普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521727117328172691731917296172970.16
213.561722217216172190.03
单位质量响应值RSD%判断
1279.361269.840.53数据可信
供试品溶液-2024081611批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116060-1606090.17793.395.8390.1893.395.83
216397-1639792.06992.07
317787-1778799.87499.87
416565-1656593.01393.01
515283-1528385.81485.81
617706-1770699.41999.42
5min117784-1778499.857101.583.5599.86101.583.55
217824-17824100.082100.08
319053-19053106.983106.98
417632-1763299.00499.00
517515-1751598.34798.35
618739-18739105.220105.22
10min117357-1735797.460101.614.1097.46101.614.10
217844-17844100.194100.19
319138-19138107.460107.46
417704-1770499.40899.41
517620-1762098.93798.94
618913-18913106.197106.20
15min117383-1738397.606101.314.0697.61101.314.06
217814-17814100.026100.03
319229-19229107.971107.97
417646-1764699.08399.08
517536-1753698.46598.46
618647-18647104.703104.70
30min117310-1731097.196101.724.2797.20101.724.27
217883-17883100.413100.41
319271-19271108.207108.21
417693-1769399.34699.35
517666-1766699.19599.19
618869-18869105.950105.95
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521717517168171921716417175171750.07
213.561717217149171600.10
单位质量响应值RSD%判断
1270.341265.490.28数据可信
供试品溶液-2024081611批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115600-1560088.05592.354.7688.0692.354.76
216005-1600590.34190.34
316035-1603590.51190.51
417661-1766199.68999.69
515928-1592889.90789.91
616937-1693795.60295.60
5min117348-1734897.922100.984.3897.92100.984.38
217511-1751198.84298.84
317307-1730797.69197.69
419203-19203108.393108.39
517466-1746698.58898.59
618504-18504104.447104.45
10min117506-1750698.814101.244.2798.81101.244.27
217483-1748398.68498.68
317375-1737598.07498.07
419270-19270108.771108.77
517523-1752398.91098.91
618461-18461104.204104.20
15min117553-1755399.079101.744.7999.08101.744.79
217488-1748898.71298.71
317349-1734997.92897.93
419382-19382109.403109.40
517531-1753198.95598.95
618841-18841106.349106.35
30min117543-1754399.023101.534.3299.02101.534.32
217625-1762599.48699.49
317373-1737398.06398.06
419333-19333109.126109.13
517528-1752898.93898.94
618518-18518104.526104.53
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521719717147171581718517194171760.14
213.561735917339173490.09
单位质量响应值RSD%判断
1270.411279.420.50数据可信
供试品溶液-2024081711批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min115997-1599789.80191.204.1589.8091.204.15
216274-1627491.35691.36
317477-1747798.10998.11
416348-1634891.77191.77
515525-1552587.15187.15
615852-1585288.98788.99
5min118312-18312102.796102.382.51102.80102.382.51
218640-18640104.638104.64
318704-18704104.997105.00
418378-18378103.167103.17
517541-1754198.46898.47
617851-17851100.208100.21
10min118529-18529104.014103.261.91104.01103.261.91
218724-18724105.109105.11
318764-18764105.334105.33
418390-18390103.234103.23
517921-17921100.601100.60
618036-18036101.247101.25
15min118411-18411103.352103.062.11103.35103.062.11
218678-18678104.851104.85
318769-18769105.362105.36
418477-18477103.723103.72
517747-1774799.62599.62
618069-18069101.432101.43
30min118438-18438103.504103.252.04103.50103.252.04
218699-18699104.969104.97
318701-18701104.980104.98
418472-18472103.694103.69
517684-1768499.27199.27
618368-18368103.111103.11
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数500
标示量(mg)25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%
113.521714817123171071715317135171330.11
213.561727917264172720.07
单位质量响应值RSD%判断
1267.231273.750.37数据可信
供试品溶液-2024081711批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116270-1627091.65192.425.0991.6592.425.08
215882-1588289.46689.47
316347-1634792.08592.08
417609-1760999.19499.19
515266-1526685.99686.00
617062-1706296.11396.11
5min118301-18301103.092103.212.04103.09103.212.04
218125-18125102.101102.10
318732-18732105.520105.52
418528-18528104.371104.37
517695-1769599.67899.68
618550-18550104.495104.49
10min118433-18433103.836103.781.70103.84103.781.70
218417-18417103.746103.75
318742-18742105.576105.58
418516-18516104.303104.30
517834-17834100.461100.46
618599-18599104.771104.77
15min118266-18266102.895103.621.73102.89103.621.73
218497-18497104.196104.20
318717-18717105.435105.44
418509-18509104.264104.26
517818-17818100.371100.37
618560-18560104.551104.55
30min118302-18302103.098103.442.02103.10103.452.02
218314-18314103.165103.17
318657-18657105.097105.10
418478-18478104.089104.09
517699-1769999.70199.70
618732-18732105.520105.52
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