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%
115.102043067204306320442942046177204622720445660.08
215.182058017205930720586620.05
单位质量响应值RSD%判断
135401.72135616.730.12数据可信
供试品溶液-25081402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%
5min1577926-57792625.53027.2920.5725.5327.2920.57
2529107-52910723.37423.37
3671307-67130729.65529.66
4826533-82653336.51236.51
5639716-63971628.26028.26
6461792-46179220.40020.40
10min11578518-157851869.73270.0817.8770.0270.3917.85
21818824-181882480.34780.61
31737848-173784876.77077.10
41789538-178953879.05479.46
51537616-153761667.92568.24
61056257-105625746.66146.89
15min11872418-187241882.71583.3811.6183.7784.4611.68
22037579-203757990.01191.16
31969149-196914986.98888.17
42095130-209513092.55393.84
51871287-187128782.66583.73
61478658-147865865.32066.07
20min11943364-194336485.84990.474.5687.8392.484.67
22084449-208444992.08294.23
32042701-204270190.23792.39
42212205-221220597.725100.04
52012231-201223188.89190.88
61993121-199312188.04789.52
30min12138903-213890394.48796.102.1697.4299.122.25
22181642-218164296.37599.55
32149745-214974594.96698.12
42262535-226253599.949103.35
52139108-213910894.49697.47
62180726-218072696.33598.78
45min12194601-219460196.94898.391.70100.93102.471.70
22253616-225361699.555103.80
32184997-218499796.523100.73
42272629-2272629100.394104.90
52201275-220127597.242101.27
62256390-225639099.677103.20
60min12186493-218649396.58998.131.45101.65103.301.40
22217410-221741097.955103.31
32219670-221967098.055103.33
42253570-225357099.553105.18
52187827-218782796.648101.75
62262808-226280899.961104.59
极限12153101-215310195.11498.161.59101.25104.431.60
22227745-222774598.412104.85
32248007-224800799.307105.68
42231486-223148698.577105.31
52247308-224730899.276105.46
62224884-222488498.285104.02
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%
110.233196713200313196093200133198583198360.07
210.303211083214663212870.08
单位质量响应值RSD%判断
31264.5231192.910.17数据可信
供试品溶液-25081402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%
5min1132261-13226138.17038.6718.5738.1738.6718.57
2119606-11960634.51834.52
3160190-16019046.23146.23
4160393-16039346.28946.29
5136098-13609839.27839.28
695322-9532227.51027.51
10min1272536-27253678.65480.1718.2979.0880.6018.27
2324890-32489093.76394.15
3309802-30980289.40989.92
4308745-30874589.10489.62
5265249-26524976.55176.99
6185495-18549553.53453.84
15min1310136-31013689.50590.3410.4590.8091.6610.54
2343196-34319699.046100.47
3332566-33256695.97897.49
4334538-33453896.54898.05
5303916-30391687.71089.00
6253867-25386773.26674.17
20min1319557-31955792.22495.813.4094.5298.133.52
2345218-34521899.630102.16
3336109-33610997.00199.57
4343322-34332299.083101.66
5320072-32007292.37394.63
6327602-32760294.54696.26
30min1349150-349150100.76599.801.94104.08103.191.99
2354702-354702102.367106.00
3348012-348012100.436104.09
4342417-34241798.821102.50
5334949-33494996.66699.95
6345569-34556999.731102.50
45min1349674-349674100.916100.752.11105.35105.242.07
2360943-360943104.168108.94
3349982-349982101.005105.77
4341637-34163798.596103.37
5340906-34090698.385102.75
6351409-351409101.417105.29
60min1345760-34576099.78699.972.01105.34105.591.92
2353376-353376101.984107.91
3351822-351822101.536107.43
4337797-33779797.488103.36
5338401-33840197.662103.12
6351259-351259101.373106.37
极限1337472-33747297.39498.592.00104.06105.321.98
