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%
110.243943148394155539300703925389391669439313710.29
210.354012970401216940125700.02
单位质量响应值RSD%判断
383922.95387687.920.70数据可信
长期12月-供试品溶液-2024112521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%
5min11533916-153391635.74836.437.1435.7536.437.14
21556852-155685236.28336.28
31617803-161780337.70337.70
41365546-136554631.82431.82
51693084-169308439.45739.46
61611124-161112437.54737.55
10min12903320-290332067.66268.772.4267.7468.852.43
22930199-293019968.28868.37
33024295-302429570.48170.57
42843824-284382466.27566.35
53021027-302102770.40570.49
62983030-298303069.52069.60
15min13629799-362979984.59384.190.8184.8284.420.81
23598731-359873183.86984.10
33647445-364744585.00485.24
43566450-356645083.11683.33
53603498-360349883.98084.22
63629213-362921384.57984.82
20min13927992-392799291.54290.480.9291.9690.900.92
23888673-388867390.62691.04
33881135-388113590.45090.88
43818884-381888488.99989.40
53893856-389385690.74691.18
63885309-388530990.54790.97
30min14081940-408194095.13094.351.1995.7594.971.19
24036800-403680094.07894.70
34029206-402920693.90194.53
43982354-398235492.80993.41
54037715-403771594.09994.73
64121820-412182096.05996.69
45min14137966-413796696.43594.961.0497.2795.791.05
24082753-408275395.14995.98
34066689-406668994.77495.61
44005882-400588293.35794.16
54083516-408351695.16796.01
64069902-406990294.84995.69
60min14145817-414581796.61895.171.0297.6796.221.02
24073252-407325294.92795.97
34094185-409418595.41596.46
44016670-401667093.60994.62
54087673-408767395.26396.32
64084749-408474995.19596.25
极限14100978-410097895.57394.800.7796.8496.050.77
24061464-406146494.65395.90
34070062-407006294.85396.11
44010713-401071393.47094.69
54083915-408391595.17696.44
64079352-407935295.06996.33
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%
110.243958931395934239581873953907395401839568770.07
210.354020073402231040211920.04
单位质量响应值RSD%判断
386413.77388520.970.39数据可信
长期12月-供试品溶液-2024112521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%
5min11662926-166292638.58836.1110.7038.5936.1110.70
21696170-169617039.35939.36
31601512-160151237.16337.16
41662611-166261138.58038.58
51443782-144378233.50333.50
61270739-127073929.48729.49
10min13159678-315967873.31972.042.0773.4172.122.08
23168617-316861773.52773.61
33085747-308574771.60471.69
43149468-314946873.08273.17
53044832-304483270.65470.73
63018129-301812970.03570.10
15min13676418-367641885.31085.430.9685.5685.670.97
23712841-371284186.15586.41
33689106-368910685.60585.85
43719831-371983186.31886.57
53669622-366962285.15385.38
63621845-362184584.04484.27
20min13887955-388795590.21990.231.0290.6690.661.03
23925744-392574491.09691.54
33884360-388436090.13590.57
43925196-392519691.08391.52
53890151-389015190.27090.69
63817480-381748088.58488.99
30min14041421-404142193.78093.770.6494.4294.400.65
24038079-403807993.70294.35
34047074-404707493.91194.54
44066287-406628794.35795.00
54059421-405942194.19894.82
63993041-399304192.65793.26
45min14125905-412590595.74095.710.5896.5996.550.59
24132411-413241195.89196.74
34146218-414621896.21297.05
44146802-414680296.22597.08
54113410-411341095.45096.28
64083988-408398894.76895.58
60min14154151-415415196.39696.280.6097.4697.330.60
24160184-416018496.53697.60
34124252-412425295.70296.76
44179128-417912896.97598.04
54161558-416155896.56897.61
64114585-411458595.47896.50
极限14184731-418473197.10596.770.7598.3898.030.76
24161364-416136496.56397.84
34190625-419062597.24298.51
44212002-421200297.73899.02
54138145-413814596.02497.28
64133616-413361695.91997.15
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%
