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101278-202104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%
19.651887390188681618851931882481188126318846290.15
29.821901124190183219014780.03
单位质量响应值RSD%判断
195298.34193633.200.61数据可信
供试品溶液-20200718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%
5min118715-187150.8660.874.490.870.884.50
220251-202510.9370.94
319078-190780.8830.88
417852-178520.8260.83
519203-192030.8890.89
618184-181840.8420.84
10min134645-346451.6031.572.271.611.572.26
233209-332091.5371.54
335044-350441.6221.62
433452-334521.5481.55
533275-332751.5401.54
633800-338001.5641.57
15min139100-391001.8101.781.571.821.791.48
238798-387981.7961.80
339083-390831.8091.81
438726-387261.7921.80
537596-375961.7401.75
638091-380911.7631.77
20min139619-396191.8341.861.441.841.871.43
240304-403041.8651.87
340329-403291.8661.88
440858-408581.8911.90
540422-404221.8711.88
639288-392881.8181.83
30min140351-403511.8681.891.491.881.911.50
241285-412851.9111.92
341594-415941.9251.94
441551-415511.9231.94
540469-404691.8731.89
640338-403381.8671.88
45min140903-409031.8931.901.511.911.921.38
241238-412381.9091.93
341590-415901.9251.94
441628-416281.9271.94
541081-410811.9011.92
639951-399511.8491.87
60min140505-405051.8751.911.801.901.931.71
240688-406881.8831.91
342135-421351.9501.97
442087-420871.9481.97
541248-412481.9091.93
640629-406291.8801.90
90min140834-408341.8901.890.581.921.920.64
240721-407211.8851.91
340757-407571.8861.91
441116-411161.9031.93
541169-411691.9051.93
640564-405641.8771.90
120min140162-401621.8591.880.921.891.910.78
240351-403511.8681.90
340519-405191.8751.91
440900-409001.8931.92
541141-411411.9041.93
640337-403371.8671.90
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140249-402491.8631.901.351.901.931.26
240962-409621.8961.93
340895-408951.8931.93
441916-419161.9401.97
541281-412811.9111.95
640844-408441.8901.92
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101278-202104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%
19.651879908187920918789081878926187908618792070.03
29.821901686190008919008880.06
单位质量响应值RSD%判断
194736.48193573.120.43数据可信
供试品溶液-20200718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%
5min121509-215090.9970.6144.161.000.6044.62
210456-104560.4850.48
311206-112060.5190.52
47173-71730.3330.33
59120-91200.4230.42
618989-189890.8800.88
10min134204-342041.5861.3314.761.591.3414.72
226756-267561.2401.24
328647-286471.3281.33
424924-249241.1551.16
524542-245421.1381.14
633662-336621.5601.56
15min139336-393361.8231.685.581.831.695.56
235379-353791.6401.64
336269-362691.6811.69
434856-348561.6161.62
533904-339041.5721.58
637936-379361.7591.76
20min139918-399181.8501.801.811.861.811.87
238255-382551.7731.78
339271-392711.8201.83
438298-382981.7751.78
538208-382081.7711.78
639123-391231.8141.82
30min140810-408101.8921.852.201.911.862.21
238713-387131.7951.81
340362-403621.8711.88
440405-404051.8731.88
538852-388521.8011.81
640073-400731.8581.87
45min140519-405191.8781.861.301.901.881.39
240022-400221.8551.87
340991-409911.9001.92
439624-396241.8371.85
540131-401311.8601.88
639676-396761.8391.86
60min140786-407861.8911.871.521.911.891.48
240327-403271.8691.89
340548-405481.8801.90
440929-409291.8971.92
539418-394181.8271.85
639701-397011.8401.86
90min140059-400591.8571.842.311.881.862.32
239578-395781.8351.86
340673-406731.8851.91
438617-386171.7901.81
538694-386941.7941.82
640666-406661.8851.91
120min138852-388521.8011.872.311.831.902.27
239558-395581.8341.86
341041-410411.9021.93
440982-409821.9001.93
540571-405711.8811.91
641093-410931.9051.93
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142299-422991.9611.921.982.001.952.09
241289-412891.9141.95
341860-418601.9401.97
440963-409631.8991.93
539942-399421.8521.88
641608-416081.9291.96
