非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.243653636622365853661336685366080.15
211.373689136965369280.15
单位质量响应值RSD%判断
3256.943247.850.20数据可信
供试品溶液-6042701批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110692-1069229.49531.848.6229.5031.848.62
211898-1189832.82232.82
312433-1243334.29834.30
410012-1001227.61927.62
512505-1250534.49734.50
611710-1171032.30332.30
10min120503-2050356.56057.421.6356.6157.481.63
221083-2108358.16058.21
321288-2128858.72658.78
420413-2041356.31256.36
520887-2088757.61957.68
620718-2071857.15357.21
15min124421-2442167.36867.431.2467.5167.581.24
224529-2452967.66667.82
324911-2491168.72068.88
424567-2456767.77167.91
524135-2413566.57966.73
624103-2410366.49166.64
20min126588-2658873.34673.091.2973.6073.351.29
226570-2657073.29773.56
326882-2688274.15774.43
426765-2676573.83474.09
526062-2606271.89572.16
626099-2609971.99772.26
30min128853-2885379.59479.121.6179.9779.501.60
228675-2867579.10379.49
329139-2913980.38380.78
429147-2914780.40680.78
528100-2810077.51777.90
628170-2817077.71078.09
45min130552-3055284.28183.541.6284.7984.051.61
230296-3029683.57584.09
330665-3066584.59385.12
430796-3079684.95485.46
529598-2959881.65082.16
629793-2979382.18882.70
60min130994-3099485.50185.591.5986.1586.241.58
231130-3113085.87686.53
331475-3147586.82887.50
431587-3158787.13787.79
530270-3027083.50384.15
630697-3069784.68185.33
极限131710-3171087.47687.571.6188.2788.361.60
231890-3189087.97288.77
332268-3226889.01589.83
432236-3223688.92789.72
530933-3093385.33286.12
631427-3142786.69587.48
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.342665172666182664102665432663722664920.04
211.392684452688932686690.12
单位质量响应值RSD%判断
23500.1823588.150.27数据可信
供试品溶液-6042701批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192015-9201535.13938.348.6735.1438.348.67
2102787-10278739.25239.25
3107858-10785841.18941.19
487805-8780533.53133.53
5109625-10962541.86441.86
6102223-10222339.03739.04
10min1162930-16293062.22062.791.3062.2862.851.31
2166292-16629263.50363.57
3167333-16733363.90163.97
4161627-16162761.72261.78
5164713-16471362.90162.97
6163616-16361662.48262.55
15min1187305-18730571.52871.621.2171.6971.791.21
2189034-18903472.18872.36
3190901-19090172.90173.08
4187727-18772771.68971.85
5184559-18455970.47970.65
6185830-18583070.96571.13
20min1201481-20148176.94177.001.3977.2277.291.38
2203197-20319777.59777.89
3204818-20481878.21678.51
4203323-20332377.64577.92
5197148-19714875.28775.58
6199838-19983876.31476.60
30min1219434-21943483.79783.461.7484.2183.881.73
2220155-22015584.07384.49
3222036-22203684.79185.22
4221473-22147384.57684.98
5212011-21201180.96381.38
6216272-21627282.59083.00
45min1233244-23324489.07188.731.9389.6289.281.92
2234222-23422289.44590.01
3236489-23648990.31090.88
4235229-23522989.82990.38
5224117-22411785.58686.14
6230773-23077388.12788.68
60min1239586-23958691.49391.652.0892.1992.352.07
2242112-24211292.45893.17
3244303-24430393.29494.01
4244174-24417493.24593.94
5230911-23091188.18088.88
6238910-23891091.23591.93
极限1245365-24536593.70093.542.1394.5594.392.12
2246880-24688094.27895.14
3250171-25017195.53596.41
4248213-24821394.78795.64
5235335-23533589.87090.71
6243658-24365893.04893.90
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.243686936915368303685236859368650.09
211.373767837785377320.21
单位质量响应值RSD%判断
3279.803318.560.84数据可信
供试品溶液-6042702批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17020-702019.09222.2626.5919.0922.2626.59
210085-1008527.42727.43
34791-479113.03013.03
47732-773221.02821.03
58697-869723.65223.65
610775-1077529.30429.30
10min117137-1713746.60650.508.1046.6450.538.12
220019-2001954.44354.49
316536-1653644.97144.99
418417-1841750.08750.12
519073-1907351.87151.91
620223-2022354.99855.05
15min122062-2206260.00063.014.1860.1163.134.20
224389-2438966.32866.46
322179-2217960.31860.41
422790-2279061.97962.10
523645-2364564.30564.43
623956-2395665.15065.29
20min124831-2483167.53069.772.7567.7470.002.76
226751-2675172.75273.00
325177-2517768.47168.67
425246-2524668.65968.88
526037-2603770.81071.04
625888-2588870.40570.65
30min127817-2781775.65177.031.7975.9777.371.81
229217-2921779.45879.83
328181-2818176.64176.95
427967-2796776.05976.39
528574-2857477.70978.06
628194-2819476.67677.04
45min129739-2973980.87882.021.1381.3382.491.14
230621-3062183.27683.78
330182-3018282.08382.52
430041-3004181.69982.16
530473-3047382.87483.35
629893-2989381.29781.79
60min130806-3080683.78084.410.9084.3685.020.90
231465-3146585.57286.21
331148-3114884.71085.29
430763-3076383.66384.26
531194-3119484.83585.45
630849-3084983.89784.53
极限131368-3136885.30886.430.9186.0387.180.92
232171-3217187.49288.27
331805-3180586.49687.21
431801-3180186.48687.22
531984-3198486.98387.74
631560-3156085.83086.60
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.342692222696672699072693222697362695710.11
