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5000
标示量(mg)10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%
110.266072860508608786075961269608280.47
210.296113161165611480.04
单位质量响应值RSD%判断
5928.655942.470.17数据可信
供试品溶液-5122601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%
5min15398-53988.1785.6531.268.185.6531.26
22413-24133.6563.66
32973-29734.5044.50
43450-34505.2275.23
53236-32364.9034.90
64905-49057.4317.43
10min131307-3130747.43236.9854.1347.5237.0454.07
27658-765811.60211.64
343858-4385866.44866.50
416110-1611024.40824.47
516807-1680725.46425.52
630707-3070746.52346.61
15min137193-3719356.35056.2532.6556.9756.7332.76
219152-1915229.01729.19
354031-5403181.86182.65
434927-3492752.91753.25
531131-3113147.16647.50
646344-4634470.21570.81
20min141640-4164063.08865.5725.9164.3366.6726.10
226582-2658240.27440.77
358482-5848288.60590.30
441735-4173563.23264.15
538459-3845958.26859.13
652771-5277179.95281.33
30min147982-4798272.69677.9018.6774.6479.7318.97
236575-3657555.41456.35
364604-6460497.880100.56
452150-5215079.01180.63
548879-4887974.05575.56
658317-5831788.35590.62
45min163208-6320895.76589.8212.5298.5292.5112.90
245081-4508168.30169.86
366165-66165100.245104.01
460769-6076992.07094.57
558413-5841388.50090.83
662058-6205894.02297.27
60min165371-6537199.04293.358.29102.8697.048.67
251373-5137377.83480.15
363598-6359896.356101.24
463659-6365996.44899.97
562904-6290495.30498.62
662782-6278295.11999.41
90min166231-66231100.34597.583.29105.26102.313.81
260350-6035091.43594.61
364825-6482598.215104.17
465835-6583599.745104.34
564974-6497498.440102.81
664230-6423097.313102.66
120min164063-6406397.06095.951.34103.09101.761.47
263092-6309295.58999.78
362458-6245894.628101.67
464624-6462497.910103.61
562625-6262594.881100.35
663107-6310795.612102.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限164889-6488998.31296.602.55105.42103.481.64
266173-66173100.257105.51
361880-6188093.753101.85
464008-6400896.977103.77
563353-6335395.984102.51
662246-6224694.307101.80
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%
115.226415046345886400616407006432576400220.52
215.286420146411916416020.10
单位质量响应值RSD%判断
42051.3841989.660.11数据可信
供试品溶液-5122601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%
5min1171834-17183424.53632.0660.5424.5432.0660.54
274240-7424010.60110.60
370140-7014010.01510.02
4336481-33648148.04548.05
5330477-33047747.18847.19
6363803-36380351.94751.95
10min1529441-52944175.59875.7720.4075.8776.1220.58
2358754-35875451.22651.34
3446780-44678063.79563.91
4616434-61643488.01988.55
5618171-61817188.26788.79
6614214-61421487.70288.28
15min1627090-62709089.54192.055.0190.6593.255.33
2615787-61578787.92788.61
3605226-60522686.41987.24
4676411-67641196.58398.09
5674562-67456296.31997.82
6669094-66909495.53897.09
20min1653805-65380593.35596.191.9995.4698.412.21
2672583-67258396.03697.70
3667330-66733095.28697.07
4676345-67634596.57499.16
5694722-69472299.198101.77
6677005-67700596.66899.28
30min1655151-65515193.54797.882.4396.69101.172.34
2697137-69713799.542102.27
3696757-69675799.488102.33
4694390-69439099.150102.81
5692386-69238698.864102.54
6677248-67724896.703100.39
45min1680459-68045997.16197.401.23101.35101.780.98
2682464-68246497.447101.28
3696526-69652699.455103.40
4679890-67989097.080101.84
5682939-68293997.515102.29
6670685-67068595.765100.53
60min1668597-66859795.46795.871.69100.73101.331.58
2674773-67477396.349101.27
3675619-67561996.470101.52
4656803-65680393.78399.62
5689435-68943598.443104.30
6663213-66321394.698100.52
90min1675413-67541396.44197.091.51102.77103.621.25
2689555-68955598.460104.45
3688134-68813498.257104.38
4673438-67343896.159103.04
5688531-68853198.314105.27
6664852-66485294.933101.81
120min1651838-65183893.07494.711.39100.47102.311.21
2677283-67728396.708103.79
3664876-66487694.936102.15
4666553-66655395.175103.12
5664824-66482494.929102.97
6654218-65421893.414101.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1663119-66311994.68594.761.37103.12103.411.29
2669039-66903995.530103.69
