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101278-202405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%
110.183986125403078440216394015225401871540144980.43
210.304100229410523341027310.09
单位质量响应值RSD%判断
394351.47398323.400.71数据可信
加速6月-供试品溶液-2024112521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%
5min11271579-127157928.84728.3123.1128.8528.3123.10
2943164-94316421.39621.40
31119800-111980025.40425.40
41586458-158645835.99035.99
51590087-159008736.07236.07
6975747-97574722.13622.14
10min13079619-307961969.86465.817.6969.9365.877.71
22696567-269656761.17461.22
32681322-268132260.82860.88
43061276-306127669.44769.53
53164133-316413371.78171.86
62722304-272230461.75861.81
15min13717317-371731784.33081.893.2584.5582.103.27
23527087-352708780.01580.20
33484452-348445279.04879.24
43696634-369663483.86184.10
53732932-373293284.68484.92
63500387-350038779.40979.60
20min13929921-392992189.15388.251.4989.5688.641.51
23846132-384613287.25387.61
33828844-382884486.86087.23
43944348-394434889.48189.90
53951837-395183789.65190.08
63839315-383931587.09887.46
30min14065032-406503292.21892.210.5392.8292.800.56
24040829-404082991.66992.22
34055776-405577692.00892.57
44099120-409912092.99293.61
54078796-407879692.53193.16
64048631-404863191.84692.40
45min14115041-411504193.35393.730.2594.1694.520.25
24130983-413098393.71594.47
34135292-413529293.81294.58
44146072-414607294.05794.88
54129979-412997993.69294.52
64132406-413240693.74794.51
60min14125572-412557293.59294.030.2894.6195.030.29
24140724-414072493.93694.90
34144533-414453394.02295.00
44159587-415958794.36395.40
54150074-415007494.14895.19
64148714-414871494.11795.09
极限14130072-413007293.69494.210.3694.9295.420.34
24158427-415842794.33795.51
34162474-416247494.42995.61
44167741-416774194.54895.79
54140221-414022193.92495.17
64159274-415927494.35695.53
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101278-202405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%
110.184063557406359740600864059229406140740615750.05
210.304105828410429441050610.03
单位质量响应值RSD%判断
398975.93398549.610.08数据可信
加速6月-供试品溶液-2024112521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%
5min11456825-145682532.84729.3528.1332.8529.3528.13
21584113-158411335.71735.72
31086928-108692824.50724.51
4651980-65198014.70014.70
51453810-145381032.77932.78
61575392-157539235.52135.52
10min13233074-323307472.89767.539.5172.9767.609.53
23047315-304731568.70968.79
33043519-304351968.62368.68
42439331-243933155.00055.03
53029330-302933068.30368.38
63178897-317889771.67571.75
15min13767600-376760084.94982.774.1485.1882.984.17
23700022-370002283.42583.66
33733076-373307684.17184.38
43368796-336879675.95776.11
53686367-368636783.11783.34
63769117-376911784.98385.22
20min13953120-395312089.13288.411.9689.5688.812.00
23942941-394294188.90289.32
33951877-395187789.10489.50
43765709-376570984.90685.23
53944287-394428788.93389.34
63969356-396935689.49889.93
30min14076552-407655291.91592.140.7792.5492.740.81
24093351-409335192.29492.91
34092497-409249792.27592.87
44031416-403141690.89791.41
54098935-409893592.42093.03
64125720-412572093.02493.65
45min14127310-412731093.05993.370.1993.8994.170.19
24149953-414995393.57094.39
34143351-414335193.42194.22
44138697-413869793.31694.03
54143382-414338293.42294.23
64143008-414300893.41394.25
60min14130666-413066693.13593.750.3894.1794.760.38
24157417-415741793.73894.77
34159510-415951093.78594.79
44156602-415660293.72094.64
54166325-416632593.93994.96
64178336-417833694.21095.25
极限14137790-413779093.29693.900.4094.5495.110.39
24153896-415389693.65994.90
34167458-416745893.96595.18
44167407-416740793.96495.09
54177143-417714394.18395.41
64182687-418268794.30895.56
