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%
115.32 8463758468338457678452378461238460670.08
215.228501598504548503060.03
单位质量响应值RSD%判断
55226.3155867.670.82数据可信
供试品溶液-25100901批-厄贝沙坦-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%
5min1462588-4625883.9886.7531.173.996.7531.18
21108397-11083979.5569.56
3600823-6008235.1805.18
4887549-8875497.6527.65
5964314-9643148.3148.31
6673103-6731035.8035.80
10min11561765-156176513.46516.329.3013.5116.409.36
21928902-192890216.63016.74
31952959-195295916.83816.90
42032394-203239417.52317.61
52031007-203100717.51117.60
61850532-185053215.95516.02
15min11789547-178954715.42918.037.4015.6218.297.46
22062511-206251117.78218.07
32168069-216806918.69218.94
42184850-218485018.83719.12
52175710-217571018.75819.05
62168585-216858518.69718.94
20min12149017-214901718.52818.761.7218.8919.221.75
22113808-211380818.22518.71
32191826-219182618.89719.35
42192699-219269918.90519.39
52198061-219806118.95119.45
62212645-221264519.07719.53
30min12230051-223005119.22719.011.9519.8019.681.77
22125439-212543918.32519.02
32249124-224912419.39120.05
42197727-219772718.94819.65
52207378-220737819.03119.74
62219220-221922019.13319.79
45min12148171-214817118.52118.801.9019.3119.681.87
22142607-214260718.47319.37
32246449-224644919.36820.25
42149080-214908018.52919.44
52188002-218800218.86419.78
62207092-220709219.02919.90
60min12176106-217610618.76218.681.4719.7519.771.34
22119673-211967318.27519.38
32214600-221460019.09420.19
42158623-215862318.61119.73
52151827-215182718.55219.68
62179669-217966918.79219.88
极限12163123-216312318.65018.521.5919.8519.821.42
22142872-214287218.47519.78
32205405-220540519.01420.32
42114505-211450518.23119.55
52113913-211391318.22619.56
62149774-214977418.53519.83
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241276861274731273401272801272811274120.14
210.281278661276801277730.11
单位质量响应值RSD%判断
12442.5812429.280.08数据可信
供试品溶液-25100901批-非奈利酮-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%
5min179712-79712115.53876.1148.44115.5476.1148.44
272138-72138104.560104.56
367230-6723097.44697.45
427952-2795240.51540.51
551408-5140874.51374.51
616617-1661724.08524.09
10min1223704-223704324.246273.9723.89325.53274.8223.91
2203786-203786295.376296.54
3175027-175027253.692254.77
4209483-209483303.634304.08
5218452-218452316.634317.46
6103654-103654150.241150.51
15min1266120-266120385.726349.0915.45390.61352.9815.52
2244694-244694354.670359.11
3219771-219771318.546322.45
4277819-277819402.683406.51
5259783-259783376.541380.89
6176872-176872256.366258.30
20min1316585-316585458.872398.0313.84468.04405.8013.91
2271516-271516393.547401.93
3241567-241567350.138357.58
4306254-306254443.898452.20
5292253-292253423.604432.13
6219494-219494318.144322.93
30min1345810-345810501.232461.1610.02515.50473.3610.15
2300836-300836436.045448.80
3297913-297913431.808443.14
4354251-354251513.467526.70
5336354-336354487.526500.76
6273837-273837396.911405.23
45min1352824-352824511.399496.735.24531.24514.045.48
2331649-331649480.707498.31
3328959-328959476.808492.94
4368024-368024533.430552.37
5353132-353132511.845530.50
6321614-321614466.162478.89
60min1357527-357527518.215514.113.21543.74536.943.47
2354641-354641514.032536.98
3343933-343933498.512519.94
4374584-374584542.939567.80
5353932-353932513.005537.35
6343547-343547497.952515.86
极限1348922-348922505.743522.593.27537.02551.142.86
2367984-367984533.372562.03
3352945-352945511.574538.54
4369302-369302535.283566.18
5348548-348548505.201535.24
