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%
111.159696297135969769720296765970080.18
211.199747897508974930.03
单位质量响应值RSD%判断
8700.278712.510.10数据可信
供试品溶液-B0012N01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%
5min110377-1037710.79117.0329.9110.7917.0329.90
213906-1390614.46114.46
312713-1271313.22113.22
417261-1726117.95017.95
522233-2223323.12123.12
621794-2179422.66422.66
10min138772-3877240.32052.3618.7940.4452.5618.82
244152-4415245.91546.08
343733-4373345.47945.63
455135-5513557.33657.54
562933-6293365.44665.70
657402-5740259.69459.95
15min168995-6899571.75077.598.2072.3278.368.28
268993-6899371.74872.42
370440-7044073.25273.90
483989-8398987.34288.18
577094-7709480.17281.16
678129-7812981.24882.16
20min178755-7875581.89986.415.0483.2688.045.18
277997-7799781.11182.58
381738-8173885.00186.47
487504-8750490.99892.80
586995-8699590.46892.34
685575-8557588.99290.81
30min189610-8961093.18894.691.7795.4697.281.98
288774-8877492.31894.69
390727-9072794.34996.76
492397-9239796.08698.90
592226-9222695.90898.79
692604-9260496.30199.11
45min194749-9474998.53297.431.30101.84101.081.37
292712-9271296.41499.81
392330-9233096.01699.48
493300-9330097.025100.91
595496-9549699.309103.25
693557-9355797.292101.17
60min196181-96181100.02198.470.98104.43103.200.94
293468-9346897.200101.67
394647-9464798.426102.95
494036-9403697.791102.75
594963-9496398.755103.80
694855-9485598.642103.60
90min189934-8993493.52594.791.3299.04100.611.49
290274-9027493.87899.42
390755-9075594.379100.00
490689-9068994.310100.36
592964-9296496.676102.82
692292-9229295.977102.03
120min190237-9023793.84095.751.86100.40102.621.80
293998-9399897.751104.34
391400-9140095.049101.72
490717-9071794.339101.44
591737-9173795.400102.62
694343-9434398.110105.23
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189464-8946493.03693.412.00100.63101.342.10
288039-8803991.55499.23
387794-8779491.29999.02
489902-8990293.491101.64
591507-9150795.161103.44
692219-9221995.901104.11
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%
111.159818697701975529777097583977580.27
211.199707897111970940.03
单位质量响应值RSD%判断
8767.538676.850.74数据可信
供试品溶液-B0012N01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%
5min115922-1592216.52816.2913.6416.5316.2913.64
213290-1329013.79613.80
317991-1799118.67618.68
413055-1305513.55213.55
517864-1786418.54418.54
616024-1602416.63416.63
10min132751-3275133.99835.152.9034.1835.332.91
233666-3366634.94835.10
333145-3314534.40734.61
433769-3376935.05535.21
535538-3553836.89137.10
634298-3429835.60435.79
15min140794-4079442.34742.191.8342.9142.761.86
239858-3985841.37541.92
340683-4068342.23242.82
440346-4034641.88242.42
541985-4198543.58344.20
640177-4017741.70742.29
20min142873-4287344.50544.771.6945.5445.811.63
242812-4281244.44245.44
342315-4231543.92644.98
444278-4427845.96446.97
542746-4274644.37345.47
643728-4372845.39346.44
30min146997-4699748.78648.941.0150.3150.480.99
247531-4753149.34050.84
346902-4690248.68850.23
447168-4716848.96450.48
547796-4779649.61651.21
646464-4646448.23349.78
45min150043-5004351.94851.042.1854.0253.122.09
248093-4809349.92451.97
348385-4838550.22752.32
450771-5077152.70454.76
549310-4931051.18753.33
648401-4840150.24452.33
60min150090-5009051.99752.311.3954.6454.961.35
249219-4921951.09353.69
350768-5076852.70155.35
450962-5096252.90255.55
550214-5021452.12654.84
651070-5107053.01455.66
90min152450-5245054.44753.401.7557.6756.631.63
250830-5083052.76555.93
351775-5177553.74656.98
451098-5109853.04356.28
550172-5017252.08255.37
652331-5233154.32357.55
120min150948-5094852.88854.221.7256.7258.041.65
251271-5127153.22356.97
352711-5271154.71858.55
453143-5314355.16658.99
552783-5278354.79258.66
652539-5253954.53958.37
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154054-5405456.11255.641.0460.5360.061.00
252865-5286554.87859.22
354188-5418856.25160.69
453963-5396356.01760.45
553483-5348355.51960.00
653043-5304355.06259.50