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101278-202405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%
110.184046825405121840504924052075405348740508190.07
210.304158776415799641583860.02
单位质量响应值RSD%判断
397919.35403726.801.03数据可信
加速6月-供试品溶液-2024112621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%
5min11477624-147762433.14732.298.1833.1532.298.18
21338387-133838730.02330.02
31372095-137209530.78030.78
41328545-132854529.80329.80
51483243-148324333.27333.27
61636401-163640136.70936.71
10min12988850-298885067.04764.505.3667.1264.575.36
22692263-269226360.39460.46
32742077-274207761.51261.58
42778624-277862462.33262.40
53034015-303401568.06168.13
63016443-301644367.66667.75
15min13513071-351307178.80778.122.5579.0378.342.56
23369399-336939975.58475.79
33410673-341067376.51076.72
43445577-344557777.29377.50
53597945-359794580.71180.94
63557635-355763579.80780.04
20min13805146-380514685.35985.020.9885.7685.411.00
23749907-374990784.12084.49
33767149-376714984.50784.88
43758193-375819384.30684.68
53841131-384113186.16686.57
63818877-381887785.66786.08
30min14005831-400583189.86189.750.5290.4590.330.53
23987693-398769389.45490.01
33993999-399399989.59590.16
43971998-397199889.10289.67
54029661-402966190.39590.99
64015470-401547090.07790.68
45min14095437-409543791.87191.740.2992.6692.520.29
24106914-410691492.12892.88
34085957-408595791.65892.42
44072363-407236391.35392.12
54084994-408499491.63792.43
64093269-409326991.82292.62
60min14127010-412701092.57992.340.4693.5793.320.46
24143362-414336292.94693.91
34093775-409377591.83492.80
44097548-409754891.91892.88
54120590-412059092.43593.44
64115163-411516392.31393.32
极限14126455-412645592.56792.720.3093.7693.900.28
24142207-414220792.92094.09
34149835-414983593.09194.26
44130148-413014892.65093.82
54115530-411553092.32293.53
64135264-413526492.76493.97
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101278-202405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%
110.184066230406480340629144063784406466840644800.04
210.304123309412281641230620.01
单位质量响应值RSD%判断
399261.30400297.280.19数据可信
加速6月-供试品溶液-2024112621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%
5min11721339-172133938.71330.0216.0938.7130.0216.08
21299774-129977429.23229.23
31291517-129151729.04629.05
41217254-121725427.37627.38
51389920-138992031.25931.26
61087916-108791624.46724.47
10min13338477-333847775.08264.598.1675.1764.658.16
22727844-272784461.34961.41
32729782-272978261.39361.46
42767026-276702662.23062.29
52806462-280646263.11763.19
62860999-286099964.34464.40
15min13733087-373308783.95778.143.9784.2178.353.98
23387484-338748476.18476.39
33348539-334853975.30875.51
43432431-343243177.19577.39
53436548-343654877.28877.50
63508417-350841778.90479.10
20min13899388-389938887.69785.291.4688.1485.671.48
23765556-376555684.68785.06
33766231-376623184.70285.07
43773306-377330684.86185.23
53748613-374861384.30684.69
63800629-380062985.47685.85
30min14064124-406412491.40290.320.7592.0490.900.77
23983585-398358589.59190.15
34010983-401098390.20790.76
44036057-403605790.77191.33
53990910-399091089.75590.32
64011034-401103490.20890.77
45min14126132-412613292.79692.150.7293.6392.920.73
24083355-408335591.83492.59
34094118-409411892.07692.83
44139902-413990293.10693.87
54070430-407043091.54492.31
64070938-407093891.55592.32
60min14132154-413215492.93292.940.3093.9893.920.30
24119770-411977092.65393.62
34133180-413318092.95593.92
44155330-415533093.45394.42
54130040-413004092.88493.86
64125703-412570392.78793.75
极限14151542-415154293.36893.260.5294.6294.450.52
24120939-412093992.68093.85
34165561-416556193.68394.85
44175957-417595793.91795.09
54128245-412824592.84494.02
64139550-413955093.09894.27
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