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%
110.103016753019703015843019963019683018390.07
210.143021223021353021280.01
单位质量响应值RSD%判断
29885.0529795.660.22数据可信
加速3月-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%
5min198968-9896833.07330.439.2833.0730.439.29
295055-9505531.76531.77
386436-8643628.88528.89
481134-8113427.11327.11
5101173-10117333.81033.81
683559-8355927.92427.92
10min1216191-21619172.24774.491.8472.3074.541.84
2225536-22553675.36975.42
3224623-22462375.06475.11
4221212-22121273.92473.97
5227929-22792976.16976.23
6221954-22195474.17274.22
15min1248028-24802882.88685.181.5783.0685.351.57
2256072-25607285.57485.75
3256912-25691285.85586.03
4254552-25455285.06685.23
5259947-25994786.86987.05
6253843-25384384.82985.00
20min1262342-26234287.66989.661.3487.9889.981.34
2268435-26843589.70590.03
3270728-27072890.47290.79
4268253-26825389.64589.95
5272910-27291091.20191.53
6267109-26710989.26289.57
30min1274712-27471291.80393.591.1792.2694.061.18
2279971-27997193.56094.03
3282285-28228594.33494.80
4280152-28015293.62194.08
5284399-28439995.04095.52
6278926-27892693.21193.67
45min1281021-28102193.91195.901.2594.5296.521.25
2286927-28692795.88596.51
3289474-28947496.73697.36
4287006-28700695.91196.53
5291500-29150097.41398.05
6285879-28587995.53596.15
60min1287927-28792796.21997.150.7996.9997.940.80
2290264-29026497.00097.79
3292917-29291797.88798.67
4290319-29031997.01997.79
5293928-29392898.22599.03
6288990-28899096.57497.35
极限1300556-300556100.440100.440.61101.37101.380.62
2299290-299290100.016100.96
3302646-302646101.138102.09
4299144-29914499.968100.90
5302932-302932101.234102.20
6298778-29877899.845100.78
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%
110.103018673015903016153016493017153016870.04
210.143020473017933019200.06
单位质量响应值RSD%判断
29870.0029775.150.23数据可信
中间条件3月-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%
5min1111660-11166037.33735.686.9037.3435.686.90
2109237-10923736.52636.53
397765-9776532.69132.69
4114332-11433238.23038.23
597195-9719532.50032.50
6110058-11005836.80136.80
10min1224011-22401174.90475.011.7074.9775.071.70
2231534-23153477.42077.48
3222214-22221474.30474.36
4222519-22251974.40674.47
5220811-22081173.83473.89
6224813-22481375.17375.23
15min1258846-25884686.55386.451.2886.7486.641.28
2264508-26450888.44688.64
3256967-25696785.92486.10
4258812-25881286.54186.73
5254722-25472285.17485.35
6257407-25740786.07186.26
20min1273759-27375991.53991.601.3691.8791.921.36
2280425-28042593.76894.11
3272065-27206590.97391.29
4275090-27509091.98492.32
5269451-26945190.09990.42
6272768-27276891.20891.54
30min1285476-28547695.45795.901.1295.9496.381.13
2292149-29214997.68898.18
3286394-28639495.76496.24
4288549-28854996.48596.97
5282768-28276894.55295.02
6285547-28554795.48195.96
45min1290504-29050497.13898.331.2397.7898.971.23
2300136-300136100.359101.02
3294314-29431498.41299.05
4295986-29598698.97199.62
5291036-29103697.31697.94
6292463-29246397.79398.43
60min1293220-29322098.04699.181.2098.8599.981.20
2303253-303253101.401102.22
3296583-29658399.17199.97
4297017-29701799.316100.13
5294145-29414598.35699.14
6295440-29544098.78999.59
极限1299039-29903999.992100.380.91100.96101.350.91
2305186-305186102.048103.04
3301451-301451100.799101.76
4298772-29877299.903100.88
5298392-29839299.776100.73
6298299-29829999.745100.71
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%
110.103040313034133045253043663044863041640.16
210.143028313030633029470.06
单位质量响应值RSD%判断
30115.2529876.430.57数据可信
长期3月-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%
5min1125827-12582741.83139.406.5541.8339.406.56
2127287-12728742.31742.32
3122881-12288140.85240.85
4114513-11451338.07038.07
5111217-11121736.97436.97
6109444-10944436.38536.38
10min1239590-23959079.65278.441.3579.7278.511.35
2239015-23901579.46179.53
3237231-23723178.86878.94
4234904-23490478.09478.16
5233272-23327277.55277.61
6231743-23174377.04377.10
15min1269105-26910589.46488.840.5789.6789.040.58
2267014-26701488.76988.97
3268764-26876489.35189.55
4266778-26677888.69188.88
5266798-26679888.69788.89
6264940-26494088.08088.27
20min1281865-28186593.70693.190.4194.0693.540.41
2278943-27894392.73593.09
3280908-28090893.38893.74
4279727-27972792.99693.34
5281095-28109593.45093.79
6279372-27937292.87893.21
30min1291990-29199097.07296.700.3897.5897.200.38
2290182-29018296.47196.98
3291102-29110296.77797.28
4290114-29011496.44996.95
5292299-29229997.17597.67
6289592-28959296.27596.77
45min1296700-29670098.63898.300.5099.3198.960.50
2293276-29327697.50098.17
3296036-29603698.41899.08
4295169-29516998.12998.79
5297535-29753598.91699.57
6295294-29529498.17198.82
60min1298318-29831899.17698.900.48100.0199.730.47
2295188-29518898.13698.96
3297661-29766198.95899.79
4297130-29713098.78199.60
5299406-29940699.538100.36
6297297-29729798.83799.65
极限1302091-302091100.431100.640.60101.43101.630.59
2301299-301299100.167101.16
3301853-301853100.351101.35
4306004-306004101.731102.72
5303576-303576100.924101.91
6301464-301464100.222101.20
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