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%
114.968678148626628668208643088579978639200.45
215.028657858646508652180.10
单位质量响应值RSD%判断
57748.6657604.390.18数据可信
供试品溶液-25112601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%
5min1241544-24154425.07028.7142.8925.0728.7142.89
2412215-41221542.78342.78
3403070-40307041.83441.83
4272772-27277228.31128.31
5235130-23513024.40424.40
694942-949429.8549.85
10min1752082-75208278.05878.8013.6978.3479.1213.78
2823215-82321585.44185.92
3819149-81914985.01985.48
4804634-80463483.51283.83
5802729-80272983.31483.59
6553619-55361957.46057.57
15min1865865-86586589.86790.682.0391.0191.882.09
2874474-87447490.76192.19
3867073-86707389.99391.40
4868876-86887690.18091.42
5908110-90811094.25295.45
6857882-85788289.03989.79
20min1874649-87464990.77990.501.3092.9292.701.35
2873731-87373190.68493.12
3862396-86239689.50791.92
4865994-86599489.88192.13
5892200-89220092.60194.84
6862724-86272489.54191.28
30min1875290-87529090.84590.952.1994.0094.161.88
2865832-86583289.86493.30
3862029-86202989.46992.87
4858740-85874089.12892.37
5886332-88633291.99295.26
6909496-90949694.39697.13
45min1850440-85044088.26689.082.5492.4393.302.29
2851446-85144688.37192.81
3858978-85897889.15293.55
4826353-82635385.76690.00
5871935-87193590.49794.79
6890714-89071492.44696.23
60min1846383-84638387.84589.192.7692.9994.402.43
2850202-85020288.24293.66
3846806-84680687.88993.28
4842428-84242887.43592.62
5865505-86550589.83095.13
6904831-90483193.91298.72
极限1896719-89671993.07091.204.3199.1997.403.93
2830635-83063586.21192.61
3835395-83539586.70593.07
4926664-92666496.178102.34
5895230-89523092.91599.21
6887810-88781092.14598.00
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%
110.186576965335654636522164463652500.75
210.196518865274652310.10
单位质量响应值RSD%判断
6409.636401.470.10数据可信
供试品溶液-25112601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%
5min13905-39055.49426.2562.455.4926.2562.45
220437-2043728.75528.75
326774-2677437.67137.67
435568-3556850.04450.04
516695-1669523.49023.49
68558-855812.04112.04
10min131605-3160544.46854.7128.4844.5355.0028.63
234956-3495649.18349.50
349471-4947169.60670.02
453369-5336975.09075.65
539914-3991456.15956.42
623995-2399533.76133.89
15min140319-4031956.72967.5416.7057.2868.4416.96
242791-4279160.20761.07
355920-5592078.67979.87
458676-5867682.55783.95
549716-4971669.95070.84
640575-4057557.08957.60
20min145043-4504363.37573.6712.4964.5675.3212.82
248937-4893768.85470.39
358883-5888382.84884.91
460716-6071685.42787.73
553977-5397775.94677.61
646594-4659465.55866.70
30min150587-5058771.17681.348.2473.0783.818.61
255044-5504477.44779.75
362601-6260188.07991.07
462842-6284288.41991.68
559537-5953783.76886.27
656270-5627079.17281.04
45min155049-5504977.45485.525.2380.1388.895.55
259761-5976184.08487.24
364406-6440690.61994.58
461818-6181886.97891.22
562137-6213787.42790.86
661520-6152086.55889.31
60min157879-5787981.43688.184.2384.9892.504.37
262021-6202187.26391.36
364274-6427490.43395.41
463034-6303488.68993.89
563231-6323188.96693.37
665605-6560592.30696.02
极限163340-6334089.11987.404.5993.5792.704.22
258564-5856482.39987.46
358663-5866382.53988.52
464314-6431490.49096.68
562632-6263288.12393.52
665194-6519491.72896.47
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%
114.968778058802178716508785608770568770580.37
215.028697668749588723620.43
单位质量响应值RSD%判断
58626.8758080.030.67数据可信
供试品溶液-25112601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%
5min116843-168431.7281.4222.911.731.4222.89
211096-110961.1381.14
312761-127611.3091.31
418448-184481.8931.89
512949-129491.3281.33
610663-106631.0941.09
10min132952-329523.3803.363.323.403.373.35
232009-320093.2843.30
333033-330333.3893.40
434614-346143.5513.57
531592-315923.2413.26
632098-320983.2933.30
15min140787-407874.1844.101.654.244.151.70
239418-394184.0444.09
340180-401804.1224.17
440346-403464.1394.20
539912-399124.0944.15
638970-389703.9984.05
20min144160-441604.5304.480.854.634.580.87
243764-437644.4904.58
343537-435374.4664.56
443634-436344.4764.58
543774-437744.4914.59
643041-430414.4154.51
30min146483-464834.7694.811.034.924.961.02
247083-470834.8304.97
347552-475524.8785.03
446604-466044.7814.94
547225-472254.8454.99
646313-463134.7514.89
45min150173-501735.1475.221.365.355.421.29
251979-519795.3325.53
350882-508825.2205.42
450507-505075.1815.39
551296-512965.2625.46
650285-502855.1595.35
60min152821-528215.4195.451.605.685.711.46
254740-547405.6165.87
353192-531925.4575.72
452295-522955.3655.63
552706-527065.4075.67
653210-532105.4595.71
极限155608-556085.7055.662.616.035.982.43
256679-566795.8156.13
355601-556015.7046.02
455093-550935.6525.98
552423-524235.3785.70
655479-554795.6916.00
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%
