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%
110.152237422375221342240622130222840.63
210.062202822038220330.04
单位质量响应值RSD%判断
2195.472190.160.18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%
5min18809-880936.06135.035.4836.0635.045.48
28131-813133.28533.29
38452-845234.60034.60
49241-924137.82937.83
58743-874335.79135.79
67974-797432.64332.64
10min115738-1573864.42659.337.3564.4959.397.34
214783-1478360.51660.57
314393-1439358.92058.98
415221-1522162.30962.37
512654-1265451.80151.86
614166-1416657.99158.05
15min117917-1791773.34670.913.1973.5171.073.18
217462-1746271.48371.64
317133-1713370.13770.29
417474-1747471.53271.70
517624-1762472.14772.29
616325-1632566.82966.98
20min119351-1935179.21677.721.8479.5178.001.85
219081-1908178.11178.39
319262-1926278.85279.12
419072-1907278.07478.36
518728-1872876.66676.93
618424-1842475.42175.68
30min121035-2103586.11084.181.5886.5384.591.58
220206-2020682.71683.12
320867-2086785.42285.83
420461-2046183.76084.18
520507-2050783.94984.34
620308-2030883.13483.52
45min122015-2201590.12288.761.5490.6989.301.54
221640-2164088.58789.13
322100-2210090.47091.02
421375-2137587.50288.06
521692-2169288.79989.33
621271-2127187.07687.60
60min122348-2234891.48590.381.1692.2091.081.17
221898-2189889.64390.33
322355-2235591.51492.21
422196-2219690.86391.56
521921-2192189.73790.42
621755-2175589.05789.73
90min122351-2235191.49791.661.3292.3792.501.32
222180-2218090.79791.64
322961-2296193.99494.84
422420-2242091.78092.63
522252-2225291.09291.92
622180-2218090.79791.62
极限122770-2277093.21291.741.1394.2392.731.13
222222-2222290.96991.96
322680-2268092.84493.85
422336-2233691.43692.44
522180-2218090.79791.78
622269-2226991.16292.13
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%
110.152186621957217802188521646218270.55
210.062187121886218780.05
单位质量响应值RSD%判断
2150.442174.750.80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%
5min18356-835634.68635.928.5334.6935.928.53
28605-860535.71935.72
38568-856835.56635.57
49126-912637.88237.88
57539-753931.29431.29
69731-973140.39340.39
10min115092-1509262.64661.942.2462.7062.002.24
214851-1485161.64661.71
314391-1439159.73759.80
415406-1540663.95064.01
514841-1484161.60561.66
614952-1495262.06562.13
15min117846-1784674.07872.811.2074.2472.971.20
217652-1765273.27373.44
317264-1726471.66271.82
417556-1755672.87473.04
517572-1757272.94173.10
617350-1735072.01972.19
20min118916-1891678.52078.702.2878.8178.982.27
218471-1847176.67376.96
318479-1847976.70676.98
419096-1909679.26779.56
519568-1956881.22681.50
619225-1922579.80280.09
30min120446-2044684.87185.071.5785.2985.481.56
220355-2035584.49384.91
320308-2030884.29884.70
420327-2032784.37784.80
521142-2114287.76088.17
620381-2038184.60185.02
45min121793-2179390.46289.932.1091.0290.492.09
221536-2153689.39589.95
320826-2082686.44886.99
421898-2189890.89891.46
522131-2213191.86592.42
621807-2180790.52091.09
60min122278-2227892.47591.891.2693.1892.601.26
221989-2198991.27691.98
321896-2189690.89091.58
421964-2196491.17291.89
522640-2264093.97894.69
622061-2206191.57592.29
90min122207-2220792.18191.531.5393.0492.391.52
222042-2204291.49692.35
321605-2160589.68290.52
422206-2220692.17793.04
522514-2251493.45594.32
621730-2173090.20191.07
极限122489-2248993.35192.980.8994.3794.000.88
222537-2253793.55094.56
322401-2240192.98693.98
422164-2216492.00293.02
522648-2264894.01195.03
622166-2216692.01093.03
