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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058493348498668484518503488483618492720.11
215.088487188503158495160.14
单位质量响应值RSD%判断
56430.0356333.950.13数据可信
供试品溶液-25120101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%
5min195083-9508310.11815.5244.3510.1215.5244.33
2161500-16150017.18617.19
3154384-15438416.42916.43
4108625-10862511.56011.56
5263063-26306327.99427.99
692189-921899.8109.81
10min1679469-67946972.30770.266.8372.4270.446.85
2630303-63030367.07567.27
3653967-65396769.59369.78
4589718-58971862.75662.88
5708683-70868375.41675.73
6699322-69932274.42074.53
15min1836398-83639889.00788.651.8989.9289.601.82
2834926-83492688.85089.79
3811381-81138186.34587.30
4840613-84061389.45690.28
5819241-81924187.18188.33
6855543-85554391.04491.98
20min1884961-88496194.17592.072.2996.0894.012.18
2868261-86826192.39894.32
3848190-84819090.26292.18
4872312-87231292.82994.65
5834931-83493188.85190.97
6882642-88264293.92895.88
30min1898720-89872095.63992.422.8998.5995.382.75
2856296-85629691.12494.07
3859792-85979291.49794.41
4883354-88335494.00496.86
5829092-82909288.23091.33
6883578-88357894.02897.02
45min1874265-87426593.03791.182.0097.0595.171.89
2860457-86045791.56795.53
3853286-85328690.80494.74
4859047-85904791.41795.31
5825421-82542187.83991.92
6868444-86844492.41796.45
60min1856837-85683791.18290.562.2696.2395.562.12
2832642-83264288.60793.59
3847788-84778890.21995.16
4874876-87487693.10298.01
5826320-82632087.93593.00
6867631-86763192.33197.39
极限1840077-84007789.39989.282.2995.4695.282.11
2828186-82818688.13394.10
3845329-84532989.95795.90
4872204-87220492.81798.76
5815982-81598286.83492.87
6831887-83188788.52794.62
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161294481295561297941296541298981296700.14
210.111290761295631293200.27
单位质量响应值RSD%判断
12762.8012791.300.16数据可信
供试品溶液-25120101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%
5min19148-91486.4395.5518.006.445.5517.98
26463-64634.5494.55
39580-95806.7436.74
46419-64194.5184.52
57008-70084.9324.93
68694-86946.1196.12
10min128775-2877520.25317.0316.5620.3217.0916.54
221245-2124514.95315.00
322008-2200815.49015.56
418983-1898313.36113.41
526145-2614518.40218.46
628050-2805019.74219.81
15min142791-4279130.11727.289.8230.4127.539.84
237587-3758726.45526.67
333807-3380723.79424.04
435088-3508824.69624.89
541855-4185529.45929.72
641433-4143329.16229.45
20min154335-5433538.24234.967.9038.8735.517.93
248868-4886834.39534.91
343865-4386530.87331.38
446747-4674732.90233.37
552490-5249036.94437.53
651730-5173036.40937.02
30min171420-7142050.26746.906.3151.3247.846.35
264748-6474845.57146.46
360118-6011842.31343.17
464916-6491645.69046.53
570340-7034049.50750.50
668261-6826148.04449.06
45min188400-8840062.21859.505.4363.8360.965.46
282977-8297758.40159.80
377695-7769554.68456.01
483017-8301758.42959.78
590750-9075063.87265.42
684383-8438359.39160.94
60min199184-9918469.80868.684.7072.1170.804.72
294112-9411266.23868.29
390848-9084863.94165.87
499524-9952470.04872.04
5104002-10400273.19975.46
697790-9779068.82771.04
极限1132781-13278193.45593.103.7796.5495.993.69
2130183-13018391.62694.41
3128898-12889890.72293.36
4138708-13870897.626100.40
5137299-13729996.63599.70
6125833-12583388.56491.54
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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058576998563868573798571898571748571650.06
215.088550938564518557720.12
单位质量响应值RSD%判断
56954.4956748.810.26数据可信
供试品溶液-25120101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%
5min15955-59550.6281.1022.000.631.1021.94
211544-115441.2181.22
311615-116151.2261.23
49952-99521.0501.05
511414-114141.2051.20
611931-119311.2591.26
10min125213-252132.6613.178.462.673.188.47
231554-315543.3303.34
331997-319973.3773.39
430423-304233.2113.22
531620-316203.3373.35
629521-295213.1163.13
15min136331-363313.8344.053.613.874.103.67
239967-399674.2184.27
339110-391104.1284.18
437899-378994.0004.05
539522-395224.1714.22
637504-375043.9584.01
20min140626-406264.2884.452.314.374.542.38
242689-426894.5054.60
342238-422384.4584.55
441969-419694.4294.52
543522-435224.5934.69
641702-417024.4014.49
30min145780-457804.8324.921.094.965.071.19
247000-470004.9605.11
346365-463654.8935.04
446712-467124.9305.07
547103-471034.9715.12
647004-470044.9615.10
45min150389-503895.3185.401.065.505.601.09
251322-513225.4165.62
350893-508935.3715.57
451892-518925.4775.67
551550-515505.4405.64
650903-509035.3725.57
60min152812-528125.5745.630.905.815.880.98
254163-541635.7165.98
353146-531465.6095.87
452974-529745.5915.85
553329-533295.6285.89
653453-534535.6415.90
极限154714-547145.7745.801.306.086.131.33
255422-554225.8496.18
355014-550145.8066.13
454318-543185.7336.05
556189-561895.9306.26
654363-543635.7376.06
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161311061306031307701308021307481308060.15
