富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.321726011729951730391722241719311725580.28
210.391710531721221715880.45
单位质量响应值RSD%判断
16720.7416514.730.88数据可信
供试品溶液-2025120221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%
5min1183326-18332699.093100.211.9499.09100.211.94
2186398-186398100.753100.75
3180366-18036697.49397.49
4189719-189719102.548102.55
5188866-188866102.087102.09
6183681-18368199.28599.28
10min1186839-186839100.992102.802.24101.16102.972.24
2190391-190391102.912103.08
3184763-18476399.870100.03
4195047-195047105.428105.60
5195125-195125105.470105.64
6188963-188963102.140102.31
15min1187401-187401101.295102.862.27101.63103.202.27
2189081-189081102.204102.54
3185012-185012100.004100.33
4195455-195455105.649106.00
5195513-195513105.680106.03
6189275-189275102.308102.64
20min1187022-187022101.091103.052.35101.59103.562.35
2190839-190839103.154103.66
3185053-185053100.026100.52
4195818-195818105.845106.37
5195863-195863105.869106.39
6189304-189304102.324102.83
30min1187205-187205101.190103.082.41101.86103.762.41
2191010-191010103.246103.93
3184724-18472499.848100.51
4195853-195853105.864106.56
5196090-196090105.992106.69
6189384-189384102.367103.04
45min1186471-186471100.793103.092.50101.63103.942.50
2191001-191001103.241104.10
3184831-18483199.906100.74
4196170-196170106.035106.91
5196157-196157106.028106.90
6189664-189664102.519103.37
极限1186983-186983101.070103.052.46102.08104.072.45
2191105-191105103.298104.32
3184650-18465099.808100.80
4196048-196048105.969107.02
5195939-195939105.910106.96
6189107-189107102.218103.24
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.321716871730281727631720891720711723280.32
210.391724591727581726080.13
单位质量响应值RSD%判断
16698.4516612.900.37数据可信
供试品溶液-2025120321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%
5min1187269-187269100.990100.890.82100.99100.890.82
2188465-188465101.635101.64
3188023-188023101.397101.40
4185456-185456100.013100.01
5184934-18493499.73199.73
6188302-188302101.547101.55
10min1190289-190289102.619103.390.67102.79103.560.67
2192482-192482103.802103.97
3193590-193590104.399104.57
4190643-190643102.810102.98
5191031-191031103.019103.19
6192263-192263103.683103.85
15min1189945-189945102.433103.270.70102.77103.610.70
2192419-192419103.768104.11
3193422-193422104.308104.65
4190255-190255102.601102.94
5191052-191052103.030103.37
6191913-191913103.495103.84
20min1189258-189258102.063103.290.72102.57103.800.72
2192017-192017103.551104.07
3193278-193278104.231104.75
4191515-191515103.280103.79
5190921-190921102.960103.47
6192233-192233103.667104.18
30min1188795-188795101.813102.980.69102.49103.660.69
2192025-192025103.555104.24
3192371-192371103.742104.43
4190441-190441102.701103.38
5190583-190583102.777103.46
6191484-191484103.263103.95
45min1189031-189031101.940102.830.74102.79103.680.74
2191694-191694103.377104.24
3192568-192568103.848104.71
4189787-189787102.348103.20
5189563-189563102.227103.08
6191418-191418103.228104.09
极限1188320-188320101.557102.830.82102.58103.860.81
2192010-192010103.547104.58
3192131-192131103.612104.65
4189430-189430102.156103.18
5190482-190482102.723103.75
6191658-191658103.357104.39
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.321715641718481713801717541718301716750.12
210.391718781721881720330.13
单位质量响应值RSD%判断
16635.1716557.560.34数据可信
供试品溶液-2025120421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%
5min1184247-18424799.71699.031.5299.7299.041.52
2186173-186173100.758100.76
3180627-18062797.75697.76
4185093-185093100.173100.17
5178915-17891596.83096.83
6182862-18286298.96698.97
10min1187371-187371101.406101.041.13101.57101.211.12
2189048-189048102.314102.48
3184677-18467799.948100.11
4188866-188866102.215102.38
5184084-18408499.62799.79
6186162-186162100.752100.92
15min1188546-188546102.042101.171.24102.38101.501.24
2189211-189211102.402102.74
3184949-184949100.095100.42
4188990-188990102.282102.62
5183806-18380699.47799.80
6186063-186063100.698101.03
20min1187952-187952101.721101.161.20102.23101.661.20
2189353-189353102.479102.99
3184541-18454199.875100.37
4189080-189080102.331102.84
5184189-18418999.684100.18
6186373-186373100.866101.37
30min1187911-187911101.699100.881.31102.37101.551.31
2188976-188976102.275102.95
3184041-18404199.604100.27
4188757-188757102.156102.83
5183540-18354099.33399.99
6185191-185191100.226100.90
45min1187495-187495101.473100.651.13102.32101.491.13
2188277-188277101.897102.75
3184059-18405999.614100.44
4187582-187582101.520102.37
5183245-18324599.173100.00
6185192-185192100.227101.06
极限1187204-187204101.316100.941.20102.33101.951.20
2188996-188996102.286103.31
3183551-18355199.339100.33
4188506-188506102.021103.04
5184154-18415499.665100.66
6186634-186634101.007102.01
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
110.321724041722561723541719651719151721790.14
210.391708271707581707920.03
单位质量响应值RSD%判断
16684.0116438.111.05数据可信
供试品溶液-G01T79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%
5min1158620-15862086.03383.997.8586.0383.997.85
2150100-15010081.41281.41
3164068-16406888.98888.99
4169117-16911791.72791.73
5134674-13467473.04573.05
6152514-15251482.72282.72
10min1177877-17787796.47895.273.2196.6295.413.22
2171900-17190093.23693.37
3179482-17948297.34997.50
4182967-18296799.23999.39
5167305-16730590.74490.87
6174406-17440694.59594.73
15min1180105-18010597.68798.201.0697.9998.501.07
2179865-17986597.55697.85
3182634-18263499.05899.37
4183964-18396499.780100.10
5178815-17881596.98797.26
6180953-18095398.14698.44
20min1179224-17922497.20998.900.9197.6899.370.91
2182634-18263499.05899.51
3182814-18281499.15699.63
4183808-18380899.695100.18
5182078-18207898.75799.19
6183549-18354999.554100.01
30min1179884-17988497.56799.321.1198.2099.951.09
2183342-18334299.442100.06
3182766-18276699.13099.77
4182256-18225698.85399.50
5185480-185480100.602101.20
6184962-184962100.321100.95
45min1178785-17878596.97198.800.9997.7699.600.98
2182561-18256199.01999.80
3181643-18164398.52199.33
4183146-18314699.336100.15
5183756-18375699.667100.43
6183102-18310299.312100.10
极限1178801-17880196.97999.031.2697.9399.991.24
2182210-18221098.82899.78
3182186-18218698.81599.79
4182455-18245598.96199.94
5185446-185446100.583101.52
6184409-184409100.021100.98
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