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%
110.002159521461216032155021571215560.27
210.082142021493214560.25
单位质量响应值RSD%判断
2155.602128.570.90数据可信
供试品溶液-2025041221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%
5min13636-363615.23814.295.1615.2414.295.17
23403-340314.26114.26
33567-356714.94814.95
43342-334214.00614.01
53371-337114.12714.13
63141-314113.16313.16
10min18623-862336.13734.943.8736.1634.973.87
28414-841435.26135.28
38567-856735.90235.93
48464-846435.47135.49
58215-821534.42734.45
67747-774732.46632.49
15min111267-1126747.21745.932.4447.3046.012.44
210831-1083145.39045.47
311286-1128647.29747.38
410931-1093145.80945.89
510828-1082845.37745.46
610614-1061444.48144.56
20min113163-1316355.16353.812.2755.3353.972.27
212836-1283653.79353.95
313110-1311054.94155.10
412939-1293954.22454.38
512469-1246952.25552.41
612526-1252652.49352.64
30min115367-1536764.39963.112.3764.6663.362.37
215105-1510563.30163.55
315570-1557065.25065.51
414891-1489162.40562.65
514704-1470461.62161.86
614713-1471361.65961.90
45min117618-1761873.83372.721.8674.2073.071.87
216955-1695571.05471.41
317773-1777374.48274.85
417491-1749173.30173.65
517106-1710671.68772.03
617165-1716571.93472.27
60min119033-1903379.76378.952.0180.2579.422.01
218597-1859777.93578.41
319479-1947981.63282.12
418793-1879378.75779.23
518402-1840277.11877.58
618729-1872978.48978.95
90min120639-2063986.49385.410.7487.1186.010.74
220189-2018984.60785.21
320416-2041685.55886.18
420309-2030985.11085.72
520375-2037585.38785.98
620351-2035185.28685.88
极限121228-2122888.96186.941.3389.7387.691.32
220732-2073286.88387.63
320391-2039185.45486.22
420615-2061586.39287.14
520783-2078387.09687.83
620720-2072086.83287.57
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%
110.002155421661214662142421545215300.43
210.082132921226212780.35
单位质量响应值RSD%判断
2153.002110.911.40数据可信
供试品溶液-2025041221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%
5min12806-280611.81614.9712.6211.8214.9812.62
23579-357915.07115.07
34085-408517.20217.20
43546-354614.93214.93
53394-339414.29214.29
63927-392716.53616.54
10min17697-769732.41134.634.3332.4334.654.34
28262-826234.79134.82
38695-869536.61436.64
48235-823534.67734.70
57968-796833.55333.58
68483-848335.72135.75
15min110397-1039743.78145.502.5143.8545.592.52
210749-1074945.26345.35
310892-1089245.86545.95
410889-1088945.85345.94
510693-1069345.02745.11
611217-1121747.23447.32
20min112557-1255752.87653.561.4953.0253.721.50
212485-1248552.57352.73
312811-1281153.94654.11
412641-1264153.23053.39
512843-1284354.08154.24
612979-1297954.65354.82
30min115624-1562465.79163.392.3066.0363.642.29
215082-1508263.50963.76
314879-1487962.65462.91
414811-1481162.36862.62
514678-1467861.80862.05
615255-1525564.23764.49
45min117923-1792375.47272.622.3275.8272.982.31
217036-1703671.73772.09
317463-1746373.53573.90
417177-1717772.33172.68
516774-1677470.63470.98
617108-1710872.04072.40
60min119834-1983483.51979.282.9083.9979.752.89
218542-1854278.07978.55
319063-1906380.27380.76
418545-1854578.09178.56
518368-1836877.34677.81
618609-1860978.36178.84
90min121615-2161591.01985.873.8691.6386.483.84
220239-2023985.22585.83
319810-1981083.41884.03
420116-2011684.70785.31
519533-1953382.25282.85
621039-2103988.59389.21
极限121677-2167791.28087.162.9492.0487.922.91
220388-2038885.85286.60
320003-2000384.23184.99
420695-2069587.14587.89
521107-2110788.88089.61
620327-2032785.59586.36
