非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.554084253408609340863724084594408639440855410.03
210.724103533410311441033240.01
单位质量响应值RSD%判断
387255.07382772.760.83数据可信
供试品溶液-250601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%
5min11000236-100023623.35925.299.7223.3625.299.71
21033372-103337224.13324.13
31148470-114847026.82026.82
4976706-97670622.80922.81
51081217-108121725.25025.25
61257378-125737829.36429.36
10min12261079-226107952.80349.075.6552.8449.125.65
22023173-202317347.24847.29
32023144-202314447.24747.29
41955472-195547245.66745.70
52147812-214781250.15850.20
62197696-219769651.32351.37
15min12774476-277447664.79362.982.1764.9263.102.18
22647731-264773161.83361.95
32649970-264997061.88562.01
42638285-263828561.61261.73
52730569-273056963.76863.89
62740322-274032263.99564.13
20min13068899-306889971.66970.741.0571.9070.961.06
23014283-301428370.39370.62
32990726-299072669.84370.07
42999400-299940070.04670.26
53048942-304894271.20371.43
63051302-305130271.25871.50
30min13334472-333447277.87178.230.7378.2278.580.72
23390756-339075679.18579.52
33323178-332317877.60777.95
43349970-334997078.23278.57
53363562-336356278.55078.90
63337604-333760477.94478.30
45min13605988-360598884.21184.250.4384.7084.730.42
23616983-361698384.46884.94
33586113-358611383.74784.22
43617561-361756184.48284.95
53625720-362572084.67285.15
63593471-359347183.91984.41
60min13767708-376770887.98887.420.5988.6188.040.58
23768348-376834888.00388.62
33728866-372886687.08187.69
43744493-374449387.44688.05
53739702-373970287.33487.96
63712472-371247286.69887.33
极限13814767-381476789.08789.760.6789.8690.520.66
23881498-388149890.64591.40
33847952-384795289.86290.62
43862965-386296590.21390.96
53833941-383394189.53590.30
63820779-382077989.22790.00
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.554117999411801241211114117001411130841170860.09
210.724184297419018841872420.10
单位质量响应值RSD%判断
390245.12390600.930.07数据可信
供试品溶液-250601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%
5min11330677-133067730.64422.5022.6130.6422.5022.60
2881344-88134420.29620.30
31021622-102162223.52723.53
4917871-91787121.13821.14
51047602-104760224.12524.13
6662240-66224015.25115.25
10min12429576-242957655.95047.849.4156.0047.879.41
22114612-211461248.69748.73
32000868-200086846.07846.12
41929540-192954044.43544.47
52103576-210357648.44348.48
61885381-188538143.41843.44
15min12887699-288769966.50062.124.0366.6462.234.04
22738609-273860963.06763.18
32623743-262374360.42260.54
42623839-262383960.42460.53
52712649-271264962.46962.59
62597916-259791659.82759.92
20min13124064-312406471.94469.991.7372.2070.211.75
23053348-305334870.31570.54
32975274-297527468.51768.73
43054855-305485570.35070.56
53032821-303282169.84270.07
62995142-299514268.97569.17
30min13363874-336387477.46677.241.0377.8477.571.04
23415214-341521478.64978.99
33313678-331367876.31076.64
43337355-333735576.85677.18
53352195-335219577.19777.54
63341022-334102276.94077.25
45min13599429-359942982.89183.070.9283.3983.540.92
23668006-366800684.47084.94
33583057-358305782.51482.97
43613350-361335083.21183.67
53574523-357452382.31782.79
63605300-360530083.02683.47
60min13702122-370212285.25686.071.0485.9086.681.02
23806231-380623187.65388.26
33704343-370434385.30785.90
43734150-373415085.99386.59
53726959-372695985.82886.43
63752330-375233086.41286.99
极限13805726-380572687.64288.661.2588.4389.401.23
23938336-393833690.69591.45
33813982-381398287.83288.57
43840326-384032688.43889.18
53838080-383808088.38789.14
63862135-386213588.94189.66
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.554196690419495241933684185413417797541896800.19
210.724223646422101842223320.05
单位质量响应值RSD%判断
397126.07393874.250.59数据可信
供试品溶液-250602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%
5min11377364-137736431.31225.0921.8131.3125.0921.81
21249342-124934228.40228.40
31196242-119624227.19527.19
4691092-69109215.71115.71
51124220-112422025.55825.56
6984554-98455422.38222.38
10min12405815-240581554.69350.178.0054.7550.218.01
22423970-242397055.10655.15
32178975-217897549.53649.58
41995310-199531045.36145.39
52180199-218019949.56449.61
62055716-205571646.73446.77
15min12808701-280870163.85261.543.5864.0061.663.60
22839370-283937064.54964.69
32699241-269924161.36461.49
42604498-260449859.21059.31
52663209-266320960.54460.67
62626807-262680759.71759.83
20min13023463-302346368.73467.482.3968.9867.712.40
23081375-308137570.05170.30
32961201-296120167.31967.55
42907445-290744566.09766.30