211.392745782739012742400.18
单位质量响应值RSD%判断
23771.6924077.260.91数据可信
供试品溶液-6042702批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162688-6268823.56027.4326.4223.5627.4326.42
291138-9113834.25234.25
342929-4292916.13416.13
469460-6946026.10526.10
576437-7643728.72728.73
695234-9523435.79135.79
10min1139411-13941152.39456.467.5452.4356.517.55
2163447-16344761.42761.48
3135974-13597451.10251.13
4148680-14868055.87755.92
5151833-15183357.06257.11
6162104-16210460.92260.98
15min1173154-17315465.07568.013.6765.2068.153.69
2190004-19000471.40871.57
3175180-17518065.83765.95
4178283-17828367.00367.14
5182281-18228168.50568.65
6186860-18686070.22670.39
20min1191802-19180272.08474.312.3472.3274.562.35
2205033-20503377.05677.33
3195427-19542773.44673.67
4195377-19537773.42773.68
5198394-19839474.56174.82
6200270-20027075.26675.54
30min1213699-21369980.31381.901.5580.6782.281.56
2223571-22357184.02384.43
3217752-21775281.83682.18
4215571-21557181.01781.39
5217879-21787981.88482.27
6219052-21905282.32582.73
45min1229161-22916186.12487.801.1786.6188.321.19
2237563-23756389.28289.83
3234365-23436588.08088.56
4232695-23269587.45287.96
5233709-23370987.83388.35
6234271-23427188.04488.59
60min1236590-23659088.91690.671.5589.5591.341.56
2246109-24610992.49393.19
3243341-24334191.45392.08
4237089-23708989.10389.75
5241593-24159390.79691.46
6242901-24290191.28891.98
极限1242306-24230691.06492.951.2591.8493.761.26
2251383-25138394.47595.33
3249041-24904193.59594.38
4245923-24592392.42393.22
5247256-24725692.92493.74
6248089-24808993.23894.08
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.243710237146371703696637182371130.24
211.373784237883378620.08
单位质量响应值RSD%判断
3301.873329.990.60数据可信
供试品溶液-6042703批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17507-750720.31227.2913.5120.3127.2913.51
210998-1099829.75829.76
311321-1132130.63230.63
410531-1053128.49528.49
510271-1027127.79127.79
69890-989026.76026.76
10min118186-1818649.20853.244.4249.2453.284.43
220535-2053555.56455.61
320349-2034955.06055.11
420039-2003954.22254.27
519749-1974953.43753.48
619198-1919851.94651.99
15min122908-2290861.98564.182.0762.1064.322.08
224240-2424065.58965.73
324110-2411065.23765.38
423892-2389264.64764.78
523754-2375464.27464.41
623421-2342163.37363.50
20min125344-2534468.57669.931.1968.8070.181.20
226232-2623270.97971.23
326014-2601470.38970.64
425902-2590270.08670.33
525912-2591270.11370.36
625669-2566969.45569.69
30min127693-2769374.93276.151.1175.2776.511.12
228504-2850477.12677.50
328396-2839676.83477.20
428160-2816076.19576.56
528245-2824576.42576.78
627864-2786475.39575.75
45min129437-2943779.65180.740.8580.1181.220.86
230159-3015981.60482.10
329942-2994281.01781.51
429844-2984480.75281.24
529978-2997881.11581.60
629678-2967880.30380.78
60min130342-3034282.10083.140.8682.6983.760.87
231022-3102283.94084.57
330772-3077283.26383.89
430886-3088683.57284.20
530866-3086683.51784.14
630471-3047182.44983.06
极限131030-3103083.96184.730.6984.6985.490.71
231437-3143785.06285.84
331543-3154385.34986.12
431375-3137584.89585.66
531443-3144385.07985.84
631060-3106084.04284.79
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.342726512727582733422714822722412724950.26
211.392779972778422779200.04
单位质量响应值RSD%判断
24029.5424400.351.09数据可信
供试品溶液-6042703批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164146-6414623.81932.3813.8623.8232.3813.86
294182-9418234.97234.97
398453-9845336.55836.56
491624-9162434.02234.02
588639-8863932.91432.91
686103-8610331.97231.97
10min1146916-14691654.55358.183.5454.5958.243.56
2160626-16062659.64459.70
3161654-16165460.02660.09
4160373-16037359.55059.61
5155810-15581057.85657.91
6154745-15474557.46057.51
15min1178816-17881666.39868.141.5866.5368.291.59
2186276-18627669.16869.33
3186435-18643569.22769.39
4184581-18458168.53968.69
5182692-18269267.83767.99
6182269-18226967.68067.83
20min1195088-19508872.44073.511.0872.6873.781.09
2199954-19995474.24774.52
3200268-20026874.36474.64
4199123-19912373.93974.21
5196195-19619572.85173.12
6197186-19718673.21973.48
30min1212899-21289979.05479.971.0379.4280.361.05
2218007-21800780.95181.35
3217594-21759480.79781.20
4216268-21626880.30580.70
5214228-21422879.54779.93
6213261-21326179.18879.57
45min1227990-22799084.65885.160.7285.1585.680.73
2231858-23185886.09486.63
3230727-23072785.67486.21
4229223-22922385.11585.64
5227673-22767384.54085.06
6228581-22858184.87785.39
60min1235892-23589287.59287.890.7388.2388.550.74
2239362-23936288.88089.56
3238083-23808388.40589.08
4236559-23655987.83988.51
5235060-23506087.28387.94
6235146-23514687.31587.97
极限1241418-24141889.64489.461.1390.4290.271.13
2243668-24366890.47991.30
3243713-24371390.49691.32
4240960-24096089.47490.29
5239112-23911288.78789.59
6236694-23669487.89088.69
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