110.243930785393337839347043931968393395939329590.05
210.353933498393799339357460.09
单位质量响应值RSD%判断
384078.03380265.310.71数据可信
长期12月-供试品溶液-2024112721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%
5min11820315-182031542.82644.288.5342.8344.288.54
22121783-212178349.91849.92
31854882-185488243.63943.64
41884225-188422544.33044.33
51639602-163960238.57438.57
61971204-197120446.37646.38
10min13243561-324356176.31075.272.8976.4175.382.89
23335333-333533378.46978.58
33190030-319003075.05175.15
43224764-322476475.86875.97
53136601-313660173.79473.88
63067016-306701672.15772.26
15min13684976-368497686.69586.060.8586.9686.330.85
23685878-368587886.71687.00
33674537-367453786.45086.71
43623912-362391285.25985.53
53664476-366447686.21386.46
63615348-361534885.05785.32
20min13863371-386337190.89290.490.6591.3590.940.65
23856829-385682990.73891.22
33838717-383871790.31290.77
43802398-380239889.45889.91
53873120-387312091.12291.56
63842840-384284090.40990.86
30min14014590-401459094.45093.970.7895.1194.630.76
23972452-397245293.45994.14
33980719-398071993.65394.31
43961162-396116293.19393.85
54045094-404509495.16895.81
63991553-399155393.90894.56
45min14093116-409311696.29795.431.0997.1796.301.08
24063453-406345395.59996.49
34049298-404929895.26696.13
43988792-398879293.84394.71
54111806-411180696.73797.59
64031897-403189794.85795.72
60min14111277-411127796.72596.320.7697.8197.400.76
24098007-409800796.41297.51
34088472-408847296.18897.26
44046022-404602295.18996.26
54139027-413902797.37798.45
64081600-408160096.02697.10
极限14156140-415614097.78096.911.0899.0898.201.07
24088655-408865596.19297.51
34112453-411245396.75298.04
44063494-406349495.60096.88
54185059-418505998.46099.75
64109170-410917096.67597.96
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%
110.243920300392272039183023940776393503239274260.26
210.353970315396042339653690.18
单位质量响应值RSD%判断
383537.70383127.440.08数据可信
长期12月-供试品溶液-2024112621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%
5min12045602-204560247.97941.5819.8747.9841.5819.87
21763976-176397641.37441.37
31952403-195240345.79345.79
41118981-111898126.24626.25
52057332-205733248.25448.25
61699475-169947539.86139.86
10min13465832-346583281.29180.043.5181.4080.143.53
23521405-352140582.59482.69
33497802-349780282.04082.14
43240232-324023275.99976.06
53467641-346764181.33381.44
63282381-328238176.98877.08
15min13768085-376808588.38088.081.4188.6788.351.43
23819785-381978589.59289.87
33785822-378582288.79689.08
43668723-366872386.04986.28
53765947-376594788.33088.62
63722202-372220287.30487.56
20min13937593-393759392.35692.820.5392.8493.290.53
23993148-399314893.65994.13
33953334-395333492.72593.21
43948604-394860492.61493.03
53941667-394166792.45192.94
63971062-397106293.14193.59
30min14048258-404825894.95196.251.0095.6496.920.97
24135116-413511696.98897.67
34085608-408560895.82796.51
44158473-415847397.53698.16
54076589-407658995.61696.31
64116930-411693096.56297.22
45min14140151-414015197.10798.250.9898.0199.130.95
24212302-421230298.79999.70
34179644-417964498.03398.93
44257314-425731499.855100.70
54166745-416674597.73098.63
64176422-417642297.95798.83
60min14197578-419757898.45499.100.8199.57100.210.79
24258387-425838799.880101.00
34218341-421834198.940100.06
44274097-4274097100.248101.31
54188453-418845398.23999.36
64214622-421462298.85399.95
极限14205867-420586798.64899.510.9499.98100.840.91
24271545-4271545100.188101.53
34236809-423680999.374100.71
44304018-4304018100.950102.24
54200172-420017298.51499.85
64237962-423796299.401100.71
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101278-202405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%
