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)1.5
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%
110.451725251731041728901728251731481728980.15
210.401728901728971728940.01
单位质量响应值RSD%判断
16545.2616624.420.34数据可信
供试品溶液-G01T78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%
5min1167536-16753690.73477.7213.1190.7377.7213.11
2150348-15034881.42681.43
3136219-13621973.77473.77
4113408-11340861.42061.42
5137750-13775074.60374.60
6155824-15582484.39184.39
10min1184640-18464099.99893.664.79100.1593.794.80
2174007-17400794.23994.37
3171761-17176193.02393.15
4158890-15889086.05286.15
5175269-17526994.92395.05
6173047-17304793.71993.86
15min1185099-185099100.24697.882.95100.5698.162.95
2176528-17652895.60495.90
3184667-184667100.012100.29
4175869-17586995.24795.49
5186837-186837101.188101.47
6175386-17538694.98695.28
20min1185411-185411100.41599.363.66100.9099.803.64
2176485-17648595.58196.03
3189910-189910102.852103.30
4181531-18153198.31498.72
5191644-191644103.791104.24
6175742-17574295.17995.63
30min1184805-184805100.087100.094.28100.74100.704.26
2176781-17678195.74196.35
3192167-192167104.074104.69
4184339-18433999.835100.40
5195189-195189105.711106.34
6175530-17553095.06495.68
45min1184533-18453399.94099.974.45100.76100.764.43
2175787-17578795.20395.97
3192087-192087104.031104.82
4184412-18441299.874100.61
5195420-195420105.836106.64
6175332-17533294.95795.73
极限1184542-18454299.94599.954.47100.93100.904.44
2175627-17562795.11696.05
3191899-191899103.929104.89
4184809-184809100.089100.99
5195352-195352105.799106.78
6175120-17512094.84295.77
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)1.5
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%
110.451728361723371727751721971724611725210.17
210.401717401712341714870.21
单位质量响应值RSD%判断
16509.1916489.130.09数据可信
供试品溶液-G01T78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%
5min1153004-15300483.29482.429.4083.2982.429.41
2158029-15802986.03086.03
3167048-16704890.94090.94
4126459-12645968.84368.84
5144906-14490678.88678.89
6158941-15894186.52686.53
10min1182720-18272099.47194.596.6299.6194.736.62
2181615-18161598.87099.01
3178720-17872097.29497.45
4152496-15249683.01883.13
5168917-16891791.95792.09
6178069-17806996.93997.08
15min1186635-186635101.60397.554.47101.9197.854.47
2185027-185027100.727101.04
3178887-17888797.38597.70
4164140-16414089.35689.61
5179431-17943197.68197.97
6181012-18101298.54198.85
20min1186951-186951101.77598.723.17102.2599.183.18
2185512-185512100.991101.47
3178945-17894597.41697.89
4171442-17144293.33293.73
5184682-184682100.539100.99
6180468-18046898.24598.72
30min1186685-186685101.63099.482.15102.27100.102.16
2185311-185311100.882101.53
3178942-17894297.41598.05
4178148-17814896.98297.54
5186636-186636101.603102.22
6180669-18066998.35598.99
45min1186027-186027101.27299.242.13102.08100.022.13
2185271-185271100.860101.67
3178330-17833097.08197.88
4178139-17813996.97797.70
5186027-186027101.272102.06
6179949-17994997.96398.76
极限1186182-186182101.35699.112.11102.34100.072.11
2184716-184716100.558101.54
3178300-17830097.06598.03
4177920-17792096.85897.74
5185593-185593101.035101.99
6179667-17966797.80998.77
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)1.5
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%
110.451725111729541728251726331727551727360.10
210.401717041718371717700.06
单位质量响应值RSD%判断
16529.7616516.350.06数据可信
供试品溶液-G01T78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%
5min1149110-14911081.05783.1111.9381.0683.1111.92
2176258-17625895.81595.81
3167782-16778291.20791.21
4159284-15928486.58786.59
5133506-13350672.57472.57
6131395-13139571.42771.43
10min1175237-17523795.26094.636.3495.3994.776.35
2189725-189725103.135103.30
3181454-18145498.63998.79
4174713-17471394.97595.12
5161829-16182987.97188.09
6161528-16152887.80787.93
15min1184591-184591100.34497.774.08100.6498.074.09
2190726-190726103.679104.01
3182602-18260299.26399.58
4175982-17598295.66595.97
5171987-17198793.49393.76
6173246-17324694.17794.44
20min1189170-189170102.83498.973.63103.2999.423.64
2190683-190683103.656104.16
3182681-18268199.30699.79
4175432-17543295.36695.83
5176320-17632095.84896.27
6178044-17804496.78597.21
30min1191119-191119103.89399.533.52104.53100.163.52
2190349-190349103.475104.15
3182731-18273199.33399.98
4175340-17534095.31695.94
5178065-17806596.79797.38
6180991-18099198.38798.97
45min1190792-190792103.71599.473.40104.52100.263.40
2189853-189853103.205104.05
3182267-18226799.08199.89
4174988-17498895.12495.90
5178919-17891997.26198.01
6181052-18105298.42199.17
极限1191050-191050103.85699.433.51104.83100.383.51
2189495-189495103.010104.03
3183175-18317599.575100.55
4174476-17447694.84695.78
5178444-17844497.00397.91
6180809-18080998.28999.20
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)1.5
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%
110.451721561724551724891722651725991723930.11
210.401728091727661727880.02
单位质量响应值RSD%判断
16496.9416614.230.51数据可信
供试品溶液-G01T78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%
5min1153311-15331183.17882.726.6583.1882.726.65
2133647-13364772.50972.51
3161441-16144187.58987.59
4152136-15213682.54082.54
5152975-15297582.99583.00
6161252-16125287.48687.49
10min1180118-18011897.72295.353.7697.8695.483.76
2164044-16404489.00189.12
3176585-17658595.80595.95
4173506-17350694.13494.27
5177100-17710096.08496.22
6183096-18309699.33799.48
15min1184606-184606100.15798.522.29100.4698.812.29
2177358-17735896.22496.49
3179222-17922297.23697.54
4177058-17705896.06296.36
5185297-185297100.532100.83
6185957-185957100.890101.20
20min1184547-184547100.12599.341.94100.5999.801.94
2182378-18237898.94899.38
3179875-17987597.59098.06
4178346-17834696.76097.21
5187498-187498101.726102.19
6185924-185924100.872101.35
30min1185889-185889100.85399.702.17101.49100.322.16
2184568-184568100.136100.73
3180010-18001097.66398.29
4177917-17791796.52897.14
5188383-188383102.206102.84
6185813-185813100.812101.46
45min1184246-18424699.96199.482.21100.76100.272.20
2184835-184835100.281101.04
3179645-17964597.46598.26
4177541-17754196.32497.10
5188579-188579102.312103.12
6185274-185274100.519101.33
极限1184182-18418299.92799.262.01100.90100.222.00
2183349-18334999.475100.40
3179305-17930597.28198.24
4178151-17815196.65597.59
5188054-188054102.027103.00
6184710-184710100.213101.20
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