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%
111.069804198051979919780197795979360.14
211.099816198059981100.08
单位质量响应值RSD%判断
8854.978846.710.07数据可信
供试品溶液-2025051521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%
5min142748-4274843.36844.4214.3243.3744.4214.32
247357-4735748.04448.04
351036-5103651.77751.78
434268-3426834.76534.77
548082-4808248.78048.78
639208-3920839.77739.78
10min168403-6840369.39670.915.7569.8871.405.79
270709-7070971.73572.27
375415-7541576.51077.08
466536-6653667.50267.89
573327-7332774.39174.93
664986-6498665.92966.37
15min178112-7811279.24680.903.1280.5082.183.19
281576-8157682.76084.09
381531-8153182.71484.14
477697-7769778.82579.96
582715-8271583.91685.28
676819-7681977.93479.11
20min181659-8165982.84485.352.4584.9887.542.53
286221-8622187.47289.72
386236-8623687.48889.83
482552-8255283.75085.76
585447-8544786.68788.99
682688-8268883.88885.93
30min186389-8638987.64389.211.7490.7092.341.83
289522-8952290.82194.04
388926-8892690.21793.53
485931-8593187.17890.12
589209-8920990.50493.77
687612-8761288.88491.86
45min187990-8799089.26791.561.9093.2995.671.98
291396-9139692.72396.95
391386-9138692.71297.03
489059-8905990.35294.26
592372-9237293.71397.98
689278-8927890.57494.53
60min188910-8891090.20092.572.2095.2297.712.25
292142-9214293.47998.74
391690-9169093.02198.37
489895-8989591.20096.11
594560-9456095.932101.24
690306-9030691.61796.58
90min187871-8787189.14692.362.3895.1798.522.40
292651-9265193.996100.30
391866-9186693.19999.58
489338-8933890.63596.56
593688-9368895.048101.42
690802-9080292.12098.10
120min184753-8475385.98391.012.9893.0098.202.91
291059-9105992.38199.73
390313-9031391.62499.04
489083-8908390.37697.31
592504-9250493.847101.28
690520-9052091.83498.84
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192352-9235293.69293.780.99101.66101.980.97
292669-9266994.014102.39
391058-9105892.380100.82
491959-9195993.294101.23
593777-9377795.138103.61
692787-9278794.134102.16
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%
111.069798398182981119797898389981290.18
211.099779397769977810.02
单位质量响应值RSD%判断
8872.428817.040.45数据可信
供试品溶液-2025051521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%
5min143604-4360444.26845.124.0544.2745.124.06
246378-4637847.08447.08
346793-4679347.50547.51
442541-4254143.18943.19
544531-4453145.20945.21
642828-4282843.48043.48
10min167633-6763368.66371.332.1869.1571.842.17
270917-7091771.99772.52
370085-7008571.15271.68
471056-7105672.13872.62
572113-7211373.21173.71
669781-6978170.84371.33
15min177499-7749978.67981.311.9379.9382.601.93
281916-8191683.16384.49
379177-7917780.38281.70
480525-8052581.75183.03
580510-8051081.73683.05
680923-8092382.15583.43
20min181846-8184683.09285.601.4985.2287.801.49
284604-8460485.89288.14
384855-8485586.14788.36
484994-8499486.28888.48
585254-8525486.55288.78
684322-8432285.60687.79
30min183510-8351084.78188.342.0987.8391.492.07
287233-8723388.56191.76
387308-8730888.63791.81
488482-8848289.82992.98
588370-8837089.71592.90
687177-8717788.50491.64
45min187092-8709288.41891.341.6892.4195.471.68
290951-9095192.33696.52
389717-8971791.08395.24
490522-9052291.90096.05
591245-9124592.63496.82
690300-9030091.67595.79
60min186766-8676688.08791.332.0293.0696.481.99
291679-9167993.07598.29
389189-8918990.54795.71
491336-9133692.72797.89
590819-9081992.20297.41
689998-8999891.36896.50
90min185120-8512086.41691.023.0092.3797.182.91
290615-9061591.99598.24
387818-8781889.15595.33
492150-9215093.55399.75
591726-9172693.12299.36
690502-9050291.88098.03
120min186827-8682788.14991.012.1995.0698.182.16
291219-9121992.60899.88
387819-8781989.15696.32
491441-9144192.833100.07
591138-9113892.52699.80
689410-8941090.77197.94
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189303-8930390.66392.781.4098.56100.961.43
292928-9292894.343102.64
391751-9175193.148101.30
491481-9148192.874101.14
592252-9225293.656101.96
690631-9063192.011100.19
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%
111.069729297245975789749397434974080.15
211.099818898433983100.18
单位质量响应值RSD%判断
8807.238864.740.47数据可信
供试品溶液-2025051521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%
5min137701-3770138.31346.048.8438.3146.048.84
244871-4487145.59945.60
345669-4566946.41046.41
449121-4912149.91849.92
547376-4737648.14548.14
647067-4706747.83147.83
10min162787-6278763.80670.524.9264.2371.034.95
269243-6924370.36770.87
370583-7058371.72972.24
472582-7258273.76074.31
570505-7050571.64972.18
670682-7068271.82972.36
15min172859-7285974.04179.143.4575.1880.433.49
279372-7937280.66081.95
377830-7783079.09380.41
480680-8068081.98983.36
577741-7774179.00380.33
678747-7874780.02581.35
20min177624-7762478.88483.023.0280.8485.193.07
282600-8260083.94186.13
381542-8154282.86585.06
485263-8526386.64788.93
581215-8121582.53384.74
681900-8190083.22985.45
30min182500-8250083.83986.422.2786.6789.522.32
286855-8685588.26591.38
383153-8315384.50387.61
487305-8730588.72291.97
585435-8543586.82289.95
685017-8501786.39789.54
45min183948-8394885.31088.812.7789.0892.872.78
290065-9006591.52795.62
385023-8502386.40390.45
489260-8926090.70994.94
588330-8833089.76493.85
687728-8772889.15293.26
60min183426-8342684.78089.362.9689.4994.402.98
290749-9074992.22297.34
387220-8722088.63693.65
489967-8996791.42796.67
588731-8873190.17195.26
687492-8749288.91294.01
90min183251-8325184.60290.023.6790.2696.063.64
291922-9192293.41499.55
387448-8744888.86794.86
491847-9184793.33899.60
587741-8774189.16595.25
689280-8928090.72996.81
120min187545-8754588.96690.881.6995.5697.921.79
290565-9056592.03599.21
387775-8777589.20096.18
491254-9125492.735100.03
590115-9011591.57898.66
689338-8933890.78897.88
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191057-9105792.53592.051.82100.12100.101.77
291279-9127992.760100.96
387680-8768089.10397.08
492480-9248093.981102.31
589876-8987691.33599.43
691088-9108892.566100.67
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