厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166467564595645976446964450645570.15
210.116460764482645440.14
单位质量响应值RSD%判断
6354.046384.170.34数据可信
供试品溶液-BJ86589批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15986-59868.45214.2961.168.4514.2961.18
210895-1089515.38315.38
36986-69869.8649.86
47333-733310.35410.35
522287-2228731.46831.47
67244-724410.22810.23
10min123312-2331232.91537.1542.0033.0137.3142.08
225282-2528235.69735.87
320998-2099829.64829.76
420435-2043528.85328.97
548449-4844968.40868.76
619404-1940427.39727.51
15min130391-3039142.91147.5830.8243.3748.1531.01
232166-3216645.41745.98
330842-3084243.54743.99
428244-2824439.87940.31
554442-5444276.86977.98
626110-2611036.86637.28
20min136154-3615451.04854.3223.6251.9855.4223.92
236629-3662951.71852.79
337152-3715252.45753.38
433246-3324646.94247.82
556418-5641879.65981.62
631211-3121144.06844.90
30min144414-4441462.71064.8517.0064.2166.5617.41
245727-4572764.56466.21
344986-4498663.51865.02
440938-4093857.80259.20
560882-6088285.96288.81
638645-3864554.56555.88
45min151454-5145472.65075.4411.7174.8577.8612.20
255141-5514177.85680.22
353476-5347675.50577.72
448987-4898769.16771.21
564647-6464791.27895.08
646862-4686266.16768.09
60min157250-5725080.83481.537.5183.8484.798.10
258896-5889683.15886.39
358071-5807181.99385.04
454690-5469077.21980.03
565126-6512691.95596.77
652415-5241574.00776.67
90min160938-6093886.04187.992.1989.9592.162.90
263011-6301188.96893.12
362727-6272788.56792.53
462222-6222287.85491.52
564333-6433390.83596.67
660684-6068485.68389.16
120min163258-6325889.31790.982.3394.1896.121.87
263970-6397090.32295.46
365474-6547492.44697.39
463781-6378190.05694.70
563149-6314989.16396.01
666974-6697494.56499.00
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162481-6248188.22090.101.3394.0796.251.33
263301-6330189.37895.52
364574-6457491.17597.15
464433-6443390.97696.62
563561-6356189.74597.58
664516-6451691.09396.58
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.166476064735647466464964653647090.09
210.116486464813648380.06
单位质量响应值RSD%判断
6369.006413.250.49数据可信
供试品溶液-BJ86589批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117185-1718524.18119.9619.6024.1819.9619.59
213698-1369819.27419.27
312213-1221317.18517.18
417393-1739324.47424.47
514336-1433620.17220.17
610289-1028914.47814.48
10min148780-4878068.63864.576.8968.9164.806.93
246225-4622565.04365.26
343243-4324360.84761.04
449092-4909269.07769.35
546916-4691666.01566.24
641087-4108757.81357.97
15min158794-5879482.72981.901.8683.7682.841.93
258282-5828282.00882.95
356738-5673879.83680.70
458980-5898082.99084.03
559386-5938683.56284.52
657059-5705980.28781.09
20min162432-6243287.84887.180.7989.8089.020.81
262437-6243787.85589.70
361270-6127086.21387.97
461858-6185887.04089.00
561518-6151886.56288.45
662208-6220887.53289.23
30min165299-6529991.88292.431.0994.8195.241.01
265049-6504991.53094.35
366727-6672793.89196.60
465080-6508091.57494.50
566403-6640393.43596.28
665554-6555492.24194.91
45min165323-6532391.91693.100.8395.8696.950.79
266723-6672393.88597.73
365817-6581792.61196.37
466133-6613393.05597.00
566766-6676693.94697.83
666231-6623193.19396.89
60min164123-6412390.22791.310.8095.2096.190.70
265005-6500591.46896.35
364926-6492691.35796.14
464468-6446890.71295.69
565444-6544492.08697.02
665397-6539792.02096.75
90min163335-6333589.11890.771.1595.0996.671.06
264739-6473991.09496.99
364051-6405190.12695.93
464460-6446090.70196.69
565309-6530991.89697.85
665173-6517391.70497.46
120min162780-6278088.33789.851.9095.3096.751.75
263602-6360289.49496.41
362435-6243587.85294.65
463833-6383389.81996.81
564893-6489391.31098.28
665579-6557992.27699.05
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162544-6254488.00588.320.6195.9596.220.57
262559-6255988.02695.93
362444-6244487.86595.64
463195-6319588.92196.92
562563-6256388.03296.02
663320-6332089.09796.89
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.161300851300261299091301311299781300260.07
210.111305841306181306010.02
单位质量响应值RSD%判断
12797.8312918.000.67数据可信
供试品溶液-BXK6BP1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120106-2010614.06210.2021.2014.0610.2021.20
213990-139909.7859.78
313623-136239.5289.53
413965-139659.7679.77
515150-1515010.59610.60
610671-106717.4637.46
10min157873-5787340.47732.7013.0540.6332.8213.08
245497-4549731.82131.93
345280-4528031.66931.78
443538-4353830.45130.56
548365-4836533.82733.94
639993-3999327.97228.05
15min189859-8985962.84956.235.9463.4556.706.00
278108-7810854.63055.09
378613-7861354.98355.44
480577-8057756.35756.80
577917-7791754.49654.99
677301-7730154.06554.46
20min1104236-10423672.90467.693.9674.2168.794.05
295213-9521366.59367.66
396140-9614067.24268.31
496797-9679767.70168.77
594808-9480866.31067.41
693466-9346665.37166.37
30min1116659-11665981.59378.671.8483.7180.521.96
2111521-11152177.99979.81
3111824-11182478.21180.03
4111861-11186178.23780.06
5111853-11185378.23180.07
6111165-11116577.75079.47
45min1124580-12458087.13385.750.9090.1588.471.01
2121613-12161385.05887.73
3122176-12217685.45188.14
4122785-12278585.87788.57
5121683-12168385.10787.81
6122746-12274685.85088.43
60min1127927-12792789.47488.700.6893.4692.380.77
2125679-12567987.90291.52
3127061-12706188.86892.50
4127592-12759289.24092.89
5126265-12626588.31191.96
6126437-12643788.43291.97
90min1132018-13201892.33589.571.5797.3294.241.65
2126862-12686288.72993.33
3127557-12755789.21593.84
4126703-12670388.61893.26
5128111-12811189.60394.23
6127127-12712788.91493.44
120min1128588-12858889.93689.080.6395.9594.740.73
2126748-12674888.64994.23
3126339-12633988.36393.98
4127221-12722188.98094.61
5127785-12778589.37595.00
6127475-12747589.15894.67
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1129053-12905390.26188.651.5897.2795.301.55
2125566-12556687.82394.39
3127001-12700188.82695.42
4125743-12574387.94694.56
5124097-12409786.79593.42
6129008-12900890.23096.73
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