贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.239679679671679671939666619662679670510.07
211.259642529636489639500.05
单位质量响应值RSD%判断
86113.1885684.440.36数据可信
供试品溶液-1996048批-依折麦布-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%
5min139950-399504.1754.7611.274.184.7611.19
254195-541955.6645.66
347952-479525.0125.01
441482-414824.3354.34
543822-438224.5804.58
646019-460194.8104.81
10min164868-648686.7806.773.186.836.823.26
267990-679907.1067.17
365453-654536.8416.90
461773-617736.4566.50
563607-636076.6486.70
664828-648286.7756.83
15min171217-712177.4437.282.677.567.412.67
271107-711077.4327.57
370315-703157.3497.48
466325-663256.9327.05
568807-688077.1917.32
670355-703557.3537.48
20min172292-722927.5557.352.217.767.562.17
270616-706167.3807.60
370877-708777.4087.62
468789-687897.1897.39
568146-681467.1227.33
671107-711077.4327.64
30min168390-683907.1487.181.117.447.481.15
268525-685257.1627.47
369955-699557.3117.61
468130-681307.1207.40
567995-679957.1067.39
669313-693137.2447.54
45min173273-732737.6587.422.978.037.792.89
272225-722257.5487.93
371543-715437.4777.85
469566-695667.2717.63
567480-674807.0537.42
671903-719037.5157.89
60min174039-740397.7387.546.298.198.006.05
273166-731667.6478.12
375496-754967.8908.35
466998-669987.0027.44
566165-661656.9157.36
677112-771128.0598.52
极限180561-805618.4208.319.258.968.858.86
283928-839288.7729.33
389383-893839.3429.89
473071-730717.6378.15
569103-691037.2227.74
681019-810198.4689.01
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.122566502569842561032560252564752564470.16
210.092565292571322568300.17
单位质量响应值RSD%判断
25340.6125453.910.32数据可信
供试品溶液-1996048批-贝派度酸-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%
5min193144-9314436.57240.319.6636.5740.319.66
2115115-11511545.19945.20
3113285-11328544.48144.48
492752-9275236.41836.42
5104497-10449741.03041.03
697136-9713638.14038.14
10min1167907-16790765.92767.163.9966.3367.614.02
2177772-17777269.80170.30
3175609-17560968.95269.45
4159931-15993162.79663.20
5176328-17632869.23469.69
6168746-16874666.25766.68
15min1205658-20565880.75081.262.9281.8982.462.92
2207008-20700881.28082.56
3210004-21000482.45783.72
4196210-19621077.04078.14
5208737-20873781.95983.18
6214188-21418884.09985.26
20min1220576-22057686.60887.732.1588.6489.822.08
2216518-21651885.01487.20
3222064-22206487.19289.37
4223933-22393387.92689.88
5228639-22863989.77391.91
6228837-22883789.85191.95
30min1226484-22648488.92788.872.1091.9391.942.06
2219316-21931686.11389.24
3231136-23113690.75493.90
4222931-22293187.53290.47
5231660-23166090.96094.09
6226511-22651188.93892.03
45min1238691-23869193.72092.291.3997.7196.351.36
2230506-23050690.50694.59
3238525-23852593.65597.81
4232420-23242091.25895.17
5235284-23528492.38396.53
6234890-23489092.22896.31
60min1235346-23534692.40790.572.4797.4395.662.36
2220631-22063186.62991.72
3236239-23623992.75897.95
4228892-22889289.87394.79
5230080-23008090.33995.51
6232861-23286191.43196.54
极限1234049-23404991.89892.501.2197.9598.591.19
2232910-23291091.45097.50
3234738-23473892.16898.39
4233572-23357291.71097.63
5238259-23825993.55199.72
6239940-23994094.211100.33
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.239635369637379622769632529634819632560.06
211.259568049603209585620.26
单位质量响应值RSD%判断
85775.2485205.510.48数据可信
供试品溶液-1996048批-依折麦布-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%
5min138997-389974.0954.3418.854.104.3418.87
245136-451364.7404.74
344208-442084.6424.64
426514-265142.7842.78
545947-459474.8254.83
647182-471824.9554.95
10min159786-597866.2786.493.806.326.543.87
263044-630446.6206.67
365609-656096.8906.94
459258-592586.2236.25
561007-610076.4076.46
662371-623716.5506.60
15min165688-656886.8986.962.387.017.082.41
268272-682727.1697.30
368098-680987.1517.28
465887-658876.9197.02
565333-653336.8616.99
664343-643436.7576.88
20min166949-669497.0317.122.517.227.312.41
268870-688707.2327.44
369241-692417.2717.48
469684-696847.3187.49
566091-660916.9407.14
665797-657976.9107.11
30min166119-661196.9437.004.257.217.274.02
267288-672887.0667.35
367174-671747.0547.34
471502-715027.5097.77
563951-639516.7166.99
663784-637846.6986.98
45min166652-666526.9997.149.607.357.509.08
267280-672807.0657.43
