.87
539195-3919579.94279.94
636507-3650774.45974.46
10min143592-4359288.91089.842.3789.7690.702.37
245607-4560793.01993.92
345073-4507391.93092.78
443118-4311887.94388.82
543745-4374589.22290.11
643154-4315488.01688.84
15min144193-4419390.13590.361.5891.9892.231.58
245310-4531092.41494.35
345014-4501491.81093.69
443832-4383289.39991.25
543867-4386789.47191.35
643611-4361188.94890.75
20min143744-4374489.22089.801.5292.0692.661.52
244965-4496591.71094.67
344646-4464691.05993.95
443118-4311887.94390.79
543822-4382289.37992.25
643863-4386389.46292.26
30min143606-4360688.93889.331.5192.7793.201.51
244872-4487291.52095.50
344280-4428090.31394.22
443627-4362788.98192.80
543252-4325288.21692.08
643150-4315088.00891.80
45min143371-4337188.45989.061.4093.2893.921.40
244237-4423790.22595.22
344614-4461490.99495.90
443076-4307687.85792.67
543388-4338888.49493.34
643312-4331288.33993.10
极限145164-4516492.11691.710.4797.9297.560.50
245053-4505391.88997.89
345121-4512192.02897.95
445038-4503891.85997.65
544801-4480191.37597.21
644626-4462691.01996.77
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%
113.931617271615681616881615531616831616440.05
214.001618531618561618540.01
单位质量响应值RSD%判断
11604.0211561.000.27数据可信
供试品溶液-2022081001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%
5min149721-4972127.82827.853.1627.8327.853.16
249920-4992027.93927.94
347088-4708826.35426.35
450242-5024228.12028.12
551974-5197429.08929.09
649650-4965027.78827.79
10min188596-8859649.58650.222.5149.8950.522.49
293078-9307852.09452.40
389062-8906249.84650.14
487045-8704548.71849.03
588769-8876949.68250.01
691777-9177751.36651.67
15min1107602-10760260.22360.881.6861.0861.741.67
2111309-11130962.29863.19
3109805-10980561.45662.30
4106247-10624759.46560.32
5107995-10799560.44361.32
6109660-10966061.37562.25
20min1115776-11577664.79866.012.7466.3367.552.70
2121142-12114267.80169.38
3119507-11950766.88668.42
4113077-11307763.28764.80
5117012-11701265.49067.04
6121093-12109367.77469.34
30min1126814-12681470.97671.461.8373.2273.741.81
2131158-13115873.40775.74
3129329-12932972.38374.66
4125967-12596770.50272.72
5124766-12476669.82972.10
6128030-12803071.65673.97
45min1133643-13364374.79874.652.4077.8477.722.35
2137849-13784977.15280.30
3136157-13615776.20579.28
4130486-13048673.03176.03
5129646-12964672.56175.61
6132516-13251674.16777.28
极限1155749-15574987.17087.040.4891.0490.950.49
2155890-15589087.24991.26
3156615-15661587.65591.58
4155397-15539786.97390.79
5154482-15448286.46190.32
6155003-15500386.75390.69
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%
19.954170641742417064170341718417150.04
29.994177941720417500.10
单位质量响应值RSD%判断
4192.464179.180.23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%
5min140147-4014781.83288.193.8181.8388.193.81
243298-4329888.25588.25
344413-4441390.52890.53
444700-4470091.11391.11
543899-4389989.48089.48
643135-4313587.92387.92
10min143633-4363388.93892.542.3289.8593.522.33
244752-4475291.21992.20
345829-4582993.41494.42
446525-4652594.83395.84
546097-4609793.96094.95
645579-4557992.90493.88
15min143955-4395589.59492.452.2991.4994.462.29
244280-4428090.25792.25
345518-4551892.78094.82
446643-4664395.07397.14
545763-4576393.27995.32
645976-4597693.71495.72
20min144147-4414789.98592.142.0592.8895.182.06
244230-4423090.15593.15
345251-4525192.23695.31
446601-4660194.98898.11
545301-4530192.33895.41
645706-4570693.16396.21
30min143550-4355088.76991.231.9892.6695.292.00
244002-4400289.69093.69
344768-4476891.25195.35
446014-4601493.79197.97
545267-4526792.26896.37
644937-4493791.59695.68
45min143922-4392289.52791.421.7394.4196.501.75
244559-4455990.82595.82
344811-4481191.33996.45
446226-4622694.22399.44
545063-4506391.85396.98
644530-4453090.76695.87
极限144484-4448490.67290.971.0696.5597.061.08
244222-4422290.13896.14
344702-4470291.11797.25
445189-4518992.10998.38
545137-4513792.00398.15
644042-4404289.77195.88
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%
113.938023680093804648047080515803560.23
214.008042580383804040.04
单位质量响应值RSD%判断
