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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.201943868194363019435051942091194119219428570.06
210.211958179195604419571120.08
单位质量响应值RSD%判断
190476.18191685.800.45数据可信
供试品溶液-2024112321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%
5min17571-75710.3570.8339.230.360.8339.03
227401-274011.2911.29
316532-165320.7790.78
417375-173750.8180.82
513805-138050.6500.65
622555-225551.0621.06
10min122058-220581.0391.279.971.041.2710.00
230057-300571.4161.42
328027-280271.3201.32
426623-266231.2541.26
526714-267141.2581.26
627979-279791.3181.32
15min130874-308741.4541.595.601.461.605.62
235931-359311.6921.70
333013-330131.5551.56
435255-352551.6611.67
534734-347341.6361.64
632742-327421.5421.55
20min137356-373561.7601.763.251.771.773.26
239109-391091.8421.85
337097-370971.7471.76
438348-383481.8061.81
536986-369861.7421.75
635579-355791.6761.68
30min137514-375141.7671.843.861.781.853.86
240508-405081.9081.92
338534-385341.8151.83
440901-409011.9261.94
539713-397131.8711.88
637379-373791.7611.77
45min139660-396601.8681.898.711.881.918.59
241331-413311.9471.96
338280-382801.8031.82
438133-381331.7961.81
546688-466882.1992.21
637104-371041.7481.76
60min140051-400511.8861.855.001.901.874.88
240311-403111.8991.92
337739-377391.7781.80
438410-384101.8091.83
542210-422101.9882.01
636866-368661.7361.76
极限141143-411431.9381.892.901.961.912.95
241124-411241.9371.96
338858-388581.8301.85
440368-403681.9011.93
540477-404771.9071.93
638423-384231.8101.83
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.201946230194597119457361945541194500719456970.03
210.211981829198526119835450.13
单位质量响应值RSD%判断
190754.61194274.731.30数据可信
供试品溶液-2024112321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%
5min124366-243661.1390.7329.171.140.7329.35
215271-152710.7140.71
315056-150560.7040.70
410922-109220.5110.51
513501-135010.6310.63
614760-147600.6900.69
10min123445-234451.0961.3523.631.101.3523.63
225159-251591.1761.18
342022-420221.9651.97
425021-250211.1701.17
527950-279501.3071.31
629604-296041.3841.39
15min132174-321741.5041.5913.361.511.6013.14
233451-334511.5641.57
331467-314671.4711.48
442968-429682.0092.01
533857-338571.5831.59
630407-304071.4221.43
20min135598-355981.6641.672.571.671.682.63
235316-353161.6511.66
335651-356511.6671.68
437364-373641.7471.76
536196-361961.6921.70
634646-346461.6201.63
30min137603-376031.7581.782.121.771.792.20
237579-375791.7571.77
336833-368331.7221.73
439038-390381.8251.84
538391-383911.7951.81
638569-385691.8031.81
45min138680-386801.8081.782.101.821.792.05
238076-380761.7801.80
337594-375941.7581.77
438887-388871.8181.83
538186-381861.7851.80
636685-366851.7151.73
60min139532-395321.8481.812.621.871.832.55
240031-400311.8721.89
337869-378691.7711.79
437831-378311.7691.79
539345-393451.8401.86
637789-377891.7671.79
极限140443-404431.8911.853.471.911.883.36
241831-418311.9561.98
338137-381371.7831.81
439911-399111.8661.89
539316-393161.8381.86
638385-383851.7951.82
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.201958518195911119571301957557195686019578350.05
210.211944302194350919439060.03
单位质量响应值RSD%判断
191944.61190392.360.58数据可信
供试品溶液-2024112421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%
5min117415-174150.8200.9320.190.820.9320.39
215135-151350.7130.71
325895-258951.2191.22
423144-231441.0901.09
518154-181540.8550.85
618762-187620.8830.88
10min131181-311811.4681.5315.531.471.5415.47
242663-426632.0092.01
330616-306161.4411.44
431017-310171.4601.46
531320-313201.4751.48
628565-285651.3451.35
15min136419-364191.7151.727.201.721.727.13
234793-347931.6381.64
336056-360561.6981.70
441563-415631.9571.96
535298-352981.6621.67
634458-344581.6221.63
20min155167-551672.5971.9117.652.611.9217.66
236575-365751.7221.73
338358-383581.8061.82
436962-369621.7401.75
538554-385541.8151.82
638104-381041.7941.80
30min138996-389961.8361.812.041.851.821.92
239090-390901.8401.85
337199-371991.7511.77
438403-384031.8081.82
537849-378491.7821.79
639114-391141.8411.85
45min139383-393831.8541.852.281.871.872.23
239003-390031.8361.85
339998-399981.8831.90
438747-387471.8241.84
538413-384131.8081.83
640856-408561.9231.94
60min137140-371401.7491.803.041.771.823.06
237501-375011.7661.79
339581-395811.8631.89
438061-380611.7921.81
537570-375701.7691.79
639910-399101.8791.90
极限139623-396231.8651.905.271.891.925.19
240298-402981.8971.92
339924-399241.8801.91
438567-385671.8161.84
539157-391571.8431.87
644496-444962.0952.12
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.201954282195415519538111953979195236519537180.04
210.211995777199334519945610.09
单位质量响应值RSD%判断
191540.98195353.671.40数据可信
供试品溶液-2024112421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%
5min124116-241161.1221.1526.581.121.1426.61
214425-144250.6710.67
327658-276581.2871.29
420261-202610.9430.94
528581-285811.3301.33
632752-327521.5241.52
10min141210-412101.9171.6121.211.921.6221.06
232119-321191.4941.50
344659-446592.0782.08
426595-265951.2371.24
536105-361051.6801.68
627343-273431.2721.28
15min138108-381081.7731.8816.841.781.8916.78
245824-458242.1322.14
343280-432802.0142.02
434060-340601.5851.59
549315-493152.2952.30
632082-320821.4931.50
20min137496-374961.7451.8912.401.761.9012.21
245015-450152.0942.10
340389-403891.8791.89
446626-466262.1692.18
532795-327951.5261.54
640840-408401.9001.91
30min143652-436522.0311.828.782.051.848.79
242720-427201.9882.00
336308-363081.6891.71
436137-361371.6811.69
539994-399941.8611.88
636305-363051.6891.70
45min132768-327681.5251.7514.521.541.7714.45
232475-324751.5111.53
341182-411821.9161.94
435933-359331.6721.69
546633-466332.1702.19
636293-362931.6891.71
60min145110-451102.0991.979.402.121.999.12
246440-464402.1612.18
340052-400521.8641.89
442108-421081.9591.98
535712-357121.6621.69
644689-446892.0792.10
极限134985-349851.6281.9513.131.651.9812.95
244354-443542.0642.09
335468-354681.6501.68
447597-475972.2152.24
542419-424191.9742.00
646731-467312.1742.20
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