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2000
标示量(mg)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%
110.211745541744361739741746481745151744250.16
210.201734951737321736140.10
单位质量响应值RSD%判断
17083.7417020.980.27数据可信
供试品溶液-25052901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%
5min1185459-18545997.68796.011.0397.6996.011.03
2183456-18345696.63296.63
3182020-18202095.87695.88
4181054-18105495.36795.37
5181101-18110195.39295.39
6180515-18051595.08395.08
10min1186394-18639498.18096.610.9998.3496.770.99
2184633-18463397.25297.41
3183059-18305996.42396.58
4181444-18144495.57295.73
5182860-18286096.31896.48
6182083-18208395.90996.07
15min1185478-18547897.69796.111.2198.0296.431.21
2184272-18427297.06297.39
3182516-18251696.13796.46
4179216-17921694.39994.72
5181710-18171095.71396.03
6181576-18157695.64295.96
20min1185635-18563597.78096.101.0798.2796.581.07
2183606-18360696.71197.20
3182297-18229796.02296.50
4180796-18079695.23195.71
5181941-18194195.83496.31
6180385-18038595.01595.49
30min1185047-18504797.47095.830.9998.1296.470.99
2183052-18305296.41997.07
3181401-18140195.55096.19
4180375-18037595.00995.64
5181042-18104295.36196.00
6180686-18068695.17395.81
45min1184291-18429197.07295.361.0697.8996.161.06
2182180-18218095.96096.77
3180662-18066295.16195.96
4179199-17919994.39095.18
5180446-18044695.04795.84
6179463-17946394.52995.32
极限1183713-18371396.76895.071.1997.7496.031.18
2182656-18265696.21197.18
3179392-17939294.49295.45
4179278-17927894.43295.38
5179316-17931694.45295.41
6178596-17859694.07295.02
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2000
标示量(mg)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%
110.211735911731381728951731901729191731470.17
210.201721951727671724810.24
单位质量响应值RSD%判断
16958.5716909.900.21数据可信
供试品溶液-25052902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%
5min1183068-18306897.10097.821.2997.1097.821.29
2184940-18494098.09398.09
3183426-18342697.29097.29
4188078-18807899.75899.76
5181299-18129996.16296.16
6185743-18574398.51998.52
10min1184272-18427297.73998.791.3397.9098.951.33
2186848-18684899.10599.27
3185275-18527598.27198.43
4189472-189472100.497100.66
5183120-18312097.12897.29
6188504-18850499.984100.15
15min1184193-18419397.69798.721.2098.0299.051.20
2186447-18644798.89399.22
3185639-18563998.46498.79
4188790-188790100.135100.47
5183257-18325797.20197.52
6188437-18843799.948100.28
20min1182526-18252696.81398.211.2897.3098.701.28
2185858-18585898.58099.07
3184450-18445097.83398.32
4188231-18823199.839100.34
5182704-18270496.90797.39
6187235-18723599.31199.81
30min1183174-18317497.15798.191.3097.8198.851.29
2185691-18569198.49299.15
3184498-18449897.85998.51
4188134-18813499.787100.45
5181942-18194296.50397.15
6187329-18732999.360100.02
45min1181976-18197696.52197.711.3197.3398.531.31
2184938-18493898.09298.91
3183277-18327797.21198.03
4187232-18723299.309100.14
5181355-18135596.19297.00
6186520-18652098.93199.76
极限1181361-18136196.19597.221.3497.1798.201.34
2184086-18408697.64098.63
3182602-18260296.85397.83
4186077-18607798.69699.70
5179919-17991995.43096.40
6185725-18572598.51099.50
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2000
标示量(mg)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%
110.211735741737481735961738901735741736760.09
210.201724731724841724780.01
单位质量响应值RSD%判断
17010.3816909.610.43数据可信
供试品溶液-25052903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%
5min1180350-18035095.51497.381.7995.5197.381.79
2186978-18697899.02499.02
3183969-18396997.43197.43
4180467-18046795.57695.58
5183143-18314396.99396.99
6188314-18831499.73299.73
10min1181541-18154196.14598.282.0496.3098.452.04
2189333-189333100.271100.44
3185796-18579698.39898.56
4181378-18137896.05896.22
5185037-18503797.99698.16
6190391-190391100.832101.00
15min1181673-18167396.21598.181.9796.5398.511.97
2188919-188919100.052100.38
3186124-18612498.57298.90
4181037-18103795.87896.20
5184702-18470297.81998.14
6189903-189903100.573100.91
20min1180708-18070895.70497.912.0296.1898.402.02
2188693-18869399.933100.43
3184987-18498797.97098.46
4180819-18081995.76296.24
5184614-18461497.77298.26
6189448-189448100.332100.83
30min1179886-17988695.26897.482.0395.9198.132.03
2188063-18806399.599100.26
3184169-18416997.53798.19
4180012-18001295.33595.97
5183783-18378397.33297.98
6188483-18848399.821100.49
45min1179407-17940795.01597.091.9095.8197.911.90
2187095-18709599.08699.92
3183561-18356197.21598.03
4179553-17955395.09295.89
5182986-18298696.91097.72
6187396-18739699.246100.08
极限1178367-17836794.46496.561.9495.4297.531.94
2185453-18545398.21799.21
3182713-18271396.76697.74
4178616-17861694.59695.55
5181720-18172096.24097.21
6187065-18706599.070100.07
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2000
标示量(mg)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%
110.211738801737451739581738301734061737640.13
210.201735021741301738160.26
单位质量响应值RSD%判断
17019.0017040.780.10数据可信
供试品溶液-25052903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%
5min1183690-18369096.88397.811.2296.8897.811.22
2186139-18613998.17498.17
3183909-18390996.99897.00
4185925-18592598.06298.06
5189433-18943399.91299.91
6183589-18358996.83096.83
10min1184572-18457297.34898.561.5797.5198.721.57
2189008-18900899.68899.85
3185032-18503297.59197.75
4186569-18656998.40198.56
5191692-191692101.103101.27
6184362-18436297.23797.40
15min1184702-18470297.41798.501.5597.7498.831.55
2188480-18848099.40999.74
3184773-18477397.45497.78
4186481-18648198.35598.68
5191729-191729101.123101.46
6184410-18441097.26397.59
20min1184225-18422597.16598.371.5597.6598.861.55
2188222-18822299.27399.77
3184813-18481397.47597.96
4187158-18715898.71299.20
5191130-191130100.807101.31
6183539-18353996.80397.29
30min1184434-18443497.27598.211.3897.9298.871.38
2187838-18783899.07199.73
3184311-18431197.21097.86
4186158-18615898.18598.84
5190528-190528100.489101.16
6183994-18399497.04397.69
45min1183905-18390596.99698.011.4697.8198.831.46
2187485-18748598.88499.71
3184142-18414297.12197.93
4185289-18528997.72698.55
5190527-190527100.489101.33
6183603-18360396.83797.65
极限1183338-18333896.69797.841.4797.6798.831.47
2187293-18729398.78399.77
3183671-18367196.87397.85
4185120-18512097.63798.62
5190158-190158100.294101.30
6183503-18350396.78497.75
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