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%
110.152159521692216212174621537216380.38
210.062148021488214840.03
单位质量响应值RSD%判断
2131.822135.590.13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%
5min15783-578324.32923.585.8524.3323.585.86
26110-611025.70525.71
35214-521421.93621.94
45721-572124.06924.07
55444-544422.90322.90
65363-536322.56222.56
10min19851-985141.44443.675.8241.4843.715.81
210391-1039143.71543.76
310534-1053444.31744.35
411327-1132747.65347.69
59615-961540.45140.49
610563-1056344.43944.48
15min112755-1275553.66154.602.9553.7754.712.95
213355-1335556.18556.30
312823-1282353.94754.06
413505-1350556.81656.94
512940-1294054.43954.54
612494-1249452.56352.67
20min113846-1384658.25161.022.8458.4561.232.83
214373-1437360.46860.68
314302-1430260.16960.37
414855-1485562.49662.71
514727-1472761.95762.15
614927-1492762.79963.00
30min116001-1600167.31768.244.2967.6168.544.27
215483-1548365.13865.45
316778-1677870.58670.89
416797-1679770.66670.98
515370-1537064.66264.96
616893-1689371.07071.37
45min117916-1791675.37476.032.3375.7876.452.33
217688-1768874.41474.83
318438-1843877.57077.99
418227-1822776.68277.12
517555-1755573.85574.26
618606-1860678.27678.70
60min118705-1870578.69380.473.3779.2381.023.35
218414-1841477.46978.01
318629-1862978.37378.92
419547-1954782.23582.80
519408-1940881.65082.18
620065-2006584.41584.97
90min119934-1993483.86385.092.3584.5385.772.34
220507-2050786.27486.95
320440-2044085.99286.67
420315-2031585.46686.17
519423-1942381.71482.38
620738-2073887.24687.94
极限119107-1910780.38485.764.8581.1986.584.82
221010-2101088.39089.21
320973-2097388.23589.06
421054-2105488.57589.42
519115-1911580.41881.22
621047-2104788.54689.38
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%
110.152145121522216082151021508215200.27
210.062119721206212020.04
单位质量响应值RSD%判断
2120.202107.550.43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%
5min14272-427218.14120.9913.7118.1421.0013.70
24515-451519.17319.17
36031-603125.61125.61
45442-544223.11023.11
54466-446618.96518.97
64937-493720.96520.97
10min110124-1012442.99243.255.9343.0243.295.94
29460-946040.17240.20
311165-1116547.41347.46
410239-1023943.48043.52
59676-967641.09041.12
610447-1044744.36444.40
15min112937-1293754.93854.473.3155.0454.583.31
212210-1221051.85051.95
313292-1329256.44556.57
413179-1317955.96556.08
512433-1243352.79752.90
612915-1291554.84454.95
20min114370-1437061.02360.452.8761.2260.652.87
213614-1361457.81358.00
314799-1479962.84563.06
414461-1446161.40961.61
514160-1416060.13160.32
614007-1400759.48159.68
30min115924-1592467.62269.113.5367.9269.413.53
215370-1537065.26965.55
316955-1695572.00072.32
416585-1658570.42970.74
516174-1617468.68468.97
616641-1664170.66770.97
45min117577-1757774.64277.322.8875.0577.732.88
217883-1788375.94176.33
318929-1892980.38380.82
418702-1870279.41979.84
517896-1789675.99676.40
618254-1825477.51777.93
60min118590-1859078.94381.054.3179.4881.594.30
218887-1888780.20580.72
320118-2011885.43286.01
419929-1992984.63085.19
519052-1905280.90581.43
617940-1794076.18376.73
90min119557-1955783.05086.913.2483.7187.593.24
220562-2056287.31887.97
321361-2136190.71191.43
420988-2098889.12789.82
519941-1994184.68085.34
620393-2039386.60087.27
极限120265-2026586.05687.871.6886.8688.701.68
220865-2086588.60489.40
320934-2093488.89789.77
420992-2099289.14489.99
520234-2023485.92586.73
620868-2086888.61789.43
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