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%
113.521732117121173731710117298172430.72
213.561720217159171800.18
单位质量响应值RSD%判断
1275.371266.960.47数据可信
供试品溶液-2024081211批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min115220-1522085.69184.812.5985.6984.812.58
215732-1573288.57488.57
315149-1514985.29185.29
414727-1472782.91682.92
514798-1479883.31583.32
614756-1475683.07983.08
5min116569-1656993.28699.062.9993.2999.062.99
217963-17963101.135101.13
317642-1764299.32799.33
417970-17970101.174101.17
517600-1760099.09199.09
617822-17822100.341100.34
10min116875-1687595.00999.262.3195.0199.262.31
217515-1751598.61298.61
317833-17833100.403100.40
417869-17869100.605100.61
517674-1767499.50899.51
618010-18010101.399101.40
15min116857-1685794.90899.202.1894.9199.202.18
217601-1760199.09799.10
317795-17795100.189100.19
417796-17796100.194100.19
517875-17875100.639100.64
617788-17788100.149100.15
30min116965-1696595.51699.722.3095.5299.722.30
217532-1753298.70898.71
318055-18055101.653101.65
417953-17953101.078101.08
517878-17878100.656100.66
617890-17890100.724100.72
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%
113.521725617280171841741117160172580.58
213.561724817127171880.50
单位质量响应值RSD%判断
1276.481267.550.50数据可信
供试品溶液-2024081211批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min115223-1522385.65181.878.0485.6581.878.04
214599-1459982.14082.14
316213-1621391.22191.22
414772-1477283.11383.11
512951-1295172.86872.87
613547-1354776.22176.22
5min116913-1691395.16096.393.0895.1696.383.07
216889-1688995.02595.02
317935-17935100.910100.91
417589-1758998.96398.96
516507-1650792.87592.88
616953-1695395.38595.38
10min117425-1742598.04098.002.5798.0498.002.57
217125-1712596.35296.35
317956-17956101.028101.03
417915-17915100.797100.80
516826-1682694.67094.67
617265-1726597.14097.14
15min117410-1741097.95698.102.0397.9698.102.02
217182-1718296.67396.67
317879-17879100.595100.59
417745-1774599.84199.84
516924-1692495.22195.22
617472-1747298.30598.30
30min117562-1756298.81197.922.1498.8197.922.14
217295-1729597.30997.31
317917-17917100.808100.81
417567-1756798.83998.84
516819-1681994.63194.63
617263-1726397.12997.13
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%
113.521735917121173151724217136172350.62
213.561735417386173700.14
单位质量响应值RSD%判断
1274.781280.970.35数据可信
供试品溶液-2024081511批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min115151-1515184.85488.286.6184.8588.286.61
214687-1468782.25682.26
316163-1616390.52290.52
417602-1760298.58198.58
515802-1580288.50088.50
615171-1517184.96684.97
5min116999-1699995.204102.075.7595.20102.075.75
216985-1698595.12695.13
318985-18985106.327106.33
419561-19561109.553109.55
518349-18349102.765102.76
618468-18468103.431103.43
10min117036-1703695.411102.724.9595.41102.724.95
217466-1746697.82097.82
318945-18945106.103106.10
419392-19392108.606108.61
518463-18463103.403103.40
618748-18748105.000105.00
15min116833-1683394.275101.875.6594.27101.875.65
216984-1698495.12095.12
318931-18931106.025106.02
419252-19252107.822107.82
518492-18492103.566103.57
618647-18647104.434104.43
30min116941-1694194.879102.265.1094.88102.265.09
217239-1723996.54896.55
318763-18763105.084105.08
419154-19154107.273107.27
518578-18578104.048104.05
618879-18879105.733105.73
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%
113.521733817242172161724917273172640.27
213.561710117160171300.25
单位质量响应值RSD%判断
1276.921263.270.76数据可信
供试品溶液-2024081511批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min114685-1468582.75083.574.2382.7583.574.23
214360-1436080.91980.92
314170-1417079.84879.85
415938-1593889.81189.81
515066-1506684.89784.90
614764-1476483.19583.20
5min116353-1635392.14997.785.0692.1597.785.06
217179-1717996.80496.80
317000-1700095.79595.80
418436-18436103.887103.89
518415-18415103.769103.77
616728-1672894.26294.26
10min116692-1669294.05998.385.6494.0698.385.64
217035-1703595.99295.99
316920-1692095.34495.34
418881-18881106.394106.39
518542-18542104.484104.48
616688-1668894.03794.04
15min116647-1664793.80698.845.1293.8198.845.12
217211-1721196.98496.98
316964-1696495.59295.59
418671-18671105.211105.21
518676-18676105.239105.24
617072-1707296.20196.20
30min116723-1672394.23498.515.2594.2398.515.25
217062-1706296.14496.14
317001-1700195.80195.80
418524-18524104.383104.38
518776-18776105.803105.80
616808-1680894.71394.71
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