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%
110.011491472149490314928761491578149168314925020.10
210.221499104150096615000350.09
单位质量响应值RSD%判断
149101.10146774.461.12数据可信
供试品溶液-3786A批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1478874-47887429.13526.5113.7929.1326.5113.79
2399957-39995724.33324.33
3329498-32949820.04720.05
4454748-45474827.66727.67
5481419-48141929.29029.29
6469885-46988528.58828.59
10min1945560-94556057.52857.363.3357.5957.423.34
2949448-94944857.76557.82
3880928-88092853.59653.64
4956307-95630758.18258.24
5968997-96899758.95459.02
6955221-95522158.11658.18
15min11123990-112399068.38469.292.0968.5869.482.09
21132719-113271968.91569.10
31102367-110236767.06867.23
41157486-115748670.42270.61
51165476-116547670.90871.10
61151721-115172170.07170.26
20min11215840-121584073.97274.811.2274.3275.151.22
21223441-122344174.43474.77
31217366-121736674.06574.38
41253847-125384776.28476.63
51226175-122617574.60174.95
61241085-124108575.50875.86
30min11326747-132674780.71981.871.4881.2382.381.48
21332034-133203481.04181.54
31352607-135260782.29382.77
41379003-137900383.89984.42
51330700-133070080.96081.48
61352900-135290082.31182.83
45min11434506-143450687.27687.251.7587.9687.931.75
21434401-143440187.26987.95
31398413-139841385.08085.74
41474367-147436789.70190.40
51420752-142075286.43987.14
61441667-144166787.71188.41
60min11472066-147206689.56190.733.4490.4491.623.43
21502295-150229591.40092.27
31419558-141955886.36687.22
41573735-157373595.74696.65
51471144-147114489.50590.40
61509174-150917491.81892.71
极限11527144-152714492.91293.103.6593.9994.183.64
21554470-155447094.57495.65
31429152-142915286.95087.99
41598368-159836897.24598.36
51541212-154121293.76894.86
61530830-153083093.13694.23
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%
110.011505170150828315095611510561150998415087120.15
210.221548080154861815483490.03
单位质量响应值RSD%判断
150720.48151501.860.37数据可信
供试品溶液-3786A批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1478439-47843928.49527.8117.7328.5027.8117.73
2318937-31893718.99619.00
3574227-57422734.20134.20
4463885-46388527.62927.63
5492883-49288329.35629.36
6473334-47333428.19128.19
10min1926697-92669755.19354.105.2055.2654.165.21
2832918-83291849.60849.65
3972384-97238457.91457.99
4885648-88564852.74852.81
5929424-92942455.35655.42
6902519-90251953.75353.82
15min11100799-110079965.56365.541.9365.7565.721.95
21067959-106795963.60763.76
31131256-113125667.37767.58
41092722-109272265.08265.26
51113503-111350366.31966.51
61096326-109632665.29665.48
20min11198999-119899971.41171.631.8871.7471.951.89
21158735-115873569.01369.31
31217236-121723672.49872.85
41210685-121068572.10772.43
51212019-121201972.18772.52
61218045-121804572.54672.87
30min11313729-131372978.24578.950.7278.7479.440.74
21315208-131520878.33378.78
31338439-133843979.71680.23
41329036-132903679.15679.64
51331045-133104579.27679.77
61325857-132585778.96779.46
45min11397013-139701383.20584.661.3283.8785.331.29
21454002-145400286.59987.22
31424400-142440084.83685.53
41414849-141484984.26784.93
51422864-142286484.74585.42
61415936-141593684.33285.00
60min11464561-146456187.22887.730.6888.0888.580.68
21473608-147360887.76788.58
31485088-148508888.45189.33
41476817-147681787.95888.80
51479648-147964888.12788.99
61458337-145833786.85787.71
极限11525568-152556890.86291.350.4291.9092.400.43
21531637-153163791.22392.23
31543152-154315291.90992.99
41531150-153115091.19492.24
51531919-153191991.24092.30
61539593-153959391.69792.74
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%
110.011500067150164615019531502640150082015014250.07
210.221555644155363715546400.10
单位质量响应值RSD%判断
149992.51152117.421.00数据可信
供试品溶液-3785B批-pH5.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1517918-51791830.86032.516.3530.8632.516.35
2513817-51381730.61530.62
3518414-51841430.88930.89
4581638-58163834.65634.66
5592116-59211635.28135.28
6549663-54966332.75132.75
10min1998904-99890459.51958.731.8259.5958.801.82
2957259-95725957.03757.11
3972973-97297357.97458.04
4995801-99580159.33459.41
5984909-98490958.68558.76
61004397-100439759.84659.92
15min11155547-115554768.85267.115.1269.0567.315.10
21127820-112782067.20067.39
31138671-113867167.84668.04
41153080-115308068.70568.91
51012538-101253860.33160.54
61170087-117008769.71869.92
20min11234153-123415373.53673.341.3373.8973.691.33
21220678-122067872.73373.08
31217513-121751372.54472.89
41237480-123748073.73474.10
51216569-121656972.48872.83
61258942-125894275.01375.37
30min11329512-132951279.21879.231.1179.7379.751.12
21324730-132473078.93379.44
31314878-131487878.34678.86
41346446-134644680.22780.75
51314909-131490978.34778.85
61348163-134816380.32980.86
45min11414327-141432784.27184.181.0184.9684.871.02
21402915-140291583.59184.27
31405394-140539483.73984.42
41420119-142011984.61685.32
51397744-139774483.28383.96
61436713-143671385.60586.31
60min11468679-146867987.51087.500.9288.3988.380.92
21454895-145489586.68887.56
31461066-146106687.05687.93
41480920-148092088.23989.13
51457498-145749886.84387.71
61488196-148819688.67389.57
极限11520715-152071590.61090.431.4091.6991.501.40
21511076-151107690.03691.10
31488919-148891988.71689.78
41532257-153225791.29892.39
51504256-150425689.62990.69
61548915-154891592.29093.38
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