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%
111.243698637148370983716137189371160.22
211.373674837003368760.49
单位质量响应值RSD%判断
3302.143243.271.28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%
5min112343-1234333.84128.3224.2933.8428.3224.29
210072-1007227.61527.61
311734-1173432.17132.17
411851-1185132.49232.49
510447-1044728.64328.64
65530-553015.16215.16
10min121011-2101157.60655.227.1157.6655.277.13
220155-2015555.25955.31
320968-2096857.48857.54
421194-2119458.10858.16
520157-2015755.26555.31
617367-1736747.61547.64
15min124443-2444367.01666.113.7667.1766.253.78
224302-2430266.62966.77
324292-2429266.60266.75
425025-2502568.61168.76
524251-2425166.48966.63
622359-2235961.30261.41
20min126531-2653172.74072.032.8173.0072.282.83
226266-2626672.01472.26
326336-2633672.20672.47
427200-2720074.57574.84
526361-2636172.27472.53
624943-2494368.38768.59
30min128854-2885479.10978.421.9379.4978.791.95
228779-2877978.90479.27
328553-2855378.28478.67
429300-2930080.33280.72
528492-2849278.11778.49
627643-2764375.78976.11
45min130604-3060483.90783.261.5884.4283.761.59
230300-3030083.07483.57
330191-3019182.77583.29
431177-3117785.47986.00
530169-3016982.71583.22
629773-2977381.62982.08
60min131146-3114685.39485.651.5786.0586.291.58
231322-3132285.87686.52
330976-3097684.92785.58
432175-3217588.21588.88
531000-3100084.99385.63
630817-3081784.49185.07
极限132136-3213688.10887.651.7788.9188.441.79
232116-3211688.05388.84
331539-3153986.47187.26
432884-3288490.15990.97
531904-3190487.47288.25
631245-3124585.66586.39
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%
111.342672142671112671582672012678052672980.11
211.392646352647392646870.03
单位质量响应值RSD%判断
23571.2523238.541.01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%
5min1106321-10632140.84534.6422.8640.8534.6422.86
287960-8796033.79233.79
3103194-10319439.64439.64
4101198-10119838.87738.88
591650-9165035.20935.21
650627-5062719.44919.45
10min1162683-16268362.49860.836.0862.5760.896.09
2159350-15935061.21761.27
3164386-16438663.15263.22
4164719-16471963.28063.34
5159681-15968161.34561.40
6139279-13927953.50753.54
15min1185561-18556171.28770.453.2871.4670.613.29
2185428-18542871.23671.39
3185077-18507771.10171.27
4188363-18836372.36372.53
5184423-18442370.85071.01
6171454-17145465.86765.99
20min1199733-19973376.73176.122.2377.0276.402.25
2201133-20113377.26977.55
3198146-19814676.12276.41
4201663-20166377.47377.76
5198604-19860476.29876.58
6189613-18961372.84473.07
30min1217574-21757483.58582.811.5884.0083.221.60
2218138-21813883.80284.21
3213059-21305981.85182.27
4217732-21773283.64684.07
5217159-21715983.42683.83
6209748-20974880.57980.93
45min1231844-23184489.06788.231.5689.6388.771.57
2232601-23260189.35889.90
3225595-22559586.66787.22
4232260-23226089.22789.79
5231018-23101888.75089.30
6224620-22462086.29286.78
60min1238830-23883091.75191.071.6292.4691.761.63
2240689-24068992.46593.16
3232804-23280489.43690.13
4239969-23996992.18992.90
5238336-23833691.56192.25
6231714-23171489.01889.65
极限1244728-24472894.01792.971.5594.8893.821.56
2244704-24470494.00894.86
3237586-23758691.27392.12
4244757-24475794.02894.89
5243356-24335693.49094.34
6236919-23691991.01791.80
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%
111.243769637837377313755437454376540.41
211.373834938318383340.06
单位质量响应值RSD%判断
3350.003371.500.46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%
5min19139-913924.39826.2513.9924.4026.2513.99
28836-883623.58923.59
38739-873923.33023.33
411989-1198932.00732.01
59162-916224.46024.46
611127-1112729.70629.71
10min120295-2029554.18253.134.5954.2253.184.59
219797-1979752.85252.89
318488-1848849.35749.40
421157-2115756.48356.54
519385-1938551.75251.79
620292-2029254.17454.22
15min124448-2444865.26964.132.5565.4064.262.56
223888-2388863.77463.90
323000-2300061.40361.52
424793-2479366.19066.34
523865-2386563.71263.84
624132-2413264.42564.56
20min126642-2664271.12670.051.9171.3770.291.92
226143-2614369.79470.03
325448-2544867.93868.16
426900-2690071.81572.07
526122-2612269.73869.97
626181-2618169.89570.14
30min128926-2892677.22476.651.6577.5877.011.65
228580-2858076.30076.65
327948-2794874.61374.95
429276-2927678.15878.54
529033-2903377.50977.86
628507-2850776.10576.47
45min130917-3091782.53981.331.6583.0381.821.65
230413-3041381.19481.67
329557-2955778.90879.37
430906-3090682.51083.02
530599-3059981.69082.17
630393-3039381.14081.63
60min131582-3158284.31483.711.1084.9484.331.10
231472-3147284.02184.63
330753-3075382.10182.69
431611-3161184.39285.04
531570-3157084.28284.90
631142-3114283.14083.77
极限132540-3254086.87285.791.1987.6486.551.20
232242-3224286.07686.83
331461-3146183.99184.72
432405-3240586.51287.30
532181-3218185.91486.67
631975-3197585.36486.13
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%
