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%
110.153913879390693739096433914088391307939115250.08
210.193964779396865839667180.07
单位质量响应值RSD%判断
385371.92389275.560.72数据可信
供试品溶液-2024091311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%
5min1832304-83230419.34023.3720.8519.3423.3720.85
2912107-91210721.19521.19
31127573-112757326.20126.20
41306387-130638730.35630.36
5749733-74973317.42217.42
61106082-110608225.70225.70
10min12169992-216999250.42451.679.8450.4751.729.85
22157875-215787550.14250.19
32289406-228940653.19953.26
42620022-262002260.88160.95
51976076-197607645.91845.96
62127627-212762749.44049.50
15min12787791-278779164.78064.985.1064.9365.155.12
22748203-274820363.86064.02
32814231-281423165.39465.57
43064571-306457171.21171.41
52661670-266167061.84961.99
62702879-270287962.80762.97
20min13090136-309013671.80571.613.3072.1071.923.30
23075107-307510771.45671.76
32934297-293429768.18468.51
43244514-324451475.39375.75
53113457-311345772.34772.63
63033323-303332370.48570.79
30min13409910-340991079.23679.222.0379.6979.692.05
23362410-336241078.13278.59
33438268-343826879.89580.37
43525904-352590481.93182.46
53326394-332639477.29577.73
63393435-339343578.85379.32
45min13663232-366323285.12285.221.6985.7685.871.72
23616069-361606984.02684.66
33661393-366139385.08085.73
43771402-377140287.63688.35
53597791-359779183.60284.21
63695574-369557485.87486.51
60min13825486-382548688.89388.741.5189.7289.571.54
23771797-377179787.64588.46
33818493-381849388.73089.57
43920548-392054891.10292.01
53756306-375630687.28588.08
63820247-382024788.77189.60
极限13947239-394723991.72291.811.5192.7492.841.53
23895682-389568290.52491.54
33960237-396023792.02493.06
44043159-404315993.95195.06
53878977-387897790.13691.13
63979851-397985192.48093.51
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%
110.153933642394048439377133932453392830139345190.13
210.194012212400958440108980.05
单位质量响应值RSD%判断
387637.34393611.191.09数据可信
供试品溶液-2024091311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%
5min1774104-77410417.83621.9419.8217.8421.9419.82
21137103-113710326.20026.20
3675689-67568915.56915.57
4957091-95709122.05322.05
51067289-106728924.59224.59
61101823-110182325.38825.39
10min11917344-191734444.17848.458.9244.2248.508.92
22110230-211023048.62348.68
31850235-185023542.63242.67
42179090-217909050.20950.26
52346019-234601954.05654.11
62213743-221374351.00851.06
15min12606026-260602660.04661.893.5860.1862.053.60
22669357-266935761.50661.67
32574120-257412059.31159.44
42684146-268414661.84662.01
52839509-283950965.42665.60
62744003-274400363.22663.40
20min12987379-298737968.83369.261.8469.1069.561.86
23008841-300884169.32869.63
32919803-291980367.27667.54
42993899-299389968.98469.28
53081519-308151971.00271.32
63044675-304467570.15470.46
30min13330645-333064576.74376.921.1577.1777.371.17
23369576-336957677.64078.10
33268971-326897175.32275.73
43331858-333185876.77177.22
53367933-336793377.60278.08
63360699-336069977.43577.90
45min13611550-361155083.21583.040.9783.8183.660.99
23646287-364628784.01684.65
33541564-354156481.60382.18
43595356-359535682.84283.46
53614603-361460383.28583.94
63615515-361551583.30683.94
60min13774486-377448686.96986.740.7787.7587.540.79
23798488-379848887.52288.34
33713449-371344985.56386.32
43754349-375434986.50587.31
53772455-377245586.92387.76
63774246-377424686.96487.79
极限13911536-391153690.12790.140.7591.1091.140.76
23958796-395879691.21692.23
33872009-387200989.21690.17
43897223-389722389.79790.80
53907903-390790390.04491.07
63925338-392533890.44591.46
