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)10
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%
1 11.06100055999199986610009699900999670.11
2 11.041004201002011003100.16
单位质量响应值RSD%判断
9038.619086.050.38数据可信
供试品溶液-2025051221批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114670-1467014.53619.3819.8714.5419.3819.86
216978-1697816.82316.82
317829-1782917.66617.67
425619-2561925.38425.38
520771-2077120.58120.58
621494-2149421.29721.30
10min129775-2977529.50233.177.7629.6633.397.84
232059-3205931.76531.95
332122-3212231.82832.02
436661-3666136.32536.61
534595-3459534.27834.51
635664-3566435.33735.57
15min136530-3653036.19639.244.3436.6839.834.45
239111-3911138.75339.29
339550-3955039.18839.74
441246-4124640.86841.55
540173-4017339.80540.41
641036-4103640.66041.29
20min141400-4140041.02142.722.6241.9143.742.75
242626-4262642.23643.21
342466-4246642.07743.06
443992-4399243.58944.73
543913-4391343.51144.56
644271-4427143.86644.95
30min146990-4699046.56046.460.9247.9147.960.87
247124-4712446.69348.13
346478-4647846.05247.51
446299-4629945.87547.50
546996-4699646.56648.10
647453-4745347.01948.59
45min149253-4925348.80248.930.9450.6750.941.01
249486-4948649.03350.99
348801-4880148.35450.32
449554-4955449.10051.23
549068-4906848.61950.67
650146-5014649.68751.78
60min150617-5061750.15449.860.9252.5652.420.78
250939-5093950.47352.98
350072-5007249.61452.12
449656-4965649.20151.88
550113-5011349.65452.25
650541-5054150.07852.72
90min150940-5094050.47450.781.1053.4453.891.10
252159-5215951.68154.75
350469-5046950.00753.06
451318-5131850.84854.07
551199-5119950.73053.87
651408-5140850.93754.14
120min151102-5110250.63450.941.0154.1654.610.89
252195-5219551.71755.36
351772-5177251.29854.91
450871-5087150.40554.20
551532-5153251.06054.77
650984-5098450.51754.28
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152138-5213851.66151.291.0055.7555.530.91
250800-5080050.33554.55
352251-5225151.77355.95
451880-5188051.40555.76
551712-5171251.23955.51
651814-5181451.34055.67
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)10
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%
1 11.06100078100656998211006441003391003080.37
2 11.041010891011021010960.01
单位质量响应值RSD%判断
9069.449157.250.69数据可信
供试品溶液-2025051321批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122094-2209421.77020.0011.1621.7720.0011.15
218903-1890318.62518.63
318661-1866118.38718.39
419030-1903018.75118.75
524107-2410723.75323.75
619009-1900918.73018.73
10min133682-3368233.18732.704.6933.4332.924.72
233893-3389333.39533.60
332848-3284832.36632.57
432557-3255732.07932.29
535388-3538834.86835.13
630736-3073630.28530.49
15min139063-3906338.48938.312.6039.1038.902.64
239608-3960839.02639.60
339189-3918938.61339.18
438331-3833137.76838.33
539961-3996139.37440.03
637164-3716436.61837.16
20min141641-4164141.02941.542.0842.0742.552.10
242375-4237541.75342.76
342911-4291142.28143.27
442254-4225441.63342.62
543078-4307842.44543.53
640709-4070940.11141.06
30min144894-4489444.23545.251.5245.7346.721.51
245545-4554544.87646.35
346226-4622645.54747.01
446282-4628245.60247.05
546890-4689046.20147.76
645694-4569445.02346.42
45min147545-4754546.84747.661.1148.8349.641.11
248626-4862647.91249.89
348945-4894548.22650.20
447977-4797747.27249.23
548824-4882448.10750.18
648333-4833347.62349.52
60min149604-4960448.87648.641.3051.3851.141.21
248228-4822847.52050.03
349537-4953748.81051.31
450148-5014849.41251.89
549179-4917948.45751.07
649488-4948848.76151.19
90min150470-5047049.72949.820.5352.7852.860.46
250569-5056949.82652.86
350867-5086750.12053.17
450225-5022549.48752.52
550346-5034649.60752.75
650873-5087350.12653.09
120min149881-4988149.14850.061.0852.7553.660.97
251133-5113350.38253.97
351316-5131650.56254.17
450808-5080850.06253.64
550477-5047749.73653.43
651200-5120050.44853.97
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149954-4995449.22049.800.8453.3753.950.78
251250-5125050.49754.65
350606-5060649.86354.03
450588-5058849.84553.98
550416-5041649.67653.93
650416-5041649.67653.76
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)10
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%
1 11.061008311009881006061005111007421007360.19
2 11.041006851005931006390.07
单位质量响应值RSD%判断
9108.149115.850.06数据可信
供试品溶液-2025051421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117904-1790417.64319.1919.4917.6419.1919.48
219900-1990019.61019.61
317008-1700816.76016.76
426934-2693426.54226.54
517349-1734917.09617.10
617728-1772817.47017.47
10min130082-3008229.64430.988.1029.8431.198.18
231745-3174531.28331.50
328986-2898628.56428.75
436283-3628335.75536.05
530950-3095030.49930.69
630582-3058230.13730.33
15min136770-3677036.23536.874.8236.7637.424.93
237271-3727136.72837.29
335575-3557535.05735.56
440821-4082140.22740.92
536536-3653636.00436.53
637488-3748836.94237.47
20min140023-4002339.44040.213.2340.3741.183.36
240454-4045439.86540.84
339739-3973939.16040.05
443370-4337042.73843.88
540875-4087540.28041.21
640377-4037739.78940.73
30min144603-4460343.95344.152.4545.3245.562.58
244351-4435143.70545.12
344028-4402843.38744.72
446994-4699446.31047.92
544598-4459843.94945.32
644257-4425743.61344.99
45min147172-4717246.48546.940.7048.3448.840.71
247523-4752346.83148.73
347970-4797047.27149.08
447690-4769046.99649.12
547394-4739446.70448.57
648027-4802747.32849.19
60min147684-4768446.99048.131.2349.3650.561.25
248747-4874748.03750.46
349038-4903848.32450.66
449188-4918848.47251.12
549225-4922548.50850.89
649194-4919448.47850.87
90min150607-5060749.87050.000.2852.7652.960.46
250788-5078850.04853.00
350760-5076050.02152.89
450940-5094050.19853.39
550548-5054849.81252.73
650786-5078650.04652.98
120min151565-5156550.81450.740.8754.2654.250.95
250927-5092750.18553.70
350990-5099050.24753.68
452066-5206651.30855.05
551718-5171850.96554.44
651658-5165850.90654.39
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150392-5039249.65850.080.6953.6754.160.71
250559-5055949.82353.89
351141-5114150.39654.38
450982-5098250.24054.56
551240-5124050.49454.54
650587-5058749.85053.90
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