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%
110.522152221362216252154421638215380.52
210.532164221721216820.26
单位质量响应值RSD%判断
2047.342059.070.41数据可信
供试品溶液-25010201批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19984-998443.65052.2718.8343.6552.2718.83
29893-989343.25343.25
311351-1135149.62749.63
415448-1544867.53967.54
513937-1393760.93360.93
611122-1112248.62648.63
10min117108-1710874.79780.587.9274.8780.677.93
217435-1743576.22676.30
317824-1782477.92778.01
420300-2030088.75288.86
520278-2027888.65688.76
617646-1764677.14977.23
15min120796-2079690.92192.612.2291.1292.832.24
221220-2122092.77592.97
320857-2085791.18791.40
421553-2155394.23094.49
521908-2190895.78296.03
620756-2075690.74690.96
20min121930-2193095.87997.633.4096.2398.013.38
223730-23730103.748104.10
321673-2167394.75595.12
421780-2178095.22395.64
522405-2240597.95598.36
622471-2247198.24498.60
30min122578-2257898.712100.785.9499.22101.325.90
225736-25736112.519113.05
322030-2203096.31696.84
422191-2219197.02097.60
522693-2269399.21599.79
623080-23080100.907101.43
45min123038-23038100.723102.716.64101.40103.426.60
226623-26623116.397117.11
322605-2260598.83099.51
422452-2245298.16198.90
523069-23069100.858101.60
623167-23167101.287101.98
60min123254-23254101.667102.427.04102.51103.306.99
226688-26688116.681117.59
322187-2218797.00297.85
422439-2243998.10499.01
523063-23063100.832101.74
622924-22924100.224101.09
90min123674-23674103.503103.367.22104.51104.417.17
226958-26958117.861118.96
322229-2222997.18698.20
422532-2253298.51199.58
523245-23245101.628102.70
623215-23215101.497102.53
极限124174-24174105.690104.998.57106.87106.228.50
228014-28014122.478123.78
322216-2221697.12998.30
423100-23100100.994102.22
523308-23308101.903103.15
623277-23277101.768102.97
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%
110.522210322140219822206222022220620.29
210.532181822033219260.70
单位质量响应值RSD%判断
2097.152082.240.51数据可信
供试品溶液-25010201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%
5min12650-265011.38415.4522.9711.3815.4522.98
24548-454819.53719.54
34099-409917.60817.61
43578-357815.37015.37
54138-413817.77617.78
62565-256511.01811.02
10min110098-1009843.37842.346.2743.4042.376.27
29813-981342.15442.19
310508-1050845.13945.17
49183-918339.44739.47
510460-1046044.93344.96
69081-908139.00939.03
15min113751-1375159.07056.654.9659.1656.754.96
213461-1346157.82457.93
313214-1321456.76356.87
412154-1215452.21052.30
513850-1385059.49659.60
612702-1270254.56454.65
20min115692-1569267.40864.764.4167.6064.954.41
215269-1526965.59165.79
314844-1484463.76563.96
414372-1437261.73861.92
515922-1592268.39668.60
614354-1435461.66161.83
30min117605-1760575.62672.564.3075.9372.864.30
216670-1667071.60971.92
316369-1636970.31670.62
416395-1639570.42870.71
517994-1799477.29777.61
616310-1631070.06370.34
45min119879-1987985.39479.685.2385.8280.105.22
218384-1838478.97279.40
317824-1782476.56776.99
417594-1759475.57975.98
519619-1961984.27784.72
617989-1798977.27577.67
60min120445-2044587.82683.855.2988.4084.405.28
219918-1991885.56286.12
318474-1847479.35979.91
418632-1863280.03880.56
520882-2088289.70390.29
618769-1876980.62681.15
90min121500-2150092.35887.924.9793.0788.614.97
220928-2092889.90190.60
319521-1952183.85684.54
419473-1947383.65084.31
521665-2166593.06693.80
619711-1971184.67385.33
极限122309-2230995.83388.755.5696.7089.595.55
220970-2097090.08190.93
319443-1944383.52184.34
419878-1987885.39086.19
521600-2160092.78793.68
619766-1976684.90985.71
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%
110.522193121961217352179121853218540.44
210.532182221704217630.39
单位质量响应值RSD%判断
2077.382066.760.37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%
5min17196-719631.17532.1912.7031.1732.1912.70
27649-764933.13733.14
36100-610026.42726.43
48662-866237.52637.53
56759-675929.28129.28
68211-821135.57235.57
10min114489-1448962.77061.415.7562.8261.465.75
213792-1379259.75059.81
313436-1343658.20858.25
415654-1565467.81767.88
513604-1360458.93658.98
614073-1407360.96761.03
15min117542-1754275.99674.507.9876.1574.667.97
216432-1643271.18771.34
316403-1640371.06171.20
419746-1974685.54485.72
517114-1711474.14274.29
615950-1595069.09969.26
20min117971-1797177.85480.126.1478.1480.406.14
218300-1830079.28079.55
317857-1785777.36077.62
420788-2078890.05890.38
518062-1806278.24978.52
617980-1798077.89378.17
30min119362-1936283.88085.236.0284.2985.646.02
219544-1954484.66985.07
319101-1910182.75083.14
422038-2203895.47395.94
519142-1914282.92783.33
618848-1884881.65482.06
45min119620-1962084.99887.134.5285.5587.684.53
220244-2024487.70188.25
319599-1959984.90785.43
421892-2189294.84195.47
519764-1976485.62286.16
619550-1955084.69585.24
60min119987-1998786.58888.376.4687.2889.076.45
219382-1938283.96784.66
319835-1983585.93086.60
423027-2302799.758100.54
520194-2019487.48588.17
619967-1996786.50187.18
90min134780-34780150.675101.0424.51151.51101.8824.31
220792-2079290.07690.91
320210-2021087.55488.37
423156-23156100.317101.27
520561-2056189.07589.90
620433-2043388.52089.35
极限120267-2026787.80190.505.3888.8991.525.37
221040-2104091.15092.13
320300-2030087.94488.90
423097-23097100.061101.18
520409-2040988.41689.39
620229-2022987.63688.61
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