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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554135602413482941419734139750413537041375050.08
210.704174508417107041727890.06
单位质量响应值RSD%判断
392180.57389980.280.40数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12279895-227989552.41647.268.7452.4247.268.75
22079869-207986947.81747.82
31778342-177834240.88540.88
42077428-207742847.76147.76
52188330-218833050.31050.31
61931242-193124244.40044.40
10min13658649-365864984.11479.993.5284.2380.103.52
23503380-350338080.54480.65
33300149-330014975.87275.96
43408553-340855378.36478.47
53545916-354591681.52281.63
63459599-345959979.53779.64
15min14023349-402334992.49891.170.9492.8091.450.96
23974073-397407391.36591.65
33916457-391645790.04190.30
43939120-393912090.56290.84
53983813-398381391.58991.88
63955928-395592890.94891.22
20min14163620-416362095.72394.810.5896.2395.300.59
24118144-411814494.67895.17
34098887-409888794.23594.69
44101732-410173294.30094.78
54129839-412983994.94695.44
64132209-413220995.00195.48
30min14216581-421658196.94196.880.3497.6697.570.35
24206373-420637396.70697.40
34198378-419837896.52297.19
44210311-421031196.79697.49
54239973-423997397.47898.19
64210841-421084196.80997.50
45min14279305-427930598.38397.780.3199.3298.700.32
24251543-425154397.74498.66
34247153-424715397.64398.53
44245656-424565697.60998.52
54244821-424482197.59098.51
64251017-425101797.73298.64
60min14280990-428099098.42198.180.3799.5899.300.37
24264318-426431898.03899.17
34259145-425914597.91999.02
44252250-425225097.76198.88
54270394-427039498.17899.32
64294836-429483698.74099.86
极限14262937-426293798.00698.160.2699.3899.500.25
24264990-426499098.05499.40
34268032-426803298.12399.44
44259861-425986197.93699.28
54271612-427161298.20699.56
64289930-428993098.62799.97
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554178476418195141748684184951418288741806270.10
210.704169077417086741699720.04
单位质量响应值RSD%判断
396267.96389717.011.18数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12112386-211238648.33146.7015.1148.3346.7015.12
22495465-249546557.09657.10
31551745-155174535.50435.50
42077700-207770047.53847.54
51903684-190368443.55643.56
62105084-210508448.16448.16
10min13624563-362456382.93079.984.5183.0480.084.52
23728402-372840285.30585.43
33304126-330412675.59875.68
43422596-342259678.30978.41
53390037-339003777.56477.66
63503748-350374880.16580.27
15min14022367-402236792.03190.781.3992.3291.061.41
24045727-404572792.56692.88
33902527-390252789.28989.54
43930210-393021089.92390.20
53954712-395471290.48390.75
63951764-395176490.41690.70
20min14180319-418031995.64594.390.9896.1494.870.99
24162254-416225495.23295.75
34071763-407176393.16193.61
44097977-409797793.76194.24
54120599-412059994.27994.75
64119517-411951794.25494.74
30min14256054-425605497.37896.460.7298.0997.150.73
24234687-423468796.88997.62
34184752-418475295.74796.40
44202015-420201596.14296.83
54234855-423485596.89397.57
64183552-418355295.71996.41
45min14278695-427869597.89697.170.8298.8298.080.83
24281085-428108597.95198.90
34205567-420556796.22397.09
44247923-424792397.19298.09
54263936-426393697.55898.45
64204068-420406896.18997.10
60min14276121-427612197.83797.450.7498.9898.580.76
24298471-429847198.34999.52
34221718-422171896.59297.67
44264529-426452997.57298.69
54273575-427357597.77998.89
64221492-422149296.58797.71
极限14322814-432281498.90697.740.84100.2799.080.85
24295921-429592198.29099.68
34237318-423731896.94998.24
44259835-425983597.46598.80
54284239-428423998.02399.35
64231522-423152296.81798.15
