盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722066522065892064512062802060472064040.12
215.672077222080712078960.12
单位质量响应值RSD%判断
13130.0313267.130.74数据可信
长期6月-供试品溶液-2024042221批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min131005-3100515.74119.4010.7015.7419.4010.70
242485-4248521.56921.57
337208-3720818.89018.89
437664-3766419.12119.12
539553-3955320.08020.08
641403-4140321.02021.02
10min1108895-10889555.28456.403.0755.3756.513.08
2111168-11116856.43856.56
3108793-10879355.23255.34
4107447-10744754.54954.66
5114075-11407557.91458.03
6116160-11616058.97259.09
15min1181594-18159492.19286.527.5292.5986.947.49
2178106-17810690.42190.85
3147399-14739974.83275.24
4164084-16408483.30283.71
5173398-17339888.03188.46
6177916-17791690.32590.77
20min1185683-18568394.26896.792.5695.1797.692.53
2185539-18553994.19595.13
3193488-19348898.23099.06
4192986-19298697.97698.85
5188524-18852495.71096.63
6197713-197713100.375101.32
30min1186391-18639194.62797.182.4196.0698.622.39
2187914-18791495.40196.86
3192584-19258497.77199.14
4192464-19246497.71099.13
5189776-18977696.34697.80
6199361-199361101.212102.72
45min1186693-18669394.78197.272.3996.7499.252.36
2186604-18660494.73596.72
3192227-19222797.59099.51
4194973-19497398.984100.94
5190964-19096496.94998.94
6198171-198171100.608102.67
极限1186295-18629594.57997.492.2497.06100.012.19
2188933-18893395.91898.43
3197668-197668100.352102.81
4193922-19392298.451100.96
5190136-19013696.52999.06
6195249-19524999.124101.75
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722062082061212060512063272061202061650.06
215.672074852075062074960.01
单位质量响应值RSD%判断
13114.8213241.610.69数据可信
长期6月-供试品溶液-2024042321批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min138989-3898919.82513.9136.7519.8213.9136.76
216705-167058.4948.49
319216-192169.7719.77
434158-3415817.36817.37
519067-190679.6959.69
636048-3604818.32918.33
10min1111222-11122256.55251.4412.4056.6651.5212.43
283680-8368042.54842.60
386614-8661444.04044.09
4110429-11042956.14956.25
5106742-10674254.27554.33
6108320-10832055.07755.18
15min1181277-18127792.17387.975.1992.6088.335.22
2160289-16028981.50181.78
3175243-17524389.10589.40
4178095-17809590.55590.96
5163321-16332183.04383.40
6179856-17985691.45091.86
20min1187344-18734495.25896.351.7796.1997.201.79
2185014-18501494.07394.81
3187674-18767495.42696.22
4193135-19313598.20299.11
5193144-19314498.20799.02
6190602-19060296.91497.83
30min1192091-19209197.67198.671.0699.14100.061.03
2194412-19441298.852100.11
3192901-19290198.08399.41
4192277-19227797.76699.22
5197404-197404100.373101.74
6195203-19520399.254100.71
45min1189211-18921196.20798.311.6398.22100.251.56
2196278-19627899.800101.61
3191443-19144397.34299.21
4191337-19133797.28899.29
5197108-197108100.222102.14
6194704-19470499.000101.01
极限1188575-18857595.88497.561.2898.43100.041.22
2194348-19434898.819101.18
3191318-19131897.27899.69
4189749-18974996.48199.02
5192618-19261897.939100.42
6194606-19460698.950101.51
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.722061422064912060032068312059362062810.19
215.672098122096452097280.06
单位质量响应值RSD%判断
13122.2013384.051.40数据可信
长期6月-供试品溶液-2024042421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112326-123266.2329.4956.786.239.4956.79
227052-2705213.67813.68
34950-49502.5032.50
428386-2838614.35314.35
510690-106905.4055.41
629203-2920314.76614.77
10min1113599-11359957.43950.907.7457.4750.967.70
295707-9570748.39248.47
396798-9679848.94448.96
493566-9356647.31047.39
5106725-10672553.96353.99
697631-9763149.36549.45
15min1181925-18192591.98688.323.7892.3488.663.77
2172893-17289387.42087.76
3179445-17944590.73291.02
4162925-16292582.37982.72
5175777-17577788.87889.21
6175094-17509488.53288.89
20min1198317-198317100.27595.982.49101.1496.802.49
2191763-19176396.96197.79
3188092-18809295.10595.89
4186321-18632194.20995.01
5185399-18539993.74394.57
6189023-18902395.57596.42
30min1195553-19555398.87797.521.66100.3098.881.64
2194154-19415498.17099.54
3195259-19525998.728100.05
4192709-19270997.43998.76
5186861-18686194.48295.83
6192666-19266697.41798.80
45min1198519-198519100.37797.022.53102.3598.922.51
2195014-19501498.605100.52
3190789-19078996.46898.34
4193540-19354097.85999.72
5184972-18497293.52795.40
6188405-18840595.26397.18
极限1194383-19438398.28695.451.61100.8197.891.62
2188993-18899395.56098.02
3188159-18815995.13997.54
4186316-18631694.20796.62
5185951-18595194.02296.41
6188859-18885995.49297.94
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