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(%)100.0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%
110.151925805192492519255101925533192450619252560.03
210.191938306194002519391660.07
单位质量响应值RSD%判断
189680.39190300.880.24数据可信
供试品溶液-2024092212批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1614057-61405729.08827.9518.3129.0927.9518.31
2393866-39386618.65818.66
3592682-59268228.07628.08
4700649-70064933.19033.19
5567850-56785026.90026.90
6670896-67089631.78131.78
10min11261558-126155859.76157.575.2259.8357.645.23
21098706-109870652.04752.09
31217882-121788257.69257.75
41281048-128104860.68460.76
51214704-121470457.54257.60
61218486-121848657.72157.79
15min11475361-147536169.88968.801.8370.0968.981.85
21413890-141389066.97767.13
31445344-144534468.46768.66
41485547-148554770.37270.58
51458569-145856969.09469.28
61434951-143495167.97568.17
20min11587453-158745375.19974.591.0575.5574.941.06
21557126-155712673.76274.07
31567815-156781574.26974.61
41594057-159405775.51275.88
51585073-158507375.08675.43
61556245-155624573.72174.07
30min11722033-172203381.57481.240.6982.0981.750.70
21707054-170705480.86581.33
31705327-170532780.78381.29
41724071-172407181.67182.20
51729780-172978081.94182.45
61701515-170151580.60281.12
45min11846190-184619087.45687.010.9988.1687.701.00
21823768-182376886.39387.04
31821584-182158486.29086.98
41858481-185848188.03888.75
51853870-185387087.81988.51
61816848-181684886.06686.76
60min11912790-191279090.61190.020.8891.5190.900.89
21891077-189107789.58290.42
31875499-187549988.84489.72
41896715-189671589.84990.76
51923062-192306291.09791.98
61903237-190323790.15891.04
极限11937892-193789291.80092.650.6892.9093.730.67
21954247-195424792.57493.62
31954321-195432192.57893.65
41952380-195238092.48693.60
51978650-197865093.73094.82
61957532-195753292.73093.81
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(%)100.0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%
110.151924348192449019234311924913192341119241190.04
210.191923731192361519236730.01
单位质量响应值RSD%判断
189568.37188780.470.30数据可信
供试品溶液-2024092212批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373747-37374717.78126.6817.6217.7826.6817.62
2542831-54283125.82525.83
3582447-58244727.71027.71
4594113-59411328.26528.27
5618173-61817329.41029.41
6653645-65364531.09731.10
10min11061147-106114750.48455.646.3850.5255.706.39
21129420-112942053.73353.79
31234384-123438458.72658.79
41216639-121663957.88257.94
51126974-112697453.61653.68
61248337-124833759.39059.46
15min11425846-142584667.83568.102.1067.9968.282.11
21391835-139183566.21766.39
31468287-146828769.85470.05
41444161-144416168.70668.90
51402982-140298266.74766.93
61455236-145523669.23369.43
20min11575180-157518074.94074.271.3475.2474.611.33
21525947-152594772.59772.92
31586002-158600275.45575.80
41563097-156309774.36574.71
51552017-155201773.83874.17
61564958-156495874.45374.81
30min11725284-172528482.08181.261.2082.5581.761.20
21672185-167218579.55580.04
31727247-172724782.17482.69
41701662-170166280.95781.47
51717615-171761581.71682.21
61704024-170402481.07081.59
45min11837695-183769587.42986.781.0788.0887.461.07
21788843-178884385.10585.77
31840617-184061787.56888.27
41816249-181624986.40987.10
51835617-183561787.33088.01
61824834-182483486.81787.52
60min11899532-189953290.37189.861.2291.2290.731.22
21849414-184941487.98788.84
31912012-191201290.96591.86
41876671-187667189.28390.16
51905270-190527090.64491.52
61889465-188946589.89290.79
极限11948072-194807292.68092.281.2793.7393.351.27
21896811-189681190.24191.29
31961853-196185393.33694.43
41928532-192853291.75192.83
51961821-196182193.33494.41
61940816-194081692.33593.43
