贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 3016303021963020833020503019913019900.08
29.933005093008703006900.09
单位质量响应值RSD%判断
30627.7930280.970.81数据可信
供试品溶液-2024090421批-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%
5min1151802-15180249.70844.969.2549.7144.969.25
2152029-15202949.78249.78
3136930-13693044.83844.84
4135029-13502944.21544.22
5120974-12097439.61339.61
6127000-12700041.58641.59
10min1242879-24287979.53179.290.8379.6179.370.83
2242976-24297679.56379.65
3244729-24472980.13780.21
4238771-23877178.18678.26
5242159-24215979.29579.36
6241407-24140779.04979.12
15min1272548-27254889.24689.190.4289.4689.400.42
2271433-27143388.88189.10
3273019-27301989.40089.61
4270579-27057988.60188.81
5273365-27336589.51489.71
6273351-27335189.50989.71
20min1283926-28392692.97293.230.5693.3493.580.55
2282924-28292492.64493.01
3285497-28549793.48693.84
4283215-28321592.73993.09
5285818-28581893.59193.94
6286867-28686793.93594.29
30min1292784-29278495.87296.150.6596.3996.660.64
2291784-29178495.54596.06
3292961-29296195.93096.44
4292209-29220995.68496.19
5295888-29588896.88997.39
6296096-29609696.95797.46
45min1296467-29646797.07897.400.8297.7698.070.81
2294609-29460996.47097.15
3296893-29689397.21897.89
4295895-29589596.89197.56
5300433-30043398.37799.04
6300351-30035198.35099.02
60min1297708-29770897.48597.740.7398.3398.570.72
2295989-29598996.92297.76
3297848-29784897.53198.37
4297015-29701597.25898.09
5301421-30142198.70199.53
6300871-30087198.52199.35
极限1297211-29721197.32297.620.8598.3398.620.84
2295606-29560696.79797.80
3296897-29689797.21998.22
4296484-29648497.08498.07
5301482-30148298.72199.71
6301110-30111098.59999.60
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 3017863016683017603020143020513018560.06
29.933006443007733007080.04
单位质量响应值RSD%判断
30614.2030282.780.77数据可信
供试品溶液-2024090421批-pH6.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1131792-13179243.16440.537.9143.1640.537.91
2120954-12095439.61439.61
3130854-13085442.85642.86
4132449-13244943.37943.38
5107849-10784935.32235.32
6118584-11858438.83838.84
10min1234770-23477076.89075.951.1576.9676.021.14
2234503-23450376.80376.87
3228810-22881074.93875.01
4228950-22895074.98475.06
5231232-23123275.73275.79
6233093-23309376.34176.41
15min1265464-26546486.94386.940.9387.1487.140.92
2267330-26733087.55487.75
3262619-26261986.01186.21
4262376-26237685.93286.13
5268068-26806887.79687.98
6266924-26692487.42187.61
20min1278554-27855491.23091.640.9091.5891.980.89
2281504-28150492.19692.54
3277302-27730290.82091.16
4277269-27726990.80991.15
5283396-28339692.81693.15
6280852-28085291.98392.32
30min1289709-28970994.88495.550.8495.3896.040.83
2292738-29273895.87696.37
3288537-28853794.50094.99
4291420-29142095.44495.94
5295392-29539296.74597.23
6292602-29260295.83196.32
45min1294971-29497196.60797.001.1097.2697.661.09
2297502-29750297.43698.09
3292669-29266995.85396.50
4293103-29310395.99596.65
5301170-30117098.63799.28
6297700-29770097.50198.15
60min1297069-29706997.29497.531.1498.1198.341.14
2299471-29947198.08198.90
3293635-29363596.16996.98
4294816-29481696.55697.37
5303021-30302199.244100.06
6298642-29864297.80998.62
极限1300599-30059998.45098.580.6399.4399.560.63
2301388-30138898.70999.69
3299399-29939998.05799.03
4299331-29933198.03599.01
5304488-30448899.724100.70
6300822-30082298.52399.50
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号BEMA-231010D对照品来源自制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50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 3016253016343018273022683022553019220.11
29.933008353011463009900.08
单位质量响应值RSD%判断
30620.8930311.180.72数据可信
供试品溶液-2024090421批-pH6.7
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1139056-13905645.51649.448.6745.5249.448.67
2167631-16763154.87054.87
3140717-14071746.06046.06
4166734-16673454.57654.58
5150256-15025649.18249.18
6141898-14189846.44746.45
10min1260321-26032185.20985.361.0285.2985.451.02
2261266-26126685.51985.61
3265278-26527886.83286.91
4261503-26150385.59685.69
5258751-25875184.69584.78
6257660-25766084.33884.42
15min1284452-28445293.10893.321.0693.3393.541.05
2283217-28321792.70492.94
3291118-29111895.29095.51
4283835-28383592.90693.14
5283342-28334292.74592.97
6284614-28461493.16193.38
20min1292374-29237495.70195.841.1496.0796.221.14
2290273-29027395.01395.40
3299247-29924797.95198.33
4290658-29065895.13995.53
5291189-29118995.31395.69
6293144-29314495.95396.33
30min1297921-29792197.51797.481.1098.0598.021.09
2294875-29487596.52097.07
3304052-30405299.523100.07
4296153-29615396.93897.48
5296184-29618496.94897.48
6297713-29771397.44997.98
45min1300625-30062598.40298.221.1999.1098.931.18
2297022-29702297.22297.93
3306816-306816100.428101.14
4297685-29768597.43998.15
5298538-29853897.71998.42
6299777-29977798.12498.82
60min1301370-30137098.64698.591.1799.5099.461.16
2297674-29767497.43698.31
3307719-307719100.724101.60
4298959-29895997.85698.73
5300154-30015498.24899.11
6301344-30134498.63799.50
极限1304045-30404599.52199.461.06100.54100.491.06
2301368-30136898.64599.68
3309740-309740101.385102.43
4301573-30157398.71299.75
5301671-30167198.74499.77
6304789-30478999.765100.79
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