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430038-202402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%
110.772074346207627920764972076699207488320757410.06
210.652071189207804620746180.24
单位质量响应值RSD%判断
192733.61194799.810.76数据可信
供试品溶液-250602批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18174-81740.3790.5019.860.380.5020.04
211112-111120.5160.52
38389-83890.3890.39
413687-136870.6350.64
511076-110760.5140.51
612028-120280.5580.56
10min148678-486782.2591.5025.732.261.5025.79
229278-292781.3591.36
325649-256491.1901.19
430887-308871.4331.43
528060-280601.3021.30
630850-308501.4321.43
15min136203-362031.6801.735.801.681.745.83
238090-380901.7671.77
333986-339861.5771.58
439425-394251.8291.83
536745-367451.7051.71
639709-397091.8431.85
20min139380-393801.8271.884.751.831.894.90
242723-427231.9821.99
337480-374801.7391.74
441385-413851.9201.93
540476-404761.8781.88
642082-420821.9531.96
30min141939-419391.9461.973.361.961.983.33
242891-428911.9902.00
339914-399141.8521.86
443760-437602.0312.04
542976-429761.9942.00
643573-435732.0222.03
45min145209-452092.0982.034.192.112.044.17
245104-451042.0932.11
340207-402071.8661.88
444207-442072.0512.06
544060-440602.0442.06
643765-437652.0312.04
60min145683-456832.1202.043.812.142.063.94
245927-459272.1312.15
341355-413551.9191.93
443462-434622.0172.03
543643-436432.0252.04
644291-442912.0552.07
90min144603-446032.0702.033.972.092.053.96
245608-456082.1162.14
340934-409341.8991.92
442703-427031.9822.00
543609-436092.0242.04
645094-450942.0922.11
120min151194-511942.3762.165.322.402.185.34
245680-456802.1202.14
345508-455082.1122.13
447637-476372.2102.23
544867-448672.0822.10
644733-447332.0762.10
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限144793-447932.0792.072.922.112.102.86
245436-454362.1082.14
345373-453732.1052.13
442019-420191.9501.98
544918-449182.0842.11
645256-452562.1002.13
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430038-202402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%
110.772103740210410821032922103808210118321032260.06
210.652147681211857021331260.97
单位质量响应值RSD%判断
195285.61200293.521.80数据可信
供试品溶液-250602批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111820-118200.5370.5948.960.540.6049.05
212663-126630.5760.58
324382-243821.1091.11
415085-150850.6860.69
57960-79600.3620.36
66430-64300.2920.29
10min131716-317161.4421.2217.131.441.2217.23
230472-304721.3851.39
322976-229761.0451.05
430560-305601.3891.39
523620-236201.0741.07
621429-214290.9740.97
15min138756-387561.7621.658.091.771.658.16
238478-384781.7491.75
333817-338171.5371.54
439490-394901.7951.80
534472-344721.5671.57
632756-327561.4891.49
20min143213-432131.9651.864.811.971.874.75
242636-426361.9381.94
340009-400091.8191.83
442225-422251.9201.93
538357-383571.7441.75
639449-394491.7941.80
30min144924-449242.0421.982.422.051.992.49
244209-442092.0102.02
344152-441522.0072.02
443256-432561.9671.98
543102-431021.9601.97
641926-419261.9061.91
45min145951-459512.0892.032.512.102.042.45
245894-458942.0872.10
344377-443772.0182.03
443691-436911.9862.00
543249-432491.9661.98
644736-447362.0342.04
60min144053-440532.0032.042.342.022.062.26
245737-457372.0792.10
345706-457062.0782.09
443103-431031.9601.98
545368-453682.0632.08
644996-449962.0462.06
90min144474-444742.0222.021.892.042.041.95
245657-456572.0762.10
344397-443972.0182.04
443307-433071.9691.99
543859-438591.9942.01
645060-450602.0492.07
120min144047-440472.0031.953.192.031.973.28
244617-446172.0282.05
340738-407381.8521.87
442427-424271.9291.95
542526-425261.9331.95
642763-427631.9441.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限144077-440772.0041.984.922.032.004.80
245034-450342.0472.07
339868-398681.8131.84
446107-461072.0962.12
542952-429521.9531.98
643236-432361.9661.99