6375581-375581544.384567.83
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%
115.32 8604468606418605048599438596768602420.05
215.228596898597108597000.01
单位质量响应值RSD%判断
56151.5756484.890.42数据可信
供试品溶液-25100901批-厄贝沙坦-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%
5min125110-251100.2140.2042.500.210.2043.62
214558-145580.1240.12
337949-379490.3230.32
413283-132830.1130.11
533984-339840.2890.29
619340-193400.1640.16
10min154080-540800.4600.5524.710.460.5524.76
258121-581210.4940.50
375021-750210.6380.64
441342-413420.3520.35
577217-772170.6570.66
682495-824950.7010.70
15min178160-781600.6650.769.880.670.7710.16
287584-875840.7450.75
395755-957550.8140.82
480550-805500.6850.69
597192-971920.8260.84
698671-986710.8390.85
20min193906-939060.7990.876.100.810.896.41
2100688-1006880.8560.87
3104914-1049140.8920.91
497277-972770.8270.84
5107606-1076060.9150.93
6110197-1101970.9370.96
30min1111033-1110330.9440.993.380.971.023.37
2118073-1180731.0041.03
3119051-1190511.0121.04
4112236-1122360.9540.98
5120200-1202001.0221.05
6119064-1190641.0121.04
45min1122433-1224331.0411.072.351.081.112.31
2123713-1237131.0521.09
3127984-1279841.0881.13
4127061-1270611.0801.11
5130622-1306221.1111.15
6126178-1261781.0731.11
60min1129640-1296401.1021.131.651.151.181.65
2135216-1352161.1501.20
3131792-1317921.1211.17
4133985-1339851.1391.18
5135189-1351891.1501.20
6133606-1336061.1361.19
极限1131899-1318991.1221.151.921.181.222.14
2132931-1329311.1301.19
3137760-1377601.1711.24
4135743-1357431.1541.21
5138048-1380481.1741.24
6137116-1371161.1661.23
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241299421300271300881301061297881299900.10
210.281298771299571299170.05
单位质量响应值RSD%判断
12694.3412637.840.32数据可信
供试品溶液-25100901批-非奈利酮-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%
5min172703-72703103.46584.1954.16103.4684.1854.16
228090-2809039.97539.98
364953-6495392.43592.44
425966-2596636.95336.95
5111939-111939159.302159.30
651285-5128572.98472.98
10min1186178-186178264.952217.8536.32266.10218.7836.33
288340-88340125.718126.16
3184675-184675262.813263.84
476023-76023108.189108.60
5180208-180208256.456258.23
6203046-203046288.957289.77
15min1232801-232801331.302286.0725.40335.40289.4225.51
2137209-137209195.264197.10
3242571-242571345.206349.15
4137641-137641195.879197.49
5208451-208451296.649301.27
6247410-247410352.092356.11
20min1252647-252647359.545321.8018.78367.32328.3418.99
2170228-170228242.254246.26
3260187-260187370.275378.06
4178498-178498254.023257.81
5227201-227201323.333331.25
6267999-267999381.393389.33
30min1273428-273428389.119363.4411.72400.89373.5512.07
2217233-217233309.147315.85
3284404-284404404.739416.64
4223764-223764318.441325.05
5249529-249529355.108366.62
6283924-283924404.056416.23
45min1285631-285631406.485390.797.73422.58404.938.13
2239709-239709341.133351.27
3295870-295870421.056437.45
4265592-265592377.967388.12
5267976-267976381.360396.81
6292818-292818416.713433.37
60min1295426-295426420.424408.805.35441.03427.295.76
2264857-264857376.921390.85
3299425-299425426.115447.19
4283149-283149402.953417.30
5275727-275727392.391412.08
6304973-304973434.011455.30
极限1299289-299289425.922426.423.67451.20449.454.05
2280247-280247398.823416.94
3309557-309557440.534466.34
4304317-304317433.077451.90
5295356-295356420.325444.38
6309063-309063439.831465.94
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%
115.32 8474278476778478488474578480568476930.04
215.228495108493798494440.02
单位质量响应值RSD%判断
55332.4455811.040.61数据可信
