非布司他片项目信息
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101278-202104对照品来源中检院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%
110.033929888392769239280573928093392484439277150.05
210.123988501398640439874520.04
单位质量响应值RSD%判断
391596.71394017.000.44数据可信
供试品溶液-20250401批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1488189-48818911.18614.6454.7311.1914.6454.74
2426583-4265839.7749.77
3978300-97830022.41522.42
4244370-2443705.5995.60
51152147-115214726.39826.40
6543565-54356512.45412.45
10min11184054-118405427.12934.0137.6127.1534.0437.62
21175847-117584726.94126.96
32123309-212330948.65048.69
4823520-82352018.86918.88
52205002-220500250.52250.57
61393991-139399131.93931.96
15min11338039-133803930.65740.2429.3730.7240.3229.40
21623311-162331137.19437.25
32461912-246191256.40856.53
41127765-112776525.84025.88
52250163-225016351.55651.68
61736078-173607839.77739.85
20min11405692-140569232.20841.5424.2332.3241.6924.27
21739132-173913239.84739.97
32458348-245834856.32656.54
41317945-131794530.19730.28
52174649-217464949.82650.04
61781830-178183040.82640.97
30min11408130-140813032.26340.6519.3932.4340.8619.44
21727205-172720539.57439.76
32344029-234402953.70754.01
41472721-147272133.74333.88
51966269-196626945.05245.35
61725868-172586839.54439.75
45min11405690-140569032.20839.0414.6632.4339.3214.74
21675437-167543738.38838.64
32129658-212965848.79549.19
41523626-152362634.91035.10
51793899-179389941.10241.47
61694312-169431238.82039.09
60min11392197-139219731.89837.4912.5632.1737.8412.66
21616792-161679237.04437.36
32001946-200194645.86946.35
41539016-153901635.26235.51
51695221-169522138.84139.28
61571196-157119636.00036.34
极限11393665-139366531.93236.6510.9332.2637.0611.05
21576536-157653636.12236.50
31915414-191541443.88644.44
41512583-151258334.65734.96
51635488-163548837.47337.98
61564150-156415035.83836.24
非布司他片项目信息
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101278-202104对照品来源中检院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%
110.033926644392158939328873930113392745739277380.11
210.123950922394765739492900.06
单位质量响应值RSD%判断
391599.00390246.050.25数据可信
供试品溶液-20250401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%
5min1722054-72205416.62416.5233.6316.6216.5233.62
2694543-69454315.99015.99
3492793-49279311.34511.35
41163833-116383326.79426.79
5515324-51532411.86411.86
6717248-71724816.51316.51
10min11538144-153814435.41238.5622.1135.4438.5822.12
21648202-164820237.94637.97
31400977-140097732.25432.27
42335456-233545653.76853.81
51308366-130836630.12230.14
61817803-181780341.85041.88
15min12357932-235793254.28656.5810.9354.3756.6710.95
22459545-245954556.62556.71
32299375-229937552.93753.01
42870618-287061866.08966.22
52111938-211193848.62248.69
62645519-264551960.90761.00
20min12856899-285689965.77366.545.9165.9566.725.94
22893060-289306066.60666.79
32787225-278722564.16964.33
43122342-312234271.88472.13
52646856-264685660.93761.09
63034519-303451969.86270.06
30min13305311-330531176.09775.991.6176.3876.291.66
23286977-328697775.67575.97
33265440-326544075.17975.45
43367263-336726377.52377.89
53226274-322627474.27774.53
63352536-335253677.18477.50
45min13588094-358809482.60782.480.4783.0282.900.49
23556106-355610681.87182.29
33573933-357393382.28182.67
43587177-358717782.58683.08
53584307-358430782.52082.90
63606122-360612283.02283.47
60min13744648-374464886.21185.920.4886.7686.480.46
23707281-370728185.35185.91
33727446-372744685.81586.35
43716537-371653785.56486.20
53749742-374974286.32986.84
63747187-374718786.27086.85
极限13866687-386668789.02188.710.5989.7289.420.55
23825621-382562188.07588.78
33856093-385609388.77789.45
43830674-383067488.19288.97
53885534-388553489.45590.11
63854329-385432988.73689.46
非布司他片项目信息
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101278-202104对照品来源中检院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%
110.033920477392410839260863926168392903839251750.09
210.123921495391916939203320.05
单位质量响应值RSD%判断
391343.47387384.580.72数据可信
供试品溶液-20250401批-pH1.0(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%
5min11171948-117194827.09019.1432.6727.0919.1432.67
2794516-79451618.36518.37
3477265-47726511.03211.03
41066388-106638824.65024.65
5575824-57582413.31013.31
6882433-88243320.39820.40
10min12309113-230911353.37646.5013.0753.4246.5313.08
21970066-197006645.53845.57
31655199-165519938.26038.28
42249577-224957751.99952.04
51766973-176697340.84440.87
62119275-211927548.98749.02
15min12693529-269352962.26159.525.4162.4059.635.44
22585158-258515859.75659.86
32339832-233983254.08654.17
42703088-270308862.48262.61
52490183-249018357.56157.65
62637199-263719960.95961.08
20min12921855-292185567.53965.932.8167.7866.142.84
22864518-286451866.21466.42
32724796-272479662.98463.16
42926083-292608367.63767.87
52788751-278875164.46364.65
62887664-288766466.74966.97
30min13186935-318693573.66773.240.8774.0273.560.91
23181161-318116173.53373.85
33132486-313248672.40872.69
43205307-320530774.09174.44
53144310-314431072.68172.98
63160969-316096973.06673.39
45min13418081-341808179.01079.220.4879.4879.660.47
23426430-342643079.20379.64
33435559-343555979.41479.81
43450692-345069279.76380.23
53430431-343043179.29579.71
63402884-340288478.65879.11
60min13561641-356164182.32882.700.5682.9383.280.54
23578703-357870382.72283.29
33599781-359978183.21083.74
43590818-359081883.00383.60
53589511-358951182.97283.52
63547116-354711681.99282.57
极限13695841-369584185.43086.020.7186.1786.740.68
23722134-372213486.03886.75
33752398-375239886.73787.41
43724831-372483186.10086.84
53746712-374671286.60687.29
63687063-368706385.22785.95
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