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)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%
111.159684496710967979650897136967990.24
211.199696097117970380.12
单位质量响应值RSD%判断
8681.528671.850.08数据可信
供试品溶液-B0069N01批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13449-34493.5999.8231.533.609.8231.53
210559-1055911.01811.02
310058-1005810.49510.50
410057-1005710.49410.49
511401-1140111.89711.90
610942-1094211.41811.42
10min124832-2483225.91232.2510.1525.9532.3610.21
231474-3147432.84332.97
330892-3089232.23532.35
433564-3356435.02435.14
531716-3171633.09533.23
632947-3294734.38034.51
15min141055-4105542.84046.794.6743.1747.264.76
245934-4593447.93148.42
343747-4374745.64946.12
446506-4650648.52849.03
545691-4569147.67848.18
646118-4611848.12348.63
20min151642-5164253.88855.461.7554.6956.441.87
253940-5394056.28657.31
352437-5243754.71755.70
453620-5362055.95257.00
553247-5324755.56356.59
653977-5397756.32457.37
30min161965-6196564.66064.961.3066.0666.561.29
261146-6114663.80565.45
362866-6286665.60067.19
461581-6158164.25965.93
563091-6309165.83567.48
662878-6287865.61267.28
45min168256-6825671.22471.521.7073.3573.841.69
269927-6992772.96875.32
367105-6710570.02372.34
467747-6774770.69373.07
568229-6822971.19673.57
669950-6995072.99275.39
60min173630-7363076.83276.811.9179.7479.931.87
274760-7476078.01181.18
371841-7184174.96578.06
471960-7196075.08978.26
575009-7500978.27181.44
674435-7443577.67280.88
90min179506-7950682.96382.710.7786.7386.680.71
279631-7963183.09487.13
379585-7958583.04686.98
478479-7847981.89285.89
579865-7986583.33887.38
678508-7850881.92285.99
120min180492-8049283.99285.582.0388.6890.472.02
282549-8254986.13991.09
379705-7970583.17188.02
481886-8188685.44790.36
583902-8390287.55192.52
683523-8352387.15592.14
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184381-8438188.05089.041.4693.6794.881.45
285800-8580089.53195.44
385132-8513288.83494.61
483493-8349387.12492.98
586479-8647990.24096.18
686674-8667490.44396.39
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)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%
111.159699497084969239681996988969620.11
211.199702496740968820.21
单位质量响应值RSD%判断
8696.148657.910.32数据可信
供试品溶液-B0069N01批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110800-1080011.26911.412.6111.2711.412.61
210599-1059911.06011.06
311245-1124511.73411.73
410644-1064411.10611.11
511162-1116211.64711.65
611141-1114111.62511.63
10min138006-3800639.65739.983.8339.7840.113.82
235875-3587537.43437.56
337684-3768439.32139.45
439081-3908140.77940.90
539971-3997141.70841.84
639288-3928840.99541.12
15min155596-5559658.01256.831.8558.5857.401.84
253439-5343955.76156.30
354211-5421156.56657.13
455447-5544757.85658.43
554850-5485057.23357.83
653225-5322555.53856.12
20min163454-6345466.21164.871.5567.4266.071.54
261812-6181264.49865.66
361129-6112963.78564.98
462984-6298465.72166.94
562458-6245865.17266.40
661158-6115863.81565.02
30min173154-7315476.33373.342.9878.2875.262.92
270879-7087973.95975.83
369629-6962972.65474.56
471170-7117074.26276.21
570063-7006373.10775.06
666811-6681169.71471.62
45min180490-8049083.98780.981.9086.7883.721.88
276971-7697180.31583.01
377095-7709580.44583.16
477727-7772781.10483.88
576434-7643479.75582.52
676913-7691380.25582.94
60min182596-8259686.18583.731.7389.9187.371.72
279676-7967683.13886.73
378876-7887682.30385.91
480432-8043283.92787.60
580866-8086684.38088.03
679030-7903082.46486.04
90min187305-8730591.09887.582.3595.7892.152.29
282721-8272186.31590.83
384697-8469788.37792.90
484336-8433688.00092.61
582526-8252686.11290.70
682002-8200285.56590.06
120min188713-8871392.56888.923.2398.2694.463.11
285149-8514988.84994.32
384911-8491188.60094.10
487965-8796591.78797.37
581741-8174185.29390.84
682808-8280886.40691.85
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194354-9435498.45491.593.92105.1898.123.78
286839-8683990.61297.07
385193-8519388.89595.38
488598-8859892.44899.05
586214-8621489.96096.45
685485-8548589.19995.60
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)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%
111.159672196969970399711597031969750.16
211.199680796751967790.05
单位质量响应值RSD%判断
8697.318648.700.40数据可信
供试品溶液-B0069N01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%
5min118259-1825919.06118.1210.6719.0618.1210.67
214960-1496015.61715.62
315222-1522215.89115.89
418285-1828519.08819.09
519581-1958120.44120.44
617810-1781018.59318.59
10min144675-4467546.63844.157.1446.8544.357.15
239692-3969241.43641.61
337572-3757239.22339.40
443683-4368345.60245.81
542933-4293344.81945.05
645203-4520347.18947.40
15min159831-5983162.46059.304.0763.1959.994.10
254714-5471457.11857.75
353514-5351455.86556.48
457566-5756660.09560.81
557139-5713959.65060.37
658065-5806560.61661.35
20min166953-6695369.89566.854.6071.3268.204.61
262231-6223164.96566.23
359496-5949662.11063.34
467309-6730970.26671.65
564478-6447867.31168.70
663780-6378066.58267.99
30min172623-7262375.81473.582.5178.0175.672.58
268693-6869371.71173.70
368190-6819071.18673.11
471645-7164574.79376.96
571557-7155774.70176.84
670172-7017273.25575.40
45min178703-7870382.16179.102.7685.2082.012.80
273193-7319376.40979.20
373816-7381677.05979.77
475579-7557978.90081.90
577396-7739680.79783.76
675928-7592879.26482.22
60min181356-8135684.93182.342.2888.8986.132.34
276717-7671780.08883.72
377282-7728280.67884.25
479606-7960683.10486.98
580148-8014883.66987.53
678123-7812381.55585.39
90min183861-8386187.54685.272.5392.4589.982.54
281760-8176085.35289.88
378471-7847181.91986.39
481672-8167285.26090.06
583846-8384687.53092.32
680470-8047084.00688.75
120min187254-8725491.08888.351.7296.9694.001.76
283910-8391087.59793.07
383500-8350087.16992.55
483502-8350287.17192.92
585292-8529289.03994.81
684333-8433388.03893.72
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191116-9111695.11989.963.07102.0096.603.02
283693-8369387.37093.82
384887-8488788.61794.96
485534-8553489.29296.01
586930-8693090.74997.50
684902-8490288.63295.29
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