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%
111.331014261012251013421011931012960.11
211.341010231012861011540.19
单位质量响应值RSD%判断
8940.518920.110.17数据可信
供试品溶液-2025051521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%
5min148405-4840548.67151.246.9048.6751.246.90
252662-5266252.95152.95
356037-5603756.34456.34
451510-5151051.79351.79
545850-4585046.10246.10
651285-5128551.56651.57
10min175806-7580676.22275.683.3276.7676.253.34
275889-7588976.30576.89
377863-7786378.29078.92
475647-7564776.06276.64
570461-7046170.84871.36
675927-7592776.34476.92
15min185223-8522385.69184.423.6987.0885.833.69
283316-8331683.77385.21
385403-8540385.87287.37
487231-8723187.71089.13
578221-7822178.65079.95
684338-8433884.80186.22
20min189751-8975190.24388.132.7192.5890.482.72
286972-8697287.44989.82
389938-8993890.43292.88
487094-8709487.57289.97
583554-8355484.01286.19
688571-8857189.05791.42
30min188297-8829788.78288.871.9092.1292.191.94
286941-8694187.41890.76
391146-9114691.64695.10
488956-8895689.44492.81
586380-8638086.85489.96
688566-8856689.05292.40
45min191564-9156492.06690.701.5396.4095.021.57
288667-8866789.15493.46
391721-9172192.22496.70
490603-9060391.10095.46
588525-8852589.01193.08
690167-9016790.66295.00
60min191018-9101891.51790.821.4796.8796.141.51
288757-8875789.24494.54
391344-9134491.84597.34
490384-9038490.88096.25
588669-8866989.15694.22
691765-9176592.26997.62
90min191093-9109391.59390.321.8097.9696.651.83
288396-8839688.88195.17
391216-9121691.71798.23
491057-9105791.55797.94
587384-8738487.86393.91
689802-8980290.29596.67
120min186715-8671587.19188.561.7294.5895.901.72
286854-8685487.33194.61
389825-8982590.31897.86
489370-8937089.86097.26
586591-8659187.06694.09
689108-8910889.59796.98
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190387-9038790.88390.600.6199.2498.920.66
290093-9009390.58798.84
390090-9009090.58499.13
490974-9097491.47399.87
589601-8960190.09398.09
689483-8948389.97498.35
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%
111.331019021018771017191019101016471018110.12
211.341014741016471015600.13
单位质量响应值RSD%判断
8985.978955.910.24数据可信
供试品溶液-2025051621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%
5min148629-4862948.67448.6510.8648.6748.6510.85
239699-3969939.73639.74
353018-5301853.06853.07
447563-4756347.60747.61
547887-4788747.93247.93
654823-5482354.87454.87
10min171227-7122771.29472.095.4071.8372.635.43
265605-6560565.66666.11
376139-7613976.21076.80
470201-7020170.26770.80
573721-7372173.79074.32
675256-7525675.32675.94
15min180207-8020780.28282.294.3481.6183.634.36
276919-7691976.99178.16
386793-8679386.87488.31
481587-8158781.66382.97
585366-8536685.44686.80
682391-8239182.46883.91
20min186202-8620286.28386.372.8788.5188.632.92
282685-8268582.76284.79
387902-8790287.98490.39
484738-8473884.81787.03
589833-8983389.91792.22
686399-8639986.48088.84
30min188392-8839288.47590.243.2091.6693.463.20
288121-8812188.20391.15
390572-9057290.65794.04
487434-8743487.51690.68
595223-9522395.31298.61
691204-9120491.28994.61
45min186180-8618086.26190.543.4090.4394.763.35
289809-8980989.89393.82
391445-9144591.53195.92
489386-8938689.47093.60
595587-9558795.676100.04
690313-9031390.39794.74
60min188111-8811188.19390.532.7093.3295.752.72
289231-8923189.31494.24
392214-9221492.30097.70
488756-8875688.83993.96
594514-9451494.602100.03
689847-8984789.93195.27
90min188103-8810388.18589.142.5194.2995.372.47
287674-8767487.75693.67
387387-8738787.46993.90
489278-8927889.36195.47
593414-9341493.50199.98
688503-8850388.58694.93
120min184899-8489984.97888.433.2592.0695.653.21
287107-8710787.18894.08
389732-8973289.81697.22
487002-8700287.08394.19
593245-9324593.332100.85
688091-8809188.17395.50
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191724-9172491.81092.271.0599.84100.481.15
292010-9201092.09699.96
391759-9175991.845100.24
491364-9136491.44999.52
594076-9407694.164102.71
692190-9219092.276100.58
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%
111.331010871010621011451009141013531011120.16
211.341007861009491008680.12
单位质量响应值RSD%判断
8924.278894.890.24数据可信
供试品溶液-2025051622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%
5min148706-4870649.08745.6710.8149.0945.6710.81
243897-4389744.24144.24
347430-4743047.80147.80
437569-3756937.86337.86
551334-5133451.73651.74
642941-4294143.27743.28
10min176295-7629576.89270.546.1777.4471.046.20
267611-6761168.14068.63
370725-7072571.27971.81
464073-6407364.57565.00
572999-7299973.57074.15
668227-6822768.76169.24
15min186289-8628986.96481.044.3888.3682.334.42
278128-7812878.74079.99
379061-7906179.68081.00
476973-7697377.57678.71
582993-8299383.64385.03
679032-7903279.65180.90
20min187956-8795688.64584.482.5891.0186.672.61
282801-8280183.44985.57
384312-8431284.97287.18
483133-8313383.78485.78
582638-8263883.28585.61
682091-8209182.73484.86
30min190450-9045091.15887.492.3294.5190.622.37
287297-8729787.98091.03
385470-8547086.13989.29
485624-8562486.29489.23
587069-8706987.75191.00
684954-8495485.61988.67
45min189737-8973790.43988.981.3794.8093.081.44
288993-8899389.69093.72
386978-8697887.65991.77
487628-8762888.31492.20
589293-8929389.99294.21
687078-8707887.76091.76
60min191788-9178892.50789.382.0197.8894.472.05
287748-8774888.43593.46
387928-8792888.61693.70
488730-8873089.42594.30
589321-8932190.02095.24
686606-8660687.28492.26
90min192234-9223492.95689.212.4499.3595.292.44
287737-8773788.42494.43
387690-8769088.37694.44
488896-8889689.59295.46
588809-8880989.50495.73
685711-8571186.38292.33
120min187463-8746388.14887.252.3195.5894.322.28
285599-8559986.26993.26
385709-8570986.38093.43
486635-8663587.31394.17
589924-8992490.62897.84
684083-8408384.74191.65
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190761-9076191.47191.820.8499.8899.870.81
292289-9228993.011100.96
391635-9163592.352100.36
490122-9012290.82798.66
591090-9109091.803100.03
690761-9076191.47199.32
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