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101278-202104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%
19.651897965189556618968531896183189479718962730.07
29.821901934190119819015660.03
单位质量响应值RSD%判断
196504.97193642.161.04数据可信
供试品溶液-20200721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%
5min135298-352981.6291.5218.281.631.5218.32
242204-422041.9471.95
333410-334101.5421.54
426640-266401.2291.23
526011-260111.2001.20
634712-347121.6021.60
10min136117-361171.6661.705.421.671.715.48
239690-396901.8311.84
338763-387631.7881.79
436157-361571.6681.67
536481-364811.6831.69
634186-341861.5771.58
15min139095-390951.8041.812.021.811.822.00
240159-401591.8531.86
339728-397281.8331.84
439597-395971.8271.83
538717-387171.7861.79
637983-379831.7521.76
20min138859-388591.7931.852.401.801.862.45
240319-403191.8601.87
341411-414111.9111.92
440373-403731.8631.87
540478-404781.8681.88
639080-390801.8031.81
30min139874-398741.8401.872.501.861.892.53
241345-413451.9081.92
340626-406261.8741.89
442276-422761.9511.97
539856-398561.8391.85
639791-397911.8361.85
45min140325-403251.8611.861.961.881.881.99
239275-392751.8121.83
341604-416041.9201.94
440329-403291.8611.88
540327-403271.8611.88
639723-397231.8331.85
60min139879-398791.8401.872.321.861.902.35
242378-423781.9551.98
340879-408791.8861.91
439828-398281.8381.86
540399-403991.8641.89
640385-403851.8631.89
90min139242-392421.8111.862.591.841.892.63
241010-410101.8921.92
341769-417691.9271.96
440347-403471.8621.89
540878-408781.8861.91
639106-391061.8041.83
120min139715-397151.8321.863.481.861.893.42
239498-394981.8221.86
342599-425991.9652.00
441458-414581.9131.94
538969-389691.7981.83
639646-396461.8291.86
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139435-394351.8191.872.001.861.911.92
241163-411631.8991.94
341532-415321.9161.95
440025-400251.8471.88
541129-411291.8981.93
640276-402761.8581.89
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101278-202104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%
19.651878786187993918784691880583187624918788050.09
29.821910029190845319092410.06
单位质量响应值RSD%判断
194694.82194423.730.10数据可信
供试品溶液-20200721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%
5min122740-227401.0521.1823.871.051.1823.88
223021-230211.0651.06
319879-198790.9200.92
434373-343731.5901.59
532059-320591.4831.48
621173-211730.9790.98
10min134293-342931.5861.624.701.591.624.80
234576-345761.5991.60
335291-352911.6331.63
437549-375491.7371.74
535954-359541.6631.67
632688-326881.5121.51
15min137659-376591.7421.772.981.751.773.02
237866-378661.7521.76
338636-386361.7871.79
440226-402261.8611.87
537421-374211.7311.74
637144-371441.7181.72
20min138272-382721.7701.792.201.781.802.15
238523-385231.7821.79
339447-394471.8251.83
440026-400261.8521.86
538721-387211.7911.80
637649-376491.7421.75
30min139652-396521.8341.831.151.851.841.18
239263-392631.8161.83
340259-402591.8621.88
439150-391501.8111.83
539664-396641.8351.85
639029-390291.8051.82
45min140665-406651.8811.881.731.901.901.75
240137-401371.8571.87
341471-414711.9181.94
441179-411791.9051.92
540820-408201.8881.91
639543-395431.8291.85
60min140448-404481.8711.861.501.891.881.41
239438-394381.8241.85
340596-405961.8781.90
440297-402971.8641.89
539298-392981.8181.84
640653-406531.8811.90
90min140549-405491.8761.841.201.901.871.06
239582-395821.8311.86
339603-396031.8321.86
439837-398371.8431.87
539106-391061.8091.84
639786-397861.8401.87
120min138654-386541.7881.812.411.821.842.35
238840-388401.7971.83
338761-387611.7931.82
441047-410471.8991.93
538593-385931.7851.82
639378-393781.8221.85
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141883-418831.9371.882.361.971.922.26
239814-398141.8421.88
341747-417471.9311.97
440244-402441.8621.90
539998-399981.8501.89
639857-398571.8441.88
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