厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598254648260138258368261388245138255930.08
214.608316028323448319730.07
单位质量响应值RSD%判断
56586.2256984.450.50数据可信
供试品溶液-25101501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%
5min11410719-141071911.89710.0417.2711.9010.0417.27
21053039-10530398.8818.88
31334435-133443511.25411.25
41345227-134522711.34511.34
5885835-8858357.4717.47
61111568-11115689.3749.37
10min12301577-230157719.41018.763.5719.5418.873.65
22186629-218662918.44118.54
32279184-227918419.22219.35
42281420-228142019.24019.37
52092435-209243517.64717.73
62204655-220465518.59318.70
15min12481862-248186220.93120.222.6421.2820.542.72
22406975-240697520.29920.60
32420289-242028920.41220.75
42415697-241569720.37320.71
52292953-229295319.33819.62
62365961-236596119.95320.26
20min12488306-248830620.98520.451.9421.5720.992.05
22413674-241367420.35620.88
32447797-244779720.64421.21
42443545-244354520.60821.17
52350882-235088219.82620.32
62401846-240184620.25620.79
30min12442403-244240320.59820.580.4521.4121.350.48
22427196-242719620.47021.23
32455417-245541720.70821.50
42429434-242943420.48921.28
52439169-243916920.57121.29
62448013-244801320.64521.40
45min12448759-244875920.65220.422.0721.6921.421.88
22401074-240107420.25021.23
32384681-238468120.11121.14
42373731-237373120.01921.04
52508629-250862921.15722.10
62409069-240906920.31721.30
60min12384941-238494120.11320.031.7021.3921.251.55
22391920-239192020.17221.38
32382278-238227820.09121.34
42297865-229786519.37920.62
52416442-241644220.37921.56
62374096-237409620.02221.23
极限12470131-247013120.83220.062.0022.3321.511.94
22378834-237883420.06221.49
32338107-233810719.71821.19
42345443-234544319.78021.24
52370212-237021219.98921.39
62370918-237091819.99521.43
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598260228261158247168257498247258254650.09
214.608321728323718322720.02
单位质量响应值RSD%判断
56577.4557004.930.54数据可信
供试品溶液-25101501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%
5min139451-394510.3330.3125.570.330.3125.91
251820-518200.4370.44
329373-293730.2480.25
429916-299160.2520.25
528826-288260.2430.24
644322-443220.3740.37
10min180643-806430.6800.708.300.680.708.18
294650-946500.7980.80
381699-816990.6890.69
479371-793710.6690.67
575326-753260.6350.64
687829-878290.7410.74
15min1101808-1018080.8590.874.610.870.884.57
2111577-1115770.9410.95
3101001-1010010.8520.86
499277-992770.8370.85
5100030-1000300.8440.85
6106646-1066460.8990.91
20min1113564-1135640.9580.973.040.980.983.07
2119848-1198481.0111.03
3110249-1102490.9300.95
4113979-1139790.9610.98
5112028-1120280.9450.96
6117087-1170870.9871.01
30min1124901-1249011.0531.072.061.081.102.41
2130622-1306221.1011.14
3123526-1235261.0421.07
4125528-1255281.0591.09
5125286-1252861.0561.09
6128488-1284881.0831.12
45min1141582-1415821.1941.182.241.241.222.14
2139335-1393351.1751.22
3144629-1446291.2201.26
4138758-1387581.1701.21
5136099-1360991.1481.19
6137143-1371431.1561.20
60min1142218-1422181.1991.200.821.261.260.84
2143992-1439921.2141.27
3140694-1406941.1861.24
4141126-1411261.1901.25
5142467-1424671.2011.26
6141742-1417421.1951.25
极限1144422-1444221.2181.221.291.291.291.39
2147970-1479701.2481.32
3142523-1425231.2021.27
4144175-1441751.2161.28
5144146-1441461.2161.28
6145864-1458641.2301.30
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33对照品稀释倍数2500
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.598384638391378401298364878369438382320.19
214.608295138298278296700.03
单位质量响应值RSD%判断
57452.5056826.710.78数据可信
供试品溶液-25101501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%
5min1554307-5543074.6464.0318.734.654.0318.77
2457945-4579453.8383.84
3359616-3596163.0143.01
4559861-5598614.6924.69
5395313-3953133.3133.31
6561201-5612014.7044.70
10min11183366-11833669.9189.875.309.979.915.37
21192866-11928669.99810.04
31119095-11190959.3809.41
41233998-123399810.34310.39
51088990-10889909.1279.16
61246110-124611010.44410.50
15min11477163-147716312.38112.334.2712.5412.484.34
21475312-147531212.36512.52
31406993-140699311.79311.93
41511478-151147812.66812.84
51392982-139298211.67511.81
61559304-155930413.06913.24
20min11605275-160527513.45413.652.5713.7513.942.62
21655905-165590513.87914.17
31597937-159793713.39313.66
41667118-166711813.97314.28
51573513-157351313.18813.46
61672869-167286914.02114.33
30min11775494-177549414.88115.322.5315.3315.772.57
21840410-184041015.42515.87
31808204-180820415.15515.57
41878264-187826415.74216.21
51785661-178566114.96615.38
61882770-188277015.78016.25
45min11964926-196492616.46916.621.6617.0817.241.74
21994836-199483616.71917.34
31970191-197019116.51317.10
41990966-199096616.68717.33
51940750-194075016.26616.85
62037084-203708417.07417.72
60min11974214-197421416.54717.162.1717.3417.952.17
22058398-205839817.25218.05
32033379-203337917.04317.81
42065499-206549917.31218.14
52041368-204136817.10917.87
62108548-210854817.67318.51
极限12028792-202879217.00417.491.9017.9918.481.91
22091337-209133717.52818.52
32067564-206756417.32918.29
42110456-211045617.68918.70
52078173-207817317.41818.37
62145304-214530417.98119.01
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