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101278-202003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250
标示量(mg)40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%
19.753808744380594137972813803596379596838023060.15
29.793846860384577738463180.02
单位质量响应值RSD%判断
389980.10392882.330.53数据可信
供试品溶液-4226B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11522769-152276935.01341.6520.1635.0141.6420.16
21922423-192242344.20244.20
31589741-158974136.55336.55
41388621-138862131.92831.93
52166744-216674449.82049.82
62277000-227700052.35552.35
10min13396447-339644778.09477.007.4178.1777.097.42
23350476-335047677.03777.14
33047224-304722470.06470.15
43074905-307490570.70170.77
53628233-362823383.42383.53
63595474-359547482.67082.79
15min13807128-380712887.53786.924.5487.7987.184.56
23800957-380095787.39587.66
33591496-359149682.57982.82
43566186-356618681.99782.22
53984444-398444491.61491.91
63930828-393082890.38190.68
20min14008059-400805992.15791.463.7792.6091.913.79
24000093-400009391.97492.44
33822129-382212987.88288.30
43777119-377711986.84787.26
54112570-411257094.56095.06
64145633-414563395.32095.82
30min14156219-415621995.56394.922.9096.2195.582.93
24156179-415617995.56296.23
34009229-400922992.18492.80
43961915-396191591.09691.70
54274555-427455598.28498.99
64210710-421071096.81697.53
45min14181961-418196196.15595.652.8197.0296.522.84
24176762-417676296.03696.92
34043644-404364492.97593.80
44003521-400352192.05292.86
54307979-430797999.05399.98
64246561-424656197.64198.57
60min14165542-416554295.77895.542.5496.8596.632.57
24173728-417372895.96697.06
34038229-403822992.85093.88
44026528-402652892.58193.59
54286735-428673598.56499.71
64241796-424179697.53198.68
极限14154101-415410195.51595.252.9496.8096.542.97
24160393-416039395.65996.97
34005914-400591492.10793.34
43998742-399874291.94393.16
54306738-430673899.024100.39
64228558-422855897.22798.59
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101278-202003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250
标示量(mg)40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%
19.753802809380971738058193807738379987838051920.11
29.793798177382016438091700.41
单位质量响应值RSD%判断
390276.10389087.840.22数据可信
供试品溶液-4226B批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11669328-166932838.55445.5714.3938.5545.5714.40
22260010-226001052.19752.20
31729938-172993839.95439.95
42217332-221733251.21151.21
51747154-174715440.35240.35
62214667-221466751.15051.15
10min13490758-349075880.62281.043.4180.7181.143.42
23617054-361705483.53983.65
33369879-336987977.83077.92
43613268-361326883.45183.57
53363371-336337177.68077.77
63597822-359782283.09583.21
15min13798306-379830687.72589.502.0787.9989.782.09
23936213-393621390.91091.21
33802892-380289287.83188.09
43954118-395411891.32491.62
53805365-380536587.88888.15
63953781-395378191.31691.61
20min13999556-399955692.37393.781.5792.8394.261.59
24117286-411728695.09295.60
34015332-401533292.73793.19
44131003-413100395.40995.91
53995084-399508492.27092.73
64104330-410433094.79395.29
30min14135884-413588495.52297.021.1096.1997.711.12
24236883-423688397.85498.57
34180122-418012296.54397.21
44247177-424717798.09298.81
54166245-416624596.22396.89
64237563-423756397.87098.58
45min14179413-417941396.52797.921.2497.4098.821.26
24289693-428969399.074100.01
34220299-422029997.47198.35
44291110-429111099.107100.04
54182000-418200096.58797.46
64275515-427551598.74699.68
60min14168826-416882696.28297.421.2097.3798.541.22
24264268-426426898.48799.64
34182775-418277596.60597.70
44274156-427415698.71599.87
54166677-416667796.23397.32
64251465-425146598.19199.34
极限14163418-416341896.15897.241.3997.4698.581.41
24269046-426904698.59799.97
34156001-415600195.98697.30
44258617-425861798.35699.73
54151575-415157595.88497.19
64262001-426200198.43499.80
