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200
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%
114.882146281215120821467532143240215021421475390.15
214.872156622215889521577580.08
单位质量响应值RSD%判断
144323.86145108.140.39数据可信
供试品溶液-25092601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%
5min1501027-50102720.72525.8238.3720.7325.8238.36
2515963-51596321.34321.34
3510473-51047321.11621.12
4637508-63750826.37126.37
5480314-48031419.86819.87
61099567-109956745.48445.48
10min11829452-182945275.67677.289.1675.9177.569.22
21939535-193953580.22980.47
31566086-156608664.78265.02
41926886-192688679.70680.00
51866532-186653277.21077.43
62080187-208018786.04886.55
15min12238918-223891892.61490.375.1293.6891.525.19
22270578-227057893.92395.05
31993174-199317482.44883.40
42225867-222586792.07493.25
52107262-210726287.16888.25
62272876-227287694.01895.48
20min12336440-233644096.64892.574.4298.7594.724.39
22316290-231629095.81497.99
32067958-206795885.54287.41
42283968-228396894.47796.68
52226497-222649792.10094.15
62195906-219590690.83493.34
30min12318076-231807695.88895.881.5399.0699.061.62
22359693-235969397.609100.85
32255147-225514793.28596.11
42338339-233833996.72699.98
52326232-232623296.22599.30
62309507-230950795.53499.05
45min12306244-230624495.39994.451.7499.6498.701.57
22253619-225361993.22297.54
32345852-234585297.037100.89
42246668-224666892.93497.26
52251681-225168193.14297.28
62296226-229622694.98499.56
60min12293675-229367594.87995.571.08100.18100.870.81
22304880-230488095.342100.70
32350250-235025097.219102.15
42312198-231219895.645101.00
52323306-232330696.104101.28
62278711-227871194.26099.89
极限12322980-232298096.09193.821.36102.44100.181.28
22264445-226444593.670100.09
32269771-226977193.89099.91
42268093-226809393.820100.24
52229539-222953992.22698.47
62253673-225367393.22499.90
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1000
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%
1 10.033233513239673232793227333238933234450.16
2 9.993242033245203243620.07
单位质量响应值RSD%判断
32247.7632468.670.49数据可信
供试品溶液-25092601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%
5min180929-8092922.54118.3830.0022.5418.3829.99
251471-5147114.33614.34
389694-8969424.98224.98
457008-5700815.87815.88
538808-3880810.80910.81
677935-7793521.70721.71
10min1177262-17726249.37356.3416.3049.6256.5416.30
2188105-18810552.39352.55
3242683-24268367.59467.87
4234367-23436765.27865.45
5159276-15927644.36344.48
6212002-21200259.04959.29
15min1275935-27593576.85671.9011.8177.6572.7311.83
2239996-23999666.84667.59
3278536-27853677.58078.61
4293925-29392581.86782.77
5210943-21094358.75459.37
6249510-24951069.49670.39
20min1313430-31343087.29979.059.8188.9580.689.77
2268032-26803274.65576.14
3283010-28301078.82680.72
4321766-32176689.62191.43
5258095-25809571.88773.15
6258456-25845671.98773.66
30min1333909-33390993.00388.646.9395.6391.157.01
2295816-29581682.39384.71
3330121-33012191.94894.71
4348477-34847797.06199.87
5301729-30172984.04086.10
6299440-29944083.40385.87
45min1342339-34233995.35192.255.1599.0195.745.20
2303470-30347084.52587.75
3347221-34722196.711100.50
4343035-34303595.54599.43
5332556-33255692.62695.62
6318583-31858388.73592.13
60min1341664-34166495.16395.643.6899.88100.163.67
2325356-32535690.62194.79
3345723-34572396.294101.16
4358646-35864699.893104.84
5355148-35514898.919102.95
6333730-33373092.95397.34
极限1347355-34735596.74894.883.18102.52100.463.11
2335105-33510593.33698.51
3324646-32464690.42396.36
