非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院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500
标示量(mg)20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%
110.652088217208760820886252087564208847320880970.03
210.282176625217566621761460.04
单位质量响应值RSD%判断
196065.45211687.355.42数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250601批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17996-79960.3530.4620.020.350.4619.91
28854-88540.3910.39
311576-115760.5110.51
412110-121100.5350.53
513015-130150.5750.57
68865-88650.3920.39
10min128833-288331.2731.3410.701.271.3510.88
226716-267161.1801.18
329388-293881.2981.30
430148-301481.3311.33
531346-313461.3841.39
636327-363271.6041.61
15min135065-350651.5491.624.611.551.624.67
235302-353021.5591.56
337756-377561.6671.67
439297-392971.7361.74
537301-373011.6471.65
635500-355001.5681.57
20min139352-393521.7381.773.741.751.783.69
239091-390911.7261.73
341543-415431.8351.84
441856-418561.8491.86
540124-401241.7721.78
637983-379831.6781.69
30min141460-414601.8311.866.431.841.876.40
240723-407231.7991.81
342079-420791.8581.87
441969-419691.8541.87
547317-473172.0902.10
639412-394121.7411.75
45min141966-419661.8531.860.751.871.870.63
241694-416941.8411.86
342313-423131.8691.88
442510-425101.8771.89
541802-418021.8461.86
641954-419541.8531.87
60min141979-419791.8541.862.711.871.882.72
242186-421861.8631.88
342587-425871.8811.90
443921-439211.9401.96
540965-409651.8091.83
640851-408511.8041.82
极限143079-430791.9031.832.941.931.852.97
242530-425301.8781.90
341306-413061.8241.85
441213-412131.8201.84
540064-400641.7691.79
640216-402161.7761.80
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院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500
标示量(mg)20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%
110.652128052212784421260842125733212544921266320.06
210.282086345208470420855240.06
单位质量响应值RSD%判断
199683.76202871.981.13数据可信
供试品溶液-250601批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110031-100310.4480.5255.100.450.5255.21
223705-237051.0591.06
37835-78350.3500.35
413303-133030.5940.59
56891-68910.3080.31
67696-76960.3440.34
10min128143-281431.2571.237.921.261.237.96
226046-260461.1641.17
327042-270421.2081.21
431724-317241.4171.42
526252-262521.1731.17
626176-261761.1691.17
15min136286-362861.6211.635.181.621.635.28
236573-365731.6341.64
334944-349441.5611.56
440168-401681.7941.80
535473-354731.5851.59
635536-355361.5871.59
20min140033-400331.7881.813.261.801.823.17
239131-391311.7481.76
340320-403201.8011.81
443054-430541.9231.93
540546-405461.8111.82
640228-402281.7971.80
30min139773-397731.7771.832.531.791.842.47
239661-396611.7721.78
341919-419191.8731.88
442109-421091.8811.89
541093-410931.8361.85
640880-408801.8261.84
45min142626-426261.9041.902.571.921.912.42
240309-403091.8011.82
343363-433631.9371.95
442566-425661.9021.92
542959-429591.9191.93
642938-429381.9181.93
60min143761-437611.9551.912.531.971.932.36
241108-411081.8361.86
343967-439671.9641.98
442085-420851.8801.90
543197-431971.9301.95
642976-429761.9201.94
极限143061-430611.9241.863.081.951.883.08
239290-392901.7551.78
341656-416561.8611.88
442314-423141.8901.92
542074-420741.8801.90
641647-416471.8601.88
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院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500
标示量(mg)20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%
110.652130724213082721306152131614213069421308950.02
210.282069008206896420689860.01
单位质量响应值RSD%判断
200084.04201263.230.42数据可信
供试品溶液-250603批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1339455-33945515.20913.6933.7015.2113.6833.72
2294479-29447913.19413.19
3178835-1788358.0138.01
4468291-46829120.98220.98
5336720-33672015.08715.09
6215037-2150379.6359.63
10min1882088-88208839.52137.6718.7039.5637.7018.71
2765140-76514034.28234.31
3689761-68976130.90430.92
41125360-112536050.42150.47
5730427-73042732.72632.76
6852407-85240738.19238.21
15min11307949-130794958.60257.498.5758.7257.618.59
21223588-122358854.82254.93
31196155-119615553.59353.68
41480046-148004666.31366.47
51186141-118614153.14453.25
61305477-130547758.49158.60
20min11539576-153957668.98067.745.1469.2367.985.17
21467641-146764165.75765.98
31461960-146196065.50265.71
41651117-165111773.97774.28
51437537-143753764.40864.63
61513802-151380267.82568.06
30min11750263-175026378.42077.632.7678.8278.022.79
21691819-169181975.80176.17
31730603-173060377.53977.89
41818149-181814981.46181.93
51691049-169104975.76776.13
61713696-171369676.78177.17
45min11901688-190168885.20484.222.3185.7884.792.34
21840963-184096382.48383.03
31893307-189330784.82985.35
41950177-195017787.37788.03
51842311-184231182.54483.08
61850466-185046682.90983.47
60min11978950-197895088.66687.581.9989.4388.322.01
21919655-191965586.00986.73
31970624-197062488.29389.00
42012272-201227290.15991.00
51931065-193106586.52087.24
61915176-191517685.80886.55
极限12033983-203398391.13290.111.5792.1091.061.60
21977115-197711588.58489.50
32018804-201880490.45191.36
42056611-205661192.14593.19
52001777-200177789.68990.60
61978612-197861288.65189.58
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