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%
111.159789398150979039812297953980040.13
211.029798198342981620.27
单位质量响应值RSD%判断
8789.608907.620.95数据可信
加速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%
5min126395-2639526.78632.2825.0726.7932.2825.08
240619-4061941.22141.22
337230-3723037.78237.78
439058-3905839.63739.64
524308-2430824.66824.67
623270-2327023.61523.61
10min155900-5590056.72861.2612.6257.0361.6212.68
268619-6861969.63670.09
363416-6341664.35564.78
468958-6895869.98070.42
552497-5249753.27553.55
652831-5283153.61453.88
15min171126-7112672.18075.517.2373.1176.557.35
279424-7942480.60181.83
377635-7763578.78579.92
480501-8050181.69482.91
569011-6901170.03370.90
668769-6876969.78870.65
20min179296-7929680.47182.034.1682.2083.914.35
283480-8348084.71786.84
383077-8307784.30886.32
484767-8476786.02388.15
577462-7746278.61080.25
676923-7692378.06379.70
30min184849-8484986.10687.611.4088.7390.401.60
287325-8732588.61991.69
386311-8631187.59090.54
487825-8782589.12692.21
586677-8667787.96190.48
685009-8500986.26888.77
45min188787-8878790.10290.561.4393.6894.331.19
287756-8775689.05693.11
388825-8882590.14194.06
488966-8896690.28494.36
591542-9154292.89896.39
689570-8957090.89794.36
60min191756-9175693.11591.672.0597.7096.441.72
290218-9021891.55596.60
387822-8782289.12394.04
488394-8839489.70494.78
591948-9194893.31097.84
691846-9184693.20797.68
90min185031-8503186.29190.002.7791.9195.792.54
289110-8911090.43096.49
386971-8697188.25994.17
488430-8843089.74095.81
591388-9138892.74298.31
691172-9117292.52398.03
120min187634-8763488.93289.172.0595.5195.961.74
287026-8702688.31595.38
385845-8584587.11794.01
486942-8694288.23095.30
590954-9095492.30198.90
688803-8880390.11996.65
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189011-8901190.33091.551.2897.8999.321.15
291079-9107992.428100.47
389496-8949690.82298.68
489043-8904390.36298.41
591522-9152292.878100.50
691102-9110292.45299.99
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%
111.159772897541976679728997579975610.18
211.029792897879979040.04
单位质量响应值RSD%判断
8749.878884.211.08数据可信
加速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%
5min125842-2584226.31934.8814.0626.3234.8814.06
238147-3814738.85138.85
331956-3195632.54632.55
435276-3527635.92735.93
539019-3901939.73939.74
635239-3523935.89035.89
10min150531-5053151.46461.539.6851.7661.929.70
262808-6280863.96864.40
357084-5708458.13858.50
464919-6491966.11866.52
566411-6641167.63768.08
660761-6076161.88362.28
15min167070-6707068.30875.676.1769.1776.746.24
276002-7600277.40578.55
371093-7109372.40673.41
477577-7757779.00980.14
579669-7966981.14082.33
674384-7438475.75776.84
20min177187-7718778.61282.003.3680.2483.913.46
279891-7989181.36683.37
379602-7960281.07282.88
483108-8310884.64286.65
584374-8437485.93288.03
678905-7890580.36282.29
30min183723-8372385.26987.301.6287.7790.121.77
286815-8681588.41891.32
384315-8431585.87288.58
486152-8615287.74390.69
587132-8713288.74191.79
686179-8617987.77090.59
45min187014-8701488.62090.212.4292.0694.002.49
290155-9015591.81995.71
385687-8568787.26990.94
487875-8787589.49793.42
591529-9152993.21997.25
689189-8918990.83694.63
60min188670-8867090.30790.321.2194.7495.121.27
289680-8968091.33696.24
386661-8666188.26192.90
488908-8890890.54995.47
588751-8875190.39095.46
689453-8945391.10595.91
90min183540-8354085.08289.323.1690.5195.123.15
291562-9156293.25299.18
386357-8635787.95193.57
487162-8716288.77194.70
587914-8791489.53795.61
689672-8967291.32897.15
120min184812-8481286.37888.612.4192.7695.402.41
289989-8998991.65098.61
385636-8563687.21793.81
485582-8558287.16294.08
586915-8691588.52095.59
689094-8909490.73997.57
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189891-8989191.55191.041.2698.8998.821.21
288603-8860390.23998.22
387758-8775889.37896.94
489784-8978491.44299.32
589320-8932090.96999.02
690994-9099492.674100.51
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