366765-667657.0117.38
480541-805418.4588.80
565703-657036.9007.25
661175-611756.4246.78
60min168117-681177.1537.9419.997.588.3719.03
2102909-10290910.80711.25
369310-693107.2787.72
483727-837278.7929.23
565148-651486.8417.27
664436-644366.7677.19
极限166901-669017.0257.6115.077.538.1414.23
269384-693847.2867.85
377218-772188.1098.63
492585-925859.72310.26
565155-651556.8427.35
663813-638136.7017.20
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.122561132562242559322560132564452561450.08
210.092544602541232542920.10
单位质量响应值RSD%判断
25310.7725202.380.31数据可信
供试品溶液-1996048批-贝派度酸-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%
5min199133-9913339.14138.4717.0139.1438.4717.01
2101174-10117439.94739.95
3101954-10195440.25440.25
464671-6467125.53425.53
5109740-10974043.32943.33
6107907-10790742.60542.60
10min1166510-16651065.74366.164.6166.1866.584.68
2171102-17110267.55668.00
3172474-17247468.09868.55
4152411-15241160.17660.46
5171133-17113367.56868.05
6171708-17170867.79568.27
15min1198680-19868078.44579.584.6379.6180.744.65
2207015-20701581.73682.93
3216352-21635285.42286.63
4188700-18870074.50475.46
5198204-19820478.25779.49
6200315-20031579.09080.32
20min1213584-21358484.32984.861.1686.3786.911.27
2216169-21616985.35087.45
3217936-21793686.04888.20
4211190-21119083.38485.16
5213958-21395884.47786.58
6216726-21672685.57087.68
30min1224370-22437088.58888.551.4591.5691.541.49
2224767-22476788.74591.80
3229481-22948190.60693.72
4221794-22179487.57190.28
5220037-22003786.87789.92
6225230-22523088.92791.98
45min1228518-22851890.22690.950.8894.1894.930.89
2227877-22787789.97394.01
3232657-23265791.86095.98
4230657-23065791.07094.75
5229814-22981490.73794.74
6232657-23265791.86095.90
60min1230703-23070391.08890.791.4596.0595.781.44
2225857-22585789.17594.21
3234946-23494692.76497.90
4228707-22870790.30094.99
5227402-22740289.78594.80
6232107-23210791.64396.71
极限1230143-23014390.86791.801.4296.8497.801.39
2230253-23025390.91196.94
3238863-23886394.310100.48
4233094-23309492.03297.73
5231641-23164191.45997.47
6231108-23110891.24897.33
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.239600219617649587809590089584859596120.14
211.259574489564109569290.08
单位质量响应值RSD%判断
85450.7685060.360.33数据可信
供试品溶液-1993854批-依折麦布-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%
5min137198-371983.9174.5310.463.924.5310.43
239663-396634.1774.18
348848-488485.1445.14
442674-426744.4944.49
547630-476305.0165.02
642180-421804.4424.44
10min161508-615086.4776.652.936.526.702.98
260902-609026.4136.46
365348-653486.8816.94
462650-626506.5976.65
565186-651866.8646.92
663425-634256.6796.73
15min167061-670617.0627.101.887.187.231.91
266487-664877.0017.12
369183-691837.2857.42
465778-657786.9277.05
567934-679347.1547.29
668381-683817.2017.32
20min169141-691417.2817.220.957.477.430.99
267471-674717.1057.30
369062-690627.2727.49
468175-681757.1797.38
568696-686967.2347.45
668960-689607.2627.47
30min163071-630716.6416.973.896.927.253.79
267301-673017.0877.36
368827-688277.2487.54
466461-664616.9987.28
568454-684547.2087.50
663041-630416.6386.92
45min168373-683737.2007.171.397.557.531.43
267158-671587.0727.42
368588-685887.2227.60
466608-666087.0147.37
569013-690137.2677.64
668550-685507.2187.58
60min169094-690947.2767.190.997.707.630.94
268070-680707.1687.60
369027-690277.2697.72
467347-673477.0927.53
568155-681557.1777.63
667938-679387.1547.59
极限169089-690897.2757.211.387.787.731.33
268615-686157.2257.74
369196-691967.2867.82
466628-666287.0167.53
568706-687067.2357.77
668712-687127.2357.75
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.122547092551522551442543932552852549370.15
210.092543912541422542660.07
单位质量响应值RSD%判断
25191.4025199.800.03数据可信
供试品溶液-1993854批-贝派度酸-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%
5min186465-8646534.22142.1412.9034.2242.1412.90
298589-9858939.02039.02
3128033-12803350.67350.67
4109359-10935943.28243.28
5108739-10873943.03743.04
6107582-10758242.57942.58
10min1164613-16461365.15169.115.1065.5369.585.14
2166359-16635965.84266.28
3187924-18792474.37774.94
4171182-17118267.75168.23
5177589-17758970.28770.76
6180083-18008371.27471.75
15min1203926-20392680.71181.823.0481.8183.053.08
2200754-20075479.45580.62
