佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.262131221187212232123121294212490.25
210.282154121514215280.09
单位质量响应值RSD%判断
2071.052094.160.79数据可信
供试品溶液-2025041421批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16457-645727.83222.2720.9527.8322.2720.96
24928-492821.24221.24
35668-566824.43124.43
44744-474420.44920.45
55836-583625.15625.16
63362-336214.49214.49
10min112592-1259254.27747.7312.3654.3247.7612.36
210380-1038044.74244.78
311802-1180250.87150.91
410725-1072546.22946.26
512080-1208052.07052.11
68860-886038.19038.21
15min115459-1545966.63463.816.9366.7763.936.94
214549-1454962.71262.82
315446-1544666.57866.70
414419-1441962.15262.26
515887-1588768.47968.61
613065-1306556.31556.40
20min117401-1740175.00572.814.3475.2573.044.36
216839-1683972.58372.80
317445-1744575.19575.43
416464-1646470.96671.18
517541-1754175.60975.85
615664-1566467.51867.70
30min119688-1968884.86382.882.5885.2483.222.60
219261-1926183.02383.36
319521-1952184.14384.51
418631-1863180.30780.64
519654-1965484.71785.09
618606-1860680.19980.49
45min121106-2110690.97589.681.7091.4990.161.71
220462-2046288.19988.67
321096-2109690.93291.43
420362-2036287.76888.24
521140-2114091.12291.63
620670-2067089.09689.52
60min122125-2212595.36893.651.5896.0394.291.59
221629-2162993.23093.85
321739-2173993.70494.36
421148-2114891.15691.77
522011-2201194.87695.54
621713-2171393.59294.17
90min122150-2215095.47596.591.7996.3097.381.79
222125-2212595.36896.14
323056-2305699.381100.19
421987-2198794.77395.54
522621-2262197.50698.33
622511-2251197.03197.76
极限122832-2283298.41597.321.2699.4098.271.27
222433-2243396.69597.63
322832-2283298.41599.39
422098-2209895.25196.17
522711-2271197.89498.88
622558-2255897.23498.13
佩玛贝特片项目信息
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DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.1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%
110.262146421496215732144421512214980.24
210.282165821534215960.41
单位质量响应值RSD%判断
2095.322100.780.19数据可信
供试品溶液-PN4A批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13244-324413.88014.2322.2813.8814.2222.29
23651-365115.62115.62
32859-285912.23212.23
44658-465819.92919.93
52672-267211.43211.43
62866-286612.26212.26
10min17858-785833.62135.3011.3233.6435.3211.32
28962-896238.34438.37
37829-782933.49733.52
49812-981241.98142.01
57446-744631.85831.88
67592-759232.48332.50
15min111813-1181350.54352.597.0450.6252.677.05
213334-1333457.05057.14
312191-1219152.16052.24
413363-1336357.17457.28
511727-1172750.17550.25
611320-1132048.43348.51
20min115641-1564166.92164.825.2967.0864.995.29
215908-1590868.06368.25
315051-1505164.39664.56
415749-1574967.38367.58
514767-1476763.18163.34
613781-1378158.96359.12
30min117999-1799977.01077.563.1277.2877.843.13
218996-1899681.27581.57
317791-1779176.12076.39
418390-1839078.68378.99
518258-1825878.11878.38
617335-1733574.16974.42
45min120164-2016486.27386.751.4386.6887.161.43
220694-2069488.54088.97
319840-1984084.88685.28
420254-2025486.65887.10
520469-2046987.57887.97
620237-2023786.58586.96
60min121061-2106190.11190.290.9990.6690.841.00
221287-2128791.07891.66
320718-2071888.64389.18
421269-2126991.00191.59
521157-2115790.52191.06
621125-2112590.38490.91
90min121706-2170692.87093.321.3493.5794.031.33
222123-2212394.65495.39
321397-2139791.54892.23
421594-2159492.39193.13
521989-2198994.08194.77
622063-2206394.39895.07
极限122085-2208594.49294.760.7295.3495.610.73
222222-2222295.07895.97
321870-2187093.57294.41
422207-2220795.01495.91
522335-2233595.56196.41
622160-2216094.81395.64
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