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HX240702对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.6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%
110.61 2227522422223702232522284223350.28
210.522813628165281500.08
单位质量响应值RSD%判断
2105.092675.8616.89数据不可信!(响应值差异过大,请重新称样测定!)
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%
5min15408-540820.57322.6011.7920.5722.6011.78
26733-673325.61325.61
35680-568021.60721.61
10min17736-773629.42928.373.7129.4628.413.68
27183-718327.32527.37
37455-745528.36028.40
15min18585-858532.65837.3521.9632.7437.4321.93
212307-1230746.81746.91
38561-856132.56732.65
20min113184-1318450.15349.551.1550.2949.691.14
213000-1300049.45349.62
312890-1289049.03549.17
30min112774-1277448.59451.3911.0248.8151.6211.01
215223-1522357.91058.16
312533-1253347.67747.90
45min116017-1601760.93060.102.7561.2360.412.77
216079-1607961.16661.51
315298-1529858.19558.49
60min115584-1558459.28361.523.5559.6961.933.56
216730-1673063.64364.09
316198-1619861.61962.01
极限117274-1727465.71264.533.1266.2165.053.12
217264-1726465.67466.23
316355-1635562.21662.71
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HX240702对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.6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%
110.61 2142521366212912120621216213010.45
210.522722527223272240.01
单位质量响应值RSD%判断
2007.632587.8317.86数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-PN4A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%
5min15978-597823.69922.076.6023.7022.076.60
25456-545621.63021.63
35269-526920.88920.89
10min115644-1564462.02059.105.7262.0659.135.71
215101-1510159.86759.90
313975-1397555.40355.44
15min115781-1578162.56356.718.9662.7156.848.95
213611-1361153.96054.10
313519-1351953.59553.72
20min118658-1865873.96871.614.5874.2271.844.58
218412-1841272.99373.22
317121-1712167.87568.09
30min119894-1989478.86873.656.4379.2474.006.43
217563-1756369.62769.97
318277-1827772.45872.79
45min119349-1934976.70874.884.0877.2175.354.08
219314-1931476.56977.03
318000-1800071.36071.81
60min120814-2081482.51680.243.1583.1580.833.15
219556-1955677.52878.12
320347-2034780.66481.23
极限119556-1955677.52876.283.7878.3077.023.78
219760-1976078.33779.06
318411-1841172.98973.69
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HX240702对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.6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%
110.61 2173421764217292172121742217380.08
210.522145621427214420.10
单位质量响应值RSD%判断
2048.822038.210.37数据可信
供试品溶液-PN4A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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
15min15877-587725.78024.849.1025.7824.859.10
26038-603826.48626.49
35076-507622.26622.27
20min18607-860737.75537.451.8537.8037.491.84
28357-835736.65936.70
38648-864837.93537.97
30min19495-949541.65141.652.8841.7641.752.88
29767-976742.84442.95
39221-922140.44940.55
45min112188-1218853.46452.491.6153.6452.661.61
211857-1185752.01252.19
311852-1185251.99052.16
60min112104-1210453.09552.132.5953.3652.392.59
212014-1201452.70052.96
311532-1153250.58650.84
极限113211-1321157.95156.942.9758.3057.292.95
212536-1253654.99055.34
313196-1319657.88558.22
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HX240702对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.6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%
110.61 2108021668210622106621041211831.29
210.522141521447214310.11
单位质量响应值RSD%判断
1996.512037.171.43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%
5min110221-1022145.43347.5027.5945.4347.5027.59
27998-799835.55135.55
313839-1383961.51561.51
10min114180-1418063.03070.8310.6463.1170.9110.64
216058-1605871.37871.44
317563-1756378.06878.17
15min117286-1728676.83778.7011.8777.0278.9011.87
215847-1584770.44070.62
319984-1998488.82989.06
20min118734-1873483.27386.833.5983.5887.153.60
219828-1982888.13688.43
320038-2003889.06989.45
30min120166-2016689.63891.175.4590.0991.645.48
219606-1960687.14987.59
321760-2176096.72497.25
45min120009-2000988.94190.861.9289.5491.491.95
220539-2053991.29691.88
320775-2077592.34593.04
60min121145-2114593.99094.203.5294.7494.983.54
220474-2047491.00891.75
321961-2196197.61798.46
极限120054-2005489.14191.982.7490.0492.922.75
220902-2090292.91093.80
321125-2112593.90194.91
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