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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959911199126993409922699250992110.10
211.019937699339993580.03
单位质量响应值RSD%判断
9060.379024.340.29数据可信
供试品溶液-B0083N01批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130362-3036230.40129.559.3530.4029.559.35
230846-3084630.88630.89
332769-3276932.81132.81
424535-2453524.56724.57
529160-2916029.19829.20
629373-2937329.41129.41
10min162923-6292363.00464.347.5063.3464.667.50
264102-6410264.18564.53
367980-6798068.06868.43
455417-5541755.48955.76
566993-6699367.08067.40
668106-6810668.19468.52
15min179903-7990380.00680.163.7181.0481.203.75
280421-8042180.52581.58
380688-8068880.79281.91
474915-7491575.01275.90
580208-8020880.31281.38
684176-8417684.28585.37
20min185987-8598786.09887.582.4888.0289.512.52
285642-8564285.75387.70
388992-8899289.10791.13
484991-8499185.10186.82
590030-9003090.14692.11
689145-8914589.26091.28
30min187106-8710687.21991.202.6690.1094.102.58
289126-8912689.24192.15
392221-9222192.34095.35
493032-9303293.15295.82
591965-9196592.08495.05
693016-9301693.13696.15
45min190299-9029990.41694.312.3694.2798.232.28
293053-9305393.17397.07
395080-9508095.20399.24
496235-9623596.359100.06
594518-9451894.64098.63
695927-9592796.051100.10
60min189444-8944489.56092.692.5694.4297.662.46
289849-8984989.96594.90
393780-9378093.90198.99
495250-9525095.373100.15
593305-9330593.42698.46
693799-9379993.92099.04
90min190865-9086590.98291.831.9496.8397.831.86
289145-8914589.26095.19
392190-9219092.30998.44
493541-9354193.66299.50
590822-9082290.93997.02
693733-9373393.854100.01
120min187664-8766487.77791.112.4194.6498.132.33
289337-8933789.45296.37
392447-9244792.56699.73
493032-9303293.152100.03
590541-9054190.65897.74
692924-9292493.044100.25
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186195-8619586.30690.802.9494.1498.832.78
289668-8966889.78497.70
392648-9264892.768100.96
493768-9376893.889101.80
590328-9032890.44598.54
691476-9147691.59499.83
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959966399223998749929899208994530.31
211.019969099649996700.03
单位质量响应值RSD%判断
9082.479052.680.24数据可信
供试品溶液-B0083N01批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130141-3014130.09629.864.9830.1029.864.98
227337-2733727.29627.30
331038-3103830.99230.99
431633-3163331.58631.59
529730-2973029.68629.69
629548-2954829.50429.50
10min164108-6410864.01263.893.9564.3564.223.94
263238-6323863.14463.45
364586-6458664.49064.83
465894-6589465.79666.15
566624-6662466.52466.85
659472-5947259.38359.71
15min178536-7853678.41979.381.7279.4680.421.71
279992-7999279.87280.88
377587-7758777.47178.53
480440-8044080.32081.40
581350-8135081.22882.30
679066-7906678.94879.94
20min184020-8402083.89485.732.2685.8187.652.25
286566-8656686.43788.33
384970-8497084.84386.76
487219-8721987.08989.06
588631-8863188.49990.47
683745-8374583.62085.48
30min190838-9083890.70291.263.2093.5594.143.14
292200-9220092.06294.92
386326-8632686.19789.06
492519-9251992.38195.32
595229-9522995.08798.04
691275-9127591.13993.93
45min191358-9135891.22193.411.5195.0897.301.52
294261-9426194.12098.00
392975-9297592.83696.66
494423-9442394.28298.25
595337-9533795.19599.21
692961-9296192.82296.63
60min187110-8711086.98089.851.6991.8594.771.63
290143-9014390.00894.93
389973-8997389.83994.69
490329-9032990.19495.21
590747-9074790.61195.68
691577-9157791.44096.28
90min188963-8896388.83090.651.5694.6796.581.55
291688-9168891.55197.47
389570-8957089.43695.29
492014-9201491.87797.89
592337-9233792.19998.27
690151-9015190.01695.87
120min185332-8533285.20589.202.6492.0396.142.54
290340-9034090.20597.14
388947-8894788.81495.66
489595-8959589.46196.50
592554-9255492.41699.52
689262-8926289.12995.98
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185670-8567085.54289.442.2793.3197.362.17
290104-9010489.96997.91
389306-8930689.17397.00
490402-9040290.26798.30
590546-9054690.41198.54
691388-9138891.25199.10
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959910599245992549926299261992250.07
211.019956699686996260.09
单位质量响应值RSD%判断
9061.649048.680.11数据可信
供试品溶液-B0069N01批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124976-2497624.97327.179.1724.9727.179.17
227256-2725627.25327.25
327070-2707027.06727.07
424130-2413024.12724.13
531044-3104431.04031.04
628572-2857228.56828.57
10min159440-5944059.43261.514.7359.7161.814.74
262121-6212162.11362.42
361386-6138661.37861.68
458409-5840958.40258.67
566765-6676566.75667.10
660979-6097960.97161.29
15min175706-7570675.69678.592.1676.6379.582.19
278407-7840778.39779.39
379468-7946879.45880.44
478312-7831278.30279.22
580847-8084780.83781.92
678875-7887578.86579.86
20min187288-8728887.27785.881.1989.0687.741.14
284493-8449384.48286.35
386872-8687286.86188.73
485632-8563285.62187.41
585475-8547585.46487.45
685564-8556485.55387.42
30min190313-9031390.30190.902.5893.0593.722.55
288679-8867988.66891.47
389141-8914189.13091.96
489687-8968789.67692.41
