布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369561097411975959678096812968420.81
211.299625494750955021.12
单位质量响应值RSD%判断
8524.828458.990.55数据可信
供试品溶液-25062301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%
10min11607-16071.6951.8423.181.691.8423.18
21949-19492.0552.06
31804-18041.9021.90
42411-24112.5432.54
51343-13431.4161.42
61360-13601.4341.43
15min11662-16621.7531.8620.711.761.8720.74
21583-15831.6691.68
32318-23182.4442.46
41978-19782.0862.10
51244-12441.3121.32
61800-18001.8981.91
30min11346-13461.4191.4525.711.441.4825.44
21005-10051.0601.08
31470-14701.5501.57
41959-19592.0662.09
51015-10151.0701.09
61477-14771.5581.58
45min110248-1024810.8075.4297.1810.835.4496.64
212734-1273413.42913.46
31657-16571.7471.78
41763-17631.8591.90
52065-20652.1782.20
62349-23492.4772.50
60min11505-15051.5871.8214.451.671.8812.79
21378-13781.4531.55
31669-16691.7601.80
41937-19372.0432.09
51988-19882.0962.13
61882-18821.9852.03
90min112189-1218912.8545.68111.7312.955.75110.38
21260-12601.3291.44
32200-22002.3202.37
41311-13111.3831.44
514020-1402014.78514.83
61332-13321.4051.46
120min113563-1356314.3035.73112.1714.475.83110.86
21537-15371.6211.74
31893-18931.9962.06
41057-10571.1151.18
513030-1303013.74113.87
61535-15351.6191.68
极限114462-1446215.2518.2691.1215.508.3990.26
21136-11361.1981.32
31382-13821.4571.53
41447-14471.5261.60
514660-1466015.46015.66
613883-1388314.64014.71
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369543097089970849703396151965570.78
211.295481857726562723.66
单位质量响应值RSD%判断
8499.744984.2336.88数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25062301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%
10min1-0.0001.29115.300.001.29115.30
2-0.0000.00
3-0.0000.00
41270-12701.8101.81
52295-22953.2713.27
61866-18662.6592.66
15min11786-17862.5451.4179.382.551.4279.11
21257-12571.7911.79
3-0.0000.00
4-0.0000.01
51427-14272.0342.05
61458-14582.0782.09
30min11042-10421.4852.6046.461.502.6145.93
23216-32164.5834.59
32065-20652.9432.94
42223-22233.1683.18
51343-13431.9141.94
61055-10551.5031.53
45min12763-27633.9384.2541.623.964.2841.25
24643-46436.6176.65
34004-40045.7065.72
41744-17442.4852.51
51485-14852.1162.16
63259-32594.6444.68
60min13855-38555.4946.2334.485.546.2834.32
26326-63269.0159.09
32030-20302.8932.94
43911-39115.5745.62
55620-56208.0098.06
64478-44786.3826.44
90min14847-48476.9086.4348.626.986.5248.07
26403-64039.1259.25
36142-61428.7538.82
41183-11831.6861.76
56044-60448.6138.71
62446-24463.4863.58
120min16423-64239.1549.0719.579.279.1919.23
25388-53887.6797.85
35541-55417.8978.01
45957-59578.4898.57
56085-60858.6728.82
68788-878812.52412.64
极限17198-719810.2586.9247.6010.427.0946.40
27115-711510.14010.36
31859-18592.6492.81
46325-63259.0149.14
53027-30274.3144.51
63593-35935.1205.31
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