4356013-35601399.160105.22
5343222-34322295.597100.72
6337482-33748293.99899.41
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200
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%
114.882145976215077121547822143201214609121481640.22
214.872159912215542221576670.15
单位质量响应值RSD%判断
144365.86145102.020.36数据可信
供试品溶液-25092601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%
5min130567-305671.2641.1320.871.261.1320.67
228795-287951.1911.19
317876-178760.7390.74
433210-332101.3741.37
529952-299521.2391.24
623100-231000.9550.96
10min170629-706292.9212.7511.672.942.7611.74
270541-705412.9182.93
355160-551602.2812.29
472789-727893.0113.03
571620-716202.9622.98
658009-580092.3992.41
15min194225-942253.8973.784.513.943.834.65
292387-923873.8213.87
386705-867053.5863.62
494454-944543.9073.96
595298-952983.9423.99
685983-859833.5563.59
20min1106553-1065534.4074.322.494.504.412.59
2104501-1045014.3224.41
3101852-1018524.2134.29
4104693-1046934.3304.42
5108113-1081134.4724.56
6101422-1014224.1954.27
30min1117994-1179944.8804.892.445.025.022.41
2118168-1181684.8875.02
3120933-1209335.0025.12
4119827-1198274.9565.10
5119491-1194914.9425.08
6112765-1127654.6644.79
45min1128921-1289215.3325.370.525.535.560.56
2130021-1300215.3785.57
3129705-1297055.3655.54
4130480-1304805.3975.59
5130750-1307505.4085.60
6129461-1294615.3555.53
60min1137553-1375535.6895.561.545.945.811.48
2136222-1362225.6345.88
3133835-1338355.5355.77
4133666-1336665.5285.78
5131886-1318865.4555.71
6133513-1335135.5225.76
极限1137766-1377665.6985.740.706.016.050.78
2139416-1394165.7666.08
3137800-1378005.6996.00
4139639-1396395.7756.09
5139980-1399805.7906.11
6138500-1385005.7286.02
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1000
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%
1 10.033228893236353240433224253228923231770.21
2 9.993250193244783247480.12
单位质量响应值RSD%判断
32221.0432507.310.63数据可信
供试品溶液-25092601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%
5min182598-8259823.00213.1953.4723.0013.1953.47
230543-305438.5068.51
327019-270197.5247.52
476117-7611721.19721.20
540240-4024011.20611.21
627630-276307.6947.69
10min1174891-17489148.70438.9523.8648.9639.0923.93
2134639-13463937.49437.59
383533-8353323.26223.35
4172857-17285748.13748.37
5132752-13275236.96937.09
6140423-14042339.10539.19
15min1210752-21075258.69055.4113.8059.4955.9913.88
2215676-21567660.06160.57
3143789-14378940.04240.38
4214107-21410759.62460.39
5203133-20313356.56857.10
6206419-20641957.48458.00
20min1228264-22826463.56763.219.5865.0264.409.66
2246567-24656768.66469.84
3184407-18440751.35452.14
4232783-23278364.82566.26
5235935-23593565.70366.87
6233877-23387765.13066.29
30min1245548-24554868.38070.785.6670.5472.675.75
2274556-27455676.45878.40
3232808-23280864.83266.19
4260545-26054572.55674.71
5260256-26025672.47674.37
6251178-25117869.94871.83
45min1262370-26237073.06576.814.6575.9879.494.68
2294684-29468482.06484.85
3260247-26024772.47474.55
4277123-27712377.17380.13
5279616-27961677.86780.57
6280884-28088478.22080.88
60min1275421-27542176.69978.444.3180.4381.984.33
2304086-30408684.68288.38
3268958-26895874.89977.78
4276592-27659277.02580.84
5280790-28079078.19481.76
6284147-28414779.12982.66
极限1290552-29055280.91382.982.2085.4987.392.32
2309113-30911386.08290.73
3292283-29228381.39585.11
4299209-29920983.32488.00
5297836-29783682.94187.37
6298823-29882383.21687.62
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200
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%
