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%
19.753736328374118137319343739932374208037382910.12
29.793777721379709237874060.37
单位质量响应值RSD%判断
383414.46386864.760.64数据可信
供试品溶液-4225B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12709513-270951363.31847.7432.8163.3247.7432.81
22310532-231053253.99453.99
32086955-208695548.76948.77
42685180-268518062.74962.75
51234008-123400828.83728.84
61230169-123016928.74728.75
10min13733968-373396887.25878.679.8187.4078.779.84
23652169-365216985.34685.47
33279115-327911576.62876.74
43553513-355351383.04183.18
53016878-301687870.50070.56
62962068-296206869.21969.28
15min14020915-402091593.96388.444.8294.3088.724.87
23925612-392561291.73692.05
33718687-371868786.90187.18
43865059-386505990.32190.65
53552714-355271483.02283.24
63623297-362329784.67184.89
20min14144663-414466396.85592.753.0897.4093.233.12
24064420-406442094.98095.49
33894572-389457291.01191.48
43988913-398891393.21593.74
53809228-380922889.01689.42
63912058-391205891.41991.83
30min14183269-418326997.75794.711.7998.5295.391.84
24060354-406035494.88595.61
34014893-401489393.82394.50
44056771-405677194.80195.53
53967334-396733492.71193.31
64034096-403409694.27194.88
45min14233370-423337098.92895.311.9199.9096.201.94
24066051-406605195.01895.95
34044798-404479894.52195.40
44066295-406629595.02495.97
54025899-402589994.08094.89
64035397-403539794.30295.12
60min14210902-421090298.40395.331.6499.6096.441.67
24054048-405404894.73895.88
34065986-406598695.01696.11
44040504-404050494.42195.57
54077644-407764495.28996.31
64027321-402732194.11395.14
极限14336493-4336493101.33897.202.18102.7598.522.20
24126743-412674396.43697.79
34134285-413428596.61397.92
44159851-415985197.21098.57
54117480-411748096.22097.45
64082321-408232195.39896.64
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%
19.753705776375560237673653747578375490337462450.64
29.793766109378998737780480.45
单位质量响应值RSD%判断
384230.26385908.890.31数据可信
供试品溶液-4225B批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12479103-247910357.94358.474.0357.9458.474.03
22474063-247406357.82557.83
32453912-245391257.35457.35
42396102-239610256.00356.00
52690515-269051562.88462.88
62517445-251744558.83958.84
10min13553816-355381683.06284.421.9183.1984.541.91
23653504-365350485.39285.52
33549055-354905582.95083.08
43570781-357078183.45883.58
53725412-372541287.07287.21
63617812-361781284.55784.69
15min14030632-403063294.20690.343.3494.5290.663.34
23803549-380354988.89889.22
33888614-388861490.88791.20
43662818-366281885.60985.92
53965144-396514492.67593.01
63840212-384021289.75590.07
20min14172027-417202797.51191.644.5398.0392.164.51
23827694-382769489.46389.98
33968914-396891492.76393.28
43774078-377407888.21088.71
54064085-406408594.98895.53
63717989-371798986.89987.42
30min14253460-425346099.41493.843.89100.1594.563.88
23884494-388449490.79091.50
34068218-406821895.08495.80
43824940-382494089.39890.09
54094388-409438895.69696.45
63963742-396374292.64393.35
45min14255699-425569999.46692.745.85100.4393.675.82
23903214-390321491.22892.14
34094878-409487895.70896.64
43827276-382727689.45390.35
54111886-411188696.10597.07
63613804-361380484.46485.38
60min14242281-424228199.15392.425.57100.3393.565.53
23867659-386765990.39791.52
34030835-403083594.21195.35
43841907-384190789.79590.89
54115773-411577396.19697.37
63627206-362720684.77785.88
极限14257338-425733899.50592.825.63100.9194.165.60
23886279-388627990.83292.15
34028435-402843594.15595.51