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%
110.002134721433212602142721497213930.43
210.082146221362214120.34
单位质量响应值RSD%判断
2139.302124.210.51数据可信
供试品溶液-2025041321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%
5min12890-289012.17013.6816.9612.1713.6816.96
23494-349414.71314.71
32706-270611.39511.39
44114-411417.32417.32
52781-278111.71111.71
63504-350414.75514.76
10min17182-718230.24332.585.2130.2632.605.22
27576-757631.90231.93
37866-786633.12333.14
48373-837335.25835.29
57879-787933.17833.20
67545-754531.77231.80
15min110386-1038643.73544.332.2043.8144.402.19
210517-1051744.28744.36
310698-1069845.04945.12
410828-1082845.59645.68
510556-1055644.45144.53
610173-1017342.83842.92
20min112244-1224451.55951.861.8951.7052.021.89
212185-1218551.31051.46
312345-1234551.98452.13
412722-1272253.57253.74
512367-1236752.07752.23
612037-1203750.68750.84
30min114822-1482262.41561.773.2062.6462.003.19
214107-1410759.40459.64
315154-1515463.81364.05
414515-1451561.12261.37
515207-1520764.03664.27
614208-1420859.82960.06
45min117455-1745573.50271.962.9473.8472.302.92
216728-1672870.44170.78
317402-1740273.27973.62
416716-1671670.39070.75
517732-1773274.66975.01
616504-1650469.49869.83
60min118345-1834577.25077.474.2177.7177.934.19
217689-1768974.48874.94
318922-1892279.68080.14
417859-1785975.20375.68
519686-1968682.89783.36
617881-1788175.29675.75
90min121428-2142890.23285.025.2090.8285.615.17
220385-2038585.84086.42
320072-2007284.52285.12
418812-1881279.21679.81
521225-2122589.37789.98
619217-1921780.92281.50
极限120203-2020385.07485.273.6485.8186.003.62
220470-2047086.19886.92
319818-1981883.45384.19
419564-1956482.38383.11
521602-2160290.96591.72
619840-1984083.54584.25
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%
110.002147521418215592143821394214570.31
210.082146421375214200.30
单位质量响应值RSD%判断
2145.702125.000.69数据可信
供试品溶液-2025041321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%
5min13187-318713.39813.6517.5413.4013.6517.53
22755-275511.58211.58
33302-330213.88113.88
43873-387316.28216.28
52488-248810.45910.46
63883-388316.32416.32
10min18027-802733.74533.397.2033.7733.427.20
27260-726030.52030.54
38142-814234.22834.25
48278-827834.80034.83
57269-726930.55830.58
68686-868636.51536.54
15min111261-1126147.34044.405.4347.4244.485.43
210183-1018342.80842.88
310338-1033843.46043.54
410918-1091845.89845.98
59731-973140.90840.98
610938-1093845.98246.07
20min113006-1300654.67652.243.3454.8352.403.35
211883-1188349.95550.10
312544-1254452.73452.89
412565-1256552.82252.98
512004-1200450.46450.60
612562-1256252.80952.97
30min115256-1525664.13561.813.2964.3862.053.29
214905-1490562.65962.88
314533-1453361.09561.34
414802-1480262.22662.48
513838-1383858.17458.39
614881-1488162.55862.81
45min117401-1740173.15271.461.8373.5171.801.83
217290-1729072.68673.01
316797-1679770.61370.96
416848-1684870.82771.18
516593-1659369.75570.07
617060-1706071.71972.08
60min119826-1982683.34778.563.4683.8279.033.45
219102-1910280.30380.75
318251-1825176.72577.19
418381-1838177.27277.74
518205-1820576.53276.97
618366-1836677.20977.69
90min120871-2087187.74083.814.7788.3684.404.76
220798-2079887.43388.02
319756-1975683.05283.64
420433-2043385.89886.50
518439-1843977.51678.08
619318-1931881.21181.82
极限121880-2188091.98187.402.8492.7488.132.83
221011-2101188.32889.06
320448-2044885.96186.69
420412-2041285.81086.55
520314-2031485.39886.09
620679-2067986.93387.67
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