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%
110.153907079389707638960473894611389845338986530.13
210.193964404396417139642880.01
单位质量响应值RSD%判断
384103.74389037.100.91数据可信
供试品溶液-2024091311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%
5min1389674-3896749.07316.0537.549.0716.0537.54
2786886-78688618.32118.32
3330235-3302357.6897.69
4845413-84541319.68319.68
5899698-89969820.94720.95
6883997-88399720.58220.58
10min11436757-143675733.45143.3222.0833.4743.3522.09
21977688-197768846.04646.09
31251756-125175629.14429.16
42165999-216599950.43050.47
52157399-215739950.23050.28
62172996-217299650.59350.64
15min12311446-231144653.81662.5415.7253.9162.6715.74
22858580-285858066.55566.70
32007350-200735046.73646.82
43010755-301075570.09870.25
52971430-297143069.18369.34
62957024-295702468.84769.01
20min12967668-296766869.09572.807.9569.3173.078.00
23261830-326183075.94476.23
32688493-268849362.59562.78
43283701-328370176.45376.76
53307492-330749277.00777.32
63252003-325200375.71576.03
30min13515817-351581781.85781.801.9082.2382.231.96
23553442-355344282.73383.19
33390774-339077478.94679.27
43541322-354132282.45182.93
53580580-358058083.36583.85
63498312-349831281.45081.93
45min13775255-377525587.89886.941.0988.4587.551.09
23747708-374770887.25687.90
33695566-369556686.04286.54
43738408-373840887.04087.70
53770823-377082387.79588.46
63675802-367580285.58286.24
60min13900791-390079190.82189.521.2091.5790.331.18
23855645-385564589.76990.61
33824674-382467489.04889.74
43832895-383289589.24090.10
53883892-388389290.42791.29
63772593-377259387.83688.69
极限13995880-399588093.03491.511.2393.9892.521.19
23928176-392817691.45892.50
33923576-392357691.35192.24
43919831-391983191.26492.32
53963403-396340392.27893.34
63852853-385285389.70490.75
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%
110.153918615391870639155643910096391233439150630.10
210.193962068395642139592440.11
单位质量响应值RSD%判断
385720.49388542.100.52数据可信
供试品溶液-2024091311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%
5min1799733-79973318.59217.6333.0018.5917.6333.00
2260312-2603126.0526.05
3952816-95281622.15122.15
4860636-86063620.00820.01
5871024-87102420.25020.25
6805097-80509718.71718.72
10min11990015-199001546.26446.5922.6546.3146.6322.66
21104548-110454825.67925.69
32319945-231994553.93553.98
42212832-221283251.44451.49
52223505-222350551.69351.74
62174229-217422950.54750.59
15min12854507-285450766.36265.5216.5566.5165.6616.56
21879491-187949143.69543.77
33059257-305925771.12271.29
43061960-306196071.18571.34
53025645-302564570.34170.50
63027603-302760370.38670.54
20min13313241-331324177.02774.549.9177.3274.839.96
22560454-256045459.52659.69
33361452-336145278.14878.47
43373520-337352078.42878.75
53298463-329846376.68377.00
63331295-333129577.44777.76
30min13628116-362811684.34782.833.0684.8183.283.13
23349518-334951877.87078.17
33615806-361580684.06184.56
43634166-363416684.48884.98
53548995-354899582.50882.99
63599876-359987683.69184.17
45min13831907-383190789.08588.400.8889.7489.040.91
23781904-378190487.92388.40
33818613-381861388.77689.46
43835326-383532689.16589.84
53748643-374864387.14987.82
63797531-379753188.28688.95
60min13940904-394090491.61991.230.9692.4792.060.92
23954077-395407791.92592.59
33926361-392636191.28192.17
43957906-395790692.01492.89
53857669-385766989.68490.55
63908009-390800990.85491.72
极限14043522-404352294.00593.371.0895.0694.411.03
24062901-406290194.45595.33
34013942-401394293.31794.40
44040501-404050193.93595.02
53944319-394431991.69892.76
63992310-399231092.81493.88
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%
