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%
110.152152521370214082149121473214530.30
210.062098720921209540.23
单位质量响应值RSD%判断
2113.602082.901.04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%
5min12636-263611.27811.0268.3511.2811.0268.32
26045-604525.86325.86
31229-12295.2585.26
41689-16897.2267.23
51902-19028.1378.14
61949-19498.3398.34
10min17065-706530.22733.2927.1430.2533.3127.16
212053-1205351.56751.61
36749-674928.87528.88
46522-652227.90427.92
57346-734631.42931.44
66950-695029.73529.75
15min111083-1108347.41750.2914.4147.4950.3614.44
215208-1520865.06565.19
311087-1108747.43447.49
410932-1093246.77146.83
511143-1114347.67447.74
611070-1107047.36247.42
20min114335-1433561.33060.2010.8861.4860.3610.91
216743-1674371.63371.87
312241-1224152.37152.51
413618-1361858.26358.40
513139-1313956.21356.36
614354-1435461.41261.55
30min117942-1794276.76276.293.4877.0176.553.53
218985-1898581.22581.58
317606-1760675.32575.55
417154-1715473.39173.62
517668-1766875.59075.83
617638-1763875.46275.71
45min119935-1993585.28984.450.7185.6784.830.73
219796-1979684.69585.19
319750-1975084.49884.85
419735-1973584.43484.79
519708-1970884.31884.68
619504-1950483.44583.82
60min121448-2144891.76289.691.2992.2890.211.29
220903-2090389.43190.06
321098-2109890.26590.75
420734-2073488.70889.20
520770-2077088.86289.37
620828-2082889.11089.62
极限121168-2116890.56490.880.8591.2491.560.88
221442-2144291.73792.52
320930-2093089.54690.19
421239-2123990.86891.51
521315-2131591.19391.85
621357-2135791.37392.03
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%
110.152133621307213252126121303213060.14
210.062100821100210540.31
单位质量响应值RSD%判断
2099.112092.840.22数据可信
供试品溶液-PN4A批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12926-292612.5319.2931.5412.539.3031.53
22232-22329.5599.56
32063-20638.8358.84
41711-17117.3287.33
51175-11755.0325.03
62914-291412.48012.48
10min17991-799134.22428.1519.4934.2428.1619.50
26409-640927.44827.46
36540-654028.00928.02
45175-517522.16322.18
55213-521322.32622.33
68108-810834.72534.75
15min110928-1092846.80242.269.6546.8842.329.67
29432-943240.39540.46
39766-976641.82641.89
49296-929639.81339.86
58690-869037.21737.26
611088-1108847.48847.57
20min112767-1276754.67851.435.3154.8351.565.33
211881-1188150.88451.01
311660-1166049.93750.07
411787-1178750.48150.60
511182-1118247.89048.00
612773-1277354.70454.86
30min115691-1569167.20162.803.9967.4563.024.01
214558-1455862.34962.56
314098-1409860.37960.59
414263-1426361.08561.28
514404-1440461.68961.88
614965-1496564.09264.34
45min116991-1699172.76970.612.6973.1370.942.69
216985-1698572.74373.06
315902-1590268.10568.42
416568-1656870.95771.26
516198-1619869.37369.66
616280-1628069.72470.08
60min118073-1807377.40376.283.5277.8876.723.52
216707-1670771.55271.99
318130-1813077.64778.08
417668-1766875.66876.09
517736-1773675.95976.37
618552-1855279.45479.93
极限117836-1783676.38880.462.7277.0081.042.68
219193-1919382.19982.76
319233-1923382.37182.93
418694-1869480.06280.61
518839-1883980.68381.22
618932-1893281.08281.69
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%
110.152114221227212482110221142211720.30
210.062087720820208480.20
单位质量响应值RSD%判断
2085.912072.370.47数据可信
供试品溶液-PN4A批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11211-12115.2299.8051.575.239.8051.56
21485-14856.4116.41
32062-20628.9038.90
43674-367415.86315.86
51389-13895.9976.00
63792-379216.37216.37
10min14844-484420.91428.2919.0020.9228.3019.03
26071-607126.21226.22
37040-704030.39530.41
47518-751832.45932.49
55664-566424.45424.46
68177-817735.30435.33
15min18299-829935.83141.2112.2835.8741.2812.30
28816-881638.06338.12
310306-1030644.49644.56
410519-1051945.41645.50
58398-839836.25836.31
610936-1093647.21647.30
20min110608-1060845.80049.727.9045.9049.857.92
211247-1124748.55948.68
312232-1223252.81252.95
412148-1214852.44952.61
510357-1035744.71644.83
612504-1250453.98654.15
30min112075-1207552.13460.037.7752.3160.257.79
213612-1361258.77058.97
314842-1484264.08064.31
414062-1406260.71360.96
513721-1372159.24159.43
615115-1511565.25965.51
45min116476-1647671.13569.902.8571.4070.222.85
215768-1576868.07868.38
316665-1666571.95172.29
415748-1574867.99268.34
515812-1581268.26868.55
616675-1667571.99472.36
60min117962-1796277.55176.313.7577.9476.743.75
217858-1785877.10277.51
317106-1710673.85574.31
417480-1748075.47075.93
516905-1690572.98773.39
618735-1873580.88881.37
极限116946-1694673.16479.514.2273.6880.074.22
218678-1867880.64281.18
319063-1906382.30582.88
418291-1829178.97279.56
518522-1852279.96980.49
619000-1900082.03382.65
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