114.882165352216014921601052170012216444821640130.20
214.872165606216572121656640.01
单位质量响应值RSD%判断
145430.98145639.810.11数据可信
供试品溶液-25092601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%
5min1279716-27971611.50510.6839.7111.5110.6939.71
2223610-2236109.1989.20
3142984-1429845.8815.88
4167907-1679076.9066.91
5417642-41764217.17917.18
6326727-32672713.43913.44
10min1952451-95245139.17638.9711.2939.3039.0911.28
2775321-77532131.89131.99
3940366-94036638.67938.74
41056340-105634043.45043.53
51062024-106202443.68343.87
6898132-89813236.94237.09
15min11321834-132183454.37055.096.2354.9355.646.22
21242794-124279451.11951.58
31404403-140440357.76658.26
41435776-143577659.05759.62
51387474-138747457.07057.75
61243148-124314851.13351.69
20min11553075-155307563.88163.655.1065.0564.825.10
21446842-144684259.51260.54
31584777-158477765.18566.32
41666161-166616168.53369.75
51559413-155941364.14265.45
61474723-147472360.65961.79
30min11751241-175124172.03271.274.2973.9173.144.26
21611534-161153466.28667.97
31817378-181737874.75376.61
41793080-179308073.75375.73
51691664-169166469.58271.60
61731148-173114871.20673.01
45min11928614-192861479.32880.073.1482.0182.743.18
21870428-187042876.93579.36
31998110-199811082.18784.88
42034844-203484483.69886.49
51947367-194736780.09982.90
61901164-190116478.19980.79
60min11986276-198627681.70083.024.8185.2686.574.73
21957663-195766380.52383.80
31942545-194254579.90183.51
42206332-220633290.75194.48
52031144-203114483.54587.23
61985902-198590281.68485.15
极限12071763-207176385.21687.023.8689.6891.503.82
22080170-208017085.56289.73
32139347-213934787.99692.49
42267276-226727693.25897.99
52098898-209889886.33290.95
62036741-203674183.77688.15
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1000
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%
1 10.033257573248963249103262733255443254760.19
2 9.993259933259043259480.02
单位质量响应值RSD%判断
32450.2532627.430.39数据可信
供试品溶液-25092601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%
5min119155-191555.3067.3668.795.317.3768.73
217313-173134.7954.80
39444-94442.6162.62
418828-188285.2155.22
534909-349099.6699.67
659872-5987216.58316.58
10min176569-7656921.20826.0923.7421.2726.1723.86
293856-9385625.99626.05
374530-7453020.64320.67
477241-7724121.39421.45
5117882-11788232.65132.76
6125051-12505134.63734.82
15min1114452-11445231.70136.9514.6532.0037.3214.78
2146193-14619340.49340.83
3118279-11827932.76133.02
4114548-11454831.72832.02
5153088-15308842.40342.87
6153745-15374542.58543.15
20min1142192-14219239.38543.3510.0940.0344.1410.28
2167387-16738746.36347.16
3141763-14176339.26639.89
4142706-14270639.52740.18
5172380-17238047.74648.69
6172697-17269747.83448.88
30min1169372-16937246.91349.756.4848.0051.016.73
2183689-18368950.87852.19
3175129-17512948.50749.57
4165555-16555545.85646.94
5187921-18792152.05153.52
6195955-19595554.27655.85
45min1194843-19484353.96857.244.5555.5759.054.80
2213506-21350659.13761.01
3202300-20230056.03357.63
4198319-19831954.93156.53
5217851-21785160.34162.39
6213028-21302859.00561.18
60min1205719-20571956.98060.375.2059.1962.835.33
2225453-22545362.44664.98
3201984-20198455.94658.17
4221461-22146161.34163.55
5229578-22957863.58966.31
6223583-22358361.92864.76
极限1221486-22148661.34863.852.3464.1966.972.37
2233774-23377464.75167.97
3230905-23090563.95666.80
4234767-23476765.02667.91
5235142-23514265.13068.56
6226945-22694562.86066.38
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