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%
19.653863505387081838619113865076386133838645300.10
29.823932933393378439333580.02
单位质量响应值RSD%判断
400469.43400545.620.02数据可信
供试品溶液-20200709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%
5min1336637-3366377.5656.4523.877.566.4523.87
2149511-1495113.3603.36
3299029-2990296.7206.72
4308697-3086976.9376.94
5314936-3149367.0777.08
6313662-3136627.0487.05
10min1609950-60995013.70612.819.2013.7212.829.22
2464823-46482310.44510.45
3589028-58902813.23613.25
4588170-58817013.21713.23
5584036-58403613.12413.14
6583713-58371313.11713.13
15min1693034-69303415.57415.102.8915.6215.142.91
2636727-63672714.30814.34
3683059-68305915.34915.39
4676784-67678415.20815.25
5666441-66644114.97615.02
6675112-67511215.17115.22
20min1723621-72362116.26115.801.6216.3415.881.63
2689443-68944315.49315.56
3705359-70535915.85015.93
4701469-70146915.76315.84
5701261-70126115.75815.84
6698065-69806515.68715.77
30min1751606-75160616.89016.541.2217.0116.651.22
2739549-73954916.61916.72
3736998-73699816.56116.68
4729339-72933916.38916.50
5729169-72916916.38616.50
6728739-72873916.37616.49
45min1751309-75130916.88316.760.9317.0416.900.89
2755588-75558816.97917.11
3740089-74008916.63116.78
4746491-74649116.77516.92
5737648-73764816.57616.73
6742541-74254116.68616.84
60min1760805-76080517.09616.970.6517.2917.160.63
2758334-75833417.04117.21
3753739-75373916.93817.13
4758216-75821617.03817.23
5748004-74800416.80917.00
6751564-75156416.88917.08
90min1754769-75476916.96116.802.5317.1917.022.48
2749725-74972516.84717.06
3765753-76575317.20817.43
4748390-74839016.81717.04
5755994-75599416.98817.21
6711268-71126815.98316.21
120min1765169-76516917.19417.130.2717.4617.400.26
2763685-76368517.16117.41
3762045-76204517.12417.39
4762236-76223617.12917.39
5762504-76250417.13517.40
6759004-75900417.05617.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1766162-76616217.21717.212.2717.5217.502.19
2797414-79741417.91918.20
3765309-76530917.19817.50
4762131-76213117.12617.43
5744792-74479216.73717.04
6758477-75847717.04417.34
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%
19.653919593392010939229043912279390961339169000.15
29.823905123390382539044740.03
单位质量响应值RSD%判断
405896.37397604.281.46数据可信
供试品溶液-20200709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%
5min1199791-1997914.4763.8822.424.483.8922.39
2148485-1484853.3273.33
3224111-2241115.0215.02
4141839-1418393.1783.18
5128045-1280452.8692.87
6198110-1981104.4394.44
10min1481089-48108910.77810.188.6410.7910.198.65
2446465-44646510.00310.01
3495348-49534811.09811.11
4412230-4122309.2369.24
5405219-4052199.0799.09
6486826-48682610.90710.92
15min1635968-63596814.24813.943.7214.2813.973.72
2624439-62443913.99014.02
3645587-64558714.46414.50
4599027-59902713.42113.45
5588819-58881913.19213.22
6638754-63875414.31114.34
20min1691403-69140315.49015.341.7215.5615.401.73
2685715-68571515.36315.42
3698995-69899515.66115.73
4674444-67444415.11015.17
5667296-66729614.95015.01
6689908-68990815.45715.52
30min1731840-73184016.39616.170.8516.5016.270.87
2725499-72549916.25416.35
3717498-71749816.07516.18
4721724-72172416.17016.26
5714785-71478516.01416.10
6719717-71971716.12516.23
45min1739738-73973816.57316.530.5816.7116.660.58
2734200-73420016.44916.58
3737991-73799116.53416.67
4744240-74424016.67416.80
5732233-73223316.40516.53
6739003-73900316.55716.69
60min1749385-74938516.78916.720.4716.9616.890.48
2748126-74812616.76116.93
3748905-74890516.77916.95
4747567-74756716.74916.91
5740848-74084816.59816.76
6743152-74315216.65016.82
90min1753912-75391216.89116.671.3217.1016.881.31
2738778-73877816.55216.76
3752151-75215116.85117.06
4750545-75054516.81517.02
5729241-72924116.33816.54
6739089-73908916.55916.77
120min1744117-74411716.67116.850.7516.9217.090.74
2753697-75369716.88617.13
3755374-75537416.92417.17
4760123-76012317.03017.27
5748931-74893116.77917.01
6749615-74961516.79517.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1762140-76214017.07516.950.9617.3617.230.94
2756933-75693316.95917.24
3759980-75998017.02717.31
4764192-76419217.12117.40
5751655-75165516.84017.11
6745004-74500416.69116.98
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%