3662285-66228594.566102.83
4662772-66277294.636103.64
5675945-67594596.516105.62
6648553-64855392.605101.58
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5000
标示量(mg)10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%
110.266112561257609666097160997610630.21
210.296109661285611900.22
单位质量响应值RSD%判断
5951.565946.550.06数据可信
供试品溶液-5122601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%
5min17982-798212.0669.0618.4912.079.0618.50
26089-60899.2049.20
35315-53158.0348.03
46344-63449.5909.59
54979-49797.5267.53
65246-52467.9307.93
10min142050-4205063.56448.6817.4163.7048.7817.39
225690-2569038.83438.94
333117-3311750.06150.15
429888-2988845.18045.29
529049-2904943.91144.00
633418-3341850.51650.60
15min154177-5417781.89672.5112.2882.7473.1612.29
239753-3975360.09260.63
352430-5243079.25579.90
442687-4268764.52765.14
546591-4659170.42971.00
652177-5217778.87379.52
20min159102-5910289.34181.909.7791.0983.359.81
247380-4738071.62172.82
358736-5873688.78790.31
448553-4855373.39474.72
553151-5315180.34581.70
658168-5816887.92989.45
30min162613-6261394.64889.097.5597.3991.457.63
253384-5338480.69782.69
364016-6401696.76999.28
453960-5396081.56883.71
558746-5874688.80391.05
660902-6090292.06294.56
45min162785-6278594.90890.695.2398.7094.045.39
255919-5591984.52987.42
363818-6381896.470100.06
456841-5684185.92388.97
560307-6030791.16294.40
660287-6028791.13294.66
60min164239-6423997.10692.616.15101.9696.976.26
256522-5652285.44189.27
365801-6580199.467104.13
457069-5706986.26890.27
561601-6160193.11897.36
662374-6237494.28798.82
90min163508-6350896.00193.414.29101.9398.804.48
258159-5815987.91592.70
365478-6547898.979104.74
459502-5950289.94594.91
562022-6202293.75599.04
662093-6209393.86299.45
120min161862-6186293.51392.364.60100.5198.784.75
257097-5709786.31092.07
364502-6450297.504104.37
458504-5850488.43794.40
561441-6144192.87699.20
663196-6319695.529102.16
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限162048-6204893.79495.891.90101.83103.341.81
263658-6365896.228102.95
365550-6555099.088107.04
463674-6367496.252103.19
562982-6298295.206102.56
662712-6271294.798102.49
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%
115.226333816339746332926343906340866338250.08
215.286346576327606337080.22
单位质量响应值RSD%判断
41644.2241473.040.30数据可信
供试品溶液-5122601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%
5min114896-148962.1511.9520.612.151.9520.64
211496-114961.6601.66
316685-166852.4092.41
411173-111731.6131.61
510518-105181.5191.52
616408-164082.3692.37
10min127589-275893.9833.6513.664.013.6713.77
221889-218893.1603.18
328883-288834.1704.20
422004-220043.1773.19
522613-226133.2653.28
628740-287404.1494.18
15min132722-327224.7244.605.124.794.665.26
230579-305794.4154.47
333624-336244.8544.93
430376-303764.3864.44
530282-302824.3724.43
633629-336294.8554.93
20min136219-362195.2295.182.995.355.293.18
235271-352715.0925.19
337017-370175.3445.47
434692-346925.0095.11
534867-348675.0345.14
637121-371215.3595.49
30min139870-398705.7565.741.985.935.912.13
239677-396775.7285.89
340855-408555.8986.08
438975-389755.6275.78
538817-388175.6045.76
640366-403665.8286.01
45min141843-418436.0416.071.506.286.301.38
242864-428646.1886.41
342503-425036.1366.39
442196-421966.0926.31
541633-416336.0116.23
641110-411105.9356.19
60min144322-443226.3996.361.816.716.661.92
243658-436586.3036.59
345171-451716.5226.84
442785-427856.1776.46
544260-442606.3906.68
644174-441746.3786.69
90min145972-459726.6376.721.207.027.091.00
247206-472066.8157.18
346564-465646.7237.12
446741-467416.7487.10
546871-468716.7677.12
645740-457406.6046.99
120min145760-457606.6076.821.667.067.261.56
247808-478086.9027.34
347409-474096.8457.31
446958-469586.7807.21
547445-474456.8507.28
647889-478896.9147.37
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限146589-465896.7266.841.067.257.360.95
247856-478566.9097.42
347570-475706.8687.41
447915-479156.9187.42
547106-471066.8017.31
647326-473266.8337.37
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5000
标示量(mg)10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%