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101278-202003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250
标示量(mg)40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%
19.753950303395071539587703961399395377239549920.13
29.793891858388999638909270.04
单位质量响应值RSD%判断
405640.21397438.921.45数据可信
供试品溶液-4226B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%
5min11248060-124806027.97725.4913.0427.9825.4913.04
21308287-130828729.32729.33
3987422-98742222.13422.13
41197520-119752026.84426.84
51149327-114932725.76325.76
6932233-93223320.89720.90
10min12252381-225238150.49051.572.3050.5551.632.30
22347131-234713152.61352.68
32319174-231917451.98752.04
42236122-223612250.12550.18
52367903-236790353.07953.14
62280973-228097351.13051.18
15min12716079-271607960.88461.081.5861.0661.261.58
22748704-274870461.61561.80
32725474-272547461.09461.26
42694676-269467660.40460.58
52793594-279359462.62162.80
62670719-267071959.86760.03
20min12938696-293869665.87466.561.1466.1866.871.14
22952844-295284466.19166.51
32984415-298441566.89967.20
42959405-295940566.33866.64
53030625-303062567.93568.25
62949831-294983166.12466.42
30min13206247-320624771.87172.080.8372.3372.540.83
23189577-318957771.49871.96
33204758-320475871.83872.29
43229064-322906472.38372.84
53262955-326295573.14373.61
63201979-320197971.77672.22
45min13402444-340244476.26976.451.0976.8977.061.09
23410807-341080776.45777.08
33404034-340403476.30576.91
43404272-340427276.31076.92
53477277-347727777.94778.57
63362967-336296775.38575.98
60min13456322-345632277.47779.031.2878.2679.821.28
23559819-355981979.79780.59
33529876-352987679.12679.90
43518939-351893978.88179.66
53585663-358566380.37681.18
63503399-350339978.53279.30
极限13412862-341286276.50381.003.4177.4681.963.36
23518003-351800378.86079.83
33642215-364221581.64482.60
43724304-372430483.48484.44
53668700-366870082.23883.22
63713581-371358183.24484.19
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101278-202003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250
标示量(mg)40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%
19.753874111387459838683353872479387270138724450.07
29.793808550381131638099330.06
单位质量响应值RSD%判断
397173.85389165.781.45数据可信
供试品溶液-4226B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%
5min11236459-123645928.30726.458.5128.3126.458.52
21117429-111742925.58225.58
31247987-124798728.57028.57
41057573-105757324.21124.21
51239746-123974628.38228.38
61032757-103275723.64323.64
10min12274914-227491452.08052.540.7452.1452.600.74
22274515-227451552.07152.13
32304193-230419352.75052.81
42312158-231215852.93352.99
52294521-229452152.52952.59
62310415-231041552.89352.95
15min12686537-268653761.50462.100.5061.6862.270.49
22713946-271394662.13162.30
32712089-271208962.08962.27
42722716-272271662.33262.50
52720273-272027362.27662.46
62719468-271946862.25762.43
20min12925999-292599966.98667.861.2667.3068.171.25
23033082-303308269.43769.75
32950685-295068567.55167.87
42963906-296390667.85368.16
52941725-294172567.34667.66
62969794-296979467.98868.30
30min13206375-320637573.40473.400.3973.8773.870.39
23206006-320600673.39673.86
33205172-320517273.37773.85
43199983-319998373.25873.72
53228416-322841673.90974.38
63191439-319143973.06273.52
45min13356534-335653476.84277.840.8277.4778.470.82
23424482-342448278.39879.03
33426485-342648578.44379.08
43402960-340296077.90578.53
53413186-341318678.13978.77
63378344-337834477.34177.96
60min13393582-339358277.69079.371.8678.4980.181.84
23502169-350216980.17680.98
33409466-340946678.05478.86
43564460-356446081.60282.40
53440884-344088478.77379.58
63492126-349212679.94680.74
极限13595154-359515482.30583.111.6183.2884.081.59
23654731-365473183.66984.65
33583271-358327182.03383.01
43708422-370842284.89885.88
53562635-356263581.56082.54
63676789-367678984.17485.15
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