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%
110.153858537385895438576763851676385297238559630.09
210.193871442387379538726180.05
单位质量响应值RSD%判断
379897.83380041.020.03数据可信
供试品溶液-2024091313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%
5min1862373-86237320.42622.8910.7020.4322.8910.70
2985214-98521423.33623.34
3954142-95414222.60022.60
4874992-87499220.72520.73
51149907-114990727.23727.24
6971004-97100422.99923.00
10min12133877-213387750.54352.505.2950.5952.555.30
22181562-218156251.67351.72
32181862-218186251.68051.73
42107062-210706249.90849.95
52428694-242869457.52657.59
62265722-226572253.66653.72
15min12810424-281042466.56866.772.9766.7366.942.97
22714848-271484864.30464.47
32783338-278333865.92666.09
42781969-278196965.89466.05
52956992-295699270.04070.23
62866331-286633167.89268.06
20min13176858-317685875.24774.252.0575.5574.562.05
23034609-303460971.87872.19
33093507-309350773.27373.58
43124940-312494074.01874.32
53212528-321252876.09276.44
63164863-316486374.96375.28
30min13525191-352519183.49881.981.4783.9782.461.47
23386516-338651680.21380.68
33418558-341855880.97281.45
43463451-346345182.03682.50
53485608-348560882.56183.07
63488422-348842282.62783.11
45min13775515-377551589.42787.771.1590.0988.431.14
23658878-365887886.66587.31
33670628-367062886.94387.60
43720163-372016388.11688.77
53717884-371788488.06288.76
63689134-368913487.38188.05
60min13932065-393206593.13590.982.3793.9991.842.36
23666976-366697686.85687.70
33840530-384053090.96791.81
43881988-388198891.94992.80
53872126-387212691.71692.61
63852482-385248291.25092.12
极限14015741-401574195.11790.835.1496.1891.885.10
23560337-356033784.33185.36
33627561-362756185.92386.97
43844116-384411691.05292.10
53996634-399663494.66595.76
63963067-396306793.87094.94
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%
110.153891126388992338873233885407388613338879820.07
210.193932533393097439317540.03
单位质量响应值RSD%判断
383052.41385844.360.52数据可信
供试品溶液-2024091313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%
5min11126094-112609426.36224.458.4026.3624.448.40
2911864-91186421.34721.35
31100508-110050825.76325.76
4997871-99787123.36123.36
51128255-112825526.41326.41
61000997-100099723.43423.43
10min12195983-219598351.40951.273.7651.4751.333.76
22136639-213663950.02050.07
32305608-230560853.97554.03
42147315-214731550.27050.32
52089619-208961948.91948.98
62265500-226550053.03653.09
15min12690003-269000362.97464.372.4963.1564.542.49
22718034-271803463.63063.79
32864541-286454167.06067.24
42772095-277209564.89665.06
52681801-268180162.78262.95
62770863-277086364.86765.04
20min13021567-302156770.73671.491.9471.0571.801.94
23046592-304659271.32271.62
33154922-315492273.85874.18
43022114-302211470.74971.06
52990811-299081170.01670.32
63086983-308698372.26872.58
30min13407427-340742779.76980.430.7980.2480.900.79
23435333-343533380.42380.88
33477246-347724681.40481.89
43448906-344890680.74181.21
53405923-340592379.73480.20
63440095-344009580.53481.01
45min13631684-363168485.01985.620.4285.6786.260.42
23660201-366020185.68786.32
33669605-366960585.90786.58
43674186-367418686.01486.66
53649688-364968885.44186.08
63657413-365741385.62286.28
60min13816182-381618289.33989.760.3790.1790.600.37
23845533-384553390.02690.85
33846661-384666190.05290.91
43846112-384611290.03990.87
53830962-383096289.68590.51
63819628-381962889.41990.26
极限13900236-390023691.30691.870.3892.3492.910.37
23944552-394455292.34493.37
33925493-392549391.89892.96
43932255-393225592.05693.09
53923766-392376691.85792.89
63919825-391982591.76592.81