110.266187761328614436163261700615960.36
210.296143761701615690.31
单位质量响应值RSD%判断
6003.515983.380.24数据可信
供试品溶液-5122601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%
5min11142-11421.7147.7577.321.717.7577.34
24982-49827.4757.48
35240-52407.8627.86
412614-1261418.92718.93
54610-46106.9176.92
62395-23953.5943.59
10min120959-2095931.44837.1426.8031.4737.2226.89
221988-2198832.99233.07
326436-2643639.66639.75
434676-3467652.02952.24
528700-2870043.06343.14
615755-1575523.63923.68
15min141088-4108861.65059.0713.1562.0259.5713.24
237679-3767956.53556.98
343096-4309664.66365.19
443615-4361565.44266.23
541020-4102061.54862.10
629707-2970744.57444.88
20min148710-4871073.08769.717.8474.1470.867.96
246697-4669770.06671.14
349174-4917473.78375.03
448411-4841172.63874.15
546351-4635169.54770.79
639397-3939759.11359.91
30min154648-5464881.99680.314.5783.8682.244.73
253961-5396180.96582.82
356103-5610384.17986.25
453894-5389480.86583.19
553670-5367080.52982.54
648878-4887873.33974.79
45min160913-6091391.39787.123.7194.1789.943.76
258673-5867388.03690.79
358788-5878888.20891.21
456924-5692485.41188.63
558574-5857487.88790.79
654521-5452181.80684.08
60min159372-5937289.08488.462.6492.8892.252.74
259404-5940489.13292.87
360833-6083391.27695.26
457611-5761186.44290.61
559914-5991489.89893.78
656613-5661384.94588.12
90min163010-6301094.54392.222.3599.3296.992.39
262148-6214893.25097.97
361843-6184392.79297.79
459919-5991989.90595.04
562404-6240493.63498.52
659442-5944289.18993.31
120min161796-6179692.72192.261.5798.5598.061.67
261584-6158492.40398.16
362480-6248093.74899.77
460307-6030790.48796.62
562418-6241893.65599.58
660348-6034890.54995.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限162827-6282794.26894.091.02101.13100.911.17
262554-6255493.859100.65
363049-6304994.601101.67
462134-6213493.229100.36
563707-6370795.589102.55
661971-6197192.98499.10
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%
115.226373256353366371956372886361756366640.14
215.286379456361676370560.20
单位质量响应值RSD%判断
41830.7541692.150.24数据可信
供试品溶液-5122601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%
5min129520-295204.24112.3850.354.2412.3850.35
293308-9330813.40613.41
3158442-15844222.76422.76
492320-9232013.26413.26
556342-563428.0958.09
687186-8718612.52612.53
10min1100467-10046714.43436.6834.2414.4836.8234.29
2286859-28685941.21441.36
3353721-35372150.82051.07
4305692-30569243.92044.07
5224214-22421432.21432.30
6260824-26082437.47437.61
15min1281482-28148240.44255.4515.0740.6556.0015.28
2401397-40139757.67058.28
3449703-44970364.61065.43
4416719-41671959.87260.51
5364254-36425452.33452.78
6402208-40220857.78758.34
20min1394365-39436556.66065.688.0957.3266.848.39
2471875-47187567.79669.04
3498891-49889171.67773.21
4473899-47389968.08769.39
5434701-43470162.45563.48
6469333-46933367.43168.63
30min1501143-50114372.00177.334.4073.2979.224.74
2549236-54923678.91180.91
3566811-56681181.43683.77
4546582-54658278.52980.59
5519429-51942974.62876.35
6546055-54605578.45480.40
45min1590769-59076984.87885.441.2486.9688.191.51
2602083-60208386.50389.38
3602514-60251486.56589.80
4588660-58866084.57587.50
5585407-58540784.10886.66
6598766-59876686.02788.85
60min1596883-59688385.75687.701.5288.7991.401.86
2613391-61339188.12891.97
3624353-62435389.70393.90
4605856-60585687.04590.91
5608004-60800487.35490.84
6614108-61410888.23192.01
90min1641074-64107492.10591.701.2096.0996.371.16
2640933-64093392.08596.90
3637939-63793991.65596.85
4625572-62557289.87894.71
5635411-63541191.29295.75
6648584-64858493.18497.94
120min1633461-63346191.01291.871.4496.0297.561.55
2636151-63615191.39897.24
3644820-64482092.64498.86
4628547-62854790.30696.14
5639062-63906291.81697.29
6654436-65443694.02599.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1652617-65261793.76493.341.1499.78100.050.97
2650225-65022593.420100.28
3647199-64719992.985100.23
4636551-63655191.45698.29
5658378-65837894.592101.08
6652903-65290393.805100.64
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