依折麦布贝派度酸片项目信息
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%
111.159683789689009678989678799675699681250.06
211.179658659677419668030.14
单位质量响应值RSD%判断
86827.3586553.540.23数据可信
供试品溶液-1996049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%
5min143758-437584.5324.788.574.534.788.57
251512-515125.3345.33
344618-446184.6214.62
444897-448974.6494.65
550680-506805.2485.25
641724-417244.3214.32
10min162815-628156.5056.471.466.566.531.44
262250-622506.4476.51
360811-608116.2976.35
463366-633666.5626.61
563049-630496.5296.59
662732-627326.4966.54
15min168614-686147.1066.862.077.236.982.08
266545-665456.8917.02
365402-654026.7736.89
466496-664966.8867.01
565703-657036.8046.93
664637-646376.6946.81
20min168897-688977.1357.011.397.347.211.40
268502-685027.0947.30
368178-681787.0607.26
466850-668506.9237.12
566932-669326.9317.14
666822-668226.9207.11
30min169703-697037.2187.082.197.507.362.16
270805-708057.3327.62
367027-670276.9417.22
467935-679357.0357.31
567576-675766.9987.28
667464-674646.9867.26
45min171039-710397.3577.192.177.727.552.14
270308-703087.2817.65
368576-685767.1027.45
470890-708907.3417.70
568481-684817.0927.45
667369-673696.9777.33
60min168448-684487.0887.243.087.537.682.94
272957-729577.5558.00
368620-686207.1067.54
472372-723727.4957.93
568725-687257.1177.56
668301-683017.0737.50
极限176584-765847.9317.514.138.458.033.97
275061-750617.7738.31
369596-695967.2077.72
473571-735717.6198.14
571112-711127.3647.88
669329-693297.1807.68
依折麦布贝派度酸片项目信息
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%
110.162570022569192571362573682563772569600.15
210.192575782564772570280.31
单位质量响应值RSD%判断
25291.3425223.550.19数据可信
供试品溶液-1996049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%
5min165625-6562525.91031.5815.3225.9131.5815.32
293464-9346436.90136.90
372234-7223428.51928.52
485675-8567533.82633.83
592960-9296036.70236.70
669894-6989427.59527.60
10min1139904-13990455.23658.044.5555.5258.384.62
2152992-15299260.40460.81
3141112-14111255.71356.03
4150506-15050659.42259.80
5155218-15521861.28261.69
6142229-14222956.15456.46
15min1172417-17241768.07370.522.8168.9771.522.88
2184501-18450172.84473.92
3174642-17464268.95169.89
4180924-18092471.43272.47
5183430-18343072.42173.51
6175790-17579069.40570.34
20min1186814-18681473.75777.452.6075.4179.222.65
2201808-20180879.67781.57
3196197-19619777.46279.16
4196738-19673877.67579.50
5199359-19935978.71080.60
6196068-19606877.41179.11
30min1203469-20346980.33384.072.5982.8186.712.63
2218686-21868686.34189.12
3210695-21069583.18685.75
4212552-21255283.91986.61
5217415-21741585.83988.61
6214718-21471884.77487.34
45min1219570-21957086.69087.830.9790.0691.401.09
2224374-22437488.58692.32
3221137-22113787.30890.80
4223048-22304888.06391.69
5225253-22525388.93392.65
6221363-22136387.39790.90
60min1214497-21449784.68788.752.5189.0293.302.53
2230941-23094191.17995.90
3224673-22467388.70493.16
4224108-22410888.48193.08
5228304-22830490.13894.85
6226154-22615489.28993.76
极限1223695-22369588.31891.062.1493.5996.602.13
2233798-23379892.30798.04
3229415-22941590.57696.02
4226585-22658589.45995.05
5233816-23381692.31498.03
6236583-23658393.40798.87
依折麦布贝派度酸片项目信息
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%
111.159648859667149677959671799664559666060.12
211.179671049652139661580.14
单位质量响应值RSD%判断
86691.1286495.790.16数据可信
供试品溶液-1996049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%
5min152540-525405.4474.999.305.454.999.30
248219-482194.9995.00
349879-498795.1715.17
451817-518175.3725.37
546035-460354.7734.77
640402-404024.1894.19
10min164968-649686.7366.612.486.806.672.56
264546-645466.6926.75
363346-633466.5676.62
465504-655046.7916.85
563329-633296.5666.62
661115-611156.3366.38
15min167801-678017.0296.940.927.167.070.96
267548-675487.0037.13
366750-667506.9207.05
466828-668286.9287.06
566536-665366.8987.02
666192-661926.8626.98
20min169581-695817.2147.102.607.437.302.58
268853-688537.1387.35
366150-661506.8587.07
470248-702487.2837.50
569497-694977.2057.41
666294-662946.8737.07
30min168987-689877.1527.131.457.457.421.48
269730-697307.2297.52
367192-671926.9667.25
469789-697897.2357.53
568767-687677.1297.41
668096-680967.0607.33
45min168342-683427.0857.091.577.467.461.44
269137-691377.1687.54
367848-678487.0347.40
466614-666146.9067.28
569640-696407.2207.58
668764-687647.1297.48
60min169960-699607.2537.354.227.707.794.06
274868-748687.7628.21
368313-683137.0827.52
470792-707927.3397.79
573838-738387.6558.10
667342-673426.9827.41
极限178036-780368.0907.856.538.628.386.21
275754-757547.8548.39
370293-702937.2887.81
479317-793178.2238.75
581693-816938.4699.00
669494-694947.2057.71
依折麦布贝派度酸片项目信息
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%
110.162577272584342583702580912581502581540.11
210.192591992582702587340.26
单位质量响应值RSD%判断
25408.8625390.970.05数据可信
供试品溶液-1996049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%
5min198799-9879938.78834.9312.8638.7934.9312.86
291846-9184636.05936.06
394970-9497037.28537.29
494369-9436937.04937.05
586704-8670434.04034.04
667098-6709826.34326.34
10min1161704-16170463.48561.566.2463.9261.956.28
2164454-16445464.56564.97
3163759-16375964.29264.71
4159429-15942962.59263.00
5152661-15266159.93560.31
6138844-13884454.51054.80
15min1189700-18970074.47674.093.4775.6175.163.53
2196170-19617077.01678.13
3193608-19360876.01077.14
4187737-18773773.70674.81
5187868-18786873.75774.80
6177227-17722769.57970.48
20min1206512-20651281.07781.112.6283.0483.012.65
2212575-21257583.45785.43
3205784-20578480.79182.76
4204687-20468780.36082.29
5212107-21210783.27385.14
6197938-19793877.71079.38
30min1219973-21997386.36187.392.3789.2390.182.35
2229199-22919989.98392.88
3222147-22214787.21590.09
4216932-21693285.16787.99
5228785-22878589.82192.61
6218484-21848485.77788.31
45min1224853-22485388.27790.942.7292.1094.702.62
2234636-23463692.11896.02
3229425-22942590.07293.91
4226293-22629388.84392.61
5242082-24208295.04198.83
6232487-23248791.27494.76
60min1227044-22704489.13791.632.3693.9496.402.29
2235882-23588292.60797.53
3231882-23188291.03795.88
4230571-23057190.52295.27
5242969-24296995.390100.23
6231944-23194491.06195.56
极限1236613-23661392.89493.821.7298.6999.621.66
2238539-23853993.65099.60
3236141-23614192.70998.56
4236162-23616292.71798.48
5246861-24686196.918102.82
6239551-23955194.04899.56
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