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%
111.099603396252962279602996105961290.11
211.069620896130961690.06
单位质量响应值RSD%判断
8668.088695.210.23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%
5min143337-4333744.82344.0211.5244.8244.0211.53
245583-4558347.14647.15
345367-4536746.92346.92
433051-3305134.18434.18
542032-4203243.47343.47
645991-4599147.56847.57
10min170401-7040172.81567.097.6473.3167.587.60
271458-7145873.90874.43
363303-6330365.47465.99
463774-6377465.96166.34
560414-6041462.48562.97
659848-5984861.90062.43
15min180533-8053383.29482.212.4584.6083.452.48
281531-8153184.32785.67
380250-8025083.00284.25
477547-7754780.20681.32
580460-8046083.21984.40
676610-7661079.23780.45
20min183587-8358786.45386.761.7988.6988.911.79
285448-8544888.37890.66
384066-8406686.94889.12
483934-8393486.81288.82
585068-8506887.98590.09
681192-8119283.97686.07
30min188164-8816491.18790.932.5894.3894.042.54
289722-8972292.79896.06
388223-8822391.24894.39
488671-8867191.71194.68
589262-8926292.32395.40
683471-8347186.33389.36
45min188009-8800991.02792.602.4695.2396.732.40
291252-9125294.38198.68
389887-8988792.96997.12
491600-9160094.74198.73
590587-9058793.69397.80
685868-8586888.81292.80
60min191086-9108694.20993.592.5199.4398.742.44
291003-9100394.12399.47
390231-9023193.32598.51
492883-9288396.068101.11
591505-9150594.64399.79
686218-8621889.17494.15
90min190379-9037993.47893.172.7599.7499.362.69
292852-9285296.036102.43
388632-8863291.67197.89
491741-9174194.887100.99
590933-9093394.051100.25
685934-8593488.88194.85
120min186741-8674189.71591.032.0497.0298.261.99
289205-8920592.26499.72
387530-8753090.53197.77
489594-8959492.66699.83
589718-8971892.794100.04
685314-8531488.23995.19
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190395-9039593.49494.181.14101.79102.421.03
291784-9178494.931103.41
389282-8928292.343100.59
491779-9177994.926103.12
591270-9127094.399102.67
691848-9184894.997102.93
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%
111.099716397202974009710097121971970.13
211.069733697245972900.07
单位质量响应值RSD%判断
8764.388796.560.26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%
5min142492-4249243.45443.1411.2043.4543.1411.20
245188-4518846.21146.21
344994-4499446.01346.01
433055-3305533.80433.80
541881-4188142.83042.83
645502-4550246.53346.53
10min170544-7054472.14269.997.5672.6270.467.58
271584-7158473.20573.72
371070-7107072.68073.19
458099-5809959.41559.79
570822-7082272.42672.90
668502-6850270.05370.57
15min178694-7869480.47680.942.3281.7682.202.33
280649-8064982.47683.80
380524-8052482.34883.67
477901-7790179.66580.70
580812-8081282.64283.92
676312-7631278.04079.34
20min183829-8382985.72885.841.4487.9188.001.43
285058-8505886.98489.23
383725-8372585.62187.85
484087-8408785.99187.91
585129-8512987.05789.26
681815-8181583.66885.83
30min187848-8784889.83889.412.6392.9792.522.56
289354-8935491.37894.59
387283-8728389.26092.44
488414-8841490.41693.29
588706-8870690.71593.88
682965-8296584.84487.94
45min187776-8777689.76491.502.4793.8995.602.38
291070-9107093.13397.36
389853-8985391.88896.06
491201-9120193.26697.15
591093-9109393.15697.33
685859-8585987.80491.84
60min192291-9229194.38192.582.7199.5197.702.59
290943-9094393.00398.26
389907-8990791.94397.14
492518-9251894.61399.53
591590-9159093.66498.87
685924-8592487.87092.88
90min190578-9057892.62992.032.5098.8098.172.41
291643-9164393.718100.01
389381-8938191.40597.62
491801-9180193.88099.85
590771-9077192.82799.08
685754-8575487.69693.68
120min186479-8647988.43889.832.0695.6497.002.00
289295-8929591.31798.65
387784-8778489.77297.01
489141-8914191.16098.17
589383-8938391.40798.69
684965-8496586.88993.85
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189762-8976291.79593.481.9299.98101.651.69
292273-9227394.363102.71
389173-8917391.19399.43
492300-9230094.390102.41
591082-9108293.145101.44
693865-9386595.991103.92
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%
111.099754797404975779746997547975090.08
211.069710597080970920.02
单位质量响应值RSD%判断
8792.528778.660.12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%
5min141882-4188242.80541.1015.2442.8141.1015.24
232276-3227632.98832.99
344452-4445245.43245.43
432952-3295233.67933.68
546882-4688247.91647.92
642807-4280743.75143.75
10min168748-6874870.26468.486.4970.7468.946.54
259974-5997461.29661.66
367676-6767669.16869.67
463802-6380265.20965.58
571457-7145773.03373.56
670369-7036971.92172.41
15min180190-8019081.95880.363.9283.2181.584.00
273469-7346975.08976.14
378864-7886480.60381.88
476629-7662978.31979.42
581428-8142883.22384.57
681179-8117982.96984.25
20min186117-8611788.01686.062.4190.1888.172.34
285953-8595387.84889.73
380773-8077382.55484.72
483038-8303884.86986.84
584270-8427086.12888.40
685052-8505286.92789.13
30min189556-8955691.53189.572.2194.6892.642.23
284282-8428286.14089.00
386490-8649088.39791.48
488739-8873990.69693.61
588462-8846290.41393.64
688323-8832390.27093.44
45min188893-8889390.85391.700.7495.0195.760.72
289772-8977291.75195.57
389054-8905491.01895.09
490112-9011292.09996.02
589848-8984891.82996.06
690648-9064892.64796.82
60min190992-9099292.99892.090.9998.1797.170.94
290333-9033392.32597.16
388434-8843490.38495.46
490620-9062092.61897.56
590173-9017392.16197.41
690050-9005092.03697.24
90min190830-9083092.83391.581.1899.0497.681.22
288640-8864090.59496.45
388053-8805389.99596.08
489711-8971191.68997.66
590295-9029592.28698.56
690098-9009892.08598.31
120min188156-8815690.10089.630.7397.3496.760.78
287604-8760489.53696.40
386644-8664488.55495.64
487550-8755089.48096.47
588520-8852090.47297.77
687727-8772789.66196.91
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190287-9028792.27892.391.10100.52100.511.13
289565-8956591.54099.40
389217-8921791.18499.25
490784-9078492.786100.77
592034-9203494.063102.37
690491-9049192.486100.73
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