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%
110.266356763584633686345363465634870.15
210.296312763078631020.06
单位质量响应值RSD%判断
6187.826132.360.64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%
5min15804-58048.4737.7815.128.477.7815.12
23976-39765.8045.80
36373-63739.3049.30
45507-55078.0408.04
55156-51567.5277.53
65145-51457.5117.51
10min151288-5128874.87451.0328.6674.9751.1228.62
226141-2614138.16338.23
324382-2438235.59535.70
437520-3752054.77554.86
539607-3960757.82157.91
630794-3079444.95645.04
15min161402-6140289.63969.0122.5890.5769.6622.60
240015-4001558.41758.91
333791-3379149.33149.83
452736-5273676.98877.69
555082-5508280.41381.14
640599-4059959.27059.85
20min164936-6493694.79977.1919.1496.7278.6119.21
245683-4568366.69267.83
339447-3944757.58858.63
458701-5870185.69687.25
561197-6119789.34090.96
647289-4728969.03670.28
30min167809-6780998.99387.9413.74101.9790.2213.92
253945-5394578.75380.63
348746-4874671.16372.85
466134-6613496.54899.05
568275-6827599.673102.29
656526-5652682.52184.53
45min169691-69691101.74095.218.43105.8298.478.76
261029-6102989.09591.85
356958-5695883.15285.63
469136-69136100.930104.51
570536-70536102.974106.69
663961-6396193.37596.30
60min166839-6683997.57793.874.41102.7898.184.91
261594-6159489.92093.66
360163-6016387.83191.23
466700-6670097.374102.07
566174-6617496.606101.47
664348-6434893.94097.90
90min165573-6557395.72996.501.65102.02101.862.01
265794-6579496.051100.79
364484-6448494.13998.52
467660-6766098.775104.56
566326-6632696.828102.77
666763-6676397.466102.47
120min163967-6396793.38494.710.94100.74101.141.15
264523-6452394.196100.01
364593-6459394.29899.72
465232-6523295.231102.11
565437-6543795.530102.54
665482-6548295.596101.69
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162899-6289991.82593.601.36100.22101.081.53
263532-6353292.74999.61
363711-6371193.01099.48
465198-6519895.181103.12
564654-6465494.387102.46
664705-6470594.461101.61
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%
115.226601416600146596306597476595406598140.04
215.286586626585446586030.02
单位质量响应值RSD%判断
43351.7743102.290.41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%
5min1138482-13848219.22225.6334.3619.2225.6334.36
2182531-18253125.33625.34
3212336-21233629.47329.47
4281372-28137239.05539.06
596768-9676813.43213.43
6196464-19646427.27027.27
10min1594031-59403182.45383.095.6282.6783.375.70
2581858-58185880.76481.05
3616545-61654585.57885.91
4624978-62497886.74987.18
5541936-54193675.22275.37
6632184-63218487.74988.05
15min1699533-69953397.09797.771.9998.2398.982.07
2720897-720897100.063101.24
3710643-71064398.64099.92
4714960-71496099.239100.64
5682120-68212094.68095.67
6698193-69819396.91198.19
20min1705961-70596197.99097.801.29100.20100.091.39
2710644-71064498.640100.93
3700501-70050197.23299.61
4715812-71581299.357101.86
5689447-68944795.69797.73
6704987-70498797.854100.21
30min1707721-70772198.23498.750.81101.53102.130.86
2720640-720640100.027103.41
3706166-70616698.018101.47
4713828-71382899.082102.69
5706517-70651798.067101.17
6713873-71387399.088102.53
45min1713729-71372999.06898.681.32103.46103.161.25
2727287-727287100.950105.45
3700430-70043097.222101.77
4704327-70432797.763102.47
5707843-70784398.251102.44
6711835-71183598.805103.35
60min1682574-68257494.74393.900.80100.2399.470.85
2678763-67876394.21499.83
3679018-67901894.25099.87
4674913-67491393.68099.47
5666777-66677792.55197.83
6676764-67676493.93799.58
90min1678241-67824194.14294.761.47100.68101.371.46
2699775-69977597.131103.80
3672253-67225393.31199.98
4684980-68498095.077101.91
5674825-67482593.66899.98
6685909-68590995.206101.89
120min1665764-66576492.41093.331.39100.00101.001.33
2689977-68997795.771103.52
3668302-66830292.762100.47
4666250-66625092.478100.37
5668670-66867092.814100.16
6675537-67553793.767101.51
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1664435-66443592.22693.341.22100.84102.041.20
2685138-68513895.099103.91
3663078-66307892.037100.78
4674620-67462093.639102.56
5671096-67109693.150101.53
6676229-67622993.863102.65
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%