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%
110.153953403395452239586153952383395216639542180.07
210.194027299402524240262700.04
单位质量响应值RSD%判断
389578.13395119.731.00数据可信
供试品溶液-2024091312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%
5min1987067-98706722.64320.6314.7222.6420.6314.73
21046929-104692924.01624.02
3904107-90410720.74020.74
4778746-77874617.86417.86
5704879-70487916.17016.17
6975329-97532922.37422.37
10min12050075-205007547.02946.824.0847.0846.864.09
22179484-217948449.99750.05
31986441-198644145.56945.61
41972201-197220145.24245.28
51968246-196824645.15145.19
62089120-208912047.92447.97
15min12611351-261135159.90461.411.8060.0661.561.79
22747490-274749063.02763.19
32636635-263663560.48460.63
42699192-269919261.91962.06
52684124-268412461.57461.71
62683470-268347061.55961.71
20min12947286-294728667.61068.731.2067.9069.021.19
23032478-303247869.56569.87
32965865-296586568.03768.32
43018126-301812669.23669.51
53029288-302928869.49269.76
62983930-298393068.45168.74
30min13320652-332065276.17576.450.6876.6176.890.69
23361091-336109177.10377.56
33306073-330607375.84176.27
43335624-333562476.51976.95
53357119-335711977.01277.44
63315585-331558576.05976.50
45min13598228-359822882.54382.880.6383.1583.490.62
23627289-362728983.21083.84
33593810-359381082.44283.04
43621403-362140383.07583.68
53646750-364675083.65684.25
63589444-358944482.34282.96
60min13763795-376379586.34186.700.5087.1387.490.51
23801751-380175187.21288.03
33752928-375292886.09286.88
43777863-377786386.66487.45
53797544-379754487.11587.90
63781939-378193986.75787.55
极限13893945-389394589.32789.610.6890.3190.590.67
23907065-390706589.62890.64
33878562-387856288.97489.95
43920872-392087289.94490.92
53950139-395013990.61691.59
63886375-388637589.15390.14
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%
110.153984948398765439868283985699399251339875280.08
210.193938998393693439379660.04
单位质量响应值RSD%判断
392859.90386453.971.17数据可信
供试品溶液-2024091312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%
5min1832705-83270519.23420.0113.9119.2320.0113.92
21033728-103372823.87823.88
3731795-73179516.90416.90
4740143-74014317.09617.10
5902943-90294320.85720.86
6956160-95616022.08622.09
10min11821905-182190542.08445.219.9842.1345.269.99
22263410-226341052.28252.34
31848364-184836442.69542.73
41770518-177051840.89740.93
51910162-191016244.12244.17
62129402-212940249.18749.24
15min12565886-256588659.26959.964.9459.4160.114.95
22756619-275661963.67563.84
32551367-255136758.93459.07
42427856-242785656.08156.21
52532588-253258858.50058.64
62740736-274073663.30863.47
20min12883030-288303066.59567.872.3566.8668.152.37
23009541-300954169.51769.83
32908468-290846867.18267.45
42873316-287331666.37066.62
52917622-291762267.39467.67
63038449-303844970.18570.48
30min13269901-326990175.53176.131.0375.9576.561.05
23330873-333087376.93977.40
33275912-327591275.67076.08
43273858-327385875.62276.02
53278216-327821675.72376.15
63346487-334648777.30077.75
45min13494383-349438380.71681.792.2681.3082.382.26
23591092-359109282.95083.59
33399186-339918678.51779.10
43578605-357860582.66183.23
53571826-357182682.50583.10
63609160-360916083.36783.99
60min13662833-366283384.60785.481.0785.3786.261.06
23749054-374905486.59987.42
33713544-371354485.77886.53
43719244-371924485.91086.66
53715426-371542685.82286.60
63643126-364312684.15284.96
极限13846302-384630288.84589.190.6789.8090.160.69
23878737-387873789.59490.61
33843180-384318088.77389.72
43853138-385313889.00389.95
53840500-384050088.71189.68
63904950-390495090.20091.20
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