5768.565743.140.32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%
5min127328-2732830.77833.705.8130.7833.705.81
230075-3007533.87233.87
332159-3215936.21936.22
428529-2852932.13132.13
530484-3048434.33334.33
630960-3096034.86934.87
10min146125-4612551.94854.673.6952.2955.043.69
246771-4677152.67653.05
350041-5004156.35956.76
448720-4872054.87155.23
548905-4890555.07955.46
650683-5068357.08257.47
15min154654-5465461.55464.183.3562.4765.163.35
254754-5475461.66762.63
358333-5833365.69866.73
458090-5809065.42466.39
556923-5692364.11065.10
659146-5914666.61367.64
20min159894-5989467.45669.232.7669.0670.922.77
259700-5970067.23768.88
362815-6281570.74672.50
463433-6343371.44273.14
560233-6023367.83869.54
662727-6272770.64672.41
30min162866-6286670.80373.612.5073.1676.082.50
264741-6474172.91575.31
366514-6651474.91277.46
467553-6755376.08278.57
564716-6471672.88775.35
665759-6575974.06176.61
45min167416-6741675.92777.762.4379.0781.042.39
269460-6946078.23081.43
370315-7031579.19282.57
471513-7151380.54283.87
567368-6736875.87379.14
668206-6820676.81780.19
极限174209-7420983.57884.341.8787.5688.481.82
275791-7579185.36089.43
376351-7635185.99190.25
476198-7619885.81890.05
573479-7347982.75686.87
673274-7327482.52586.75
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%
19.954163341679416054154241560416040.14
29.994166141553416070.19
单位质量响应值RSD%判断
4181.314164.860.28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%
5min144062-4406290.08691.042.4590.0991.042.45
243795-4379589.54189.54
345889-4588993.82293.82
443702-4370289.35089.35
545957-4595793.96193.96
643755-4375589.45989.46
10min146242-4624294.54495.641.4395.5496.651.42
246300-4630094.66295.66
347449-4744997.01198.05
447635-4763597.39298.38
546950-4695095.99197.04
646085-4608594.22395.22
15min145525-4552593.07894.331.5795.1396.401.56
245546-4554693.12195.17
347090-4709096.27798.40
447011-4701196.11698.19
545870-4587093.78395.89
645772-4577293.58395.62
20min145609-4560993.24994.201.2396.3397.321.24
245334-4533492.68795.77
346860-4686095.80799.00
446404-4640494.87598.02
546340-4634094.74497.90
645901-4590193.84696.93
30min144889-4488991.77793.001.3695.9097.161.36
244807-4480791.61095.72
346350-4635094.76499.02
445610-4561093.25197.45
546005-4600594.05998.26
645247-4524792.50996.63
45min144654-4465491.29792.821.4996.4498.021.48
244617-4461791.22196.35
346023-4602394.09699.40
446209-4620994.47699.71
545627-4562793.28698.54
645261-4526192.53897.69
极限144587-4458791.16092.181.0897.3298.411.08
244562-4456291.10997.25
345211-4521192.43698.79
445567-4556793.16399.45
545685-4568593.40599.69
644889-4488991.77797.96
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%
113.938000479967799927996079911799670.05
214.008022680058801420.15
单位质量响应值RSD%判断
5740.635724.430.20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%
5min130947-3094734.99634.905.9135.0034.905.91
228586-2858632.32632.33
331720-3172035.87035.87
429083-2908332.88832.89
533575-3357537.96837.97
631243-3124335.33135.33
10min148442-4844254.78057.483.9555.1757.873.95
248056-4805654.34354.70
352258-5225859.09559.49
451975-5197558.77559.14
552277-5227759.11659.54
651977-5197758.77759.17
15min155313-5531362.55066.223.6463.5567.253.64
256662-5666264.07565.04
361035-6103569.02070.08
459320-5932067.08168.10
559513-5951367.29968.38
659529-5952967.31768.36
20min159801-5980167.62571.233.2669.3272.993.26
261791-6179169.87571.55
365791-6579174.39976.22
463005-6300571.24873.01
563338-6333871.62573.45
664210-6421072.61174.40
30min163591-6359171.91175.533.0074.3578.083.00
265971-6597174.60277.05
369713-6971378.83481.48
467245-6724576.04378.60
566870-6687075.61978.24
667377-6737776.19278.79
45min167037-6703775.80879.433.0479.0582.823.02
269643-6964378.75482.03
373359-7335982.95786.48
471290-7129080.61784.02
569278-6927878.34281.80
670850-7085080.11983.57
极限172315-7231581.77685.402.5485.8689.682.54
276024-7602485.97090.13
378239-7823988.47592.92
475626-7562685.52089.82
575019-7501984.83489.17
675913-7591385.84590.18
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