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%
110.153898822389772839017333897934389776138987960.05
210.193932901393522639340640.05
单位质量响应值RSD%判断
384117.83386071.050.36数据可信
供试品溶液-2024091311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%
5min11511421-151142135.32331.4515.8735.3231.4615.86
21544640-154464036.10036.10
31524804-152480435.63635.64
41250079-125007929.21629.22
51023351-102335123.91723.92
61220621-122062128.52728.53
10min12748617-274861764.23860.909.2264.3260.979.22
22838224-283822466.33266.41
32775431-277543164.86564.94
42466172-246617257.63757.70
52198980-219898051.39251.45
62606865-260686560.92560.99
15min13172881-317288174.15472.086.2274.3772.286.24
23303151-330315177.19877.43
33222235-322223575.30775.53
42972774-297277469.47769.67
52774171-277417164.83565.00
63060029-306002971.51671.71
20min13396839-339683979.38877.744.8679.7778.114.88
23513309-351330982.11082.51
33442196-344219680.44880.84
43259784-325978476.18576.53
53059643-305964371.50771.82
63287353-328735376.82977.19
30min13670151-367015185.77584.433.6586.3484.973.68
23774616-377461688.21788.80
33701397-370139786.50687.07
43566314-356631483.34883.87
53400915-340091579.48379.95
63562529-356252983.26083.79
45min13878291-387829190.64089.613.0291.3990.333.05
23981743-398174393.05793.84
33910005-391000591.38192.14
43791551-379155188.61289.31
53649989-364998985.30485.95
63793591-379359188.66089.37
60min13996293-399629393.39892.592.7394.3593.512.76
24104772-410477295.93396.92
34031649-403164994.22495.19
43901366-390136691.17992.08
53795182-379518288.69789.53
63940701-394070192.09893.01
极限14094285-409428595.68895.362.1096.8596.492.14
24206702-420670298.31599.51
34132236-413223696.57597.75
44032174-403217494.23695.34
53957593-395759392.49393.53
64058923-405892394.86195.98
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%
110.153939111394223239425683943748394467539424670.06
210.193920927392436539226460.07
单位质量响应值RSD%判断
388420.39384950.540.64数据可信
供试品溶液-2024091311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%
5min1868608-86860820.21726.3321.9920.2226.3421.98
2976255-97625522.72322.72
3878047-87804720.43720.44
41386598-138659832.27332.27
51349187-134918731.40331.40
61330007-133000730.95630.96
10min12147402-214740249.98155.299.3050.0355.359.31
22278928-227892853.04353.09
32121416-212141649.37649.42
42524491-252449158.75858.83
52551545-255154559.38859.46
62629605-262960561.20561.27
15min12824586-282458665.74368.574.4765.9068.754.49
22885042-288504267.15067.32
32798910-279891065.14565.30
43001609-300160969.86370.07
53029541-302954170.51370.71
63137139-313713973.01873.22
20min13193119-319311974.32075.483.0974.6275.813.11
23181126-318112674.04174.36
33144118-314411873.18073.48
43219486-321948674.93475.29
53304610-330461076.91577.27
63415348-341534879.49379.86
30min13549984-354998482.62782.712.5183.0983.212.53
23501432-350143281.49781.98
33485490-348549081.12581.59
43470458-347045880.77681.30
53611343-361134384.05584.58
63702431-370243186.17586.72
45min13797180-379718088.38088.062.5589.0388.752.56
23702832-370283286.18486.85
33739490-373949087.03787.68
43678423-367842385.61686.32
53852116-385211689.65990.37
63931696-393169691.51192.25
60min13954279-395427992.03791.242.2192.8892.122.21
23873638-387363890.16091.01
33903775-390377590.86191.70
43785423-378542388.10689.00
53966633-396663392.32493.24
64036046-403604693.94094.88
极限14021018-402101893.59093.122.6594.6494.202.66
23967500-396750092.34493.40
33870379-387037990.08491.12
43910556-391055691.01992.11
54086918-408691895.12496.24
64148773-414877396.56497.71
