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%
114.898570078633198606718517308600268585510.52
214.908634028561458597740.60
单位质量响应值RSD%判断
57659.5757702.950.06数据可信
供试品溶液-25121601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%
5min19395-93950.9750.8417.770.980.8418.09
27554-75540.7840.78
36878-68780.7140.71
49920-99201.0301.03
58643-86430.8970.90
66285-62850.6520.65
10min128747-287472.9833.036.332.993.046.38
228683-286832.9772.99
329264-292643.0373.04
431000-310003.2173.23
531219-312193.2403.25
626163-261632.7152.72
15min140949-409494.2504.252.884.294.292.92
240486-404864.2024.24
341787-417874.3374.38
441391-413914.2964.34
542138-421384.3734.42
638847-388474.0324.07
20min145880-458804.7614.781.384.854.871.42
246133-461334.7884.88
346217-462174.7964.89
446538-465384.8304.92
546641-466414.8404.93
644884-448844.6584.74
30min150920-509205.2845.351.735.435.491.75
250304-503045.2215.36
352208-522085.4185.56
451974-519745.3945.54
552630-526305.4625.61
651049-510495.2985.43
45min156585-565855.8725.852.746.086.052.74
254298-542985.6355.83
356387-563875.8526.06
456796-567965.8946.10
558795-587956.1026.31
655168-551685.7255.92
60min157394-573945.9566.021.546.226.281.55
256777-567775.8926.15
358169-581696.0376.31
457995-579956.0196.29
559424-594246.1676.44
658162-581626.0366.29
90min161075-610756.3386.381.296.676.711.34
260179-601796.2456.57
361953-619536.4306.76
462065-620656.4416.78
562256-622566.4616.81
661196-611966.3516.67
120min161785-617856.4126.541.966.826.951.93
261619-616196.3956.79
363729-637296.6147.02
463362-633626.5766.99
564894-648946.7357.15
662998-629986.5386.93
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161960-619606.4306.571.816.917.051.77
261853-618536.4196.89
363907-639076.6327.11
464475-644756.6917.18
564228-642286.6667.16
663475-634756.5877.05
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%
110.056478165274651896454064858649280.47
210.096528064704649920.63
单位质量响应值RSD%判断
6460.506441.230.22数据可信
供试品溶液-25121601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%
5min16416-64168.9645.5157.418.965.5157.39
22608-26083.6443.64
32930-29304.0944.09
42552-25523.5653.57
51939-19392.7092.71
67224-722410.09310.09
10min142381-4238159.21155.929.8559.3155.989.88
239135-3913554.67654.72
337376-3737652.21952.26
442315-4231559.11959.16
534063-3406347.59047.62
644864-4486462.68062.79
15min156669-5666979.17379.511.3679.9380.191.42
256849-5684979.42580.07
357656-5765680.55281.18
456438-5643878.85079.55
555888-5588878.08278.64
657962-5796280.98081.79
20min159478-5947883.09884.861.3584.7386.421.35
261205-6120585.51187.04
361184-6118485.48187.00
460476-6047684.49286.06
560307-6030784.25685.68
661764-6176486.29288.00
30min162175-6217586.86689.002.0589.4391.502.03
262625-6262587.49489.98
364246-6424689.75992.23
463345-6334588.50091.01
563995-6399589.40891.77
665810-6581091.94494.61
45min164613-6461390.27291.211.6593.8094.711.64
263661-6366188.94292.39
365661-6566191.73695.20
465141-6514191.01094.50
565913-6591392.08895.44
666735-6673593.23796.93
60min163544-6354488.77890.861.9093.3195.371.84
264383-6438389.95194.39
366041-6604192.26796.75
463924-6392489.30993.82
565875-6587592.03596.41
666437-6643792.82097.54
90min163536-6353688.76791.122.4094.2896.642.34
264182-6418289.67095.11
366754-6675493.26398.78
463911-6391189.29194.79
565708-6570891.80297.20
667223-6722393.91899.67
120min162397-6239787.17690.543.1293.6897.072.99
263015-6301588.03994.48
366668-6666893.14399.69
463599-6359988.85595.35
566249-6624992.55898.98
666895-6689593.460100.26
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163076-6307688.12591.302.4395.5998.842.34
264300-6430089.83597.25
367334-6733494.073101.66
464827-6482790.57198.05
565909-6590992.08399.53
666667-6666793.142100.98
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%
114.898577698630958566528599658617328598430.32
214.908648368682358665360.28
单位质量响应值RSD%判断
57746.3458156.780.51数据可信
