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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.079253509250059240519234119228679241370.12
211.089172219180589176400.07
单位质量响应值RSD%判断
83481.2182819.490.57数据可信
供试品溶液-24050701SP批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min130311-303113.2703.9211.093.273.9211.09
237103-371034.0034.00
342540-425404.5894.59
437957-379574.0954.09
535774-357743.8593.86
634594-345943.7323.73
10min163230-632306.8217.366.366.867.416.39
269238-692387.4707.51
375039-750398.0958.15
467293-672937.2607.31
564229-642296.9296.97
670419-704197.5977.64
15min169871-698717.5387.712.907.657.832.97
272412-724127.8127.94
374815-748158.0718.21
471547-715477.7197.84
568893-688937.4327.55
671079-710797.6687.79
20min167178-671787.2477.713.997.447.924.02
272278-722787.7988.01
375295-752958.1238.35
472308-723087.8018.01
569295-692957.4767.68
672693-726937.8428.05
30min169165-691657.4627.723.297.748.023.28
272896-728967.8648.17
373471-734717.9268.25
470139-701397.5677.87
569161-691617.4617.75
674494-744948.0378.33
45min165081-650817.0217.5919.007.387.9718.13
268129-681297.3507.74
364012-640126.9067.31
463404-634046.8407.22
564134-641346.9197.29
697442-9744210.51210.90
60min164500-645006.9588.5632.257.409.0230.83
268688-686887.4107.88
384578-845789.1249.61
465145-651457.0287.49
563955-639556.9007.34
6129061-12906113.92314.43
极限167155-671557.2459.6336.397.7610.2034.92
276954-769548.3028.85
3108271-10827111.68112.27
469973-699737.5498.09
566070-660707.1287.65
6147278-14727815.88916.55
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%
110.002498422490422493492494292491802493680.13
29.992473642478572476100.15
单位质量响应值RSD%判断
24936.8024785.790.43数据可信
供试品溶液-24050701SP批-贝派度酸-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min157211-5721122.94821.016.8322.9521.006.83
254207-5420721.74321.74
347710-4771019.13719.14
453980-5398021.65221.65
552308-5230820.98120.98
648791-4879119.57119.57
10min1136983-13698354.94552.176.7255.2052.416.71
2122354-12235449.07749.32
3119993-11999348.13048.34
4136445-13644554.72954.97
5140129-14012956.20756.44
6124539-12453949.95450.17
15min1188646-18864675.66869.688.9776.5370.498.94
2164531-16453165.99566.78
3149275-14927559.87660.62
4184295-18429573.92274.77
5186812-18681274.93275.79
6168724-16872467.67768.45
20min1204172-20417281.89578.188.2683.6079.778.24
2185203-18520374.28775.81
3169278-16927867.89969.31
4208207-20820783.51485.18
5211265-21126584.74086.43
6191337-19133776.74778.27
30min1237103-23710395.10487.349.1297.7289.809.08
2204843-20484382.16484.51
3186677-18667774.87877.04
4229896-22989692.21394.81
5234859-23485994.20496.84
6213113-21311385.48287.86
45min1239209-23920995.94986.8710.6599.6290.3010.54
2206368-20636882.77686.03
3176534-17653470.80973.81
4225458-22545890.43394.06
5235490-23549094.45798.14
6216394-21639486.79890.12
60min1244271-24427197.97989.0810.09102.7293.4710.01
2212030-21203085.04789.23
3185486-18548674.40078.19
4232724-23272493.34897.98
5242493-24249397.266101.99
6215468-21546886.42690.72
极限1257898-257898103.44593.879.86109.2799.259.81
2223832-22383289.78194.90
3195157-19515778.27982.89
4243436-24343697.644103.31
5253399-253399101.641107.45
6230394-23039492.41397.66
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
