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%
111.069084749089309088369088079084879087070.03
211.049111839112079111950.01
单位质量响应值RSD%判断
82161.5782535.780.33数据可信
供试品溶液-24070801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%
5min123533-235332.5633.9224.692.563.9224.78
239263-392634.2774.28
345803-458034.9894.99
428408-284083.0953.09
534557-345573.7643.76
644579-445794.8564.86
10min160925-609256.6376.964.756.677.004.78
265611-656117.1477.19
369011-690117.5177.57
463472-634726.9146.95
561267-612676.6746.72
662931-629316.8556.91
15min165750-657507.1627.371.537.267.481.69
267614-676147.3657.49
368661-686617.4797.62
467305-673057.3327.44
568281-682817.4387.55
668086-680867.4177.55
20min166391-663917.2327.9411.567.418.1411.41
278456-784568.5468.76
387469-874699.5289.75
468425-684257.4547.65
569695-696957.5927.79
666695-666957.2657.48
30min172639-726397.9138.9321.478.179.2221.02
293355-9335510.16910.47
3113026-11302612.31212.64
472397-723977.8868.16
570600-706007.6917.97
669887-698877.6137.91
45min184881-848819.24610.1521.339.6010.5420.90
298355-9835510.71411.13
3128160-12816013.96114.43
482964-829649.0379.40
594633-9463310.30810.68
669820-698207.6067.98
60min192701-9270110.09812.9821.0510.5513.4820.68
2115544-11554412.58613.12
3164197-16419717.88618.51
4129084-12908414.06114.52
5107228-10722811.68012.16
6106412-10641211.59212.05
极限1133193-13319314.50920.1125.1015.0720.7624.48
2168033-16803318.30418.98
3214184-21418423.33124.15
4250542-25054227.29227.91
5137555-13755514.98415.60
6204075-20407522.23022.82
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%
110.002504762502242500762500632500312501740.08
210.082509272505552507410.11
单位质量响应值RSD%判断
25017.4024875.100.41数据可信
供试品溶液-24070801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%
5min142349-4234916.92927.5035.4516.9327.5035.45
264429-6442925.75525.76
3106765-10676542.67942.68
448392-4839219.34419.34
562955-6295525.16625.17
687805-8780535.09935.10
10min1135327-13532754.09666.3716.1654.2866.6816.21
2167896-16789667.11567.40
3197822-19782279.07879.55
4173097-17309769.19469.41
5133296-13329653.28453.56
6188818-18881875.47975.87
15min1191358-19135876.49483.907.1977.2884.947.33
2206195-20619582.42583.46
3227385-22738590.89592.25
4216996-21699686.74387.73
5194214-19421477.63678.51
6223174-22317489.21290.44
20min1207673-20767383.01689.855.5784.6591.835.73
2223062-22306289.16791.12
3239741-23974195.83598.20
4233436-23343693.31495.26
5212970-21297085.13386.87
6231741-23174192.63794.86
30min1226124-22612490.39194.583.5292.9597.553.74
2232731-23273193.03395.97
3248724-24872499.426102.85
4237754-23775495.04098.02
5231095-23109592.37995.06
6243144-24314497.195100.44
45min1228325-22832591.27192.660.9294.8496.691.17
2232871-23287193.08897.06
3232246-23224692.83997.37
4234095-23409593.57897.62
5230310-23031092.06595.77
6233021-23302193.14897.48
60min1228659-22865991.40593.541.6695.9898.601.86
2235693-23569394.21799.22
3234106-23410693.58299.15
4232972-23297293.12998.21
5232320-23232092.86897.60
6240326-24032696.069101.43
极限1233512-23351293.34594.060.6298.94100.150.84
2236845-23684594.677100.73
3235212-23521294.024100.63
4236950-23695094.719100.83
5233809-23380993.46399.22
6235417-23541794.106100.54
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%
111.069074299091119091569094539096129089520.10