供试品溶液-25121601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%
5min161944-619446.3997.4631.736.407.4631.75
2117677-11767712.15612.16
356020-560205.7875.79
465773-657736.7946.79
560055-600556.2046.20
671787-717877.4157.42
10min1329329-32932934.01936.837.3734.0936.927.42
2399959-39995941.31541.45
3333539-33353934.45434.52
4365001-36500137.70437.78
5345283-34528335.66735.74
6366415-36641537.85037.93
15min1536866-53686655.45757.664.7055.9158.154.73
2586566-58656660.59161.18
3540213-54021355.80356.25
4562033-56203358.05758.55
5531604-53160454.91355.38
6591822-59182261.13461.64
20min1635077-63507765.60266.972.0366.6768.102.10
2660553-66055368.23469.50
3639754-63975466.08567.15
4649391-64939167.08168.22
5637873-63787365.89166.97
6667136-66713668.91470.10
30min1736031-73603176.03076.432.4277.8278.312.41
2734500-73450075.87277.90
3732862-73286275.70377.50
4734949-73494975.91877.80
5725648-72564874.95876.77
6775527-77552780.11082.06
45min1821923-82192384.90385.554.4587.5488.274.34
2802494-80249482.89685.76
3856893-85689388.51591.16
4799281-79928182.56485.29
5799990-79999082.63785.28
6888285-88828591.75894.60
60min1820324-82032484.73785.433.1688.3289.113.11
2811182-81118283.79387.58
3827163-82716385.44489.07
4804695-80469583.12386.77
5821284-82128484.83788.40
6877746-87774690.66994.53
90min1844706-84470687.25689.163.6191.7893.793.55
2844929-84492987.27992.00
3859819-85981988.81793.39
4852932-85293288.10692.68
5850895-85089587.89592.40
6925525-92552595.604100.47
120min1869744-86974489.84290.923.6295.3496.543.58
2875370-87537090.42496.11
3876511-87651190.54196.10
4866575-86657589.51595.06
5850696-85069687.87593.35
6942323-94232397.340103.27
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1855364-85536488.35789.584.2494.8596.204.15
2860280-86028088.86595.56
3862270-86227089.07095.64
4845152-84515287.30293.85
5839994-83999486.76993.22
6939949-93994997.094104.10
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%
110.056500465239648446510065332651040.30
210.096522365675654490.49
单位质量响应值RSD%判断
6478.016486.520.10数据可信
供试品溶液-25121601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%
5min11318-13181.8323.8845.771.833.8845.83
22582-25823.5903.59
31305-13051.8141.81
43346-33464.6524.65
53990-39905.5475.55
64200-42005.8395.84
10min132747-3274745.53049.095.9145.5549.135.95
234984-3498448.64048.68
333195-3319546.15346.17
435794-3579449.76649.82
537226-3722651.75751.82
637895-3789552.68752.75
15min146310-4631064.38767.304.4664.9167.894.48
248563-4856367.51968.10
346336-4633664.42364.96
449337-4933768.59669.20
547821-4782166.48867.12
652060-5206072.38173.03
20min152225-5222572.61174.762.6573.8576.102.71
253008-5300873.69975.03
352614-5261473.15274.40
454797-5479776.18777.55
554067-5406775.17276.55
655935-5593577.76979.22
30min158359-5835981.13981.873.1083.1984.043.12
257161-5716179.47481.62
357425-5742579.84181.90
459655-5965582.94185.15
558582-5858281.44983.66
662139-6213986.39588.71
45min164089-6408989.10689.534.0292.0692.613.97
261347-6134785.29488.33
365212-6521290.66793.62
463712-6371288.58291.72
563018-6301887.61790.73
668982-6898295.90999.19
60min163686-6368688.54689.273.4692.4993.353.46
262077-6207786.30990.29
363042-6304287.65091.61
463679-6367988.53692.66
564304-6430489.40593.49
668470-6847095.19799.54
90min165292-6529290.77893.074.1995.7098.134.16
264510-6451089.69194.63
365475-6547591.03395.96
467955-6795594.48199.58
566256-6625692.11997.20
672141-72141100.301105.70
120min167642-6764294.04695.403.9599.98101.503.93
267161-6716193.37799.31
366952-6695293.08699.03
469045-6904595.996102.15
567000-6700093.15399.26
673915-73915102.767109.28
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166884-6688492.99294.134.3799.97101.284.31
266098-6609891.89998.87
366043-6604391.82398.80
467558-6755893.929101.15
566015-6601591.78498.92
673605-73605102.336109.99
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%
114.898664128652338682518689938647618667300.22
214.908713098689308701200.20
单位质量响应值RSD%判断
