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%
1 9.592193122072220932193322068220190.37
2 9.612186621822218440.15
单位质量响应值RSD%判断
2296.042273.050.72数据可信
供试品溶液-25010201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%
5min15768-576822.66525.8726.9322.6625.8626.94
26538-653825.69025.69
36189-618924.31924.32
48676-867634.09134.09
53910-391015.36415.36
68415-841533.06633.07
10min112088-1208847.49850.135.0047.5450.175.01
212621-1262149.59349.64
312235-1223548.07648.12
413769-1376954.10454.16
512586-1258649.45549.48
613242-1324252.03352.09
15min115529-1552961.01961.791.5861.1461.921.60
215491-1549160.87061.00
315586-1558661.24361.36
416089-1608963.22063.37
515687-1568761.64061.75
615973-1597362.76462.91
20min117161-1716167.43266.922.1667.6567.152.17
217096-1709667.17767.40
316797-1679766.00266.22
417650-1765069.35369.61
516586-1658665.17365.38
616901-1690166.41066.66
30min118443-1844372.46970.555.5572.8070.905.54
217857-1785770.16770.51
316021-1602162.95363.29
418790-1879073.83374.20
518195-1819571.49571.81
618427-1842772.40772.76
45min118944-1894474.43874.601.5474.8975.061.55
218698-1869873.47173.93
318847-1884774.05774.49
419510-1951076.66277.15
518808-1880873.90474.34
619108-1910875.08275.56
60min119436-1943676.37176.120.9176.9576.700.93
219185-1918575.38575.96
319198-1919875.43676.00
419665-1966577.27177.89
519374-1937476.12876.69
619371-1937176.11676.72
极限119829-1982977.91676.711.3478.6277.421.35
219507-1950776.65077.35
319277-1927775.74776.43
419749-1974977.60178.35
519165-1916575.30676.00
619610-1961077.05577.78
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%
1 9.592092821014209252090720907209360.22
2 9.612365923699236790.12
单位质量响应值RSD%判断
2183.112464.008.55数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25010202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%
5min15870-587022.76116.0940.3922.7616.0940.39
25845-584522.66422.66
32035-20357.8917.89
43620-362014.03614.04
52507-25079.7219.72
65020-502019.46519.46
10min113779-1377953.42848.397.6853.4748.417.70
213022-1302250.49250.53
312385-1238548.02348.04
411608-1160845.01045.03
511189-1118943.38543.40
612889-1288949.97750.01
15min116849-1684965.33262.712.9465.4662.822.95
216481-1648163.90564.03
316338-1633863.35063.44
415903-1590361.66461.76
515528-1552860.20960.30
615939-1593961.80361.92
20min118697-1869772.49769.782.4272.7369.992.43
218216-1821670.63270.86
318108-1810870.21370.41
417807-1780769.04669.25
517547-1754768.03868.23
617604-1760468.25968.48
30min120150-2015078.13176.632.1078.4976.962.10
219299-1929974.83175.18
319749-1974976.57676.89
420164-2016478.18578.50
519231-1923174.56874.87
619988-1998877.50377.84
45min121125-2112581.91279.901.5482.4080.351.55
220736-2073680.40380.87
320485-2048579.43079.87
420599-2059979.87280.32
520524-2052479.58180.01
620166-2016678.19378.65
60min121338-2133882.73881.981.0183.3682.571.02
221159-2115982.04482.65
321228-2122882.31182.89
421250-2125082.39682.98
520734-2073480.39680.95
621146-2114681.99382.59
极限121580-2158083.67682.001.5984.4482.731.58
220983-2098381.36182.10
321416-2141683.04083.75
421106-2110681.83882.56
521175-2117582.10682.80
620628-2062879.98580.71
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%
1 9.592885728747288862885928808288310.20
2 9.612500224906249540.28
单位质量响应值RSD%判断
3006.362596.6710.35数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24122801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%
5min14546-454614.64518.2115.4114.6418.2115.42
25233-523316.85816.86
35141-514116.56116.56
46276-627620.21820.22
56968-696822.44722.45
65747-574718.51318.51
10min111369-1136936.62438.774.4636.6538.804.47
211683-1168337.63637.66
311842-1184238.14838.18
412361-1236139.82039.85
512888-1288841.51841.56
612065-1206538.86638.90
15min114536-1453646.82749.162.7746.9149.262.78
215240-1524049.09449.19
315213-1521349.00749.10
415256-1525649.14649.25
515809-1580950.92751.03
615515-1551549.98050.08
20min116922-1692254.51355.051.1354.6855.231.15
217174-1717455.32555.50
316847-1684754.27154.44
417087-1708755.04455.23
517391-1739156.02456.22
617116-1711655.13855.32
30min118744-1874460.38260.112.3660.6460.382.35
218947-1894761.03661.30
317846-1784657.48957.75
418761-1876160.43760.71
518555-1855559.77360.06
619100-1910061.52961.80
45min119890-1989064.07463.371.7864.4363.741.77
219823-1982363.85864.22
318997-1899761.19761.56
419591-1959163.11163.49
519883-1988364.05164.44
619854-1985463.95864.33
60min120545-2054566.18464.871.9266.6565.341.91
220244-2024465.21465.69
319544-1954462.95963.42
420476-2047665.96266.44
520188-2018865.03465.53
619825-1982563.86564.34
极限120331-2033165.49565.171.8766.0765.751.87
220455-2045565.89466.48
319498-1949862.81163.38
420197-2019765.06365.65
520543-2054366.17866.78
620357-2035765.57866.16
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