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%
19.822046220491205612061620643205550.38
29.792059620474205350.43
单位质量响应值RSD%判断
2093.182097.550.15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%
5min11560-15606.6838.7313.926.688.7313.92
22128-21289.1169.12
31851-18517.9307.93
42195-21959.4039.40
52155-21559.2329.23
62342-234210.03310.03
10min15742-574224.59926.5110.0624.6126.5310.05
25964-596425.55025.57
35827-582724.96324.98
46835-683529.28129.30
55655-565524.22624.24
67112-711230.46830.48
15min19001-900138.56139.303.3138.6139.363.31
28866-886637.98238.04
39354-935440.07340.13
49494-949440.67340.74
58845-884537.89237.95
69476-947640.59640.66
20min111264-1126448.25547.353.7448.3747.473.72
210466-1046644.83744.96
311605-1160549.71649.84
411212-1121248.03348.16
511071-1107147.42947.55
610691-1069145.80145.94
30min113970-1397059.84856.853.8660.0457.053.85
213452-1345257.62957.82
313583-1358358.19058.39
413143-1314356.30556.52
512506-1250653.57653.77
612969-1296955.56055.77
45min116839-1683972.13967.533.7272.4467.823.71
215417-1541766.04766.34
315988-1598868.49368.79
415441-1544166.15066.46
515246-1524665.31465.60
615644-1564467.01967.32
60min117594-1759475.37373.612.5375.7974.022.52
216968-1696872.69273.09
317849-1784976.46676.88
416744-1674471.73272.15
516945-1694572.59372.99
617001-1700172.83373.25
90min116699-1669971.53976.266.3372.0876.796.29
217909-1790976.72377.25
319690-1969084.35384.90
417434-1743474.68875.22
518329-1832978.52279.04
616738-1673871.70672.24
极限120220-2022086.62382.563.4887.2883.223.46
218935-1893581.11881.77
320024-2002485.78486.47
418684-1868480.04380.70
518776-1877680.43781.09
618996-1899681.38082.04
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%
19.822055720548205052049820645205510.29
29.792033120375203530.16
单位质量响应值RSD%判断
2092.772078.960.47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%
5min13173-317313.65511.0220.5513.6611.0220.57
22752-275211.84311.84
32761-276111.88211.88
41836-18367.9017.90
52851-285112.27012.27
61992-19928.5738.57
10min17335-733531.56729.4511.0831.5929.4711.08
27333-733331.55831.58
37359-735931.67031.69
45503-550323.68323.70
57163-716330.82730.85
66367-636727.40127.42
15min110227-1022744.01340.937.0144.0941.007.03
29657-965741.56041.63
310049-1004943.24743.32
48340-834035.89235.94
59423-942340.55340.62
69372-937240.33340.39
20min111978-1197851.54849.023.2251.7049.153.22
210990-1099047.29647.44
311059-1105947.59347.74
411334-1133448.77748.89
511619-1161950.00350.14
611357-1135748.87649.00
30min114125-1412560.78859.421.6961.0259.641.70
213586-1358658.46958.69
313901-1390159.82460.05
413529-1352958.22358.42
513728-1372859.08059.30
613975-1397560.14360.35
45min117143-1714373.77669.484.3474.1169.794.31
215094-1509464.95865.28
315769-1576967.86368.19
416591-1659171.40171.69
516092-1609269.25369.57
616174-1617469.60669.92
60min118063-1806377.73671.808.4878.1972.238.43
217202-1720274.03074.46
314297-1429761.52861.97
415700-1570067.56667.98
517229-1722974.14774.58
617607-1760775.77376.20
90min120013-2001386.12881.104.7886.7281.664.76
217405-1740574.90475.45
318826-1882681.01981.56
419333-1933383.20183.72
518328-1832878.87679.44
619168-1916882.49183.04
极限119599-1959984.34682.922.1685.0883.612.16
219193-1919382.59983.27
319784-1978485.14285.82
418913-1891381.39482.05
518693-1869380.44781.14
619430-1943083.61984.31
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%