110.266332563260631906331963137632460.13
210.296296963248631080.32
单位质量响应值RSD%判断
6164.336132.940.37数据可信
供试品溶液-5122901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%
5min14713-47136.8937.0913.686.897.0813.70
24536-45366.6346.63
36154-61549.0019.00
44835-48357.0727.07
54433-44336.4846.48
64399-43996.4346.43
10min153302-5330277.95853.4434.7678.0353.5234.71
221166-2116630.95731.03
341030-4103060.01060.11
443165-4316563.13263.21
521719-2171931.76631.84
638845-3884556.81456.89
15min163648-6364893.09074.8521.7994.0375.5221.86
233977-3397749.69450.11
352348-5234876.56377.33
460893-6089389.06189.84
542824-4282462.63363.06
653355-5335578.03678.74
20min166884-6688497.82383.2517.0799.8084.7517.21
240694-4069459.51860.49
358106-5810684.98586.60
465481-6548195.77197.54
551395-5139575.16976.29
658957-5895786.22987.80
30min167441-6744198.63891.0011.74101.7093.4311.99
249591-4959172.53174.16
364875-6487594.88597.45
469403-69403101.507104.34
557979-5797984.79986.75
664041-6404193.66596.19
45min168456-68456100.12296.036.70104.2899.477.07
257237-5723783.71486.15
367746-6774699.084102.70
469243-69243101.273105.23
565098-6509895.21198.11
666174-6617496.785100.35
60min166197-6619796.81896.003.27102.09100.503.75
261582-6158290.06893.44
365873-6587396.344101.06
467942-6794299.370104.46
565633-6563395.99399.95
666579-6657997.377102.02
90min164618-6461894.50997.222.68100.86102.792.60
265739-6573996.148100.52
365187-6518795.341101.13
469065-69065101.013107.20
568257-6825799.831104.85
665962-6596296.475102.20
120min163936-6393693.51194.631.91100.91101.281.52
265534-6553495.849101.28
364184-6418493.874100.72
465199-6519995.359102.67
566385-6638597.093103.23
662975-6297592.10698.90
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164191-6419193.88494.471.95102.32102.171.85
263852-6385293.38999.89
363834-6383493.362101.25
464918-6491894.948103.32
566998-6699897.990105.20
663741-6374193.226101.05
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%
115.226587906589026588736587926589976588710.02
215.286591436598646595040.08
单位质量响应值RSD%判断
43289.8243161.260.22数据可信
供试品溶液-5122901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%
5min1133244-13324418.49523.2743.0318.5023.2843.03
2249961-24996134.69634.70
3118292-11829216.42016.42
4143949-14394919.98119.98
594451-9445113.11013.11
6266178-26617836.94736.95
10min1551216-55121676.51377.207.0376.7277.467.13
2607288-60728884.29684.68
3560205-56020577.76077.94
4538230-53823074.71074.93
5494560-49456068.64868.79
6585531-58553181.27681.69
15min1682180-68218094.69196.101.2595.7597.221.39
2700062-70006297.17498.50
3693350-69335096.24297.29
4693273-69327396.23197.28
5682502-68250294.73695.64
6702815-70281597.55698.87
20min1699625-69962597.11398.701.3499.22100.891.35
2718778-71877899.772102.17
3701029-70102997.30899.42
4709770-70977098.521100.64
5723437-723437100.418102.38
6713889-71388999.093101.49
30min1688214-68821495.52997.941.4498.72101.221.46
2715102-71510299.261102.77
3702106-70210697.457100.65
4715850-71585099.365102.58
5706914-70691498.125101.20
6705341-70534197.906101.40
45min1694995-69499596.47097.360.79100.72101.730.79
2705303-70530397.901102.51
3703056-70305697.589101.87
4695223-69522396.502100.82
5708882-70888298.398102.56
6701100-70110097.318101.90
60min1675001-67500193.69595.291.6399.02100.741.71
2702017-70201797.445103.15
3676938-67693893.96499.33
4685423-68542395.142100.53
5681590-68159094.61099.87
6697844-69784496.866102.53
90min1663587-66358792.11195.442.1198.47101.952.07
2697115-69711596.765103.55
3676766-67676693.940100.35
4701644-70164497.393103.84
5694878-69487896.454102.77
6691445-69144595.978102.72
120min1660716-66071691.71293.271.7999.10100.841.75
2692434-69243496.115103.97
3666721-66672192.546100.00
4668717-66871792.823100.35
5679556-67955694.327101.71
6663294-66329492.07099.88
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1671902-67190293.26594.251.10101.67102.861.00
2677239-67723994.006102.93
3678343-67834394.159102.64
4673686-67368693.512102.08
5692886-69288696.178104.61
6679969-67996994.385103.22
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%