52932460-293246066.66566.89
62904155-290415566.02266.24
30min13305532-330553275.14774.721.5375.5175.061.53
23351299-335129976.18776.55
33259764-325976474.10674.45
43331593-333159375.73976.05
53243862-324386273.74574.08
63228297-322829773.39173.72
45min13511431-351143179.82879.451.1680.3279.921.18
23565979-356597981.06881.56
33488664-348866479.31079.78
43476135-347613579.02579.46
53479264-347926479.09679.56
63448285-344828578.39278.84
60min13638110-363811082.70782.441.1683.3383.041.18
23703705-370370584.19984.82
33621810-362181082.33782.93
43608212-360821282.02882.60
53600451-360045181.85182.44
63585604-358560481.51482.09
极限13724709-372470984.67684.541.0485.4485.271.05
23789913-378991386.15886.92
33707108-370710884.27685.01
43715859-371585984.47585.18
53693889-369388983.97584.70
63680242-368024283.66584.38
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.554186423418803441870604185364418328341860330.05
210.724199760419756441986620.04
单位质量响应值RSD%判断
396780.38391666.230.92数据可信
供试品溶液-250602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%
5min11328672-132867230.30426.3914.8530.3026.3914.85
21176881-117688126.84226.84
3893567-89356720.38020.38
41014503-101450323.13923.14
51314265-131426529.97629.98
61214324-121432427.69627.70
10min12392555-239255554.56950.426.1554.6250.466.16
22252419-225241951.37351.42
32042632-204263246.58846.62
42054775-205477546.86546.90
52257382-225738251.48651.54
62263292-226329251.62151.67
15min12783739-278373963.49161.932.7463.6362.062.75
22741169-274116962.52062.65
32631785-263178560.02560.14
42613596-261359659.61059.73
52779390-277939063.39263.53
62742584-274258462.55262.68
20min13022212-302221268.93067.711.5669.1867.941.58
23013705-301370568.73668.97
32925543-292554366.72566.94
42906403-290640366.28966.50
52965989-296598967.64867.89
62977886-297788667.91968.16
30min13304421-330442175.36774.291.0875.7374.641.09
23284885-328488574.92175.27
33242782-324278273.96174.28
43205027-320502773.10073.43
53244049-324404973.99074.34
63263048-326304874.42374.77
45min13513328-351332880.13179.771.0680.6280.241.05
23522890-352289080.34980.82
33547612-354761280.91381.36
43448010-344801078.64279.09
53476037-347603779.28179.76
63476093-347609379.28279.76
60min13659994-365999483.47782.540.8584.1083.140.86
23653192-365319283.32183.93
33602077-360207782.15682.74
43584965-358496581.76582.34
53600327-360032782.11682.73
63613748-361374882.42283.03
极限13744518-374451885.40484.710.5186.1685.440.51
23726632-372663284.99685.74
33693554-369355484.24284.96
43705763-370576384.52085.24
53702210-370221084.43985.19
63710887-371088784.63785.38
非布司他片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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%
110.552075549207574420753232073393207390520747830.06
210.722126867212741421271400.02
单位质量响应值RSD%判断
196661.90198427.240.64数据可信
供试品溶液-250603批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11898938-189893886.43076.5211.7286.4376.5211.72
21653938-165393875.27875.28
31432355-143235565.19365.19
41785270-178527081.25681.26
51847753-184775384.10084.10
61468410-146841066.83466.83
10min12146359-214635997.69197.151.4797.8397.281.49
22137422-213742297.28497.41
32088016-208801695.03595.14
42134061-213406197.13197.27
52182814-218281499.35099.49
62117992-211799296.40096.51
15min12164604-216460498.52199.181.0398.8399.481.03
22167431-216743198.65098.94
32205758-2205758100.394100.66
42166111-216611198.59098.89
52209968-2209968100.586100.89
62161160-216116098.36598.64
20min12162189-216218998.41199.481.3098.8899.941.29
22172158-217215898.86599.32
32230676-2230676101.529101.96
42174270-217427098.96199.42
52211016-2211016100.634101.11
62164365-216436598.51098.95
30min12161326-216132698.37299.561.4099.01100.181.39
22184149-218414999.411100.03
32235854-2235854101.764102.37
42172727-217272798.89199.52
52211557-2211557100.658101.30
62159144-215914498.27398.87
45min12156296-215629698.14399.291.3798.94100.081.36
22168446-216844698.69699.48
32229363-2229363101.469102.24
42170128-217012898.77399.56
52206722-2206722100.438101.25
62157827-215782798.21398.98
60min12151141-215114197.90999.061.4698.87100.011.45
22160758-216075898.34699.29
32228391-2228391101.425102.37
42160577-216057798.33899.29
52202858-2202858100.262101.24
62154656-215465698.06899.00
极限12148406-214840697.78499.201.4298.91100.321.41
22195503-219550399.928101.04
32223738-2223738101.213102.32
42156633-215663398.15899.28
52199672-2199672100.117101.26
62153723-215372398.02699.12
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