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101278-202003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%
19.753770044376502837605103756300375508737613940.17
29.793793279378307737881780.20
单位质量响应值RSD%判断
385784.00386943.620.22数据可信
供试品溶液-4226A批-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%
5min11125012-112501226.20623.7529.3726.2123.7529.37
21209658-120965828.17828.18
31279467-127946729.80429.80
41214845-121484528.29928.30
5562444-56244413.10213.10
6725721-72572116.90516.91
10min12223558-222355851.79649.4411.1251.8549.5011.13
22277922-227792253.06253.12
32353501-235350154.82354.89
42232059-223205951.99452.06
51811183-181118342.19042.22
61837154-183715442.79542.83
15min12637606-263760661.44160.894.6061.6161.054.63
22660318-266031861.97062.15
32718196-271819663.31863.51
42726523-272652363.51263.69
52422591-242259156.43256.56
62517546-251754658.64458.78
20min12867654-286765466.80066.392.8367.1166.692.85
22769015-276901564.50264.82
32910091-291009167.78868.12
42968030-296803069.13869.46
52766697-276669764.44864.70
62818569-281856965.65665.92
30min13069441-306944171.50073.011.8671.9673.451.86
23088719-308871971.94972.41
33169176-316917673.82374.30
43211294-321129474.80475.28
53091167-309116772.00672.40
63175283-317528373.96674.37
45min13361761-336176178.30978.531.4178.9379.131.42
23348502-334850278.00178.62
33375182-337518278.62279.27
43409579-340957979.42380.06
53298365-329836576.83377.38
63432797-343279779.96480.54
60min13409356-340935679.41880.510.8180.2181.300.81
23490776-349077681.31582.11
33456037-345603780.50581.32
43469993-346999380.83181.65
53444643-344464380.24080.96
63467307-346730780.76881.52
极限13500329-350032981.53782.790.9082.5083.740.90
23532076-353207682.27783.25
33581495-358149583.42884.42
43581402-358140283.42684.42
53566590-356659083.08183.98
63561717-356171782.96783.90
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101278-202003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%
19.753781645378031837790273774561376718937765480.16
29.793817837381880638183220.02
单位质量响应值RSD%判断
387338.26390022.680.49数据可信
供试品溶液-4226A批-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%
5min1983772-98377222.78025.1115.6422.7825.1015.64
21292239-129223929.92229.92
3853881-85388119.77219.77
41224461-122446128.35328.35
5982146-98214622.74222.74
61169194-116919427.07327.07
10min11941460-194146044.95649.256.7445.0149.306.74
22207801-220780151.12351.19
32038125-203812547.19447.24
42257854-225785452.28252.34
52026065-202606546.91546.97
62289297-228929753.01053.07
15min12509969-250996958.12060.482.5558.2760.642.57
22662111-266211161.64361.82
32571403-257140359.54259.69
42676321-267632161.97262.15
52586763-258676359.89860.05
62664472-266447261.69761.88
20min12813075-281307565.13866.271.2965.4266.571.31
22901051-290105167.17567.49
32849341-284934165.97866.26
42896498-289649867.07067.39
52829152-282915265.51165.80
62881772-288177266.72967.04
30min13130251-313025172.48372.270.5972.9172.720.57
23103372-310337271.86072.33
33131654-313165472.51572.94
43126377-312637772.39372.86
53141258-314125872.73873.17
63094151-309415171.64772.11
45min13331740-333174077.14877.190.2277.7377.790.22
23334398-333439877.21077.84
33344044-334404477.43378.02
43329254-332925477.09177.72
53323117-332311776.94977.54
63337502-333750277.28277.90
60min13456833-345683380.04579.450.7780.8080.230.74
23392149-339214978.54779.34
33461803-346180380.16080.92
43425277-342527779.31480.11
53436164-343616479.56680.33
63415120-341512079.07979.87
极限13533210-353321081.81381.680.5482.7582.640.52
23496445-349644580.96281.93
33552873-355287382.26983.21
43519686-351968681.50082.47
53536751-353675181.89582.84
63526761-352676181.66482.63
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101278-202003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%
19.753811621381252238110353808090380406038094660.10
29.793801677380095838013180.02
单位质量响应值RSD%判断
390714.46388285.800.45数据可信
供试品溶液-4226B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%
5min117743-177430.4100.4814.030.410.4813.61
223851-238510.5510.55
317101-171010.3950.40
423492-234920.5430.54
522604-226040.5220.52
620499-204990.4740.47
10min134279-342790.7920.806.350.790.806.48
234606-346060.8000.80
331306-313060.7230.72
436469-364690.8430.84
537525-375250.8670.87
633567-335670.7760.78
15min137593-375930.8690.882.330.870.882.36
238340-383400.8860.89
337946-379460.8770.88
438901-389010.8990.90
538116-381160.8810.88
636304-363040.8390.84
20min138408-384080.8870.893.720.890.893.65
236234-362340.8370.84
340074-400740.9260.93
439357-393570.9090.91
539325-393250.9090.91
637431-374310.8650.87
30min138770-387700.8960.902.150.900.902.07
238088-380880.8800.89
338818-388180.8970.90
440057-400570.9260.93
539353-393530.9090.92
637766-377660.8730.88
45min138552-385520.8910.912.530.900.922.46
238516-385160.8900.90
340892-408920.9450.95
440080-400800.9260.94
538702-387020.8940.90
638823-388230.8970.91
60min139070-390700.9030.901.330.910.911.51
238761-387610.8960.91
338841-388410.8970.91
439092-390920.9030.91
539187-391870.9050.92
637766-377660.8730.88
极限136855-368550.8520.904.050.860.914.20
239777-397770.9190.93
341270-412700.9540.97
439682-396820.9170.93
537985-379850.8780.89
638233-382330.8830.90
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101278-202003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%
19.753758244376033637594163761271376088237600300.04
29.793706109370583237059700.01
单位质量响应值RSD%判断
385644.10378546.481.32数据可信
供试品溶液-4226B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%
5min119040-190400.4490.486.270.450.486.23
219815-198150.4670.47
320238-202380.4770.48
422845-228450.5380.54
520204-202040.4760.48
620190-201900.4760.48
10min132460-324600.7650.783.830.770.783.57
232571-325710.7670.77
332024-320240.7540.76
435378-353780.8330.83
532404-324040.7630.76
633821-338210.7970.80
15min137149-371490.8750.852.690.880.862.66
237056-370560.8730.88
334509-345090.8130.82
436346-363460.8560.86
536636-366360.8630.87
635897-358970.8460.85
20min136014-360140.8480.872.100.850.882.13
238063-380630.8970.90
337035-370350.8720.88
436314-363140.8550.86
537571-375710.8850.89
637123-371230.8740.88
30min137753-377530.8890.892.850.900.902.54
238004-380040.8950.90
336521-365210.8600.87
438949-389490.9170.92
539363-393630.9270.93
637075-370750.8730.88
45min136933-369330.8700.881.190.880.891.11
237763-377630.8900.90
337357-373570.8800.89
436900-369000.8690.88
537837-378370.8910.90
636895-368950.8690.88
60min137430-374300.8820.883.380.890.893.36
238521-385210.9070.92
337515-375150.8840.89
435446-354460.8350.85
538939-389390.9170.93
636644-366440.8630.87
极限136895-368950.8690.883.530.880.893.77
239194-391940.9230.94
337931-379310.8940.91
435689-356890.8410.85
537646-376460.8870.90
635944-359440.8470.86
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