210.111305301305861305580.04
单位质量响应值RSD%判断
12874.6112913.750.22数据可信
供试品溶液-25120101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%
5min124270-2427016.92723.3634.6216.9323.3634.61
243042-4304230.01930.02
347748-4774833.30133.30
440033-4003327.92027.92
526558-2655818.52218.52
619295-1929513.45713.46
10min178088-7808854.46158.227.5754.6558.487.68
286963-8696360.65160.98
390774-9077463.30963.68
488492-8849261.71762.03
581814-8181457.06057.27
674709-7470952.10452.25
15min195370-9537066.51467.863.1167.3168.773.26
2100101-10010169.81470.82
3100406-10040670.02671.10
499520-9952069.40870.40
594681-9468166.03466.87
693751-9375165.38566.11
20min1102268-10226871.32571.831.5972.8673.491.74
2103039-10303971.86373.65
3104399-10439972.81174.66
4105426-10542673.52875.29
5101357-10135770.69072.26
6101485-10148570.77972.23
30min1111003-11100377.41776.551.6879.7479.011.69
2108903-10890375.95378.53
3109719-10971976.52279.18
4112454-11245478.42981.01
5107083-10708374.68377.04
6109395-10939576.29678.54
45min1115807-11580780.76880.661.7683.9583.961.80
2114404-11440479.78983.21
3115988-11598880.89484.40
4119268-11926883.18186.64
5113268-11326878.99782.19
6115159-11515980.31683.40
60min1118208-11820882.44282.051.5086.5286.251.55
2118044-11804482.32886.64
3118278-11827882.49186.90
4119240-11924083.16287.54
5114173-11417379.62883.69
6117937-11793782.25386.23
极限1120959-12095984.36183.330.9289.3688.440.97
2119034-11903483.01888.25
3119551-11955183.37988.70
4120488-12048884.03289.34
5117996-11799682.29487.25
6118827-11882782.87487.77
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100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.058542848543038545158539808546198543400.03
215.088472378467478469920.05
单位质量响应值RSD%判断
56766.7856166.580.76数据可信
供试品溶液-25120101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%
5min154421-544215.7837.9828.795.787.9828.81
253838-538385.7215.72
399124-9912410.53310.53
4103661-10366111.01511.02
571983-719837.6497.65
667673-676737.1917.19
10min1365807-36580738.87138.974.0538.9439.064.09
2344976-34497636.65736.72
3379363-37936340.31140.43
4386804-38680441.10241.22
5363756-36375638.65338.74
6359494-35949438.20038.28
15min1514163-51416354.63554.732.6155.1355.262.65
2489773-48977352.04352.51
3525231-52523155.81156.38
4525510-52551055.84156.42
5521926-52192655.46055.97
6514002-51400254.61855.12
20min1605028-60502864.29063.833.5765.3964.963.58
2559841-55984159.48960.54
3622669-62266966.16567.35
4606389-60638964.43565.63
5599809-59980963.73664.87
6610426-61042664.86465.98
30min1693214-69321473.66173.633.1175.4875.473.12
2651153-65115369.19270.90
3708420-70842075.27777.20
4696910-69691074.05475.97
5709856-70985675.43077.27
6698168-69816874.18876.02
45min1782604-78260483.16080.586.0285.8083.245.93
2665979-66597970.76773.25
3780533-78053382.94085.70
4778449-77844982.71885.46
5775534-77553482.40985.09
6767037-76703781.50684.16
60min1798817-79881784.88383.575.7188.4487.125.65
2695355-69535573.88977.15
3812648-81264886.35290.03
4805755-80575585.62089.28
5802916-80291685.31888.91
6803273-80327385.35688.92
极限1812449-81244986.33184.973.6590.8389.463.68
2742193-74219378.86682.95
3819733-81973387.10591.74
4798395-79839584.83889.45
5807664-80766485.82390.36
6817661-81766186.88591.40
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161303671306591303071302101306321304350.16
210.111295601295081295340.03
单位质量响应值RSD%判断
12838.0912812.460.15数据可信
供试品溶液-25120101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%
5min112655-126558.8736.3245.338.876.3245.32
213190-131909.2499.25
34241-42412.9742.97
412223-122238.5718.57
55670-56703.9763.98
66100-61004.2774.28
10min145395-4539531.83030.577.0731.9330.647.14
245410-4541031.84131.94
340817-4081728.62028.65
447140-4714033.05433.15
543782-4378230.69930.74
639054-3905427.38427.43
15min158514-5851441.02941.703.0941.4842.113.14
259990-5999042.06442.52
358385-5838540.93841.29
462247-6224743.64644.11
560572-6057242.47242.86
657120-5712040.05140.40
20min166839-6683946.86647.651.5847.7748.521.60
267598-6759847.39848.32
368393-6839347.95648.76
469900-6990049.01249.96
567518-6751847.34248.20
667490-6749047.32348.12
30min175618-7561853.02254.571.8254.4555.971.84
278902-7890255.32456.77
377703-7770354.48455.82
479464-7946455.71857.21
578416-7841654.98456.37
676857-7685753.89055.21
45min185221-8522159.75560.002.7561.7762.002.69
282045-8204557.52859.59
385392-8539259.87561.82
489027-8902762.42464.53
587039-8703961.03063.02
684666-8466659.36661.29
60min188042-8804261.73363.252.3964.4265.922.34
287732-8773261.51664.22
390862-9086263.71066.32
493499-9349965.55968.36
591183-9118363.93666.61
689901-8990163.03765.62
极限190625-9062563.54464.521.2766.9167.901.25
290577-9057763.51166.90
392724-9272465.01668.33
493427-9342765.50969.04
592495-9249564.85668.24
692265-9226564.69467.98
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