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%
110.492069099205358020488002065958206802120610920.45
210.552072175207411020731420.07
单位质量响应值RSD%判断
196481.60196506.350.01数据可信
供试品溶液-250601批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318052-31805214.55312.5515.1214.5512.5515.10
2299267-29926713.69413.69
3312124-31212414.28214.28
4233354-23335410.67810.68
5221780-22178010.14810.15
6260774-26077411.93211.93
10min1944389-94438943.21338.636.8743.2438.666.87
2850551-85055138.91938.95
3805136-80513636.84136.87
4791212-79121236.20436.23
5803290-80329036.75636.78
6870950-87095039.85239.88
15min11425329-142532965.21961.294.4165.3561.404.42
21317381-131738160.28060.40
31325930-132593060.67160.78
41259284-125928457.62157.73
51319105-131910560.35860.46
61389766-138976663.59263.71
20min11610566-161056673.69571.491.7273.9771.741.74
21558813-155881371.32771.58
31547117-154711770.79271.04
41532486-153248670.12270.35
51554255-155425571.11871.36
61571418-157141871.90472.16
30min11786126-178612681.72880.300.9282.1780.710.93
21751945-175194580.16480.57
31739207-173920779.58179.99
41749831-174983180.06780.46
51754011-175401180.25980.65
61748694-174869480.01580.43
45min11916798-191679887.70786.440.8188.3387.030.82
21885559-188555986.27886.87
31873946-187394685.74686.33
41887669-188766986.37486.94
51892999-189299986.61887.19
61877727-187772785.91986.51
60min11984732-198473290.81689.750.8291.6390.540.82
21956422-195642289.52090.30
31953623-195362389.39290.17
41961052-196105289.73290.49
51974215-197421590.33491.10
61939172-193917288.73189.52
极限12031357-203135792.94992.100.7493.9693.080.74
22010502-201050291.99592.97
31998028-199802891.42492.40
42018250-201825092.34993.31
52024877-202487792.65393.62
61994178-199417891.24892.23
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%
110.492089363209460720904842094207209551420928350.14
210.552069756207053720701460.03
单位质量响应值RSD%判断
199507.63196222.371.18数据可信
供试品溶液-250601批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1603336-60333627.41821.0627.2527.4221.0627.25
2242036-24203610.99911.00
3483489-48348921.97121.97
4419638-41963819.07019.07
5556283-55628325.27925.28
6475721-47572121.61821.62
10min11229668-122966855.88049.828.4455.9449.878.45
2943910-94391042.89442.92
31074579-107457948.83248.88
41125086-112508651.12851.17
51088276-108827649.45549.51
61116394-111639450.73350.78
15min11496101-149610167.98866.142.6468.1766.302.66
21391722-139172263.24463.36
31432902-143290265.11665.27
41483141-148314167.39967.55
51454808-145480866.11166.28
61474160-147416066.99167.15
20min11621420-162142073.68373.440.6374.0273.750.65
21605404-160540472.95573.22
31603314-160331472.86073.16
41629885-162988574.06774.37
51616274-161627473.44973.76
61620842-162084273.65673.97
30min11762088-176208880.07580.690.9680.5781.160.93
21806347-180634782.08682.51
31765440-176544080.22780.69
41782823-178282381.01781.49
51763866-176386680.15680.63
61773408-177340880.58981.06
45min11866861-186686184.83686.161.3785.5186.801.34
21943566-194356688.32288.93
31891756-189175685.96786.61
41899848-189984886.33586.99
51881984-188198485.52386.18
61891580-189158085.95986.61
60min11932834-193283487.83489.041.4588.7089.871.41
22013273-201327391.49092.29
31960670-196067089.09989.93
41958497-195849789.00089.84
51944687-194468788.37389.22
61945702-194570288.41989.26
极限11971748-197174889.60390.941.3390.6691.981.30
22050487-205048793.18194.19
31998838-199883890.83491.86
41999494-199949490.86391.90
51987285-198728590.30991.35
61999634-199963490.87091.91
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