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%
110.184017327401683540116754009527400878040128290.11
210.304037172403906940381200.04
单位质量响应值RSD%判断
394187.52392050.490.39数据可信
加速6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%
5min12013115-201311546.04244.078.9446.0444.078.94
21721602-172160239.37539.37
31999296-199929645.72645.73
41965541-196554144.95444.95
52145489-214548949.07049.07
61716878-171687839.26739.27
10min13197943-319794373.14073.376.1473.2473.476.14
22996519-299651968.53468.62
32996314-299631468.52968.63
43316850-331685075.86075.96
53511352-351135280.30980.42
63229478-322947873.86273.95
15min13749731-374973185.76085.382.2986.0385.642.31
23636916-363691683.18083.42
33636068-363606883.16183.41
43786860-378686086.61086.88
53854343-385434388.15388.44
63733565-373356585.39185.64
20min13926199-392619989.79790.041.0190.2590.491.03
23901393-390139389.22989.65
33906406-390640689.34489.78
43960403-396040390.57991.04
54005959-400595991.62192.10
63921410-392141089.68790.13
30min14060307-406030792.86493.350.5593.5294.000.57
24066278-406627893.00093.62
34083818-408381893.40194.04
44090639-409063993.55794.22
54120457-412045794.23994.93
64066823-406682393.01393.65
45min14133445-413344594.53694.850.5495.4095.710.55
24147266-414726694.85395.68
34145228-414522894.80695.65
44163542-416354295.22596.09
54178599-417859995.56996.47
64115328-411532894.12294.97
60min14155014-415501495.03095.400.4096.1096.470.42
24168700-416870095.34396.38
34176666-417666695.52596.58
44187039-418703995.76296.84
54190761-419076195.84796.96
64149750-414975094.90995.97
极限14175452-417545295.49795.710.4796.7896.990.48
24178643-417864395.57096.82
34196837-419683795.98697.25
44178608-417860895.56996.86
54217220-421722096.45297.77
64161793-416179395.18596.45
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%
110.184056807405631540544614051217404898940535580.09
210.304076327407601840761720.01
单位质量响应值RSD%判断
398188.41395744.850.44数据可信
加速6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%
5min11820184-182018441.22644.044.7141.2344.044.71
21891764-189176442.84742.85
32078143-207814347.06947.07
41947604-194760444.11244.11
51915023-191502343.37443.37
62014405-201440545.62545.63
10min13088326-308832669.94971.404.0670.0471.504.06
22973258-297325867.34367.44
33233123-323312373.22973.33
43334264-333426475.51975.62
53195284-319528472.37272.47
63089070-308907069.96670.07
15min13676152-367615283.26383.891.4483.5184.141.44
23643152-364315282.51582.76
33737866-373786684.66184.93
43785929-378592985.74986.02
53714633-371463384.13484.39
63664076-366407682.98983.25
20min13920650-392065088.80188.970.7089.2389.410.70
23888480-388848088.07288.50
33959114-395911489.67290.13
43955776-395577689.59690.05
53933175-393317589.08489.53
63910682-391068288.57589.02
30min14057249-405724991.89592.280.4492.5292.920.45
24078040-407804092.36592.99
34104500-410450092.96593.62
44080765-408076592.42793.08
54057426-405742691.89992.54
64066646-406664692.10792.75
45min14138694-413869493.73994.070.4994.5794.910.49
24153149-415314994.06794.90
34189702-418970294.89595.76
44157601-415760194.16795.03
54133283-413328393.61794.46
64146382-414638293.91394.76
60min14144694-414469493.87594.290.3994.9295.340.40
24171980-417198094.49395.53
34184610-418461094.77995.85
44174097-417409794.54195.61
54152623-415262394.05595.11
64149279-414927993.97995.03
极限14175649-417564994.57694.760.2695.8396.020.26
24179017-417901794.65395.90
34190205-419020594.90696.19
44197395-419739595.06996.35
54169860-416986094.44595.71
64190055-419005594.90396.16
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%