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(%)100.0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%
110.151935846193570319337691931443192921119331940.15
210.191924963192487319249180.01
单位质量响应值RSD%判断
190462.46188902.650.59数据可信
供试品溶液-2024092213批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338522-33852216.06228.5926.1216.0628.6026.13
2665995-66599531.60031.60
3607760-60776028.83728.84
4510496-51049624.22224.22
5755251-75525135.83635.84
6737841-73784135.00935.01
10min1941951-94195144.69456.1211.4344.7356.1811.44
21251355-125135559.37559.45
31145498-114549854.35254.42
41164870-116487055.27155.33
51272829-127282960.39460.47
61319784-131978462.62262.70
15min11315533-131553362.42068.164.3662.5668.344.39
21470297-147029769.76369.97
31435016-143501668.08968.27
41438151-143815168.23868.41
51483381-148338170.38470.60
61476224-147622470.04570.26
20min11501542-150154271.24674.522.2771.5274.862.31
21593904-159390475.62875.99
31585235-158523575.21775.55
41563955-156395574.20774.54
51594577-159457775.66076.03
61583940-158394075.15675.53
30min11693330-169333080.34681.761.0580.7882.271.09
21738949-173894982.51183.04
31729099-172909982.04382.55
41709039-170903981.09181.58
51734977-173497782.32282.86
61733875-173387582.27082.81
45min11831168-183116886.88687.520.8187.5088.210.83
21864235-186423588.45589.16
31858069-185806988.16388.85
41831679-183167986.91087.58
51850381-185038187.79888.52
61831841-183184186.91887.64
60min11894252-189425289.87990.610.7690.6891.490.77
21926919-192691991.42992.33
31921538-192153891.17492.06
41901207-190120790.20991.08
51918508-191850891.03091.95
61895451-189545189.93690.85
极限11945640-194564092.31893.040.7993.3294.130.79
21975576-197557693.73894.85
31969712-196971293.46094.54
41965915-196591593.28094.35
51970707-197070793.50794.63
61937899-193789991.95093.07
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(%)100.0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%
110.151945132194532519443061944786194163719442370.08
210.191936888193737819371330.02
单位质量响应值RSD%判断
191550.44190101.370.54数据可信
供试品溶液-2024092213批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1579653-57965327.33926.2522.9227.3426.2522.92
2605390-60539028.55328.55
3674211-67421131.79931.80
4341757-34175716.11916.12
5664586-66458631.34531.34
6474082-47408222.36022.36
10min11258728-125872859.36756.0811.1559.4356.1411.16
21231851-123185158.09958.16
31281151-128115160.42460.49
4944251-94425144.53544.57
51286100-128610060.65860.73
61132156-113215653.39753.45
15min11487714-148771470.16768.235.5870.3668.425.61
21518224-151822471.60671.80
31481851-148185169.89070.10
41311342-131134261.84861.98
51495668-149566870.54270.75
61385218-138521865.33365.50
20min11613042-161304276.07874.623.7576.4374.953.77
21652316-165231677.93078.28
31593759-159375975.16875.53
41489245-148924570.23970.51
51608569-160856975.86776.23
61535595-153559572.42572.74
30min11757415-175741582.88782.072.5683.4082.582.58
21796346-179634684.72385.25
31726130-172613081.41181.94
41662743-166274378.42278.85
51744904-174490482.29782.83
61753584-175358482.70683.18
45min11882305-188230588.77787.192.4389.4887.872.46
21914684-191468490.30491.02
31832681-183268186.43787.14
41790396-179039684.44285.04
51853707-185370787.42888.14
61818267-181826785.75786.42
60min11950478-195047891.99390.452.3692.8991.332.38
21978265-197826593.30394.22
31892080-189208089.23890.14
41857311-185731187.59888.39
51938092-193809291.40892.32
61890400-189040089.15990.01
极限12004351-200435194.53392.951.9795.6494.021.99
22024236-202423695.47196.59
31938828-193882891.44392.54
41927998-192799890.93291.92
51981654-198165493.46394.57
61947017-194701791.82992.88
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