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%
110.652103740210410821032922103808210118321032260.06
210.772147681211857021331260.97
单位质量响应值RSD%判断
197486.01198061.840.21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%
5min111820-118200.5370.5948.910.540.6049.05
212663-126630.5760.58
324382-243821.1081.11
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
20min143213-432131.9651.864.821.971.874.75
242636-426361.9381.94
340009-400091.8191.83
442225-422251.9201.93
538357-383571.7441.75
639449-394491.7931.80
30min144924-449242.0421.982.432.051.992.49
244209-442092.0102.02
344152-441522.0072.02
443256-432561.9661.98
543102-431021.9591.97
641926-419261.9061.91
45min145951-459512.0892.032.502.102.042.45
245894-458942.0862.10
344377-443772.0172.03
443691-436911.9862.00
543249-432491.9661.98
644736-447362.0342.04
60min144053-440532.0032.042.332.022.062.26
245737-457372.0792.10
345706-457062.0782.09
443103-431031.9601.98
545368-453682.0622.08
644996-449962.0462.06
90min144474-444742.0222.021.882.042.041.95
245657-456572.0762.10
344397-443972.0182.04
443307-433071.9691.99
543859-438591.9942.01
645060-450602.0482.07
120min144047-440472.0021.953.182.031.973.28
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144077-440772.0041.984.942.032.004.80
245034-450342.0472.07
339868-398681.8121.84
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%
110.652112986211299821142222118000211405021144510.10
210.772164198216407221641350.01
单位质量响应值RSD%判断
198540.00200941.040.85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%
5min125828-258281.1631.129.291.161.129.32
226863-268631.2091.21
324546-245461.1051.10
420658-206580.9300.93
526891-268911.2101.21
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
15min139878-398781.7951.867.381.801.867.43
246667-466672.1012.11
342507-425071.9131.92
437841-378411.7031.71
539923-399231.7971.80
640935-409351.8431.85
20min142355-423551.9071.922.881.911.933.03
244587-445872.0072.02
343336-433361.9511.96
441001-410011.8461.85
542063-420631.8931.90
643164-431641.9431.95
30min143925-439251.9772.037.701.992.047.55
244716-447162.0132.02
352053-520532.3432.35
443117-431171.9411.95
543439-434391.9551.97
643213-432131.9451.96
45min148030-480302.1622.023.742.182.033.78
244646-446462.0102.02
343278-432781.9481.96
444556-445562.0062.02
544039-440391.9822.00
644054-440541.9832.00
60min144368-443681.9972.035.262.012.045.21
244343-443431.9962.01
344212-442121.9902.01
444285-442851.9932.01
543284-432841.9481.97
649805-498052.2422.26
90min143700-437001.9671.923.321.991.943.37
243973-439731.9792.00
342966-429661.9341.96
442687-426871.9221.94
540026-400261.8021.82
642204-422041.9001.92
120min142398-423981.9091.966.091.931.996.09
242615-426151.9181.94
343103-431031.9401.97
443069-430691.9391.96
548972-489722.2042.23
641705-417051.8771.90
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142530-425301.9141.974.641.942.004.53
242844-428441.9291.96
342741-427411.9241.95
443941-439411.9782.00
543196-431961.9441.97
647878-478782.1552.18
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%
110.652128579212648321240122121093211711721234570.22
210.772081660208048820810740.04
单位质量响应值RSD%判断
199385.63193228.782.22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%
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
10min131051-310511.4231.5812.611.421.5812.73
235518-355181.6271.63
330153-301531.3811.38
432091-320911.4701.47
541605-416051.9061.91
637124-371241.7011.70
15min135830-358301.6411.776.481.651.786.52
240843-408431.8711.88
335314-353141.6181.62
438566-385661.7671.77
540604-406041.8601.87
640528-405281.8571.86
20min137354-373541.7112.009.051.722.008.97
246440-464402.1282.14
348398-483982.2172.22
441809-418091.9151.92
545297-452972.0752.08
642360-423601.9411.95
30min140055-400551.8351.986.251.841.996.30
244266-442662.0282.04
342921-429211.9661.98
444018-440182.0172.03
547554-475542.1792.19
640816-408161.8701.88
45min142160-421601.9311.982.711.941.992.71
243741-437412.0042.02
343923-439232.0122.03
444114-441142.0212.03
543900-439002.0112.03
641290-412901.8921.91
60min142602-426021.9522.037.291.972.057.31
242225-422251.9341.95
343501-435011.9932.01
443411-434111.9892.01
543273-432731.9822.00
650809-508092.3282.35
90min141599-415991.9062.017.101.922.047.06
247108-471082.1582.18
348409-484092.2182.24
443591-435911.9972.02
542272-422721.9371.96
640724-407241.8661.89
120min143956-439562.0141.944.352.041.964.30
243254-432541.9822.01
342955-429551.9681.99
443105-431051.9752.00
541327-413271.8931.92
638953-389531.7851.81
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140430-404301.8521.967.211.881.997.03
242292-422921.9371.97
348084-480842.2032.23
443691-436912.0022.03
542550-425501.9491.98
639239-392391.7981.83
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