58208.8758397.320.23数据可信
供试品溶液-25121601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%
5min1116635-11663511.97512.0118.3211.9812.0118.33
2106686-10668610.95410.95
3142418-14241814.62314.62
497637-9763710.02510.02
595245-952459.7799.78
6143384-14338414.72214.72
10min1685580-68558070.39170.933.8170.5271.073.80
2703872-70387272.26972.39
3722543-72254374.18674.35
4710237-71023772.92373.03
5670457-67045768.83868.95
6652510-65251066.99667.16
15min1893581-89358191.74792.141.2492.6693.061.26
2885873-88587390.95691.88
3916805-91680594.13295.12
4890708-89070891.45292.37
5894025-89402591.79392.67
6903248-90324892.74093.65
20min1908670-90867093.29794.330.9295.2396.280.90
2925520-92552095.02796.96
3914956-91495693.94295.97
4932019-93201995.69497.63
5916272-91627294.07795.97
6915137-91513793.96195.90
30min1920323-92032394.49394.961.5297.4697.961.49
2917427-91742794.19697.19
3925115-92511594.98598.06
4952802-95280297.828100.83
5915575-91557594.00696.94
6918196-91819694.27597.26
45min1917806-91780694.23594.070.9798.2698.120.97
2907929-90792993.22097.26
3924350-92435094.90699.04
4922073-92207394.67398.76
5902588-90258892.67296.66
6922304-92230494.69698.73
60min1872840-87284089.61890.840.7794.6995.940.73
2888809-88880991.25796.33
3882436-88243690.60395.79
4892109-89210991.59696.74
5887902-88790291.16496.18
6884301-88430190.79495.88
90min1887466-88746691.11990.830.9897.1896.930.94
2881959-88195990.55496.64
3879632-87963290.31596.51
4896288-89628892.02598.18
5871899-87189989.52195.55
6890613-89061391.44397.53
120min1856519-85651987.94289.661.2995.0296.781.24
2870053-87005389.33296.43
3877348-87734890.08197.28
4880613-88061390.41697.60
5866711-86671188.98896.01
6888391-88839191.21498.32
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1864201-86420188.73189.250.5296.7897.360.51
2871207-87120789.45097.54
3866895-86689589.00797.20
4877071-87707190.05298.24
5868523-86852389.17497.18
6867627-86762789.08397.20
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%
110.056550365632658166578865465656410.25
210.096600265805659040.22
单位质量响应值RSD%判断
6531.446531.620.01数据可信
供试品溶液-25121601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%
5min12475-24753.4154.4014.443.424.4014.37
23366-33664.6454.64
32863-28633.9513.95
43250-32504.4854.48
53401-34014.6934.69
63793-37935.2345.23
10min120289-2028927.99638.6232.0128.0338.6731.97
243118-4311859.49759.55
323554-2355432.50132.55
434544-3454447.66647.72
524706-2470634.09134.14
621703-2170329.94730.01
15min134511-3451147.62061.5719.9747.9762.0420.04
259255-5925581.76482.48
340665-4066556.11256.52
449800-4980068.71769.30
545012-4501262.11062.54
638462-3846253.07253.46
20min141091-4109156.70072.5917.2557.5873.7617.33
265859-6585990.87692.50
348785-4878567.31668.34
458085-5808580.14981.49
556059-5605977.35478.47
645782-4578263.17364.15
30min151759-5175971.42086.1810.8072.9388.1510.96
269033-6903395.25697.89
363651-6365187.82989.61
466593-6659391.88994.12
566878-6687892.28294.26
656835-5683578.42480.11
45min161747-6174785.20294.845.8287.5097.775.99
270350-7035097.073100.76
371301-7130198.385101.14
469262-6926295.57298.83
572965-72965100.681103.69
666781-6678192.14894.70
60min165709-6570990.66995.493.4993.9299.473.57
269037-6903795.261100.03
369977-6997796.558100.40
467960-6796093.77598.09
573014-73014100.749104.87
669525-6952595.93599.51
90min171233-7123398.29197.412.55102.55102.452.09
268648-6864894.725100.55
370303-7030397.008101.93
468531-6853194.56399.92
571738-7173898.988104.23
673101-73101100.869105.51
120min169508-6950895.91196.383.39101.26102.512.97
267705-6770593.423100.30
369957-6995796.531102.53
467112-6711292.60599.01
571257-7125798.325104.67
673566-73566101.511107.28
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169821-6982196.34395.602.82102.76102.802.43
267566-6756693.232101.15
369127-6912795.386102.45
466566-6656691.85299.29
571496-7149698.654106.09
671140-7114098.163105.06
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