19.653867036387241438522973837378383018138518610.48
29.823845863384616938460160.01
单位质量响应值RSD%判断
399156.58391651.321.35数据可信
供试品溶液-20200710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%
5min1333599-3335997.5946.0326.237.596.0226.24
2345376-3453767.8627.86
3294730-2947306.7096.71
4178102-1781024.0544.05
5226969-2269695.1675.17
6209720-2097204.7744.77
10min1591393-59139313.46212.0312.0413.4812.0412.06
2603290-60329013.73313.75
3559469-55946912.73612.75
4458786-45878610.44410.45
5482363-48236310.98010.99
6476231-47623110.84110.85
15min1685359-68535915.60114.884.2815.6514.934.31
2679561-67956115.46915.52
3671405-67140515.28415.33
4632312-63231214.39414.43
5632618-63261814.40114.44
6621817-62181714.15514.19
20min1707290-70729016.10015.762.0116.1815.832.05
2712276-71227616.21416.30
3686438-68643815.62615.70
4686321-68632115.62315.69
5679157-67915715.46015.53
6682606-68260615.53915.60
30min1726079-72607916.52816.331.0216.6516.441.06
2713654-71365416.24516.36
3727211-72721116.55416.67
4715319-71531916.28316.38
5710071-71007116.16416.27
6712571-71257116.22116.32
45min1717226-71722616.32716.651.1516.4816.791.13
2735635-73563516.74616.90
3742186-74218616.89517.04
4732684-73268416.67916.81
5727612-72761216.56316.70
6732618-73261816.67716.81
60min1739977-73997716.84516.780.6017.0316.960.60
2735186-73518616.73516.93
3742469-74246916.90117.09
4739271-73927116.82817.00
5730125-73012516.62016.80
6736076-73607616.75616.93
90min1745612-74561216.97316.860.9017.2017.080.91
2735673-73567316.74716.98
3750821-75082117.09117.32
4741115-74111516.87017.08
5738115-73811516.80217.01
6732985-73298516.68516.90
120min1747570-74757017.01716.920.9117.2817.180.93
2741321-74132116.87517.14
3751648-75164817.11017.37
4746829-74682917.00117.25
5739399-73939916.83117.08
6733041-73304116.68716.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1737776-73777616.79416.891.0917.1017.181.09
2736269-73626916.76017.06
3754516-75451617.17517.48
4749429-74942917.06017.34
5734391-73439116.71717.00
6739477-73947716.83317.12
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%
19.653916091391507539131743911717390917039130450.08
29.823929815392811839289660.04
单位质量响应值RSD%判断
405496.89400098.370.95数据可信
供试品溶液-20200710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%
5min1336994-3369947.5306.4423.967.536.4323.96
2197704-1977044.4184.42
3333503-3335037.4527.45
4322436-3224367.2057.20
5200661-2006614.4844.48
6336619-3366197.5227.52
10min1587815-58781513.13512.2114.0113.1512.2214.03
2466360-46636010.42110.43
3602598-60259813.46513.48
4585893-58589313.09213.11
5432031-4320319.6549.66
6604421-60442113.50613.52
15min1690107-69010715.42014.954.5815.4714.994.64
2643178-64317814.37214.40
3685727-68572715.32215.37
4690119-69011915.42115.47
5618635-61863513.82313.85
6686638-68663815.34315.39
20min1713647-71364715.94615.821.6016.0315.901.65
2699686-69968615.63415.70
3714550-71455015.96616.05
4714161-71416115.95816.04
5688582-68858215.38615.45
6716792-71679216.01716.10
30min1730015-73001516.31216.290.7216.4316.400.74
2733485-73348516.39016.49
3731947-73194716.35516.47
4733380-73338016.38716.50
5723082-72308216.15716.25
6721709-72170916.12616.24
45min1746534-74653416.68116.540.7716.8316.690.80
2736455-73645516.45616.59
3735866-73586616.44316.60
4743404-74340416.61116.76
5733786-73378616.39616.53
6746260-74626016.67516.83
60min1751455-75145516.79116.611.4516.9816.791.47
2750761-75076116.77616.95
3747843-74784316.71016.90
4747780-74778016.70916.90
5723761-72376116.17216.34
6737396-73739616.47716.67
90min1759184-75918416.96416.841.0017.1917.061.00
2748422-74842216.72316.93
3753614-75361416.83917.07
4741084-74108416.55916.78
5758707-75870716.95317.16
6759951-75995116.98117.21
120min1753544-75354416.83816.791.2517.1017.051.19
2760586-76058616.99517.24
3748872-74887216.73317.00
4735108-73510816.42616.69
5760110-76011016.98417.23
6750651-75065116.77317.04
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1749902-74990216.75616.820.4117.0617.120.39
2755299-75529916.87717.16
3752889-75288916.82317.12
4749008-74900816.73617.03
5753824-75382416.84417.12
6756757-75675716.91017.21
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