211.049160439162989161700.02
单位质量响应值RSD%判断
82183.7382986.410.69数据可信
供试品溶液-24070801批-依折麦布-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1255367-25536727.73825.9128.4727.7425.9128.48
2137864-13786414.97514.97
3250402-25040227.19927.20
4184022-18402219.98919.99
5274219-27421929.78629.79
6329381-32938135.77835.78
10min1722882-72288278.52174.1115.4778.8374.4015.50
2470547-47054751.11251.28
3713886-71388677.54377.85
4695392-69539275.53575.76
5742645-74264580.66781.00
6748106-74810681.26081.66
15min1813992-81399288.41787.809.7289.6088.919.78
2654308-65430871.07271.81
3850423-85042392.37493.54
4870964-87096494.60595.67
5845097-84509791.79693.02
6814875-81487588.51389.81
20min1805683-80568387.51489.337.2289.6891.427.32
2711943-71194377.33278.86
3864642-86464293.91996.11
4870232-87023294.52696.64
5853960-85396092.75895.01
6827989-82798989.93792.22
30min1846107-84610791.90591.773.4695.0494.853.67
2790783-79078385.89688.28
3868911-86891194.38297.62
4862358-86235893.67196.83
5864264-86426493.87897.16
6836935-83693590.90994.19
45min1824654-82465489.57591.332.6493.7395.432.80
2811260-81126088.12091.46
3865772-86577294.04198.32
4865341-86534193.99598.20
5845499-84549991.83996.16
6832592-83259290.43794.73
60min1828643-82864390.00890.822.0595.1695.932.33
2804986-80498687.43991.76
3851272-85127292.46697.79
4845580-84558091.84897.10
5840031-84003191.24596.59
6845999-84599991.89497.19
极限1812041-81204188.20591.192.6194.3697.322.37
2856863-85686393.07498.36
3860759-86075993.49799.85
4846125-84612591.90798.18
5849412-84941292.26498.62
6812164-81216488.21894.54
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%
110.002518502501022501442503642501912505300.30
210.082492542521752507140.83
单位质量响应值RSD%判断
25053.0024872.420.52数据可信
供试品溶液-24070801批-贝派度酸-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min130069-3006912.01211.0433.2112.0111.0433.21
214625-146255.8425.84
328968-2896811.57211.57
419277-192777.7017.70
533410-3341013.34713.35
639510-3951015.78315.78
10min1102654-10265441.00837.6316.7641.1437.7616.80
263920-6392025.53525.60
395557-9555738.17338.30
492442-9244236.92937.01
5103828-10382841.47741.63
6106854-10685442.68642.86
15min1142132-14213256.77954.1010.4557.3754.6410.52
2106914-10691442.71043.06
3137603-13760354.97055.52
4140278-14027856.03856.53
5144222-14422257.61458.22
6141472-14147256.51557.17
20min1162516-16251664.92263.127.8966.1464.268.00
2132752-13275253.03253.86
3161504-16150464.51865.68
4161576-16157664.54765.67
5165299-16529966.03467.28
6164338-16433865.65066.93
30min1199285-19928579.61175.814.4481.5577.654.59
2174308-17430869.63371.05
3190526-19052676.11277.99
4188910-18891075.46677.30
5194387-19438777.65479.64
6191189-19118976.37678.38
45min1217868-21786887.03484.492.5389.8687.182.71
2201875-20187580.64582.83
3212591-21259184.92687.65
4213107-21310785.13287.81
5210196-21019683.96986.82
6213420-21342085.25788.11
60min1231396-23139692.43889.043.2796.2392.673.41
2210945-21094584.26987.35
3220994-22099488.28391.95
4220153-22015387.94791.57
5225342-22534290.02093.80
6228542-22854291.29895.10
极限1233372-23337293.22892.241.5798.0596.861.49
2232741-23274192.97696.99
3229376-22937691.63196.28
4227702-22770290.96395.56
5235758-23575894.18198.96
6226481-22648190.47595.29
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