110.243986899398381939859413987674398582739860320.04
210.354010295400929040097920.02
单位质量响应值RSD%判断
389260.94387419.520.34数据可信
长期12月-供试品溶液-2024112621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%
5min11728760-172876040.02537.1211.0340.0337.1211.03
21784010-178401041.30441.30
31569374-156937436.33536.33
41723064-172306439.89339.89
51497126-149712634.66234.66
61318617-131861730.52930.53
10min13245282-324528275.13674.292.0075.2374.372.01
23252818-325281875.31175.40
33233038-323303874.85374.93
43262476-326247675.53575.62
53153524-315352473.01273.09
63105676-310567671.90471.97
15min13795183-379518387.86887.791.1588.1288.041.15
23796804-379680487.90688.16
33839311-383931188.89089.14
43826768-382676888.59988.86
53777406-377740687.45687.70
63716605-371660586.04986.28
20min14007304-400730492.77992.680.6793.2393.120.67
23998956-399895692.58693.04
34019019-401901993.05093.49
44028524-402852493.27093.72
54011103-401110392.86793.30
63952884-395288491.51991.94
30min14147995-414799596.03696.140.7296.6996.790.72
24156046-415604696.22396.88
34141109-414110995.87796.53
44200792-420079297.25997.92
54160097-416009796.31796.96
64110039-411003995.15895.78
45min14224907-422490797.81798.030.6898.6998.890.69
24222749-422274997.76798.64
34243939-424393998.25899.12
44283514-428351499.174100.05
54232372-423237297.99098.84
64197039-419703997.17298.01
60min14244443-424444398.27098.490.4599.3699.580.45
24243463-424346398.24799.34
34272776-427277698.925100.01
44265630-426563098.76099.86
54271831-427183198.90499.98
64226460-422646097.85398.90
极限14281286-428128699.12398.980.63100.43100.280.64
24286172-428617299.236100.55
34290120-429012099.327100.63
44308420-430842099.751101.07
54245984-424598498.30599.60
64239448-423944898.15499.42
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%
110.243938265394365739409123939434393850939401550.06
210.354034161403068540324230.07
单位质量响应值RSD%判断
384780.76389606.090.89数据可信
长期12月-供试品溶液-2024112721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%
5min11889381-188938143.87545.528.5843.8745.528.57
22211058-221105851.34551.34
31948829-194882945.25545.26
41962870-196287045.58145.58
51703887-170388739.56739.57
62045854-204585447.50947.51
10min13337264-333726477.49776.592.9577.5976.682.95
23454749-345474980.22680.34
33263778-326377875.79175.89
43327779-332777977.27777.38
53218672-321867274.74474.83
63185640-318564073.97674.08
15min13826619-382661988.86188.090.9389.1388.360.92
23812885-381288588.54288.83
33826237-382623788.85289.12
43754041-375404187.17687.45
53792553-379255388.07088.32
63748809-374880987.05487.32
20min14008240-400824093.07992.300.9893.5592.770.98
24004303-400430392.98793.48
33976113-397611392.33392.80
43917108-391710890.96391.43
54004193-400419392.98593.43
63938261-393826191.45491.92
30min14138466-413846696.10395.820.8996.7896.490.88
24130587-413058795.92096.62
34153444-415344496.45197.12
44083021-408302194.81595.48
54170079-417007996.83797.49
64081714-408171494.78595.45
45min14227924-422792498.18097.521.0399.0798.401.02
24195625-419562597.43098.34
34217896-421789697.94798.83
44139605-413960596.12997.01
54254464-425446498.79799.67
64160421-416042196.61397.49
60min14243642-424364298.54598.270.9999.6599.370.98
24236421-423642198.37899.50
34247826-424782698.64299.75
44163616-416361696.68797.78
54288011-428801199.576100.67
64210043-421004397.76598.86
极限14245865-424586598.59798.620.9599.9299.940.94
24249530-424953098.682100.03
34270496-427049699.169100.49
44181868-418186897.11198.42
54302200-430220099.905101.22
64232102-423210298.27799.59
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