110.153946702394287339358533937397393061239386870.16
210.193969919397124839705840.03
单位质量响应值RSD%判断
388047.98389654.960.30数据可信
供试品溶液-2024091312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%
5min1921275-92127521.32319.1719.9121.3219.1719.91
2823277-82327719.05519.05
3525001-52500112.15112.15
41005211-100521123.26623.27
5807505-80750518.69018.69
6886950-88695020.52920.53
10min12307196-230719653.40048.8714.2753.4548.9214.28
22156097-215609749.90349.95
31566167-156616736.24936.28
42438928-243892856.44956.50
52034388-203438847.08647.13
62167239-216723950.16150.21
15min13047831-304783170.54367.997.7970.7168.157.81
22970181-297018168.74568.90
32485074-248507457.51757.63
43122607-312260772.27372.45
52972184-297218468.79268.94
63028335-302833570.09170.25
20min13300053-330005376.38075.983.3576.7076.293.38
23293170-329317076.22176.53
33067223-306722370.99171.23
43357609-335760977.71278.05
53314435-331443576.71377.01
63365166-336516677.88778.20
30min13538953-353895381.91082.681.0382.4083.151.06
23555154-355515482.28582.76
33527171-352717181.63782.03
43604764-360476483.43383.94
53591917-359191783.13683.61
63615663-361566383.68584.17
45min13730597-373059786.34587.410.8587.0288.070.85
23762159-376215987.07687.73
33763165-376316587.09987.67
43784524-378452487.59488.29
53799161-379916187.93288.59
63821001-382100188.43889.11
60min13840260-384026088.88490.000.8389.7590.850.83
23864840-386484089.45290.30
33886227-388622789.94790.72
43898384-389838490.22991.12
53910875-391087590.51891.37
63929612-392961290.95291.82
极限13932972-393297291.02992.000.6892.0993.050.68
23958312-395831291.61692.67
33975489-397548992.01392.98
43976545-397654592.03893.13
53998932-399893292.55693.61
64006328-400632892.72793.80
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%
110.153933375393954839339833936404393514439356910.07
210.193985780398464239852110.03
单位质量响应值RSD%判断
387752.81391090.380.61数据可信
供试品溶液-2024091312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%
5min1362824-3628248.38518.7628.918.3918.7628.90
2952527-95252722.01422.01
3944948-94494821.83921.84
4917517-91751721.20521.21
5739821-73982117.09817.10
6952580-95258022.01622.02
10min11247806-124780628.83948.1021.3828.8648.1421.39
22339375-233937554.06754.12
32404122-240412255.56355.61
42215224-221522451.19751.24
51917487-191748744.31644.35
62362971-236297154.61254.66
15min12010793-201079346.47366.7615.3346.5666.9115.34
23141889-314188972.61472.78
33148150-314815072.75972.93
43040571-304057170.27370.43
52868198-286819866.28966.43
63121834-312183472.15172.32
20min12659221-265922161.45975.389.1861.6475.689.22
23411853-341185378.85379.18
33418392-341839279.00579.34
43372494-337249477.94478.26
53290439-329043976.04776.33
63417734-341773478.98979.32
30min13379574-337957478.10783.413.2478.4383.873.31
23673305-367330584.89685.40
33671183-367118384.84785.36
43647942-364794284.31084.80
53594899-359489983.08483.54
63686384-368638485.19885.70
45min13783201-378320187.43688.911.0787.9389.561.14
23883150-388315089.74690.44
33871128-387112889.46890.17
43854192-385419289.07789.75
53811070-381107088.08088.72
63879457-387945789.66190.36
60min13916783-391678390.52391.240.8591.2192.090.90
23973622-397362291.83792.73
33953485-395348591.37192.27
43954069-395406991.38592.26
53900733-390073390.15290.99
63987795-398779592.16493.06
极限14020486-402048692.92093.280.7893.8194.320.81
24057540-405754093.77694.87
34037220-403722093.30794.41
44041078-404107893.39694.47
53984477-398447792.08893.12
64074284-407428494.16395.26
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