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%
111.069693196744967369677496606967580.13
211.099657596285964300.22
单位质量响应值RSD%判断
8748.468695.220.44数据可信
供试品溶液-2025051221批-pH6.8(内含%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130348-3034831.24434.637.9231.2434.637.93
233766-3376634.76334.76
335420-3542036.46636.47
433178-3317834.15834.16
531425-3142532.35332.35
637677-3767738.79038.79
10min160708-6070862.50163.985.5362.8564.375.53
260463-6046362.24862.63
367336-6733669.32469.73
461529-6152963.34663.73
557838-5783859.54659.91
665003-6500366.92267.35
15min175310-7531077.53477.763.9878.5878.863.99
273537-7353775.70876.79
379750-7975082.10583.28
475974-7597478.21779.30
571146-7114673.24774.27
677481-7748179.76980.94
20min183402-8340285.86585.493.4287.7787.463.43
281309-8130983.71085.63
385330-8533087.85089.94
485702-8570288.23390.19
578225-7822580.53582.37
684281-8428186.77088.83
30min185873-8587388.40990.322.0791.2793.232.12
288126-8812690.72893.58
389569-8956992.21495.28
488734-8873491.35494.29
585113-8511387.62690.36
688956-8895691.58394.61
45min190233-9023392.89793.341.5296.7497.261.58
291616-9161694.32198.18
391241-9124193.93598.02
491173-9117393.86597.81
588060-8806090.66094.36
691677-9167794.38498.43
60min189651-8965192.29893.161.4197.1798.111.48
290596-9059693.27198.18
391925-9192594.63999.77
491616-9161694.32199.31
588494-8849491.10795.82
690665-9066593.34298.43
90min187456-8745690.03892.602.0495.9498.582.00
292201-9220194.924100.87
389835-8983592.48898.67
491221-9122193.91599.95
588173-8817390.77796.50
690764-9076493.44499.57
120min185899-8589988.43591.752.2295.3398.762.18
291211-9121193.904100.90
390059-9005992.71899.93
489430-8943092.07199.15
587694-8769490.28397.02
690414-9041493.084100.25
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190883-9088393.56794.360.63101.45102.390.72
291120-9112093.811101.85
392158-9215894.879103.12
492298-9229895.023103.13
591515-9151594.217101.95
691941-9194194.656102.86
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%
111.069682196942968169715897289970050.22
211.099680196781967910.02
单位质量响应值RSD%判断
8770.808727.770.35数据可信
供试品溶液-2025051221批-pH6.8(内含%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135818-3581836.76035.8419.3336.7635.8419.33
234350-3435035.25335.25
337264-3726438.24438.24
430096-3009630.88730.89
526127-2612726.81426.81
645897-4589747.10447.10
10min160683-6068362.27962.4411.6562.6962.8411.69
265634-6563467.36067.75
363041-6304164.69965.12
453367-5336754.77055.11
552026-5202653.39453.69
670296-7029672.14472.67
15min173020-7302074.94075.676.9276.0476.767.01
277637-7763779.67980.82
375831-7583177.82578.97
468204-6820469.99770.95
567551-6755169.32770.22
680125-8012582.23283.56
20min180512-8051282.62982.913.0884.5684.843.24
283243-8324385.43287.46
381967-8196784.12286.13
477502-7750279.54081.27
578233-7823380.29081.95
683245-8324585.43487.67
30min183779-8377985.98289.212.3988.8392.062.48
289545-8954591.90094.87
387953-8795390.26693.21
486289-8628988.55891.17
585707-8570787.96190.51
688293-8829390.61593.80
45min187957-8795790.27092.501.4594.0896.341.40
291663-9166394.07398.07
389712-8971292.07196.02
490133-9013392.50396.10
591244-9124493.64397.17
690055-9005592.42396.62
60min189024-8902491.36593.241.2896.1798.111.21
291714-9171494.12699.17
389889-8988992.25397.22
491259-9125993.65998.28
592039-9203994.45999.03
691172-9117293.56998.79
90min183688-8368885.88991.393.0591.7197.302.88
290587-9058792.96999.06
390098-9009892.46798.46
490543-9054392.92498.59
590578-9057892.96098.58
688774-8877491.10897.37
120min187246-8724689.54091.991.6296.3298.911.47
290356-9035692.73299.85
389983-8998392.34999.37
490976-9097693.368100.07
590694-9069493.07999.73
688531-8853190.85998.13
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191389-9138993.79294.091.33101.57102.041.24
291442-9144293.847102.00
391246-9124693.645101.69
493861-9386196.329104.06
590188-9018892.560100.25
691935-9193594.353102.64
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%
111.069697596656966419679796423966980.22
211.099869998585986420.09
单位质量响应值RSD%判断
8743.048894.681.22数据可信
供试品溶液-2025051221批-pH6.8(内含%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137946-3794638.63936.2015.2938.6436.2015.29
237220-3722037.90037.90
334677-3467735.31035.31
431146-3114631.71531.71
528478-2847828.99829.00
643852-4385244.65344.65
10min163026-6302664.17764.798.2764.6165.208.31
266171-6617167.38067.80
362116-6211663.25163.64
458859-5885959.93460.29
558844-5884459.91960.24
672763-7276374.09274.59
15min174231-7423175.58777.264.9076.7378.384.96
278677-7867780.11481.28
378707-7870780.14581.24
471933-7193373.24774.27
571660-7166072.96973.96
680014-8001481.47682.80
20min181267-8126782.75283.023.1884.7385.003.25
284596-8459686.14188.20
383324-8332484.84686.83
479280-7928080.72882.56
577806-7780679.22781.03
682895-8289584.40986.63
30min187077-8707788.66888.852.5291.5791.762.56
284779-8477986.32889.34
387935-8793589.54192.47
485735-8573587.30190.03
586893-8689388.48091.16
691140-9114092.80595.97
45min187432-8743289.02991.691.9292.9295.581.90
290876-9087692.53696.51
391697-9169793.37297.30
488357-8835789.97193.67
591203-9120392.86996.53
690679-9067992.33696.53
60min190527-9052792.18192.471.3497.0697.381.35
290590-9059092.24597.25
392448-9244894.13799.10
488821-8882190.44495.14
591569-9156993.24297.94
690899-9089992.56097.78
90min185197-8519786.75391.492.9892.6597.432.85
290158-9015891.80597.83
392791-9279194.486100.49
488673-8867390.29396.00
591665-9166593.34099.07
690623-9062392.27998.53
120min189541-8954191.17791.002.4098.0497.952.32
288652-8865290.27297.32
392031-9203193.712100.77
485732-8573287.29894.01
590824-9082492.48399.25
689427-8942791.06198.33
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189408-8940891.04192.561.8798.92100.531.75
289811-8981191.45299.50
391292-9129292.960101.06
489616-8961691.25398.93
593875-9387595.590103.38
691413-9141393.083101.37
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