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%
115.722042742039852041402041102040492041120.06
215.672046482046132046300.02
单位质量响应值RSD%判断
12984.2213058.710.41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%
5min118801-188019.67514.4336.429.6714.4336.43
229749-2974915.30815.31
341559-4155921.38521.39
417543-175439.0279.03
538386-3838619.75319.75
622258-2225811.45311.45
10min198166-9816650.51452.9516.6450.5753.0316.66
2121590-12159062.56762.65
3124007-12400763.81163.93
485958-8595844.23244.28
5103771-10377153.39853.51
683910-8391043.17843.24
15min1177292-17729291.23090.192.8791.5690.572.92
2175269-17526990.18990.62
3181361-18136193.32493.80
4169067-16906786.99887.29
5179049-17904992.13592.54
6169632-16963287.28987.59
20min1188642-18864297.07195.052.2397.9195.922.26
2187843-18784396.66097.59
3185055-18505595.22596.22
4178881-17888192.04892.83
5187346-18734696.40497.32
6180484-18048492.87393.66
30min1193303-19330399.46996.811.54100.8598.221.54
2187680-18768096.57698.05
3187241-18724196.35097.87
4185023-18502395.20996.50
5189202-18920297.35998.81
6186417-18641795.92697.23
45min1196077-196077100.89798.102.23102.83100.042.14
2190274-19027497.91199.92
3183050-18305094.19396.25
4192254-19225498.930100.75
5190939-19093998.253100.25
6191222-19122298.399100.24
极限1194215-19421599.93997.481.72102.4399.961.65
2186989-18698996.22098.77
3185535-18553595.47298.05
4187697-18769796.58598.95
5190877-19087798.221100.76
6191273-19127398.425100.81
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%
115.722038802040382044862036482041932040490.16
215.672061722060832061280.04
单位质量响应值RSD%判断
12980.2213154.310.95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%
5min112024-120246.1668.9874.086.178.9874.06
27912-79124.0574.06
336203-3620318.56518.56
410066-100665.1625.16
531860-3186016.33816.34
67060-70603.6203.62
10min198299-9829950.40748.755.9550.4448.805.99
295464-9546448.95348.98
3103312-10331252.97853.08
486937-8693744.58144.61
595121-9512148.77748.87
691220-9122046.77746.80
15min1185540-18554095.14490.356.4495.4690.676.38
2186492-18649295.63295.93
3172406-17240688.40988.81
4172961-17296188.69388.97
5156765-15676580.38880.75
6182982-18298293.83294.11
20min1189523-18952397.18698.481.1798.0399.301.16
2195286-195286100.141100.97
3191602-19160298.25299.14
4189879-18987997.36998.14
5192147-19214798.53299.34
6193840-19384099.400100.20
30min1193191-19319199.06798.722.11100.45100.092.10
2198753-198753101.919103.30
3192167-19216798.54299.98
4189423-18942397.13598.44
5187077-18707795.93297.29
6194449-19444999.712101.07
45min1190484-19048497.67997.731.9099.6199.651.86
2188373-18837396.59698.54
3189480-18948097.16499.15
4186291-18629195.52997.38
5192159-19215998.538100.43
6196759-196759100.897102.80
极限1184046-18404694.37795.771.7296.8598.231.71
2190510-19051097.692100.18
3188013-18801396.41298.93
4182832-18283293.75596.14
5185180-18518094.95997.40
6189951-18995197.40599.87
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%
115.722042082041912037362040562035712039520.14
215.672071512072542072020.04
单位质量响应值RSD%判断
12974.0513222.851.35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%
5min18657-86574.4298.2472.744.438.2472.75
27396-73963.7843.78
327503-2750314.07014.07
434340-3434017.56817.57
59624-96244.9244.92
69060-90604.6354.64
10min1107921-10792155.21249.6415.8855.2449.6915.91
289276-8927645.67345.69
3106966-10696654.72354.80
4112954-11295457.78757.88
571689-7168936.67636.70
693426-9342647.79647.82
15min1184615-18461594.44888.738.9394.7889.068.93
2180169-18016992.17492.45
3166871-16687185.37085.75
4182599-18259993.41793.84
5144623-14462373.98874.22
6181785-18178593.00093.29
20min1184310-18431094.29293.732.6595.1594.552.73
2181486-18148692.84793.63
3184592-18459294.43695.29
4189115-18911596.75097.69
5174693-17469389.37290.01
6185120-18512094.70795.51
30min1189467-18946796.93097.701.3798.3199.041.34
2192152-19215298.30499.61
3190968-19096897.69899.08
4188119-18811996.24197.72
5189658-18965897.02898.17
6195493-195493100.013101.35
45min1187016-18701695.67796.441.1697.5998.321.16
2192470-19247098.467100.32
3187546-18754695.94897.87
4189663-18966397.03199.04
5187162-18716295.75197.43
6187215-18721595.77897.67
极限1186012-18601295.16396.481.8397.6198.891.68
2189840-18984097.12199.52
3186936-18693695.63698.09
4184393-18439394.33596.88
5193764-19376499.129101.34
6190567-19056797.49399.92
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