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%
110.072180121722217822172421661217380.26
210.052182221641217320.59
单位质量响应值RSD%判断
2158.692162.390.13数据可信
供试品溶液-25022201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%
5min13111-311112.92614.0524.7112.9314.0524.71
23756-375615.60515.61
32183-21839.0709.07
43235-323513.44113.44
53273-327313.59913.60
64725-472519.63119.63
10min17508-750831.19434.448.2831.2234.468.29
28496-849635.29935.33
37455-745530.97430.99
48554-855435.54035.56
58482-848235.24135.26
69237-923738.37838.41
15min110470-1047043.50146.655.6743.5746.735.68
211914-1191449.50049.59
310398-1039843.20243.27
411424-1142447.46447.55
511617-1161748.26648.35
611545-1154547.96748.06
20min113072-1307254.31254.976.2554.4655.126.25
214067-1406758.44658.61
311752-1175248.82748.97
413175-1317554.73954.90
513921-1392157.83958.00
613389-1338955.62955.81
30min115320-1532063.65264.695.4163.8964.945.42
216686-1668669.32769.59
314267-1426759.27759.50
415185-1518563.09163.34
516142-1614267.06767.33
615825-1582565.75066.02
45min116628-1662869.08671.004.5369.4371.364.54
217644-1764473.30773.69
315918-1591866.13666.46
416819-1681969.88070.24
518015-1801574.84975.22
617506-1750672.73473.11
60min118294-1829476.00875.164.3476.4775.644.33
217171-1717171.34271.84
317324-1732471.97872.41
418005-1800574.80775.28
519304-1930480.20480.70
618442-1844276.62377.12
90min119052-1905279.15779.483.6279.7480.083.63
219705-1970581.87082.49
317909-1790974.40874.96
418924-1892478.62579.22
519815-1981582.32782.96
619369-1936980.47481.10
极限119364-1936480.45480.742.6081.1781.472.61
219866-1986682.53983.30
318483-1848376.79377.47
419500-1950081.01981.75
519556-1955681.25182.02
619823-1982382.36183.12
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%
110.072181221852218952184721708218230.33
210.052163821624216310.05
单位质量响应值RSD%判断
2167.132152.340.49数据可信
供试品溶液-25022202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%
5min12964-296412.32012.447.4512.3212.447.45
23340-334013.88213.88
32779-277911.55111.55
42924-292412.15312.15
52782-278211.56311.56
63172-317213.18413.18
10min17528-752831.28932.492.8831.3132.512.88
28206-820634.10734.13
37808-780832.45332.47
47884-788432.76932.79
57751-775132.21632.24
67721-772132.09232.11
15min111758-1175848.87146.874.5348.9446.944.53
211788-1178848.99649.08
311038-1103845.87845.95
411605-1160548.23548.31
510903-1090345.31745.39
610566-1056643.91643.99
20min113238-1323855.02255.501.8555.1855.651.85
213748-1374857.14257.30
313281-1328155.20155.35
413467-1346755.97456.13
513365-1336555.55055.70
613014-1301454.09154.24
30min115480-1548064.34164.962.3264.5965.212.32
216064-1606466.76867.03
315781-1578165.59265.83
415893-1589366.05866.31
515511-1551164.47064.71
615051-1505162.55862.80
45min117369-1736972.19273.162.0072.5573.512.00
218296-1829676.04576.41
317492-1749272.70473.05
417613-1761373.20773.57
517393-1739372.29272.64
617442-1744272.49672.84
60min118538-1853877.05177.611.7777.5278.081.77
219249-1924980.00680.50
318684-1868477.65878.13
418804-1880478.15778.64
518376-1837676.37876.85
618378-1837876.38676.85
90min119096-1909679.37081.411.8979.9782.011.89
220180-2018083.87684.50
319711-1971181.92782.53
419700-1970081.88182.49
519394-1939480.60981.21
619433-1943380.77181.36
极限119503-1950381.06282.411.7681.8083.151.76
220368-2036884.65785.43
319777-1977782.20182.94
420132-2013283.67784.42
519634-1963481.60782.34
619551-1955181.26281.99
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%
110.072186321819218932183421870218560.14
210.052184721685217660.53
单位质量响应值RSD%判断
2170.412165.770.16数据可信
供试品溶液-25022203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%
5min13920-392016.23012.5953.6116.2312.5953.62
2-0.0000.00
32416-241610.00310.00
43950-395016.35416.35
53598-359814.89714.90
64359-435918.04818.05
10min18482-848235.11834.585.9935.1534.616.00
28415-841534.84134.84
37421-742130.72530.74
48439-843934.94034.97
58419-841934.85734.88
68943-894337.02737.06
15min111697-1169748.42947.694.2548.5247.774.25
211682-1168248.36748.43
310608-1060843.92143.99
411478-1147847.52347.61
511582-1158247.95348.04
612067-1206749.96150.05
20min113891-1389157.51355.904.0957.6856.064.09
213563-1356356.15556.29
312411-1241151.38651.53
413839-1383957.29857.46
513560-1356056.14356.31
613747-1374756.91757.09
30min115804-1580465.43464.194.2365.7064.444.24
215493-1549364.14664.38
314203-1420358.80559.03
415696-1569664.98765.25
515935-1593565.97666.23
615884-1588465.76566.03
45min117582-1758272.79572.063.4273.1772.423.42
217670-1767073.16073.50
316230-1623067.19867.52
417888-1788874.06274.43
517619-1761972.94973.31
617439-1743972.20372.58
60min118853-1885378.05876.513.5978.5576.993.60
218651-1865177.22177.68
317179-1717971.12771.56
418942-1894278.42678.92
518827-1882777.95078.44
618422-1842276.27376.77
90min119548-1954880.93579.314.7581.5679.924.75
219646-1964681.34181.93
317325-1732571.73172.29
419233-1923379.63180.25
519648-1964881.34981.97
619536-1953680.88681.51
极限120221-2022183.72281.073.6184.4881.813.62
219591-1959181.11381.84
318251-1825175.56576.24
419666-1966681.42482.18
520135-2013583.36684.12
619625-1962581.25482.02
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