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%
111.099790197872980299765297856978620.14
211.069804997827979380.17
单位质量响应值RSD%判断
8824.358855.150.25数据可信
供试品溶液-2025051221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139867-3986740.49637.6423.9140.5037.6423.91
224087-2408724.46724.47
345685-4568546.40646.41
433192-3319233.71633.72
547254-4725448.00048.00
632264-3226432.77332.77
10min170773-7077371.89067.1312.1072.3467.5512.17
253872-5387254.72354.99
373902-7390275.06975.58
461183-6118362.14962.52
573523-7352374.68475.22
663275-6327564.27464.64
15min180875-8087582.15279.366.6083.4080.526.73
269922-6992271.02671.91
382544-8254483.84785.20
474917-7491776.10077.17
583319-8331984.63586.00
677161-7716178.37979.46
20min186200-8620087.56184.744.9189.7286.785.07
276093-7609377.29478.96
386312-8631287.67589.96
481788-8178883.07984.99
586755-8675588.12590.43
683374-8337484.69086.64
30min186816-8681688.18789.302.4991.3292.282.67
285433-8543386.78289.31
389460-8946090.87394.13
486384-8638487.74890.58
591335-9133592.77796.06
688020-8802089.41092.30
45min188279-8827989.67391.911.8493.7995.891.91
289468-8946890.88194.37
390358-9035891.78596.05
490562-9056291.99295.80
593246-9324694.71899.03
690956-9095692.39296.28
60min184603-8460385.93990.583.2591.0595.583.21
286892-8689288.26492.77
390688-9068892.12097.40
491614-9161493.06197.89
591915-9191593.36698.73
689310-8931090.72095.63
90min188237-8823789.63090.751.4795.7096.761.44
289102-8910290.50995.99
387772-8777289.15895.47
490441-9044191.86997.73
591230-9123092.67099.07
689242-8924290.65196.57
120min185443-8544386.79288.851.7093.8595.871.70
287097-8709788.47294.96
386773-8677388.14395.44
488753-8875390.15497.04
589601-8960191.01698.45
687173-8717388.54995.47
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188345-8834589.74092.371.4597.77100.381.42
290841-9084192.27599.75
391781-9178193.230101.51
491624-9162493.071100.96
591535-9153592.980101.42
691494-9149492.939100.85
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%
111.099756097494976929762797616975980.08
211.069756597490975280.06
单位质量响应值RSD%判断
8800.548818.080.15数据可信
供试品溶液-2025051221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140259-4025941.03637.8224.2441.0437.8224.23
223944-2394424.40624.41
345573-4557346.45246.45
432751-3275133.38333.38
547553-4755348.47148.47
632516-3251633.14333.14
10min171258-7125872.63367.5912.4673.0968.0212.53
254111-5411155.15555.43
374648-7464876.08976.60
460589-6058961.75862.13
573881-7388175.30775.85
663400-6340064.62364.99
15min181718-8171883.29579.996.6884.5681.176.82
269952-6995271.30272.19
382678-8267884.27385.64
475200-7520076.65177.71
583502-8350285.11386.49
677827-7782779.32980.42
20min186259-8625987.92485.144.7690.1187.204.93
276503-7650377.97979.66
386361-8636188.02890.33
481591-8159183.16585.07
586731-8673188.40590.73
683706-8370685.32187.29
30min187217-8721788.90089.782.5992.0792.782.78
285467-8546787.11689.66
389713-8971391.44494.72
486194-8619487.85790.69
591554-9155493.32196.62
688319-8831990.02392.94
45min188357-8835790.06292.201.9194.2296.211.98
289221-8922190.94394.45
389987-8998791.72496.02
490622-9062292.37196.18
593275-9327595.07599.42
691280-9128093.04196.96
60min184492-8449286.12290.893.2591.2895.923.18
286829-8682988.50593.03
390226-9022691.96797.28
491592-9159293.35998.19
591686-9168693.45598.85
690203-9020391.94496.89
90min189239-8923990.96191.681.3097.0797.711.21
290581-9058192.32997.83
388694-8869490.40696.74
491053-9105392.81098.68
591284-9128493.04699.48
688799-8879990.51396.48
120min184925-8492586.56489.532.0893.6996.581.99
287761-8776189.45595.98
387230-8723088.91396.25
489695-8969591.42698.33
589889-8988991.62499.09
687509-8750989.19896.17
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187973-8797389.67192.471.6197.75100.521.56
290592-9059292.34099.86
390839-9083992.592100.92
492061-9206193.838101.76
591767-9176793.538102.02
691094-9109492.852100.82
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%
111.099834798197981129800798317981960.15
211.069904598848989460.15
单位质量响应值RSD%判断
8854.468946.290.73数据可信
供试品溶液-2025051221批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128939-2893929.19638.1014.4629.2038.1014.46
239261-3926139.61039.61
344247-4424744.64144.64
441385-4138541.75341.75
538620-3862038.96338.96
634145-3414534.44934.45
10min157349-5734957.85966.177.6958.1866.597.73
266889-6688967.48467.92
370785-7078571.41571.91
470460-7046071.08771.55
563074-6307463.63564.07
664951-6495165.52965.91
15min172316-7231672.95979.465.0973.9380.625.14
279962-7996280.67381.86
381917-8191782.64683.94
482807-8280783.54384.80
575669-7566976.34277.48
679874-7987480.58481.70
20min181782-8178282.50985.462.5784.2987.502.66
283753-8375384.49886.58
385839-8583986.60288.81
487694-8769488.47490.66
583175-8317583.91585.90
685983-8598386.74888.75
30min185703-8570386.46589.942.6189.1692.942.65
288551-8855189.33992.36
388202-8820288.98692.16
491991-9199192.80995.97
588915-8891589.70692.63
691545-9154592.35995.33
45min191024-9102491.83491.501.8995.4995.491.73
289133-8913389.92693.94
388826-8882689.61693.77
490399-9039991.20395.40
593575-9357594.40798.32
691195-9119592.00696.00
60min187353-8735388.13090.962.6092.8195.972.52
290716-9071691.52396.54
387147-8714787.92293.08
491309-9130992.12197.33
592583-9258393.40698.37
691847-9184792.66497.68
90min189543-8954390.33990.871.5995.9996.891.50
288617-8861789.40595.44
388862-8886289.65295.78
489787-8978790.58696.82
592122-9212292.94198.95
691499-9149992.31398.36
120min188060-8806088.84390.002.4195.5097.032.30
287660-8766088.44095.47
387142-8714287.91795.04
490859-9085991.66798.91
592696-9269693.520100.56
688836-8883689.62696.70
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190212-9021291.01491.542.1098.6699.561.95
290161-9016190.96398.97
388016-8801688.79996.90
490259-9025991.06299.32
593478-9347894.309102.39
692247-9224793.067101.14
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