佩玛贝特片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号HX240702对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.981922919988203652048720578201292.74
210.002069420768207310.26
单位质量响应值RSD%判断
2016.932073.101.95数据可信
供试品溶液-24082002批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
佩玛贝特片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号HX240702对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.982055120361184651845118448190275.14
210.0020846208461917419094199904.95
单位质量响应值RSD%判断
1906.511999.003.35数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24082002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%
5min112596-1259664.54063.4613.1564.5463.4613.15
213887-1388771.15571.15
310830-1083055.49155.49
412864-1286465.91365.91
514080-1408072.14472.14
610054-1005451.51551.52
10min116500-1650084.54385.486.8784.6785.616.88
217479-1747989.56089.70
316635-1663585.23585.35
417552-1755289.93490.07
517399-1739989.15089.29
614533-1453374.46574.57
15min117136-1713687.80291.065.7988.1091.365.80
218782-1878296.23696.56
318261-1826193.56693.85
418519-1851994.88895.20
517905-1790591.74292.06
616025-1602582.11082.36
20min117331-1733188.80192.695.7189.2893.175.71
218796-1879696.30896.82
318949-1894997.09297.56
418738-1873896.01196.51
518367-1836794.11094.62
616355-1635583.80084.22
30min117550-1755089.92393.285.0990.5793.955.10
218709-1870995.86296.57
318973-1897397.21597.88
419045-1904597.58498.28
518270-1827093.61394.31
616686-1668685.49686.08
45min117545-1754589.89893.915.2790.7394.775.27
218947-1894797.08197.98
319099-1909997.86098.72
419095-1909597.84098.73
518520-1852094.89495.78
616766-1676685.90686.66
60min117635-1763590.35993.865.1291.3794.905.12
218759-1875996.11897.21
319110-1911097.91798.97
419200-1920098.37899.46
518413-1841394.34595.42
616797-1679786.06586.99
极限117576-1757690.05794.324.7691.2595.554.77
218906-1890696.87198.16
319247-1924798.61999.87
419153-1915398.13799.42
518432-1843294.44395.70
617131-1713187.77688.88
佩玛贝特片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号HX240702对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.981772117637194181946519434189334.53
210.0018916188712117121175200336.58
单位质量响应值RSD%判断
1897.092003.303.86数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24082002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%
5min16405-640532.86726.1951.8232.8726.1951.83
25056-505625.94525.94
35943-594330.49630.50
47607-760739.03539.04
5-0.0000.00
65612-561228.79828.80
10min112819-1281965.78158.276.7265.8558.326.73
211348-1134858.23258.28
311047-1104756.68856.75
410780-1078055.31755.40
510772-1077255.27655.28
611365-1136558.31958.38
15min115593-1559380.01573.824.8580.2173.994.86
214730-1473075.58775.76
314379-1437973.78673.96
413718-1371870.39470.58
513844-1384471.04071.15
614047-1404772.08272.26
20min116921-1692186.83080.634.8687.1980.954.86
216158-1615882.91583.23
315930-1593081.74582.07
414950-1495076.71677.05
515239-1523978.19978.45
615084-1508477.40377.72
30min117941-1794192.06485.804.7392.6086.284.73
217208-1720888.30388.79
316860-1686086.51787.00
415884-1588481.50981.99
516497-1649784.65485.06
615929-1592981.74082.21
45min118622-1862295.55989.014.5296.2789.664.52
217738-1773891.02291.68
317449-1744989.53990.20
416441-1644184.36785.01
517116-1711687.83188.41
616708-1670885.73786.37
60min118852-1885296.73990.774.7097.6591.604.70
218340-1834094.11294.96
317900-1790091.85492.69
416730-1673085.85086.66
517416-1741689.37090.12
616896-1689686.70287.51
极限119278-1927898.92592.913.97100.0293.923.96
218399-1839994.41495.45
317860-1786091.64892.67
417106-1710687.77988.77
518107-1810792.91693.85
617880-1788091.75192.73
佩玛贝特片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号HX240702对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.981910419117206572068320675202063.72
210.0020729206561930719349200103.95
单位质量响应值RSD%判断
2024.652001.000.84数据可信
供试品溶液-24082002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%
5min1-0.0005.38244.950.005.38244.95
2-0.0000.00
36497-649732.27932.28
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min16316-631631.38035.489.3331.3835.499.30
27338-733836.45736.46
36511-651132.34932.41
47434-743436.93436.93
57096-709635.25535.26
68147-814740.47740.48
15min19133-913345.37649.397.3545.4449.477.32
210183-1018350.59250.67
39244-924445.92746.06
410430-1043051.82051.89
59647-964747.92948.00
611010-1101054.70154.78
20min110761-1076153.46458.957.8953.6259.137.87
212131-1213160.27160.44
311125-1112555.27255.49
412247-1224760.84761.02
511552-1155257.39457.56
613381-1338166.48166.67
30min112702-1270263.10868.817.1463.3769.117.13
214035-1403569.73070.02
313235-1323565.75666.09
414217-1421770.63570.93
513389-1338966.52166.80
615526-1552677.13877.46
45min114334-1433471.21676.115.3671.6076.545.36
215464-1546476.83077.26
314670-1467072.88573.35
415539-1553977.20377.64
515209-1520975.56375.98
616694-1669482.94183.42
60min114835-1483573.70580.046.8174.2380.626.81
216062-1606279.80180.39
315764-1576478.32178.93
416180-1618080.38780.98
515687-1568777.93878.50
618131-1813190.08190.72
极限115174-1517475.38980.967.2976.0781.717.26
216389-1638981.42682.17
315072-1507274.88275.65
416461-1646181.78382.54
516320-1632081.08381.80
618357-1835791.20392.03
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