19.822046620463204972054020494204920.16
29.792044820410204290.14
单位质量响应值RSD%判断
2086.762086.720.01数据可信
供试品溶液-2025041421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%
5min12755-275511.85110.2820.4311.8510.2820.43
22467-246710.61210.61
32136-21369.1889.19
41669-16697.1807.18
52249-22499.6759.67
63059-305913.15913.16
10min17224-722431.07629.897.3531.1029.917.36
27316-731631.47131.49
36981-698130.03030.05
46085-608526.17626.19
56641-664128.56828.58
67450-745032.04832.07
15min19399-939940.43240.923.9240.5040.993.93
29507-950740.89740.97
39630-963041.42641.49
49119-911939.22739.28
59246-924639.77439.84
610177-1017743.77943.85
20min111863-1186351.03150.151.9451.1750.291.94
211400-1140049.04049.18
311545-1154549.66349.80
411428-1142849.16049.28
511861-1186151.02351.15
611853-1185350.98851.14
30min114245-1424561.27860.660.9461.5060.880.93
214205-1420561.10661.33
313966-1396660.07860.30
414035-1403560.37560.58
514206-1420661.11061.33
613954-1395460.02660.26
45min116365-1636570.39868.563.6770.7268.883.67
216400-1640070.54870.87
316106-1610669.28469.60
414807-1480763.69664.00
515940-1594068.57068.89
616011-1601168.87569.21
60min116420-1642070.63475.113.9971.0875.553.97
217616-1761675.77976.22
317747-1774776.34376.78
418085-1808577.79778.21
516799-1679972.26572.70
618100-1810077.86178.31
90min119115-1911582.22880.563.5482.7981.123.50
219019-1901981.81582.38
318623-1862380.11180.67
418871-1887181.17881.72
519279-1927982.93383.48
617456-1745675.09175.67
极限119486-1948683.82484.032.6184.5284.732.58
219916-1991685.67386.38
318693-1869380.41281.11
419988-1998885.98386.66
519899-1989985.60086.29
619225-1922582.70183.40
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%
19.822053920569206062051620471205400.25
29.792045420276203650.62
单位质量响应值RSD%判断
2091.652080.180.39数据可信
供试品溶液-SI4S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%
5min12448-244810.5358.3325.5910.538.3225.59
21662-16627.1527.15
31525-15256.5636.56
41839-18397.9147.91
51487-14876.3996.40
62649-264911.40011.40
10min16786-678629.20326.109.7529.2226.119.76
25733-573324.67224.68
35702-570224.53824.55
45779-577924.87024.88
55533-553323.81123.82
66853-685329.49229.51
15min110112-1011243.51740.754.4943.5840.814.50
29404-940440.47040.52
38896-889638.28438.34
49256-925639.83339.89
59362-936240.28940.34
69786-978642.11442.18
20min111313-1131348.68549.253.0748.8249.383.07
211184-1118448.13048.25
311811-1181150.82850.94
411787-1178750.72550.85
510948-1094847.11447.23
611626-1162650.03250.17
30min115101-1510164.98762.033.0965.2162.243.09
213982-1398260.17160.37
314538-1453862.56462.76
414534-1453462.54762.75
513868-1386859.68059.88
614464-1446462.24562.47
45min117297-1729774.43770.942.7574.7771.252.75
216362-1636270.41370.71
315919-1591968.50768.81
416463-1646370.84871.16
516535-1653571.15871.45
616328-1632870.26770.59
60min118461-1846179.44677.822.9579.9078.252.95
217251-1725174.23974.66
318568-1856879.90780.33
418451-1845179.40379.83
517624-1762475.84476.26
618144-1814478.08278.52
90min120175-2017586.82285.151.4787.4185.711.47
219642-1964284.52985.07
320019-2001986.15186.70
419877-1987785.54086.10
519626-1962684.46085.00
619385-1938583.42384.00
极限120275-2027587.25385.453.0887.9886.153.05
220060-2006086.32787.01
319928-1992885.75986.46
419968-1996885.93286.63
520260-2026087.18887.87
618644-1864480.23480.95
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