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%
110.151958332195925219547131949914195156719547560.21
210.191973847197418519740160.02
单位质量响应值RSD%判断
192586.80193720.900.42数据可信
供试品溶液-2024092211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%
5min1688086-68808632.06229.6421.1432.0629.6421.13
2749870-74987034.94034.94
3593106-59310627.63627.64
4776904-77690436.20036.20
5408734-40873419.04519.05
6599425-59942527.93027.93
10min11365937-136593763.64660.387.5763.7260.457.59
21378187-137818764.21764.29
31188472-118847255.37755.44
41397481-139748165.11665.20
51179100-117910054.94154.98
61265893-126589358.98559.05
15min11600624-160062474.58272.683.4274.7972.883.44
21593626-159362674.25674.48
31473558-147355868.66168.85
41611370-161137075.08275.31
51523995-152399571.01171.18
61556187-155618772.51172.70
20min11714253-171425379.87679.001.7480.2579.361.76
21707535-170753579.56379.95
31643120-164312076.56276.90
41726042-172604280.42680.82
51683118-168311878.42678.75
61699029-169902979.16779.52
30min11843086-184308685.87985.410.8786.4485.940.89
21832377-183237785.38085.94
31804065-180406584.06184.57
41850605-185060586.23086.80
51835242-183524285.51486.01
61832312-183231285.37785.91
45min11917595-191759589.35189.400.9790.1090.130.95
21905372-190537288.78289.53
31897090-189709088.39689.09
41917802-191780289.36190.12
51951063-195106390.91191.60
61922916-192291689.59990.32
60min11972520-197252091.91091.530.4892.8692.460.50
21960847-196084791.36692.32
31952194-195219490.96391.85
41977904-197790492.16193.12
51961839-196183991.41392.30
61960887-196088791.36892.29
极限12005862-200586293.46493.720.6694.6194.860.64
22005623-200562393.45394.61
31996279-199627993.01794.11
42012015-201201593.75194.92
52035086-203508694.82695.92
62013801-201380193.83494.96
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%
110.152018252202000020213202018938201916920195360.06
210.191987735198732619875300.02
单位质量响应值RSD%判断
198969.06195047.111.41数据可信
供试品溶液-2024092211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%
5min1714409-71440932.64032.176.6932.6432.176.70
2655203-65520329.93529.93
3694167-69416731.71531.72
4680555-68055531.09331.09
5791884-79188436.18036.18
6688824-68882431.47131.47
10min11331042-133104260.81360.242.2660.8960.322.26
21313487-131348760.01160.08
31282273-128227358.58458.65
41298199-129819959.31259.38
51368485-136848562.52362.60
61318147-131814760.22360.29
15min11547669-154766970.71071.530.8470.9271.740.83
21583510-158351072.34772.55
31575118-157511871.96472.16
41556932-155693271.13371.33
51570096-157009671.73471.95
61560799-156079971.31071.51
20min11640293-164029374.94276.131.2875.3176.491.27
21695942-169594277.48477.84
31686933-168693377.07277.43
41665552-166555276.09676.45
51654163-165416375.57575.95
61654340-165434075.58375.95
30min11777806-177780681.22482.621.2681.7683.161.25
21840196-184019684.07584.61
31826291-182629183.43983.97
41813036-181303682.83483.36
51793357-179335781.93582.48
61799733-179973382.22682.76
45min11863701-186370185.14986.781.3985.8687.501.37
21942540-194254088.75189.47
31908898-190889887.21487.93
41901040-190104086.85587.57
51885780-188578086.15786.89
61894750-189475086.56787.28
60min11906877-190687787.12188.911.2688.0289.821.25
21979578-197957890.44391.36
31950108-195010889.09690.01
41950344-195034489.10790.01
51932474-193247488.29189.21
61956937-195693789.40890.31
极限11946290-194629088.92290.581.2490.0291.691.24
22018430-201843092.21893.34
31985511-198551190.71491.82
41998267-199826791.29792.40
51974222-197422290.19891.31
61973188-197318890.15191.25
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