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%
110.153964709396822639683373967992396606539670660.05
210.193966103396834539672240.04
单位质量响应值RSD%判断
390843.94389325.220.28数据可信
供试品溶液-2024091312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%
5min11128973-112897326.04825.628.5026.0525.628.50
21038748-103874823.96623.97
31043846-104384624.08424.08
41052899-105289924.29224.29
51111329-111132925.64125.64
61287155-128715529.69729.70
10min12195686-219568650.65952.445.1150.7252.505.11
22129821-212982149.13949.19
32209957-220995750.98851.04
42289113-228911352.81452.87
52428041-242804156.02056.08
62385489-238548955.03855.10
15min12785356-278535664.26466.101.9464.4366.271.94
22818045-281804565.01865.18
32852015-285201565.80265.97
42918274-291827467.33067.50
52913361-291336167.21767.40
62902806-290280666.97467.16
20min13102310-310231071.57773.061.0571.8973.381.05
23182832-318283273.43473.74
33161495-316149572.94273.26
43189845-318984573.59673.92
53177758-317775873.31773.65
63185109-318510973.48773.82
30min13423853-342385378.99580.361.0079.4780.840.99
23523178-352317881.28781.76
33507220-350722080.91981.39
43491961-349196180.56781.05
53467370-346737079.99980.49
63483692-348369280.37680.88
45min13697433-369743385.30786.771.1385.9687.441.11
23822065-382206588.18388.83
33774984-377498487.09687.75
43777216-377721687.14887.81
53735182-373518286.17886.85
63759132-375913286.73187.41
60min13817395-381739588.07589.551.1488.9190.411.13
23945946-394594691.04191.89
33904835-390483590.09290.94
43894580-389458089.85690.71
53856854-385685488.98589.85
63868916-386891689.26490.14
极限13924980-392498090.55792.141.1791.5993.201.16
24054431-405443193.54494.59
34024201-402420192.84693.90
44012229-401222992.57093.63
53960603-396060391.37992.44
63985915-398591591.96393.03
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%
110.153942073394475339441443942619394400639435190.03
210.193947861394888739483740.02
单位质量响应值RSD%判断
388524.04387475.370.20数据可信
供试品溶液-2024091312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%
5min11231265-123126528.56024.0914.1328.5624.0914.13
21065716-106571624.72024.72
3861628-86162819.98619.99
4877075-87707520.34520.34
51149137-114913726.65526.66
61046248-104624824.26924.27
10min12309481-230948153.57149.937.6853.6349.987.68
21981926-198192645.97346.03
32045782-204578247.45447.50
42001079-200107946.41746.46
52364616-236461654.84954.91
62211503-221150351.29851.35
15min12794599-279459964.82363.403.9965.0163.564.00
22564776-256477659.49259.65
32722174-272217463.14363.29
42655737-265573761.60261.75
52862382-286238266.39666.58
62799098-279909864.92865.10
20min13130248-313024872.60971.222.4572.9471.522.46
22929154-292915467.94468.23
33068589-306858971.17971.47
43058454-305845470.94471.23
53122701-312270172.43472.76
63112709-311270972.20272.51
30min13463853-346385380.34779.461.2580.8479.931.26
23343974-334397477.56778.01
33426407-342640779.47979.93
43452765-345276580.09080.53
53426992-342699279.49279.98
63440580-344058079.80780.28
45min13679765-367976585.35685.240.9986.0285.880.99
23610411-361041183.74784.36
33677604-367760485.30585.93
43722391-372239186.34486.97
53676567-367656785.28185.95
63681388-368138885.39386.04
60min13813452-381345288.45788.421.1289.3189.251.12
23735994-373599486.66087.46
33812078-381207888.42589.24
43866730-386673089.69290.51
53825699-382569988.74189.60
63817702-381770288.55589.39
极限13922495-392249590.98691.101.1492.0492.121.14
23850328-385032889.31290.30
33925293-392529391.05192.06
43985336-398533692.44493.46
53950303-395030391.63192.68
63930203-393020391.16592.20
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