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%
111.231013519101355710132871013521101258410132940.05
211.291007851100746710076590.03
单位质量响应值RSD%判断
90230.9989252.350.78数据可信
供试品溶液-2024092721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%
5min111614-116141.1622.7860.051.162.7860.03
215170-151701.5181.52
343926-439264.3944.39
426307-263072.6322.63
552423-524235.2445.24
617501-175011.7511.75
10min120785-207852.0792.6226.682.092.6526.08
233218-332183.3233.34
320127-201272.0142.06
434989-349893.5003.53
519429-194291.9442.00
628569-285692.8582.88
15min131657-316573.1673.6114.633.203.6714.34
238923-389233.8943.95
330068-300683.0083.08
440368-403684.0384.11
532764-327643.2783.36
642889-428894.2914.34
20min1207121-20712120.72014.9957.1520.7915.0956.73
246034-460344.6054.70
3154407-15440715.44715.55
453228-532285.3255.44
5176533-17653317.66017.78
6261849-26184926.19526.29
30min1341732-34173234.18729.2027.8834.4929.4627.93
2154897-15489715.49615.64
3320035-32003532.01632.29
4235685-23568523.57823.75
5323938-32393832.40732.72
6374786-37478637.49437.88
45min1372627-37262737.27834.3010.9437.9634.8911.25
2279196-27919627.93128.25
3352377-35237735.25235.88
4316798-31679831.69332.13
5362685-36268536.28336.96
6373321-37332137.34738.15
60min1375638-37563837.57935.617.2238.6736.587.62
2313590-31359031.37232.00
3356832-35683235.69836.72
4338742-33874233.88834.67
5370081-37008137.02338.10
6380811-38081138.09639.32
极限1409087-40908740.92539.933.4342.4441.303.83
2377070-37707037.72238.70
3392105-39210539.22640.65
4395893-39589339.60540.77
5414898-41489841.50642.99
6405541-40554140.57042.22
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%
19.922522852513352522462520222515182518810.18
29.932513822509902511860.12
单位质量响应值RSD%判断
25391.2325295.670.27数据可信
供试品溶液-2024092721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%
5min157277-5727722.53720.3086.8522.5420.3086.85
253027-5302720.86520.86
3-0.0000.00
4105328-10532841.44441.44
5-0.0000.00
693941-9394136.96436.96
10min1150682-15068259.29061.1116.7259.5461.3416.95
2137555-13755554.12554.36
3134113-13411352.77052.77
4190117-19011774.80675.27
5133876-13387652.67752.68
6185513-18551372.99573.41
15min1201991-20199179.47979.075.7580.3979.976.05
2191925-19192575.51876.35
3193759-19375976.23976.83
4216182-21618285.06286.35
5188629-18862974.22174.81
6213173-21317383.87885.10
20min1222506-22250687.55186.352.8389.3488.133.16
2216724-21672485.27686.95
3211964-21196483.40384.84
4226463-22646389.10891.34
5213618-21361884.05485.46
6225456-22545688.71190.87
30min1237002-23700293.25592.692.5696.0295.432.79
2232572-23257291.51194.13
3230537-23053790.71193.07
4235066-23506692.49395.72
5231378-23137891.04293.39
6246850-24685097.130100.27
45min1241292-24129294.94394.400.6498.7498.180.98
2240226-24022694.52398.16
3238197-23819793.72597.09
4240873-24087394.77899.03
5237828-23782893.58096.94
6241099-24109994.86799.09
60min1243134-24313495.66793.171.82100.5297.991.97
2235550-23555092.68397.37
3231078-23107890.92495.33
4235423-23542392.63397.94
5235175-23517592.53696.93
6240410-24041094.59699.87
极限1239789-23978994.35193.551.68100.2799.411.68
2236642-23664293.11398.83
3240391-24039194.588100.01
4243012-24301295.619101.96
5234041-23404192.08997.51
6232697-23269791.56197.88
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