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%
111.159710297292970219716797331971830.14
211.199738097471974260.07
单位质量响应值RSD%判断
8715.968706.520.08数据可信
供试品溶液-B0012N01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%
5min119705-1970520.48018.519.1220.4818.519.12
217745-1774518.44318.44
315632-1563216.24716.25
419527-1952720.29520.30
517799-1779918.49918.50
616435-1643517.08217.08
10min137823-3782339.31136.963.9039.5437.163.93
235613-3561337.01437.22
334232-3423235.57935.76
435891-3589137.30337.53
535822-3582237.23137.44
633967-3396735.30335.49
15min142241-4224143.90344.212.1044.5744.822.07
242517-4251744.19044.81
341529-4152943.16343.74
443318-4331845.02245.66
541769-4176943.41244.03
643830-4383045.55546.14
20min147597-4759749.47046.243.7450.6247.343.71
244310-4431046.05347.16
343509-4350945.22146.28
444939-4493946.70747.85
543395-4339545.10246.20
643176-4317644.87545.96
30min149511-4951151.45950.811.7253.1652.431.76
249083-4908351.01452.63
347621-4762149.49551.05
450003-5000351.97053.63
548557-4855750.46852.07
648520-4852050.42952.02
45min150633-5063352.62553.061.1154.9055.250.98
250571-5057152.56154.75
351381-5138153.40355.51
450435-5043552.41954.66
551613-5161353.64455.81
651668-5166853.70155.85
60min151978-5197854.02353.342.0656.8856.121.99
249995-4999551.96254.73
350113-5011352.08554.79
451273-5127353.29056.11
552199-5219954.25357.01
652384-5238454.44557.19
90min152279-5227954.33654.360.5557.7957.730.49
252375-5237554.43657.78
352327-5232754.38657.67
451934-5193453.97757.39
552117-5211754.16857.53
652785-5278554.86258.21
120min152100-5210054.15054.091.7158.2158.061.62
251264-5126453.28157.23
351212-5121253.22757.11
451884-5188453.92557.94
553649-5364955.76059.72
652134-5213454.18558.14
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153473-5347355.57756.070.6960.2460.640.58
253881-5388156.00160.54
354098-5409856.22760.70
453806-5380655.92360.53
553871-5387155.99160.57
654581-5458156.72961.29
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%
111.159695797102969709713497181970690.11
211.199878598678987320.08
单位质量响应值RSD%判断
8705.748823.240.95数据可信
供试品溶液-B0012N01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%
5min117643-1764318.22718.309.0218.2318.309.01
215938-1593816.46516.47
315781-1578116.30316.30
419450-1945020.09320.09
518142-1814218.74218.74
619343-1934319.98319.98
10min133564-3356434.67435.291.5234.8835.491.51
234976-3497636.13336.32
333699-3369934.81434.99
434103-3410335.23135.45
534474-3447435.61435.82
634126-3412635.25535.48
15min139608-3960840.91841.041.6741.5141.641.66
240132-4013241.46042.04
338802-3880240.08640.65
439139-3913940.43441.05
540205-4020541.53542.14
640481-4048141.82042.43
20min140881-4088142.23343.542.2643.2844.602.21
243455-4345544.89245.94
342228-4222843.62544.64
442637-4263744.04745.11
541224-4122442.58843.65
642475-4247543.88044.96
30min146917-4691748.46946.983.4349.9848.523.34
246396-4639647.93149.47
343426-4342644.86246.36
445835-4583547.35148.90
543614-4361445.05746.60
646675-4667548.21949.78
45min145475-4547546.97947.582.4349.0349.642.39
247756-4775649.33651.41
345055-4505546.54548.54
446201-4620147.72949.81
544937-4493746.42348.46
646916-4691648.46850.57
60min144868-4486846.35247.022.4048.9249.602.33
246498-4649848.03650.66
345183-4518346.67849.19
446887-4688748.43851.05
543932-4393245.38547.94
645695-4569547.20749.85
90min147080-4708048.63747.881.5251.7250.981.46
247274-4727448.83852.00
345599-4559947.10750.14
446226-4622647.75550.90
546211-4621147.74050.80
645664-4566447.17550.34
120min145235-4523546.73147.923.3550.3651.563.15
245976-4597647.49751.20
344393-4439345.86149.42
448318-4831849.91653.59
548068-4806849.65853.25
646304-4630447.83651.52
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147748-4774849.32749.552.4353.4753.732.33
249361-4936150.99455.22
346097-4609747.62251.69
448511-4851150.11654.35
548745-4874550.35754.50
647346-4734648.91253.13
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