供试品溶液-25100901批-厄贝沙坦-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%
5min1376309-3763093.2433.0112.583.243.0112.56
2348809-3488093.0063.01
3371098-3710983.1983.20
4403234-4032343.4753.47
5303991-3039912.6202.62
6290392-2903922.5032.50
10min1981167-9811678.4558.2812.518.498.3212.49
2937166-9371668.0768.11
31060914-10609149.1439.18
41118050-11180509.6359.67
5884433-8844337.6227.65
6785593-7855936.7706.80
15min11272439-127243910.96610.878.7511.1011.008.79
21228166-122816610.58410.71
31343024-134302411.57411.71
41407362-140736212.12812.27
51230306-123030610.60210.72
61086322-10863229.3629.46
20min11397167-139716712.04012.266.6112.2912.506.66
21399362-139936212.05912.30
31500074-150007412.92713.19
41546889-154688913.33113.61
51412701-141270112.17412.41
61276419-127641911.00011.21
30min11582436-158243613.63714.164.6014.0214.544.68
21660898-166089814.31314.69
31690255-169025514.56614.98
41739013-173901314.98615.41
51655745-165574514.26914.64
61529463-152946313.18113.51
45min11709296-170929614.73015.493.0415.2716.033.09
21800949-180094915.52016.05
31821318-182131815.69616.27
41874101-187410116.15116.75
51805046-180504615.55516.08
61774348-177434815.29115.77
60min11804692-180469215.55216.252.7316.2516.962.79
21900557-190055716.37917.08
31896743-189674316.34617.09
41959729-195972916.88817.66
51895940-189594016.33917.04
61859274-185927416.02316.67
极限11845261-184526115.90216.812.9916.7817.702.99
21976495-197649517.03317.92
31973757-197375717.00917.94
42017858-201785817.38918.35
51940784-194078416.72517.60
61946413-194641316.77417.60
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240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06对照品稀释倍数500
标示量(mg)20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%
110.241286511285101283841285601287331285680.11
210.281288411286651287530.10
单位质量响应值RSD%判断
12555.4712524.610.18数据可信
供试品溶液-25100901批-非奈利酮-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%
5min129131-2913141.87368.3238.3141.8768.3238.31
257951-5795183.29983.30
375803-75803108.960108.96
427685-2768539.79539.79
550204-5020472.16472.16
644410-4441063.83563.84
10min1108708-108708156.258181.2312.34156.72181.9912.42
2119950-119950172.418173.34
3147225-147225211.623212.83
4110214-110214158.423158.87
5133781-133781192.298193.10
6136623-136623196.384197.09
15min1154936-154936222.707234.325.07224.91237.095.17
2153263-153263220.302223.14
3174294-174294250.532254.09
4160356-160356230.498232.70
5166205-166205238.905241.84
6169046-169046242.989245.88
20min1174708-174708251.127259.843.41255.80265.223.53
2173269-173269249.059254.35
3188770-188770271.340277.69
4179568-179568258.113262.88
5182148-182148261.822267.41
6186170-186170267.603273.19
30min1199326-199326286.514293.831.76293.98302.091.91
2201555-201555289.718297.77
3207570-207570298.364307.72
4203322-203322292.258299.89
5206434-206434296.731305.23
6208287-208287299.394307.96
45min1215296-215296309.469317.561.84320.12329.091.92
2218159-218159313.584324.86
3221536-221536318.439331.11
4220825-220825317.417328.30
5222468-222468319.778331.58
6227285-227285326.702338.59
60min1228587-228587328.574334.221.03342.66349.281.08
2232270-232270333.868348.63
3231114-231114332.206348.42
4233777-233777336.034350.44
5234918-234918337.674353.03
6234411-234411336.945352.47
极限1229773-229773330.279341.731.67348.02360.501.75
2239765-239765344.641363.11
3239228-239228343.869363.77
4238015-238015342.126360.26
5239644-239644344.467363.57
6240024-240024345.013364.28
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