110.186662766827659886669766679665640.50
210.196607666307661920.25
单位质量响应值RSD%判断
6538.706495.780.47数据可信
供试品溶液-25112601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%
5min130543-3054342.23840.5613.1542.2440.5613.15
230808-3080842.60442.60
332090-3209044.37744.38
428513-2851339.43139.43
532091-3209144.37944.38
621930-2193030.32730.33
10min145530-4553062.96365.872.6863.4366.322.69
248161-4816166.60267.08
349306-4930668.18568.68
448071-4807166.47766.92
547741-4774166.02166.51
646994-4699464.98865.32
15min152561-5256172.68773.581.5473.8674.761.60
253887-5388774.52075.73
354165-5416574.90576.16
452865-5286573.10774.28
553648-5364874.19075.42
652095-5209572.04273.10
20min154517-5451775.39277.211.9077.3779.211.90
257724-5772479.82681.87
355945-5594577.36679.45
455724-5572477.06179.05
555784-5578477.14479.19
655295-5529576.46778.33
30min155053-5505376.13378.912.0378.9581.772.02
258295-5829580.61683.54
358031-5803180.25183.19
456686-5668678.39181.24
557258-5725879.18282.09
657041-5704178.88281.59
45min156994-5699478.81781.832.1482.4885.562.12
260835-6083584.12987.95
359813-5981382.71586.55
459282-5928281.98185.70
559117-5911781.75385.54
658987-5898781.57385.16
60min157277-5727779.20882.622.6183.7487.262.53
261679-6167985.29690.05
360264-6026483.33988.09
459217-5921781.89186.52
559123-5912381.76186.46
660904-6090484.22488.72
极限158661-5866181.12283.143.0786.5488.702.93
261863-6186385.55091.26
361393-6139384.90090.58
460593-6059383.79489.33
557109-5710978.97684.58
661089-6108984.48089.91
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%
114.968504308533318571658486068528288524720.39
215.028558408531668545030.23
单位质量响应值RSD%判断
56983.4256891.010.12数据可信
供试品溶液-25112601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%
5min1104130-10413010.9486.5842.0410.956.5942.03
249031-490315.1555.15
354742-547425.7555.76
484826-848268.9188.92
549053-490535.1575.16
634014-340143.5763.58
10min1393051-39305141.32439.7712.0541.4539.8412.07
2410485-41048543.15743.21
3333664-33366435.08035.14
4429527-42952745.15945.26
5390441-39044141.05041.11
6312263-31226332.83032.87
15min1559327-55932758.80657.343.1959.3957.853.30
2550296-55029657.85658.39
3523487-52348755.03855.49
4565244-56524459.42860.03
5548601-54860157.67858.19
6525129-52512955.21055.61
20min1645061-64506167.82066.732.6669.0567.882.75
2645653-64565367.88269.06
3615344-61534464.69565.76
4655214-65521468.88770.15
5632178-63217866.46567.62
6614908-61490864.64965.67
30min1725128-72512876.23776.780.8578.2378.670.91
2730181-73018176.76978.70
3724819-72481976.20577.99
4741479-74147977.95779.98
5731918-73191876.95178.84
6728233-72823376.56478.30
45min1798176-79817683.91784.550.8386.7587.300.87
2800779-80077984.19186.98
3802062-80206284.32686.96
4814621-81462185.64688.54
5810139-81013985.17587.92
6799434-79943484.05086.64
60min1837554-83755488.05888.311.1491.8291.991.15
2832751-83275187.55391.27
3826165-82616586.86090.43
4851686-85168689.54393.39
5846899-84689989.04092.73
6844552-84455288.79392.31
极限1851755-85175589.55189.290.6794.3093.950.72
2846518-84651889.00093.70
3839862-83986288.30092.83
4856212-85621290.01994.86
5848970-84897089.25893.94
6852087-85208789.58694.09
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%
110.186433564605648676436964617645590.34
210.196492864720648240.23
单位质量响应值RSD%判断
6341.756361.530.23数据可信
供试品溶液-25112601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%
5min17851-785111.14018.8248.8811.1418.8248.88
219029-1902927.00127.00
36527-65279.2619.26
416602-1660223.55723.56
521364-2136430.31430.31
68217-821711.65911.66
10min131924-3192445.29848.547.1745.4248.757.35
236660-3666052.01852.32
331808-3180845.13445.24
436322-3632251.53951.80
536346-3634651.57351.91
632202-3220245.69345.82
15min142334-4233460.07060.620.9360.7061.371.11
242892-4289260.86161.74
342152-4215259.81160.42
443073-4307361.11861.95
543101-4310161.15862.07
642763-4276360.67861.32
20min147460-4746067.34367.081.2768.6468.501.32
247939-4793968.02369.58
346811-4681166.42267.69
447960-4796068.05269.57
546550-4655066.05267.64
646935-4693566.59867.91
30min152095-5209573.92074.071.3875.9676.241.21
251851-5185173.57475.88
352950-5295075.13377.14
452507-5250774.50476.77
551009-5100972.37974.70
652803-5280374.92476.98
45min156186-5618679.72579.791.5482.5982.781.39
255956-5595679.39882.53
357536-5753681.64084.48
456651-5665180.38583.48
554910-5491077.91481.04
656160-5616079.68882.57
60min158774-5877483.39783.111.7487.1586.991.56
258005-5800582.30686.32
359806-5980684.86188.61
458912-5891283.59387.58
556874-5687480.70184.69
659075-5907583.82487.59
极限160022-6002285.16883.841.9189.8488.641.72
258912-5891283.59388.52
359623-5962384.60289.29
459344-5934484.20689.13
556922-5692280.76985.66
659711-5971184.72689.43
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