111.342707272715982715932708162709642711400.16
211.392775072771492773280.10
单位质量响应值RSD%判断
23910.0524348.381.29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%
5min181191-8119130.25632.2013.5830.2632.2013.58
277717-7771728.96128.96
376958-7695828.67828.68
4105509-10550939.31839.32
580775-8077530.10130.10
696374-9637435.91435.91
10min1160538-16053859.82458.883.8359.8758.943.83
2158589-15858959.09859.15
3148982-14898255.51855.57
4166609-16660962.08762.15
5153788-15378857.30957.36
6159578-15957859.46759.53
15min1186946-18694669.66569.232.6569.8269.382.66
2185990-18599069.30969.46
3178939-17893966.68266.82
4193921-19392172.26572.43
5183243-18324368.28568.43
6185627-18562769.17469.33
20min1202214-20221475.35574.841.4875.6275.101.49
2201454-20145475.07275.33
3196078-19607873.06873.32
4205012-20501276.39876.69
5199696-19969674.41774.68
6200498-20049874.71574.99
30min1220662-22066282.23081.600.9282.6281.990.93
2219326-21932681.73282.12
3215366-21536680.25680.63
4220813-22081382.28682.70
5219403-21940381.76082.14
6218201-21820181.31381.71
45min1236009-23600987.94987.210.9588.4887.740.95
2235817-23581787.87788.40
3230765-23076585.99486.50
4235597-23559787.79588.35
5234007-23400787.20387.72
6232004-23200486.45686.99
60min1244736-24473691.20190.170.9891.8890.840.98
2244462-24446291.09991.77
3238695-23869588.95089.60
4242017-24201790.18890.89
5241749-24174990.08890.75
6240187-24018789.50690.18
极限1250298-25029893.27392.251.0194.1093.071.01
2250277-25027793.26694.09
3244512-24451291.11791.92
4247672-24767292.29593.15
5247541-24754192.24693.06
6244936-24493691.27592.10
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%
111.243753737390376353740137691375310.37
211.373781137844378280.07
单位质量响应值RSD%判断
3339.063327.000.26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%
5min13970-397010.68720.3838.0010.6920.3838.00
210123-1012327.25027.25
310507-1050728.28428.28
44151-415111.17411.17
58784-878423.64623.65
67879-787921.20921.21
10min115782-1578242.48349.4310.9542.5049.4610.97
220278-2027854.58654.63
320492-2049255.16255.21
416135-1613543.43443.45
518946-1894651.00051.04
618535-1853549.89449.93
15min121453-2145357.74962.214.7957.8462.334.81
224364-2436465.58565.72
324156-2415665.02565.16
422332-2233260.11560.21
522968-2296861.82761.95
623396-2339662.97963.10
20min124064-2406464.77868.773.5964.9668.993.61
226573-2657371.53171.78
326419-2641971.11771.36
425363-2536368.27468.47
525191-2519167.81168.04
625672-2567269.10669.33
30min127287-2728773.45375.872.7173.7576.202.72
229041-2904178.17578.54
328842-2884277.63978.01
428429-2842976.52876.83
527257-2725773.37373.71
628249-2824976.04376.38
45min129231-2923178.68681.272.6079.1081.732.61
230956-3095683.33083.83
330789-3078982.88083.38
430702-3070282.64683.08
529220-2922078.65779.12
630250-3025081.43081.89
60min130675-3067582.57483.822.5283.1284.422.52
231673-3167385.26085.89
331860-3186085.76386.40
431714-3171485.37085.94
529831-2983180.30280.90
631075-3107583.65084.25
极限131022-3102283.50885.572.5984.1986.312.59
232484-3248487.44388.22
332237-3223786.77887.55
432443-3244387.33388.05
530521-3052182.15982.89
632029-3202986.21886.96
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%
111.342733832733082735862732782734642734040.05
211.392761312758872760090.07
单位质量响应值RSD%判断
24109.7024232.570.36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%
5min136096-3609613.42724.2037.3513.4324.2037.35
286130-8613032.03832.04
389460-8946033.27733.28
434347-3434712.77612.78
575988-7598828.26628.27
668277-6827725.39725.40
10min1127624-12762447.47354.119.3247.5054.159.34
2158437-15843758.93558.99
3158019-15801958.77958.83
4130113-13011348.39948.42
5151441-15144156.33256.38
6147090-14709054.71454.76
15min1166383-16638361.89066.073.8261.9966.203.85
2185062-18506268.83868.99
3182577-18257767.91468.07
4173447-17344764.51864.62
5178232-17823266.29866.44
6179970-17997066.94467.08
20min1186239-18623969.27672.292.6569.4872.532.67
2200318-20031874.51374.78
3196592-19659273.12773.39
4192916-19291671.76071.97
5191677-19167771.29971.55
6198352-19835273.78274.03
30min1209281-20928177.84779.271.9278.1779.631.93
2218662-21866281.33781.73
3214208-21420879.68080.07
4214441-21444179.76780.10
5207409-20740977.15177.52
6214577-21457779.81780.19
45min1225695-22569583.95384.761.8084.4085.251.80
2232501-23250186.48587.01
3228869-22886985.13485.65
4230961-23096185.91286.37
5221002-22100282.20782.71
6228184-22818484.87985.38
60min1233733-23373386.94387.822.0187.5388.462.01
2241802-24180289.94490.61
3237105-23710588.19788.86
4239669-23966989.15189.76
5228312-22831284.92685.56
6235999-23599987.78688.43
极限1238447-23844788.69689.672.1889.4390.452.17
2246045-24604591.52392.34
3241916-24191689.98790.80
4245406-24540691.28592.04
5231939-23193986.27687.05
6242643-24264390.25791.05
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