玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159868998850985919829498110985070.31
211.029785098150980000.22
单位质量响应值RSD%判断
8834.718892.920.47数据可信
中间条件6月-供试品溶液-2025051421批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130046-3004630.43830.3713.1930.4430.3713.19
235878-3587836.34636.35
323982-2398224.29524.29
429856-2985630.24530.25
528149-2814928.51628.52
631965-3196532.38232.38
10min153303-5330353.99856.826.3054.3457.166.34
261090-6109061.88762.29
351768-5176852.44352.71
457077-5707757.82158.16
554486-5448655.19655.51
658814-5881459.58159.94
15min167472-6747268.35272.514.5069.2973.484.54
274771-7477175.74676.84
368534-6853469.42870.28
474127-7412775.09476.07
570279-7027971.19572.13
674291-7429175.26076.28
20min176598-7659877.59779.213.9879.2980.983.99
281335-8133582.39684.33
373522-7352274.48176.10
481111-8111182.16983.98
579934-7993480.97682.70
676638-7663877.63779.50
30min185365-8536586.47887.502.2889.0490.162.19
284013-8401385.10987.96
386620-8662087.74990.20
489681-8968190.85093.58
587228-8722888.36590.99
685343-8534386.45689.18
45min185764-8576486.88289.432.1890.4093.062.05
287150-8715088.28692.08
390760-9076091.94395.37
489492-8949290.65994.39
589513-8951390.68094.28
687010-8701088.14591.83
60min188628-8862889.78489.842.0094.2794.461.85
287228-8722888.36593.14
390904-9090492.08996.54
490559-9055991.74096.48
588313-8831389.46594.07
686474-8647487.60292.26
90min182943-8294384.02587.393.1589.5193.012.98
285070-8507086.17991.94
389745-8974590.91596.39
489215-8921590.37896.14
586224-8622487.34892.95
684388-8438885.48891.12
120min186529-8652987.65788.101.8994.0794.691.77
285081-8508186.19092.91
388668-8866889.82496.31
489073-8907390.23497.00
587023-8702388.15894.73
685422-8542286.53693.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限186652-8665287.78289.211.6295.1796.781.54
286993-8699388.12795.80
389653-8965390.82298.30
489266-8926690.43098.20
586679-8667987.80995.36
689128-8912890.29097.84
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159790897655982019765997621978090.26
211.029822997971981000.19
单位质量响应值RSD%判断
8772.118902.001.04数据可信
中间条件6月-供试品溶液-2025051421批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129999-2999930.48430.4013.7130.4830.4013.70
236315-3631536.90236.90
323872-2387224.25824.26
429751-2975130.23230.23
527975-2797528.42728.43
631563-3156332.07332.07
10min153225-5322554.08557.087.8654.4257.427.89
263061-6306164.08064.49
350317-5031751.13051.40
457706-5770658.63858.97
554883-5488355.76956.09
657860-5786058.79559.15
15min167390-6739068.47872.894.6669.4273.864.71
276179-7617977.40978.53
368658-6865869.76770.60
473879-7387975.07276.06
570964-7096472.11073.05
673316-7331674.50075.51
20min176112-7611277.34181.172.4479.0482.962.48
281605-8160582.92384.91
379866-7986681.15682.77
481021-8102182.33084.15
580312-8031281.60983.35
680381-8038181.67983.52
30min186334-8633487.72888.252.0490.2990.941.95
284785-8478586.15489.06
386900-8690088.30490.82
490083-9008391.53894.27
586929-8692988.33390.98
686056-8605687.44690.19
45min185031-8503186.40489.422.5289.9493.092.40
286814-8681488.21692.08
390424-9042491.88495.38
489770-8977091.22094.97
589597-8959791.04494.67
686381-8638187.77691.49
60min188511-8851189.94190.331.8594.4494.991.73
287638-8763889.05393.89
390794-9079492.26096.78
491025-9102592.49597.26
588333-8833389.76094.40
687086-8708688.49393.18
90min183257-8325784.60287.992.7490.1093.652.59
284943-8494386.31592.15
389801-8980191.25196.79
488536-8853689.96695.76
586768-8676888.16993.80
686217-8621787.61093.28
120min185861-8586187.24888.472.0593.6895.111.91
284920-8492086.29293.08
388709-8870990.14296.70
488916-8891690.35297.15
588318-8831889.74496.36
685637-8563787.02093.67
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限189049-8904990.48789.961.3997.8997.581.26
287023-8702388.42996.18
389937-8993791.39098.95
489583-8958391.03098.83
587153-8715388.56196.17
688436-8843689.86497.48
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159810497931982319788797911980130.16
211.029850498130983170.27
单位质量响应值RSD%判断
8790.408921.691.05数据可信
中间条件6月-供试品溶液-B0012N01批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128768-2876829.17022.2628.6729.1722.2628.67
230377-3037730.80130.80
315142-1514215.35415.35
420518-2051820.80520.80
520375-2037520.66020.66
616516-1651616.74716.75
10min167055-6705567.99260.2412.0268.3260.4812.08
264339-6433965.23865.58
347371-4737148.03348.20
462134-6213463.00263.23
560455-6045561.30061.53
655089-5508955.85956.04
15min182867-8286784.02579.565.1685.1080.485.27
281838-8183882.98284.05
371819-7181972.82373.53
480155-8015581.27582.21
577169-7716978.24779.16
676933-7693378.00878.81
20min186649-8664987.86085.732.2389.8787.532.38
286392-8639287.59989.59
381824-8182482.96784.48
484462-8446285.64287.48
583019-8301984.17985.96
684954-8495486.14187.81
30min190166-9016691.42689.292.3994.4292.042.44
290283-9028391.54594.51
388816-8881690.05792.49
486038-8603887.24090.03
587795-8779589.02291.74
685230-8523086.42189.05
45min187865-8786589.09390.351.7893.1094.101.78
292002-9200293.28897.27
389488-8948890.73894.17
489203-8920390.44994.20
587810-8781089.03792.74
688278-8827889.51293.10
60min189249-8924990.49690.401.2095.4995.141.29
291032-9103292.30497.32
388788-8878890.02994.47
487777-8777789.00493.76
589236-8923690.48395.18
688819-8881990.06094.65
90min184666-8466685.84987.871.6791.8593.621.54
288580-8858089.81895.86
387893-8789389.12194.57
486090-8609087.29393.04
585757-8575786.95592.65
686978-8697888.19393.78
120min186790-8679088.00388.591.3694.9695.321.35
289248-8924890.49597.53
388194-8819489.42695.86
487315-8731588.53595.25
585970-8597087.17193.84
686674-8667487.88594.45
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限187799-8779989.02687.771.0096.9695.491.13
287194-8719488.41296.46
386206-8620687.41194.84
486636-8663687.84795.55
586212-8621287.41795.05
685325-8532586.51794.06
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