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%
110.002112621280209762118021001211130.60
210.082109121043210670.17
单位质量响应值RSD%判断
2111.302089.980.72数据可信
供试品溶液-2025041321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%
5min16583-658328.13226.845.5528.1326.845.55
26468-646827.64027.64
36461-646127.61027.61
46497-649727.76427.76
55893-589325.18325.18
65781-578124.70424.70
10min113544-1354457.87954.374.6857.9354.424.68
213169-1316956.27656.32
312366-1236652.84552.89
412830-1283054.82754.87
511866-1186650.70850.75
612569-1256953.71253.75
15min116046-1604668.57167.012.6368.7167.142.63
216140-1614068.97269.11
315913-1591368.00268.14
415444-1544465.99866.14
515101-1510164.53264.66
615437-1543765.96866.10
20min117929-1792976.61774.641.9176.8874.891.91
217524-1752474.88775.14
317486-1748674.72474.97
417607-1760775.24175.49
517337-1733774.08874.32
616920-1692072.30672.55
30min119485-1948583.26782.541.6683.6582.911.66
219389-1938982.85783.24
319563-1956383.60083.97
418931-1893180.89981.27
519620-1962083.84484.20
618895-1889580.74581.11
45min120664-2066488.30587.671.4488.8388.181.44
220614-2061488.09188.61
320640-2064088.20388.71
420293-2029386.72087.23
520844-2084489.07489.57
620035-2003585.61786.11
60min121345-2134591.21590.850.8091.8991.500.81
221463-2146391.72092.38
321036-2103689.89590.55
421292-2129290.98991.64
521352-2135291.24591.89
621069-2106990.03690.67
90min121849-2184993.36992.170.8994.1992.980.90
221690-2169092.69093.51
321343-2134391.20792.01
421647-2164792.50693.31
521411-2141191.49792.30
621476-2147691.77592.56
极限122132-2213294.57893.431.0595.5694.391.05
221904-2190493.60494.58
321692-2169292.69893.66
421865-2186593.43794.40
522064-2206494.28895.24
621522-2152291.97292.91
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%
110.002127621356211282110621223212180.49
210.082133121179212550.51
单位质量响应值RSD%判断
2121.802108.630.45数据可信
供试品溶液-2025041321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%
5min15929-592925.16224.2612.5725.1624.2612.56
25841-584124.78824.79
36808-680828.89228.89
44858-485820.61720.62
55895-589525.01825.02
64969-496921.08821.09
10min111688-1168849.60250.377.0449.6450.417.04
210907-1090746.28846.33
313116-1311655.66355.71
411034-1103446.82746.86
512292-1229252.16652.21
612175-1217551.66951.70
15min114823-1482362.90763.671.7363.0363.791.73
215060-1506063.91364.03
315369-1536965.22465.36
414709-1470962.42362.54
515223-1522364.60464.73
614833-1483362.94963.07
20min116452-1645269.82070.992.4470.0571.222.44
216847-1684771.49671.72
317448-1744874.04774.30
416655-1665570.68270.90
516263-1626369.01869.25
616706-1670670.89871.12
30min118510-1851078.55479.231.5578.9079.571.56
218649-1864979.14479.49
319143-1914381.24081.61
418266-1826677.51877.85
518726-1872679.47179.82
618715-1871579.42479.77
45min119825-1982584.13584.731.1084.6185.201.11
219837-1983784.18684.66
320334-2033486.29586.80
419772-1977283.91084.37
519898-1989884.44484.93
620120-2012085.38785.86
60min120639-2063987.58987.991.2188.2188.611.22
220833-2083388.41289.03
321153-2115389.77090.42
420471-2047186.87687.48
520519-2051987.08087.70
620787-2078788.21788.84
90min121008-2100889.15590.611.4889.9291.381.48
221613-2161391.72392.49
321804-2180492.53393.34
421047-2104789.32190.07
521254-2125490.19990.97
621376-2137690.71791.48
极限121214-2121490.02990.981.3290.9491.901.32
221481-2148191.16292.08
321900-2190092.94193.90
421129-2112989.66990.57
521323-2132390.49291.41
621583-2158391.59592.51
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