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%
110.152136621358212812126921283213110.22
210.062153721507215220.10
单位质量响应值RSD%判断
2099.612139.361.33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%
5min14719-471919.98817.3642.7219.9917.3642.72
25450-545023.08423.08
32000-20008.4718.47
41778-17787.5317.53
55728-572824.26224.26
64923-492320.85220.85
10min110841-1084145.91940.9623.1645.9540.9923.17
211851-1185150.19750.24
36996-699629.63329.65
46699-669928.37528.39
511223-1122347.53747.58
610406-1040644.07644.11
15min114260-1426060.40055.2614.1360.5155.3514.15
214741-1474162.43862.56
311195-1119547.41847.48
410394-1039444.02544.09
514513-1451361.47261.59
613169-1316955.77955.89
20min116163-1616368.46165.118.5268.6765.308.56
216444-1644469.65169.88
314343-1434360.75260.89
413331-1333156.46556.60
516625-1662570.41870.64
615325-1532564.91165.11
30min119026-1902680.58776.033.7580.9176.333.78
218014-1801476.30176.64
317784-1778475.32775.57
416998-1699871.99872.22
518224-1822477.19077.53
617656-1765674.78575.09
45min120435-2043586.55584.501.9287.0184.921.93
220112-2011285.18785.66
320123-2012385.23485.60
419771-1977183.74384.09
519940-1994084.45984.93
619311-1931181.79582.23
60min120991-2099188.91087.531.6489.5188.101.61
220669-2066987.54788.16
321112-2111289.42389.93
420608-2060887.28887.78
520268-2026885.84886.46
620341-2034186.15786.73
极限121525-2152591.17290.151.8391.9290.861.81
221188-2118889.74590.50
321523-2152391.16491.82
421514-2151491.12691.76
521417-2141790.71591.47
620534-2053486.97587.69
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%
110.152156421536215792152521567215540.11
210.062172821726217270.01
单位质量响应值RSD%判断
2123.552159.741.20数据可信
供试品溶液-PN4A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%
5min17427-742731.13239.7130.0731.1339.7130.07
28187-818734.31834.32
37928-792833.23233.23
415132-1513263.43063.43
59137-913738.30038.30
69027-902737.83937.84
10min116443-1644368.92575.5912.0768.9875.6612.08
215249-1524963.92063.98
317010-1701071.30271.36
421151-2115188.66088.77
519060-1906079.89579.96
619282-1928280.82580.89
15min120146-2014684.44788.406.3384.6188.596.35
219305-1930580.92281.09
320330-2033085.21885.39
422529-2252994.43694.69
521896-2189691.78391.98
622322-2232293.56893.77
20min121447-2144789.90192.213.6790.2192.553.70
220972-2097287.90988.21
321490-2149090.08190.40
422745-2274595.34195.75
522348-2234893.67794.03
622979-2297996.32296.68
30min122408-2240893.92994.831.4994.3995.331.53
222460-2246094.14794.59
322178-2217892.96593.43
422988-2298896.36096.93
522688-2268895.10295.61
623020-2302096.49497.01
45min122695-2269595.13295.691.0395.7596.341.06
222836-2283695.72396.32
322477-2247794.21894.84
423122-2312296.92297.65
522795-2279595.55196.22
623041-2304196.58297.26
60min122766-2276695.42995.480.9696.2096.290.99
222710-2271095.19595.96
322517-2251794.38695.16
423146-2314697.02297.91
522652-2265294.95295.78
622882-2288295.91696.75
极限122702-2270295.16195.131.3296.0996.101.34
222778-2277895.48096.40
322283-2228393.40594.34
423128-2312896.94798.00
522446-2244694.08895.07
622830-2283095.69896.69
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%
110.152178721590215822168121632216540.39
210.062182121709217650.37
单位质量响应值RSD%判断
2133.402163.521.00数据可信
供试品溶液-PN4A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%
5min19889-988941.32050.9729.2341.3250.9729.23
213192-1319255.12155.12
316406-1640668.55068.55
415082-1508263.01863.02
512012-1201250.19050.19
66614-661427.63627.64
10min118832-1883278.68781.0510.1778.7681.1410.19
220179-2017984.31584.41
321359-2135989.24689.36
420614-2061486.13386.24
519631-1963182.02582.11
615772-1577265.90165.95
15min121645-2164590.44191.253.7790.6491.473.81
222265-2226593.03193.26
322479-2247993.92594.19
422186-2218692.70192.95
522205-2220592.78193.00
620256-2025684.63784.79
20min122525-2252594.11894.022.0594.4794.402.09
222694-2269494.82495.21
322862-2286295.52695.95
422599-2259994.42794.83
522739-2273995.01295.39
621594-2159490.22890.52
30min122691-2269194.81195.330.4095.3295.860.43
222819-2281995.34695.89
322919-2291995.76496.34
422807-2280795.29695.86
522910-2291095.72696.26
622741-2274195.02095.47
45min122493-2249393.98495.380.7394.6596.070.75
222860-2286095.51796.22
322939-2293995.84796.59
422906-2290695.71096.43
522895-2289595.66496.36
622877-2287795.58896.19
60min122616-2261694.49895.490.5395.3296.340.56
222910-2291095.72696.59
322951-2295195.89896.80
422913-2291395.73996.62
522878-2287895.59396.44
622859-2285995.51396.28
极限122557-2255794.25195.250.5995.2396.250.61
222925-2292595.78996.81
322906-2290695.71096.77
422784-2278495.20096.24
522831-2283195.39696.41
622766-2276695.12596.05
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