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554190486418723841898764188964418842541889980.04
210.704245942424618042460610.01
单位质量响应值RSD%判断
397061.42396828.130.05数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12092432-209243247.39543.465.8547.3943.465.84
21954968-195496844.28144.28
31831265-183126541.47941.48
41768276-176827640.05240.05
51914623-191462343.36743.37
61950098-195009844.17144.17
10min13458875-345887578.34573.934.6878.4574.034.68
23233984-323398473.25173.35
33038641-303864168.82768.92
43175668-317566871.93072.02
53401912-340191277.05577.15
63274863-327486374.17774.28
15min13907214-390721488.50086.551.9888.7886.811.99
23813319-381331986.37486.63
33723314-372331484.33584.58
43744563-374456384.81685.07
53892510-389251088.16788.43
63845825-384582587.11087.37
20min14083451-408345192.49291.221.1592.9791.681.16
24017009-401700990.98791.44
33965705-396570589.82590.26
43985104-398510490.26590.70
54054021-405402191.82692.29
64059090-405909091.94092.40
30min14176436-417643694.59894.240.8195.2894.900.82
24140837-414083793.79294.45
34117619-411761993.26693.90
44137687-413768793.72194.36
54186178-418617894.81995.49
64205424-420542495.25595.92
45min14243383-424338396.11595.490.8897.0196.360.89
24198075-419807595.08995.95
34181376-418137694.71095.55
44171227-417122794.48095.33
54241298-424129896.06896.95
64259146-425914696.47297.34
60min14276796-427679696.87296.240.7797.9897.320.78
24214213-421421395.45496.53
34226278-422627895.72796.78
44220218-422021895.59096.65
54289345-428934597.15698.25
64267526-426752696.66297.75
极限14274142-427414296.81196.340.7998.1397.630.80
24238092-423809295.99597.28
34208994-420899495.33696.60
44227694-422769495.75997.03
54277373-427737396.88598.19
64294345-429434597.26998.57
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554142108414682741389064136379413730441403050.11
210.704184201418421241842060.01
单位质量响应值RSD%判断
392445.97391047.290.26数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12157121-215712149.50842.5213.5249.5142.5213.53
22170694-217069449.82049.82
31671104-167110438.35438.35
41763770-176377040.48140.48
51770537-177053740.63640.64
61583741-158374136.34936.35
10min13552102-355210281.52575.775.8481.6375.865.85
23497252-349725280.26680.38
33076448-307644870.60870.69
43204360-320436073.54473.63
53148398-314839872.25972.35
63329273-332927376.41176.49
15min13973548-397354891.19787.732.3791.4988.002.39
23868211-386821188.78089.07
33767527-376752786.46986.71
43767415-376741586.46686.72
53723356-372335685.45585.71
63835348-383534888.02688.28
20min14133939-413393994.87992.321.5995.3792.781.60
24029524-402952492.48292.97
34008492-400849291.99992.43
43989936-398993691.57492.02
53941649-394164990.46590.91
64030260-403026092.49992.95
30min14241705-424170597.35295.461.1998.0696.121.20
24143586-414358695.10095.79
34170849-417084995.72696.36
44127270-412727094.72695.37
54098127-409812794.05794.70
64174678-417467895.81496.47
45min14320284-432028499.15596.881.42100.0897.751.43
24204043-420404396.48897.39
34240459-424045997.32398.17
44187237-418723796.10296.96
54142616-414261695.07895.93
64231893-423189397.12797.99
60min14322580-432258099.20897.521.00100.3598.611.01
24225267-422526796.97598.09
34249818-424981897.53898.61
44232287-423228797.13698.21
54200212-420021296.40097.46
64263924-426392497.86298.94
极限14341401-434140199.64097.411.19101.0098.721.20
24225258-422525896.97498.31
34252140-425214097.59198.88
44216080-421608096.76498.05
54201063-420106396.41997.70
64229781-422978197.07898.38
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