43851755-385175590.02591.32
54160044-416004497.23198.62
63644009-364400985.17086.46
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%
19.753785127380186338028413801697379464237972340.20
29.793836174384531638407450.17
单位质量响应值RSD%判断
389459.90392313.070.52数据可信
供试品溶液-4225B批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1284552-2845526.5527.208.456.557.208.43
2306502-3065027.0577.06
3304912-3049127.0217.02
4297874-2978746.8596.86
5360695-3606958.3058.30
6321073-3210737.3937.39
10min1568294-56829413.08513.694.4513.1013.714.46
2607633-60763313.99114.01
3561013-56101312.91712.93
4606033-60603313.95413.97
5631603-63160314.54314.56
6592786-59278613.64913.67
15min1607679-60767913.99215.575.2614.0415.625.24
2697316-69731616.05616.10
3667729-66772915.37415.42
4697863-69786316.06816.11
5696954-69695416.04716.10
6690457-69045715.89815.94
20min1637476-63747614.67815.917.1714.7515.997.15
2725688-72568816.70916.79
3702015-70201516.16416.24
4726451-72645116.72616.81
5733244-73324416.88316.97
6620019-62001914.27614.36
30min1735215-73521516.92816.027.7617.0416.147.72
2673096-67309615.49815.62
3728626-72862616.77716.89
4606101-60610113.95514.07
5751888-75188817.31217.44
6680527-68052715.66915.78
45min1765939-76593917.63616.1010.0217.7816.269.90
2761428-76142817.53217.69
3634286-63428614.60414.76
4760554-76055417.51217.66
5621402-62140214.30814.47
6652686-65268615.02815.18
60min1760575-76057517.51217.175.8817.7017.365.81
2658228-65822815.15615.35
3754963-75496317.38317.57
4765566-76556617.62717.82
5779309-77930917.94418.14
6756423-75642317.41717.60
极限1762124-76212417.54817.424.4817.7717.654.45
2784051-78405118.05318.28
3690987-69098715.91016.13
4766888-76688817.65817.89
5779667-77966717.95218.19
6756618-75661817.42117.64
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%
19.753792834380970338097693807821379848838037230.21
29.793749648374922737494380.01
单位质量响应值RSD%判断
390125.44382986.521.31数据可信
供试品溶液-4225B批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385342-3853428.9738.2810.268.978.2810.27
2355745-3557458.2838.28
3286087-2860876.6616.66
4358520-3585208.3488.35
5385122-3851228.9678.97
6362863-3628638.4498.45
10min1630970-63097014.69214.223.5114.7114.243.53
2614948-61494814.31914.34
3581385-58138513.53713.55
4637227-63722714.83814.86
5594596-59459613.84513.86
6604200-60420014.06914.09
15min1703955-70395516.39115.866.5416.4415.916.51
2703098-70309816.37116.42
3651489-65148915.17015.21
4713891-71389116.62316.67
5710603-71060316.54616.60
6603197-60319714.04514.10
20min1730067-73006716.99916.368.1917.0916.448.17
2687797-68779716.01516.10
3715015-71501516.64916.73
4743221-74322117.30617.39
5746182-74618217.37417.46
6593668-59366813.82313.90
30min1629638-62963814.66115.8612.8614.7915.9812.76
2760848-76084817.71617.84
3753065-75306517.53517.65
4762833-76283317.76217.89
5567070-56707013.20413.33
6614126-61412614.30014.41
45min1779601-77960118.15317.189.8418.3117.349.72
2785213-78521318.28318.44
3770021-77002117.93018.08
4593219-59321913.81313.98
5756869-75686917.62317.78
6742388-74238817.28617.43
60min1790723-79072318.41218.031.4718.6118.231.45
2757696-75769617.64317.84
3772507-77250717.98718.18
4776556-77655618.08218.28
5768048-76804817.88418.08
6781612-78161218.19918.38
极限1789972-78997218.39418.738.8018.6318.968.69
2760377-76037717.70517.95
3767912-76791217.88018.11
4945431-94543122.01422.25
5798511-79851118.59318.83
6764314-76431417.79718.02
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