3215036-21503685.10886.50
4199586-19958678.99380.23
5208991-20899182.71583.97
6212022-21202283.91585.18
20min1222656-22265688.12487.551.4690.1289.691.50
2216022-21602285.49887.55
3224233-22423388.74891.08
4218765-21876586.58488.69
5221533-22153387.67989.86
6223973-22397388.64590.84
30min1228587-22858790.47189.703.0193.4592.812.92
2227716-22771690.12693.12
3232212-23221291.90695.23
4225624-22562489.29892.37
5231918-23191891.78994.94
6213713-21371384.58487.77
45min1236830-23683093.73392.811.5097.7296.921.49
2231107-23110791.46895.47
3234926-23492692.98097.32
4229277-22927790.74494.81
5237971-23797194.18598.36
6236807-23680793.72497.85
60min1239848-23984894.92892.801.9899.9597.941.92
2233991-23399192.61097.63
3238856-23885694.53599.91
4228624-22862490.48695.56
5235770-23577093.31498.53
6229673-22967390.90196.06
极限1243230-24323096.26693.582.44102.3599.762.31
2238898-23889894.552100.60
3237730-23773094.090100.52
4225915-22591589.41395.49
5236970-23697093.789100.04
6235969-23596993.39399.57
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.239589519590819602839593379602359595770.07
211.259640809641089640940.01
单位质量响应值RSD%判断
85447.6485697.240.21数据可信
供试品溶液-1993854批-依折麦布-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%
5min141664-416644.3714.1010.464.374.1010.51
237729-377293.9583.96
333390-333903.5033.50
444957-449574.7164.72
536444-364443.8233.82
640059-400594.2034.20
10min163609-636096.6736.592.446.726.642.41
261055-610556.4056.45
363675-636756.6806.72
463460-634606.6586.71
564410-644106.7576.80
660754-607546.3746.42
15min166032-660326.9287.002.077.057.112.05
265482-654826.8706.98
368187-681877.1547.27
467838-678387.1177.24
567624-676247.0957.21
664914-649146.8106.93
20min166847-668477.0137.091.787.217.281.76
268387-683877.1757.37
368119-681197.1467.34
468606-686067.1987.40
567983-679837.1327.33
665465-654656.8687.06
30min165617-656176.8847.022.447.167.302.40
265134-651346.8337.10
368393-683937.1757.45
468477-684777.1847.47
568326-683267.1687.44
665559-655596.8787.15
45min166803-668037.0087.377.767.367.727.48
268965-689657.2357.58
369625-696257.3047.66
481077-810778.5068.87
568162-681627.1517.51
666707-667076.9987.34
60min166513-665136.9787.051.047.417.491.10
267018-670187.0317.46
367927-679277.1267.56
468178-681787.1537.61
567103-671037.0407.47
666547-665476.9827.41
极限165039-650396.8237.041.747.337.561.70
266981-669817.0277.53
368218-682187.1577.67
467616-676167.0947.63
568078-680787.1427.66
666928-669287.0227.52
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.122558312543372559472547362548122551330.29
210.092564832566302565560.05
单位质量响应值RSD%判断
25210.7725426.760.61数据可信
供试品溶液-1993854批-贝派度酸-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%
5min1109921-10992143.29438.2315.7243.2938.2315.72
295772-9577237.72137.72
375865-7586529.88129.88
4117546-11754646.29746.30
585763-8576333.77933.78
697492-9749238.39938.40
10min1177212-17721269.79868.653.2570.2869.083.29
2166478-16647865.57065.99
3169872-16987266.90767.24
4181921-18192171.65272.17
5177472-17747269.90070.28
6172859-17285968.08368.51
15min1205544-20554480.95781.521.8582.2182.711.87
2200397-20039778.92980.08
3206912-20691281.49582.57
4211488-21148883.29884.61
5209547-20954782.53383.69
6207965-20796581.91083.09
20min1218639-21863986.11486.901.5588.2789.001.58
2217516-21751685.67287.70
3218341-21834185.99787.98
4225709-22570988.89991.14
5224078-22407888.25790.33
6219532-21953286.46688.56
30min1224888-22488888.57690.703.0191.6993.762.95
2218784-21878486.17189.15
3232440-23244091.55094.49
4235660-23566092.81896.04
5235559-23555992.77995.83
6234360-23436092.30695.36
45min1231840-23184091.31493.891.9295.4197.961.85
2234336-23433692.29796.23
3244012-24401296.108100.06
4239505-23950594.33398.59
5241888-24188895.27199.35
6238767-23876794.04298.12
60min1231452-23145291.16193.001.8496.2798.111.79
2230120-23012090.63695.60
3239103-23910394.17499.20
4236764-23676493.25398.56
5240474-24047494.71499.85
6238856-23885694.07799.20
极限1221832-22183287.37292.753.3893.5098.893.19
2232213-23221391.46197.43
3239891-23989194.485100.55
4235061-23506192.58298.92
5244681-24468196.371102.56
6239252-23925294.233100.40
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