111.079247939181639190549186399180349197370.32
211.089213129219149216130.05
单位质量响应值RSD%判断
83083.7483178.070.09数据可信
供试品溶液-24050701SP批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1213961-21396123.08825.5019.5223.0925.5019.53
2203067-20306721.91221.91
3315045-31504533.99534.00
4270653-27065329.20529.21
5209624-20962422.62022.62
6205673-20567322.19322.19
10min1491544-49154453.04057.2616.1653.3057.5416.16
2436397-43639747.09047.33
3623157-62315767.24267.62
4651357-65135770.28570.61
5490591-49059152.93853.19
6490841-49084152.96553.21
15min1634628-63462868.48079.4511.4069.3380.3811.42
2734769-73476979.28680.05
3807776-80777687.16488.29
4859563-85956392.75293.86
5677085-67708573.06173.90
6704159-70415975.98376.82
20min1706662-70666276.25382.4212.6177.8684.2212.62
2659107-65910771.12172.77
3884732-88473295.46897.56
4882016-88201695.17597.31
5709236-70923676.53178.18
6741038-74103879.96281.64
30min1770918-77091883.18686.5412.6185.6489.2612.59
2681326-68132673.51975.96
3959544-959544103.540106.69
4884087-88408795.39898.59
5766937-76693782.75785.26
6749244-74924480.84883.42
45min1751791-75179181.12381.6111.7684.5085.2911.76
2648769-64876970.00673.26
3894844-89484496.559100.86
4822741-82274188.77893.03
5712047-71204776.83480.26
6707583-70758376.35279.82
60min1733888-73388879.19182.6713.2883.4787.2613.18
2634791-63479168.49872.53
3931951-931951100.563105.94
4822090-82209088.70893.95
5760353-76035382.04686.32
6713735-71373577.01681.33
极限1757569-75756981.74686.6811.9886.9192.1911.97
2686007-68600774.02478.82
3963140-963140103.928110.42
4858658-85865892.65498.88
5791598-79159885.41890.60
6762875-76287582.31987.49
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%
110.002596882479172479762475672476952501692.13
29.992502512494312498410.24
单位质量响应值RSD%判断
25016.9025009.110.03数据可信
供试品溶液-24050701SP批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min118601-186017.4167.9414.497.427.9414.48
222982-229829.1629.16
318219-182197.2637.26
418745-187457.4737.47
516881-168816.7306.73
624041-240419.5849.58
10min157633-5763322.97722.418.1723.0622.508.17
261502-6150224.51924.62
348831-4883119.46819.55
458591-5859123.35923.44
552728-5272821.02121.10
657994-5799423.12123.23
15min186311-8631134.41034.388.4734.7534.728.41
280018-8001831.90132.28
376332-7633230.43130.73
493842-9384237.41237.75
586198-8619834.36534.67
694713-9471337.75938.12
20min1108960-10896043.43943.588.5044.1644.308.46
2121882-12188248.59149.32
394379-9437937.62638.26
4112918-11291845.01745.78
5104579-10457941.69342.38
6113188-11318845.12545.91
30min1139107-13910755.45854.377.0356.6655.577.01
2150849-15084960.13961.41
3120937-12093748.21449.27
4136348-13634854.35855.62
5134378-13437853.57354.73
6136577-13657754.45055.73
45min1159460-15946063.57260.127.9265.3961.937.86
2167181-16718166.65068.59
3132236-13223652.71954.31
4147895-14789558.96260.82
5146904-14690458.56760.32
6151153-15115360.26162.15
60min1172229-17222968.66367.285.5571.1969.755.55
2180011-18001171.76574.44
3153105-15310561.03963.21
4164171-16417165.45067.97
5174478-17447869.56071.96
6168540-16854067.19269.75
极限1194229-19422977.43476.686.4580.7279.906.43
2209817-20981783.64887.12
3172126-17212668.62271.47
4186907-18690774.51577.76
5196040-19604078.15681.33
6194841-19484177.67880.98
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