110.184073647407672240757494072658407112340739800.06
210.304048638404619940474180.05
单位质量响应值RSD%判断
400194.50392953.201.30数据可信
长期6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%
5min11407020-140702031.90232.1413.1131.9032.1413.12
21700031-170003138.54638.55
31330924-133092430.17730.18
41438321-143832132.61232.61
51492413-149241333.83833.84
61136276-113627625.76325.76
10min13004207-300420768.11667.294.5068.1967.364.51
23176668-317666872.02672.11
32907019-290701965.91365.98
42941074-294107466.68566.76
53005859-300585968.15468.23
62772123-277212362.85462.91
15min13593246-359324681.47281.032.2081.6981.252.22
23702546-370254683.95084.20
33541047-354104780.28880.50
43537236-353723680.20280.42
53598267-359826781.58681.81
63469835-346983578.67478.87
20min13860296-386029687.52786.891.2687.9387.291.28
23897007-389700788.35988.79
33813131-381313186.45786.85
43806077-380607786.29786.70
53855647-385564787.42187.83
63761601-376160185.28985.66
30min14048743-404874391.80091.700.4192.4092.290.43
24056390-405639091.97392.60
34033399-403339991.45292.04
44043631-404363191.68492.27
54064404-406440492.15592.76
64019101-401910191.12791.69
45min14138358-413835893.83193.370.4694.6394.170.48
24137946-413794693.82294.66
34105502-410550293.08693.87
44116756-411675693.34294.14
54119482-411948293.40394.21
64089797-408979792.73093.49
60min14166546-416654694.47194.570.4295.4895.580.43
24175663-417566394.67795.72
34164897-416489794.43395.43
44201892-420189295.27296.27
54167052-416705294.48295.50
64149366-414936694.08195.05
极限14154474-415447494.19794.670.2795.4295.880.27
24185795-418579594.90796.16
34173640-417364094.63195.84
44181531-418153194.81096.02
54181070-418107094.80096.02
64174431-417443194.64995.83
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%
110.184102677410273641017454099396410132841015760.04
210.304157374415240941548920.09
单位质量响应值RSD%判断
402905.30403387.570.09数据可信
长期6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%
5min11096409-109640924.45232.1221.4624.4532.1221.46
21637959-163795936.53036.53
31710911-171091138.15738.16
41472395-147239532.83732.84
51019869-101986922.74522.75
61702671-170267137.97337.97
10min12896741-289674164.60369.146.9164.6669.216.92
23197049-319704971.30171.38
33288908-328890873.34973.43
43208707-320870771.56171.63
52767417-276741761.71961.77
63241734-324173472.29772.38
15min13536796-353679678.87881.163.2579.0881.383.27
23700671-370067182.53382.77
33716128-371612882.87783.13
43707360-370736082.68282.91
53446322-344632276.86077.05
63726816-372681683.11683.36
20min13833296-383329685.49086.341.7285.8686.741.74
23903520-390352087.05787.48
33938749-393874987.84288.27
43872687-387268786.36986.78
53759590-375959083.84784.21
63920883-392088387.44487.87
30min14046901-404690190.25490.670.6890.8291.270.71
24070502-407050290.78191.40
34089814-408981491.21191.84
44077131-407713190.92891.54
54020111-402011189.65790.20
64089951-408995191.21491.84
45min14139745-413974592.32592.060.9793.0992.860.99
24122814-412281491.94792.77
34169407-416940792.98693.82
44133310-413331092.18192.99
54053461-405346190.40191.14
64149029-414902992.53293.36
60min14166621-416662192.92493.210.5593.8994.210.56
24144748-414474892.43693.46
34200642-420064293.68394.72
44188974-418897493.42394.44
54170951-417095193.02193.97
64203429-420342993.74594.78
极限14162449-416244992.83193.510.5194.0194.720.53
24200171-420017193.67394.90
34221452-422145294.14795.39
44202951-420295193.73594.96
54175605-417560593.12594.28
64194135-419413593.53894.78
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