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对照品来源中检院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%
113.531731617329173281732217286173160.11
213.571731717349173330.14
单位质量响应值RSD%判断
1279.821277.300.14数据可信
供试品溶液-3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%
2min116291-1629191.19087.593.2991.1987.593.29
216043-1604389.80189.80
314840-1484083.06883.07
415373-1537386.05186.05
515769-1576988.26888.27
615570-1557087.15487.15
5min118165-18165101.679102.512.50101.68102.512.50
218642-18642104.349104.35
317683-1768398.98198.98
417975-17975100.616100.62
518490-18490103.499103.50
618925-18925105.933105.93
10min118206-18206101.909102.842.51101.91102.842.51
218763-18763105.027105.03
317715-1771599.16099.16
418064-18064101.114101.11
518550-18550103.834103.83
618937-18937106.001106.00
15min118215-18215101.959102.792.49101.96102.792.49
218735-18735104.870104.87
317731-1773199.25099.25
418053-18053101.052101.05
518469-18469103.381103.38
618974-18974106.208106.21
30min118293-18293102.396102.872.58102.40102.872.57
218751-18751104.959104.96
317691-1769199.02699.03
418034-18034100.946100.95
518523-18523103.683103.68
618977-18977106.225106.22
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对照品来源中检院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%
113.531727517289173551733917339173190.21
213.571739417361173780.14
单位质量响应值RSD%判断
1280.041280.620.04数据可信
供试品溶液-3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%
2min116863-1686394.26195.323.4994.2695.323.49
217409-1740997.31397.31
316690-1669093.29493.29
416750-1675093.62993.63
518094-18094101.142101.14
616506-1650692.26592.27
5min119758-19758110.443103.174.15110.44103.174.15
218795-18795105.060105.06
317696-1769698.91798.92
417728-1772899.09699.10
518386-18386102.774102.77
618378-18378102.729102.73
10min119292-19292107.838102.853.24107.84102.853.24
218691-18691104.479104.48
317723-1772399.06899.07
417761-1776199.28099.28
518367-18367102.668102.67
618563-18563103.763103.76
15min119237-19237107.531102.633.31107.53102.633.31
218762-18762104.876104.88
317614-1761498.45998.46
417771-1777199.33699.34
518367-18367102.668102.67
618411-18411102.914102.91
30min119259-19259107.654102.783.22107.65102.783.22
218709-18709104.580104.58
317679-1767998.82298.82
417785-1778599.41599.41
518380-18380102.741102.74
618510-18510103.467103.47
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对照品来源中检院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%
113.531733117314173541731917336173310.10
213.571729517296172960.01
单位质量响应值RSD%判断
1280.931274.580.36数据可信
供试品溶液-3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%
2min114754-1475482.63984.524.3882.6484.524.38
214486-1448681.13881.14
316311-1631191.36091.36
414727-1472782.48882.49
514928-1492883.61383.61
615329-1532985.85985.86
5min118255-18255102.248103.480.92102.25103.480.92
218603-18603104.198104.20
318627-18627104.332104.33
418475-18475103.481103.48
518286-18286102.422102.42
618608-18608104.226104.23
10min117901-17901100.266103.771.78100.27103.771.78
218531-18531103.794103.79
318865-18865105.665105.67
418680-18680104.629104.63
518549-18549103.895103.90
618633-18633104.366104.37
15min118007-18007100.859104.221.67100.86104.221.66
218740-18740104.965104.96
318904-18904105.883105.88
418681-18681104.634104.63
518677-18677104.612104.61
618638-18638104.394104.39
30min117985-17985100.736104.731.99100.74104.731.99
219028-19028106.578106.58
318938-18938106.074106.07
418668-18668104.562104.56
518811-18811105.363105.36
618755-18755105.049105.05
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