2350886-350886101.266108.33
3347371-347371100.251107.27
4332016-33201695.820102.77
5339687-33968798.034104.57
6342210-34221098.762104.89
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%
115.102059005205764120577682056245205258020566480.13
215.182061673206301920623460.05
单位质量响应值RSD%判断
136201.85135859.420.18数据可信
供试品溶液-25081402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%
5min139841-398411.7531.4935.001.751.4934.90
225397-253971.1181.12
341564-415641.8291.83
447281-472812.0812.08
514962-149620.6580.66
634550-345501.5201.52
10min174289-742893.2693.0912.793.293.1112.85
262786-627862.7632.78
377236-772363.3993.42
481679-816793.5943.62
558578-585782.5782.59
666361-663612.9202.94
15min191247-912474.0153.917.374.073.967.46
282648-826483.6373.68
393762-937624.1264.18
498427-984274.3314.39
583078-830783.6563.69
684216-842163.7063.76
20min1100632-1006324.4284.405.604.534.505.77
295188-951884.1894.27
3105153-1051534.6274.73
4108207-1082074.7624.87
595849-958494.2184.29
695288-952884.1934.28
30min1111406-1114064.9034.943.315.055.093.52
2110223-1102234.8504.98
3115570-1155705.0865.24
4117961-1179615.1915.36
5111141-1111414.8915.01
6107857-1078574.7464.88
45min1121329-1213295.3395.362.175.545.552.35
2121376-1213765.3415.53
3122522-1225225.3925.60
4126309-1263095.5585.78
5120178-1201785.2895.47
6118488-1184885.2145.40
60min1127075-1270755.5925.611.855.865.872.04
2127262-1272625.6005.84
3129432-1294325.6965.97
4130759-1307595.7546.04
5126783-1267835.5795.82
6123970-1239705.4555.70
极限1129854-1298545.7145.721.326.046.041.53
2128604-1286045.6595.96
3131930-1319305.8066.14
4132187-1321875.8176.16
5128421-1284215.6515.95
6128777-1287775.6675.98
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%
110.233209243207013204003203363195313203780.17
210.303215143216863216000.04
单位质量响应值RSD%判断
31317.5031223.300.22数据可信
供试品溶液-25081402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%
5min163894-6389418.41515.3242.3818.4215.3242.37
233818-338189.7479.75
366646-6664619.20819.21
481834-8183423.58623.59
520913-209136.0276.03
651769-5176914.92114.92
10min1145443-14544341.91939.4718.0242.1239.6418.12
2115133-11513333.18333.29
3158121-15812145.57345.79
4170735-17073549.20849.47
5111915-11191532.25632.32
6120275-12027534.66534.83
15min1190167-19016754.80953.1311.1055.4853.7411.23
2164345-16434547.36747.84
3200666-20066657.83558.55
4213743-21374361.60462.41
5172458-17245849.70550.13
6164712-16471247.47348.02
20min1213100-21310061.41961.058.2162.7062.248.36
2195257-19525756.27657.28
3227438-22743865.55166.91
4236199-23619968.07669.57
5206074-20607459.39460.37
6192780-19278055.56256.64
30min1237726-23772668.51669.395.0470.4871.275.21
2231780-23178066.80368.43
3250834-25083472.29474.38
4257177-25717774.12276.37
5242747-24274769.96371.60
6224289-22428964.64466.34
45min1258835-25883574.60075.353.1577.3277.993.37
2256366-25636673.88976.26
3265766-26576676.59879.49
4274544-27454479.12882.20
5262278-26227875.59378.01
6250732-25073272.26574.68
60min1269728-26972877.74078.832.7281.2982.312.91
2270232-27023277.88581.08
3278747-27874780.33984.08
4283541-28354181.72185.67
5276010-27601079.55082.81
6262770-26277075.73478.95
极限1279067-27906780.43181.141.3984.8585.501.67
2278674-27867480.31884.38
3283346-28334681.66586.30
4288300-28830083.09287.95
5281771-28177181.21185.35
6277943-27794380.10784.17
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%