593391-9339193.37996.31
694276-9427694.26497.09
45min192785-9278592.77393.112.1296.5396.942.11
291211-9121191.19994.99
392176-9217692.16495.99
491597-9159791.58595.32
596266-9626696.254100.23
694688-9468894.67698.55
60min188865-8886588.85489.505.5093.6494.365.28
287097-8709787.08691.89
381420-8142081.41086.25
491449-9144991.43796.19
595375-9537595.363100.40
692868-9286892.85697.78
90min193496-9349693.48492.862.3499.2598.712.32
290301-9030190.28996.06
392374-9237492.36298.11
490598-9059890.58696.35
595366-9536695.354101.45
695081-9508195.069101.02
120min188413-8841388.40290.512.4295.2197.392.39
288104-8810488.09394.86
389324-8932489.31396.09
491604-9160491.59298.37
593228-9322893.216100.38
692438-9243892.42699.44
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190750-9075090.73891.391.5398.5399.281.57
291451-9145191.43999.19
389732-8973289.72197.49
490369-9036990.35798.15
592973-9297392.961101.16
693107-9310793.095101.13
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.9510007599822992549926299261995350.39
211.019956699686996260.09
单位质量响应值RSD%判断
9089.959048.680.33数据可信
供试品溶液-B0069N01批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124976-2497624.93427.139.1824.9327.139.17
227256-2725627.21027.21
327070-2707027.02427.02
424130-2413024.08924.09
531044-3104430.99230.99
628572-2857228.52428.52
10min159440-5944059.34061.414.7359.6261.724.75
262121-6212162.01662.32
361386-6138661.28361.58
458409-5840958.31158.58
566765-6676566.65367.00
660979-6097960.87661.19
15min175706-7570675.57978.472.1676.5179.462.20
278407-7840778.27579.27
379468-7946879.33480.32
478312-7831278.18079.10
580847-8084780.71181.80
678875-7887578.74279.74
20min187288-8728887.14185.741.1988.9287.601.14
284493-8449384.35186.21
386872-8687286.72688.59
485632-8563285.48887.27
585475-8547585.33187.31
685564-8556485.42087.29
30min190313-9031390.16190.762.5892.9193.572.54
288679-8867988.53091.33
389141-8914188.99191.82
489687-8968789.53692.27
593391-9339193.23496.16
694276-9427694.11796.93
45min192785-9278592.62992.962.1296.3796.782.11
291211-9121191.05794.84
392176-9217692.02195.84
491597-9159791.44395.17
596266-9626696.104100.07
694688-9468894.52998.39
60min188865-8886588.71589.365.5093.4994.215.28
287097-8709786.95091.74
381420-8142081.28386.12
491449-9144991.29596.04
595375-9537595.214100.25
692868-9286892.71297.63
90min193496-9349693.33992.712.3499.1098.562.32
290301-9030190.14995.91
392374-9237492.21897.96
490598-9059890.44596.20
595366-9536695.205101.30
695081-9508194.921100.86
120min188413-8841388.26490.372.4295.0697.242.38
288104-8810487.95694.72
389324-8932489.17495.94
491604-9160491.45098.21
593228-9322893.071100.22
692438-9243892.28299.28
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190750-9075090.59791.241.5398.3899.121.56
291451-9145191.29799.04
389732-8973289.58197.34
490369-9036990.21798.00
592973-9297392.816101.00
693107-9310792.950100.97
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115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.95100075998229968499913100068999120.17
211.019935399670995120.23
单位质量响应值RSD%判断
9124.389038.330.68数据可信
供试品溶液-B0069N01批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129547-2954729.45926.978.3329.4626.968.33
226456-2645626.37726.38
328063-2806327.97927.98
426121-2612126.04326.04
528768-2876828.68228.68
623321-2332123.25123.25
10min161239-6123961.05659.455.4261.3859.755.43
258389-5838958.21458.51
362670-6267062.48362.79
458513-5851358.33858.63
562665-6266562.47862.80
654304-5430454.14254.40
15min177131-7713176.90077.752.6377.9178.712.66
277386-7738677.15578.09
380156-8015679.91680.92
477451-7745177.21978.16
580597-8059780.35681.37
675154-7515474.92975.79
20min183136-8313682.88785.201.8284.7587.021.82
285106-8510684.85286.65
386399-8639986.14188.03
485541-8554185.28587.08
587722-8772287.46089.37
684801-8480184.54786.24
30min186158-8615885.90089.362.3488.6892.132.30
291572-9157291.29894.04
391312-9131291.03993.89
490188-9018889.91892.66
590402-9040290.13293.01
688121-8812187.85890.49
45min188336-8833688.07292.252.3891.8196.022.33
293297-9329793.01896.77
393636-9363693.35697.22
494471-9447194.18997.93
593421-9342193.14297.02
692018-9201891.74395.35
60min186046-8604685.78990.002.5690.5094.782.51
289742-8974289.47494.26
392441-9244192.16597.06
491197-9119790.92495.71
591993-9199391.71896.63
690190-9019089.92094.55
90min189275-8927589.00891.491.6294.6897.281.59
292318-9231892.04297.82
392712-9271292.43598.36
493574-9357493.29499.09
591227-9122790.95496.89
691478-9147891.20496.83
120min185849-8584985.59289.792.7592.2596.602.64
289126-8912688.86095.66
391149-9114990.87697.83
493207-9320792.92899.76
590932-9093290.66097.60
690112-9011289.84396.48
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188022-8802287.75990.372.7295.3798.182.60
288748-8874888.48396.27
391267-9126790.99498.95
494965-9496594.681102.55
591052-9105290.78098.73
689820-8982089.55197.19
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