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430038-202402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%
110.772112986211299821142222118000211405021144510.10
210.652164198216407221641350.01
单位质量响应值RSD%判断
196327.86203205.162.44数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250603批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125828-258281.1631.129.311.161.129.28
226863-268631.2091.21
324546-245461.1051.11
420658-206580.9300.93
526891-268911.2111.21
624692-246921.1121.11
10min134830-348301.5681.586.441.571.586.45
236634-366341.6491.65
337782-377821.7011.70
431118-311181.4011.40
535150-351501.5821.58
635474-354741.5971.60
15min139878-398781.7951.867.371.801.867.43
246667-466672.1012.11
342507-425071.9141.92
437841-378411.7041.71
539923-399231.7971.80
640935-409351.8431.85
20min142355-423551.9071.922.871.911.933.03
244587-445872.0072.02
343336-433361.9511.96
441001-410011.8461.85
542063-420631.8941.90
643164-431641.9431.95
30min143925-439251.9782.037.691.992.047.55
244716-447162.0132.02
352053-520532.3432.35
443117-431171.9411.95
543439-434391.9561.97
643213-432131.9451.96
45min148030-480302.1622.023.732.182.033.78
244646-446462.0102.02
343278-432781.9481.96
444556-445562.0062.02
544039-440391.9832.00
644054-440541.9832.00
60min144368-443681.9972.035.252.022.055.18
244343-443431.9962.01
344212-442121.9902.01
444285-442851.9942.01
543284-432841.9491.97
649805-498052.2422.26
90min143700-437001.9671.923.331.991.943.37
243973-439731.9802.00
342966-429661.9341.96
442687-426871.9221.94
540026-400261.8021.82
642204-422041.9001.92
120min142398-423981.9091.976.101.931.996.09
242615-426151.9191.94
343103-431031.9411.97
443069-430691.9391.96
548972-489722.2052.23
641705-417051.8781.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限142530-425301.9151.974.651.942.004.53
242844-428441.9291.96
342741-427411.9241.95
443941-439411.9782.00
543196-431961.9451.97
647878-478782.1562.18
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430038-202402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%
110.772128579212648321240122121093211711721234570.22
210.652081660208048820810740.04
单位质量响应值RSD%判断
197164.07195406.010.64数据可信
供试品溶液-250603批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119165-191650.8780.9919.250.880.9919.09
225250-252501.1571.16
316510-165100.7560.76
418180-181800.8330.83
524751-247511.1341.13
626073-260731.1941.19
10min131051-310511.4221.5812.621.421.5812.73
235518-355181.6271.63
330153-301531.3811.38
432091-320911.4701.47
541605-416051.9061.91
637124-371241.7011.70
15min135830-358301.6411.776.471.651.786.52
240843-408431.8711.88
335314-353141.6181.62
438566-385661.7671.77
540604-406041.8601.87
640528-405281.8561.86
20min137354-373541.7112.009.051.722.008.97
246440-464402.1272.14
348398-483982.2172.22
441809-418091.9151.92
545297-452972.0752.08
642360-423601.9401.95
30min140055-400551.8351.986.231.841.996.30
244266-442662.0282.04
342921-429211.9661.98
444018-440182.0162.03
547554-475542.1782.19
640816-408161.8701.88
45min142160-421601.9311.982.731.941.992.71
243741-437412.0042.02
343923-439232.0122.03
444114-441142.0212.03
543900-439002.0112.03
641290-412901.8911.91
60min142602-426021.9512.037.281.972.057.12
242225-422251.9341.95
343501-435011.9932.01
443411-434111.9892.01
543273-432731.9822.00
650809-508092.3272.34
90min141599-415991.9062.017.111.922.047.06
247108-471082.1582.18
348409-484092.2172.24
443591-435911.9972.02
542272-422721.9361.96
640724-407241.8651.89
120min143956-439562.0131.944.362.041.964.30
243254-432541.9812.01
342955-429551.9681.99
443105-431051.9752.00
541327-413271.8931.92
638953-389531.7841.81
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限140430-404301.8521.967.221.881.987.15
242292-422921.9371.97
348084-480842.2032.23
443691-436912.0012.03
542550-425501.9491.98
639239-392391.7971.82
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