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%
111.099737797208973569743197382973510.09
211.069728997054971720.18
单位质量响应值RSD%判断
8778.278785.900.07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%
5min129415-2941530.07627.8510.1730.0827.8510.16
226422-2642227.01527.02
331517-3151732.22532.22
424232-2423224.77624.78
526920-2692027.52527.52
624902-2490225.46125.46
10min153287-5328754.48454.333.4154.8254.643.44
251714-5171452.87553.18
356133-5613357.39457.75
452362-5236253.53853.81
554119-5411955.33455.64
651191-5119152.34152.62
15min163370-6337064.79364.791.2665.7365.701.31
263008-6300864.42365.31
364445-6444565.89266.89
462981-6298164.39565.27
564096-6409665.53566.46
662277-6227763.67664.54
20min168148-6814869.67869.661.8271.3471.301.83
267910-6791069.43571.04
370260-7026071.83873.57
467409-6740968.92370.51
566573-6657368.06869.72
668489-6848970.02771.60
30min175394-7539477.08776.862.2379.5279.262.23
274773-7477376.45278.83
376751-7675178.47581.00
473819-7381975.47777.83
577318-7731879.05481.46
672961-7296174.59976.95
45min179178-7917880.95681.612.1984.2584.872.19
279574-7957481.36184.59
381928-8192883.76887.17
479049-7904980.82484.01
581768-8176883.60486.89
677387-7738779.12582.30
60min183715-8371585.59584.972.6589.7889.142.61
283284-8328485.15489.28
384430-8443086.32690.65
481621-8162183.45487.54
585912-8591287.84192.05
679661-7966181.45085.51
90min187644-8764489.61289.272.5594.7594.382.51
287707-8770789.67794.75
388287-8828790.27095.56
485323-8532387.23992.25
590555-9055592.58997.78
684326-8432686.22091.18
120min185832-8583287.76090.052.2293.9096.152.17
289479-8947991.48897.56
389724-8972491.73998.03
487855-8785589.82895.81
589892-8989291.91198.13
685649-8564987.57293.49
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190154-9015492.17993.540.9599.29100.650.95
292311-9231194.384101.47
392562-9256294.641101.95
491339-9133993.390100.37
591369-9136993.421100.66
691194-9119493.242100.14
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%
111.099722897440972969747197344973560.11
211.069767697858977670.14
单位质量响应值RSD%判断
8778.728839.690.49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%
5min161016-6101662.19560.478.4762.1960.468.47
259834-5983460.99060.99
351236-5123652.22652.23
455731-5573156.80856.81
564243-6424365.48465.48
663857-6385765.09165.09
10min183775-8377585.39484.152.5986.0884.822.63
281440-8144083.01383.69
379602-7960281.14081.72
481346-8134682.91883.55
583649-8364985.26585.99
685496-8549687.14887.87
15min190666-9066692.41890.142.4594.0691.742.47
287223-8722388.90890.51
384654-8465486.29087.77
489602-8960291.33392.89
589276-8927691.00192.68
689146-8914690.86892.56
20min192931-9293194.72793.431.6697.3996.041.62
291009-9100992.76795.36
391631-9163193.40195.84
492287-9228794.07096.64
589010-8901090.73093.42
693112-9311294.91197.61
30min195909-9590997.76295.821.63101.4899.471.57
292317-9231794.10197.72
394786-9478696.617100.10
494813-9481396.645100.26
592028-9202893.80697.50
694176-9417695.99699.75
45min192924-9292494.71995.851.1899.52100.561.11
295325-9532597.167101.83
394277-9427796.099100.65
494216-9421696.036100.72
592526-9252694.31499.05
694959-9495996.794101.62
60min193714-9371495.52595.541.48101.38101.321.43
291677-9167793.44899.19
393872-9387295.686101.31
494982-9498296.817102.57
592752-9275294.544100.33
695398-9539897.241103.14
90min193605-9360595.41494.960.55102.33101.800.60
292939-9293994.735101.52
392613-9261394.402101.09
493346-9334695.150101.98
592632-9263294.422101.26
693801-9380195.613102.59
120min190718-9071892.47193.331.11100.45101.221.03
290361-9036192.10799.94
392600-9260094.389102.12
491788-9178893.561101.45
591096-9109692.856100.74
692817-9281794.610102.65
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191300-9130093.06492.661.16102.07101.591.12
288962-8896290.68199.54
391268-9126893.031101.81
491105-9110592.865101.79
590678-9067892.430101.35
692086-9208693.865102.96
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%
111.099816398145976449771997773978890.26
211.069716397285972240.09
单位质量响应值RSD%判断
8826.788790.600.30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%
5min143821-4382144.67042.6310.5644.6742.6310.56
233729-3372934.38234.38
345693-4569346.57846.58
441846-4184642.65742.66
545201-4520146.07746.08
640624-4062441.41141.41
10min165642-6564266.91469.171.9567.4169.641.93
268110-6811069.42969.81
367631-6763168.94169.46
467461-6746168.76869.24
568763-6876370.09570.61
669513-6951370.86071.32
15min175004-7500476.45779.192.9577.7080.432.87
280324-8032481.88083.03
376515-7651577.99779.28
476966-7696678.45779.70
576599-7659978.08379.37
680679-8067982.24283.49
20min180450-8045082.00984.893.0684.1087.012.98
286320-8632087.99290.06
380499-8049982.05884.21
483086-8308684.69686.81
583300-8330084.91487.07
686000-8600087.66689.83
30min181666-8166683.24887.943.4886.2591.003.39
289530-8953091.26494.31
385118-8511886.76789.83
486012-8601287.67890.73
585638-8563887.29790.40
689622-8962291.35894.49
45min180127-8012781.67989.544.8585.6093.584.71
290924-9092492.68596.74
386795-8679588.47692.50
488561-8856190.27794.30
588332-8833290.04394.12
692268-9226894.05598.21
60min183445-8344585.06290.053.8289.8995.093.74
292039-9203993.82298.91
387312-8731289.00394.01
487280-8728088.97194.00
587561-8756189.25794.33
692399-9239994.18999.38
90min185874-8587487.53891.563.0993.3297.603.04
292463-9246394.254100.38
387827-8782789.52895.53
490904-9090492.66598.68
588925-8892590.64896.71
692953-9295394.754101.00
120min185830-8583087.49389.643.7594.2496.693.62
290623-9062392.37999.55
382641-8264184.24291.23
488011-8801189.71696.76
588870-8887090.59297.66
691638-9163893.413100.71
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190709-9070992.46694.081.68100.19102.131.65
293836-9383695.654103.85
392841-9284194.640102.57
493520-9352095.332103.37
590044-9004491.78899.87
692791-9279194.589102.92
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