110.266308162890630856315463278630980.23
210.296308163197631390.13
单位质量响应值RSD%判断
6149.906135.960.17数据可信
供试品溶液-5123001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%
5min14109-41096.0156.5114.706.026.5214.70
24496-44966.5826.58
35510-55108.0668.07
44870-48707.1297.13
53934-39345.7595.76
63776-37765.5285.53
10min118967-1896727.76650.7835.5527.8350.8535.51
223249-2324934.03534.11
346370-4637067.88267.97
447003-4700368.80968.89
529605-2960543.34043.40
642939-4293962.86062.92
15min130886-3088645.21572.1325.6145.5972.7625.66
240015-4001558.57959.03
357052-5705283.52084.36
461868-6186890.57091.41
544944-4494465.79566.34
660851-6085189.08289.84
20min138036-3803655.68281.7918.6456.5683.2318.78
251734-5173475.73576.84
361792-6179290.45992.23
465568-6556895.98797.84
553697-5369778.60979.89
664397-6439794.27396.02
30min147864-4786470.06990.3611.9671.5792.7112.23
261434-6143489.93591.88
364801-6480194.86497.64
467990-6799099.533102.45
560982-6098289.27391.42
667294-6729498.514101.31
45min156013-5601381.99995.246.9884.2798.597.32
266128-6612896.80799.75
365624-6562496.06999.90
468473-68473100.240104.26
566966-6696698.033101.18
667123-6712398.263102.16
60min162358-6235891.28896.933.0794.47101.343.54
267813-6781399.273103.29
366703-6670397.648102.55
467816-6781699.278104.41
565845-6584596.392100.62
666727-6672797.684102.67
90min166570-6657097.45496.201.57101.65101.691.16
267299-6729998.521103.64
364702-6470294.719100.70
465700-6570096.180102.42
565034-6503495.205100.51
664984-6498495.132101.20
120min165866-6586696.42394.541.81101.71101.091.56
265093-6509395.292101.51
363052-6305292.30499.34
464509-6450994.437101.74
563348-6334892.73799.10
665602-6560296.037103.16
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164869-6486994.96494.762.11101.32102.371.90
266666-6666697.594104.87
362588-6258891.62499.69
465556-6555695.969104.33
564393-6439394.267101.66
664325-6432594.167102.36
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%
115.226584706587826593626600696616186596600.19
215.286611306611266611280.01
单位质量响应值RSD%判断
43341.6643267.540.13数据可信
供试品溶液-5123001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%
5min1166904-16690423.12524.4132.7923.1324.4132.79
2235038-23503832.56532.57
3189735-18973526.28826.29
4113268-11326815.69415.69
5243135-24313533.68733.69
6109034-10903415.10715.11
10min1546449-54644975.71277.122.7375.9777.392.82
2570524-57052479.04879.41
3576166-57616679.83080.12
4539825-53982574.79574.97
5562639-56263977.95678.33
6544088-54408875.38575.55
15min1662893-66289391.84693.331.2592.9494.461.18
2670724-67072492.93194.17
3672995-67299593.24694.42
4673894-67389493.37094.38
5672646-67264693.19794.44
6688585-68858595.40696.41
20min1679497-67949794.14795.991.6896.2798.161.68
2695991-69599196.43298.70
3706332-70633297.865100.08
4680379-68037994.26996.31
5689875-68987595.58597.86
6704789-70478997.65199.72
30min1686146-68614695.06896.011.6498.2399.241.62
2696780-69678096.54199.89
3702792-70279297.374100.68
4678583-67858394.02097.11
5685469-68546994.97498.31
6707768-70776898.064101.21
45min1669550-66955092.76995.251.6596.9999.551.65
2687201-68720195.21499.63
3692914-69291496.006100.39
4679527-67952794.15198.29
5700233-70023397.020101.41
6695365-69536596.345100.59
60min1675265-67526593.56094.581.5198.8199.941.48
2682139-68213994.51399.99
3698474-69847496.776102.23
4673833-67383393.36298.54
5674502-67450293.45598.93
6691426-69142695.800101.11
90min1668082-66808292.56592.991.2998.8699.401.28
2673106-67310693.26199.79
3681030-68103094.359100.89
4660033-66003391.45097.67
5664169-66416992.02398.53
6680563-68056394.294100.67
120min1653779-65377990.58391.582.1597.9099.022.00
2653587-65358790.55798.12
3665607-66560792.22299.80
4653338-65333890.52297.76
5651577-65157790.27897.81
6687967-68796795.320102.74
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1663173-66317391.88592.901.05100.21101.360.95
2674224-67422493.416101.98
3662035-66203591.727100.33
4675512-67551293.595101.83
5668705-66870592.651101.19
6679352-67935294.127102.61
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