115.102058080206359620566392060847205551820589360.16
215.182054981205429820546400.03
单位质量响应值RSD%判断
136353.38135351.780.53数据可信
供试品溶液-25081402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%
5min1272748-27274812.01811.5320.3212.0211.5420.32
2268294-26829411.82211.82
3161766-1617667.1287.13
4267285-26728511.77811.78
5277975-27797512.24912.25
6322383-32238314.20614.21
10min1790539-79053934.83532.7814.9234.9732.9114.94
2804942-80494235.46935.60
3519047-51904722.87122.95
4792540-79254034.92335.05
5764125-76412533.67133.81
6792449-79244934.91935.08
15min11212719-121271953.43848.8910.8953.9649.3810.92
21212362-121236253.42253.95
3883720-88372038.94139.27
41129456-112945649.76950.29
51120660-112066049.38149.89
61097727-109772748.37148.92
20min11414217-141421762.31758.756.9263.4359.797.01
21413381-141338162.28063.40
31163911-116391151.28752.05
41328604-132860458.54459.62
51358684-135868459.87060.93
61321128-132112858.21559.30
30min11615742-161574271.19769.883.2973.0071.563.44
21649595-164959572.68874.50
31496895-149689565.96067.30
41563026-156302668.87470.60
51593136-159313670.20171.92
61596134-159613470.33372.06
45min11811749-181174979.83479.151.5682.4381.611.72
21831236-183123680.69283.31
31757502-175750277.44379.51
41768124-176812477.91180.40
51800185-180018579.32481.83
61808128-180812879.67482.19
60min11877960-187796082.75183.981.3486.2487.321.39
21916715-191671584.45987.97
31884583-188458383.04385.97
41890923-189092383.32286.68
51920388-192038884.62188.01
61943888-194388885.65689.05
极限12000479-200047988.15087.801.0892.5592.071.22
21988879-198887987.63992.09
31955534-195553486.16990.02
41990791-199079187.72392.00
51998355-199835588.05692.38
62020884-202088489.04993.40
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%
110.233208103215763202473211383202173207980.19
210.303205793204993205390.02
单位质量响应值RSD%判断
31358.5531120.290.54数据可信
供试品溶液-25081402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%
5min130592-305928.8268.3421.468.838.3421.45
229134-291348.4058.41
317150-171504.9484.95
430396-303968.7698.77
530425-304258.7788.78
635735-3573510.31010.31
10min188089-8808925.41423.8514.1025.5123.9414.13
288598-8859825.56125.65
359054-5905417.03717.09
488211-8821125.44925.55
584807-8480724.46724.56
687320-8732025.19225.31
15min1132167-13216738.13135.0710.1938.5135.4310.23
2131396-13139637.90838.29
398357-9835728.37628.62
4125260-12526036.13836.52
5122588-12258835.36735.74
6119684-11968434.52934.92
20min1154017-15401744.43541.926.6345.2442.666.72
2153562-15356244.30345.10
3127716-12771636.84737.41
4146718-14671842.32943.11
5146892-14689242.37943.14
6142851-14285141.21341.99
30min1177573-17757351.23149.963.4552.5351.173.59
2180846-18084652.17553.47
3163373-16337347.13448.10
4172396-17239649.73750.99
5173149-17314949.95451.19
6171585-17158549.50350.74
45min1201604-20160458.16457.201.8960.0358.972.03
2203788-20378858.79460.66
3193555-19355555.84257.33
4196897-19689756.80658.61
5197116-19711656.86958.66
6196653-19665356.73558.52
60min1211267-21126760.95261.460.9763.4663.871.09
2216240-21624062.38664.91
3210507-21050760.73262.85
4212650-21265061.35163.79
5213907-21390761.71364.13
6213676-21367661.64764.06
极限1222437-22243764.17463.820.6267.3666.910.81
2222538-22253864.20367.42
3218907-21890763.15665.94
4221853-22185364.00667.12
5220885-22088563.72666.83
6220738-22073863.68466.79
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