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 11.069878199327988539916999087990430.23
2 11.049930799018991620.21
单位质量响应值RSD%判断
8955.068982.070.22数据可信
供试品溶液-2025051521批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133552-3355233.59235.9413.3033.5935.9413.30
239966-3996640.01440.01
340724-4072440.77340.77
437993-3799338.03938.04
535211-3521135.25335.25
627917-2791727.95027.95
10min162195-6219562.27064.876.2462.6465.276.29
267769-6776967.85068.29
369990-6999070.07470.53
466383-6638366.46366.89
563539-6353963.61564.01
658882-5888258.95359.26
15min175180-7518075.27076.802.8376.3477.922.91
278393-7839378.48779.69
379333-7933379.42880.66
477639-7763977.73278.89
576216-7621676.30777.41
673497-7349773.58574.55
20min181261-8126181.35882.611.6383.2684.591.73
283685-8368583.78585.86
384172-8417284.27386.39
483193-8319383.29385.32
581804-8180481.90283.85
680975-8097581.07282.86
30min184849-8484984.95187.221.5187.7690.111.55
287704-8770487.80990.81
388856-8885688.96392.01
486930-8693087.03489.98
587215-8721587.32090.18
687113-8711387.21789.90
45min187606-8760687.71189.771.6991.4693.631.70
291843-9184391.95395.93
390140-9014090.24894.29
488475-8847588.58192.50
590490-9049090.59994.43
689420-8942089.52793.18
60min187550-8755087.65589.681.2292.3894.541.23
290634-9063490.74395.74
389893-8989390.00195.04
489356-8935689.46394.36
589725-8972589.83394.67
690297-9029790.40595.05
90min189662-8966289.77089.751.0795.4795.601.03
290339-9033990.44796.45
390394-9039490.50296.54
487825-8782587.93093.83
589573-8957389.68095.51
690074-9007490.18295.83
120min186775-8677586.87989.031.6893.5795.881.64
290815-9081590.92497.94
389345-8934589.45296.50
487542-8754287.64794.52
589576-8957689.68396.51
689513-8951389.62096.27
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191264-9126491.37391.320.7999.0399.160.66
291458-9145891.56899.59
390020-9002090.12898.17
490775-9077590.88498.73
592022-9202292.13299.96
691721-9172191.83199.48
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)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 11.069911499176986619908199253990570.24
2 11.049887099133990020.19
单位质量响应值RSD%判断
8956.338967.570.09数据可信
供试品溶液-2025051621批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139130-3913039.20632.3419.1939.2132.3419.19
222796-2279622.84022.84
329004-2900429.06029.06
436847-3684736.91836.92
529605-2960529.66229.66
636285-3628536.35536.36
10min161452-6145261.57159.159.1362.0159.509.18
253168-5316853.27153.52
356767-5676756.87757.20
466281-6628166.40966.82
553456-5345653.56053.89
663061-6306163.18363.59
15min172573-7257372.71472.406.0473.8373.426.11
267934-6793468.06668.91
372114-7211472.25473.21
479015-7901579.16880.32
567269-6726967.39968.32
674645-7464574.79075.90
20min178798-7879878.95179.494.5280.8881.314.60
277281-7728177.43179.03
379183-7918379.33681.09
484775-8477584.93986.97
574351-7435174.49576.17
681645-8164581.80383.74
30min182970-8297083.13185.493.5085.9488.203.56
285169-8516985.33487.80
384793-8479384.95787.60
489551-8955189.72492.70
581556-8155681.71484.22
687890-8789088.06090.91
45min185156-8515685.32188.183.4889.0591.833.49
289018-8901889.19092.60
388291-8829188.46292.05
491327-9132791.50495.47
583594-8359483.75687.17
690657-9065790.83394.66
60min185843-8584386.00988.192.8190.6992.832.89
287748-8774887.91892.32
387517-8751787.68692.25
491495-9149591.67296.66
585202-8520285.36789.71
690339-9033990.51495.35
90min184394-8439484.55787.992.9990.1993.603.02
288500-8850088.67194.05
387569-8756987.73993.28
491165-9116591.34297.35
585311-8531185.47690.76
689974-8997490.14895.99
120min184212-8421284.37586.922.9190.9593.522.92
288711-8871188.88395.25
386230-8623086.39792.91
489425-8942589.59896.62
583442-8344283.60489.84
688507-8850788.67895.52
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189016-8901689.18890.121.1496.7097.671.19
289666-8966689.84097.19
388588-8858888.76096.23
491114-9111491.29099.30
590880-9088091.05698.22
690392-9039290.56798.39
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 11.069949299593999309927799761996110.26
2 11.049973999429995840.23
单位质量响应值RSD%判断
9006.429020.290.11数据可信
供试品溶液-2025051622批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131748-3174831.62833.0318.9331.6333.0318.92
223480-2348023.39123.39
333061-3306132.93632.94
430873-3087330.75630.76
541520-4152041.36341.36
638254-3825438.10938.11
10min155649-5564955.43959.978.2855.7960.348.34
253927-5392753.72353.98
360931-6093160.70161.07
459415-5941559.19159.53
567024-6702466.77167.23
664225-6422563.98264.41
15min167954-6795467.69773.865.8668.6674.905.92
270123-7012369.85870.71
374591-7459174.30975.35
475683-7568375.39776.40
579565-7956579.26480.47
676935-7693576.64477.78
20min175292-7529275.00880.073.8876.7381.923.96
278612-7861278.31579.95
380558-8055880.25482.12
481780-8178081.47183.31
584385-8438584.06686.15
681585-8158581.27783.26
30min182587-8258782.27586.002.5784.8388.752.67
285195-8519584.87387.38
386551-8655186.22488.98
488148-8814887.81590.56
588718-8871888.38391.40
686782-8678286.45489.34
45min183616-8361683.30088.053.0186.7791.753.08
287444-8744487.11490.56
389076-8907688.74092.46
490083-9008389.74393.46
591201-9120190.85694.85
688905-8890588.56992.42
60min183171-8317182.85788.543.6087.2593.223.62
289397-8939789.05993.47
389036-8903688.70093.40
488944-8894488.60893.32
593066-9306692.71497.72
689640-8964089.30194.14
90min184373-8437384.05487.942.3589.3793.602.44
288524-8852488.19093.59
388259-8825987.92693.61
488525-8852588.19193.89
590208-9020889.86795.91
689774-8977489.43595.26
120min183065-8306582.75186.682.6989.0093.322.78
286497-8649786.17092.55
387522-8752287.19193.86
486949-8694986.62193.30
590262-9026289.92196.96
687741-8774187.41094.23
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188880-8888088.54490.120.9195.7197.721.06
290755-9075590.41297.75
391106-9110690.76298.39
490994-9099490.65098.29
590723-9072390.38098.42
690315-9031589.97497.76
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