左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.341881661877961879431878241878221879100.09
217.421879601878311878960.05
单位质量响应值RSD%判断
10836.7910786.220.34数据可信
供试品溶液-24082901批-左氨氯地平-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%
5min1217994-217994203.691203.911.49203.69203.921.49
2217999-217999203.695203.70
3219323-219323204.933204.93
4219043-219043204.671204.67
5222495-222495207.896207.90
6212543-212543198.597198.60
10min1218688-218688204.339205.611.52206.60207.871.52
2220369-220369205.910208.17
3221739-221739207.190209.47
4221107-221107206.599208.87
5224103-224103209.399211.71
6214259-214259200.201202.41
15min1219232-219232204.847205.491.54209.38210.041.54
2219663-219663205.250209.80
3221411-221411206.884211.46
4220934-220934206.438211.01
5224245-224245209.532214.17
6214019-214019199.977204.41
20min1218916-218916204.552205.151.63211.36211.981.62
2219166-219166204.786211.62
3221265-221265206.747213.62
4220723-220723206.241213.10
5223963-223963209.268216.23
6213310-213310199.314205.97
30min1218508-218508204.171204.741.63213.25213.861.62
2219103-219103204.727213.83
3220447-220447205.983215.16
4220483-220483206.016215.17
5223438-223438208.778218.07
6212753-212753198.794207.66
45min1218663-218663204.316204.611.59215.67216.001.59
2218827-218827204.469215.85
3220324-220324205.868217.33
4219794-219794205.373216.82
5223416-223416208.757220.37
6212830-212830198.866209.94
极限1218295-218295203.972204.411.50217.59218.071.50
2218542-218542204.203217.86
3219873-219873205.446219.20
4219506-219506205.104218.83
5223200-223200208.555222.48
6213140-213140199.155212.44
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.101962611961391964761961941962001962540.07
216.181961341960571960960.03
单位质量响应值RSD%判断
12189.6912119.650.41数据可信
供试品溶液-24082901批-叶酸-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%
5min1231634-231634195.528197.212.56195.53197.212.56
2237060-237060200.109200.11
3239254-239254201.961201.96
4239979-239979202.573202.57
5227299-227299191.869191.87
6226534-226534191.223191.22
10min1237985-237985200.890202.792.47203.06204.982.47
2242778-242778204.935207.16
3246251-246251207.867210.11
4246869-246869208.389210.64
5234082-234082197.595199.73
6233453-233453197.064199.19
15min1238909-238909201.670203.372.51206.07207.812.51
2243279-243279205.358209.86
3246992-246992208.493213.05
4247736-247736209.121213.69
5233549-233549197.145201.47
6235058-235058198.419202.73
20min1240006-240006202.596203.462.48209.24210.162.48
2243447-243447205.500212.28
3246946-246946208.454215.32
4247439-247439208.870215.76
5233756-233756197.320203.84
6234586-234586198.020204.54
30min1239236-239236201.946203.342.41210.84212.312.42
2243241-243241205.326214.39
3246624-246624208.182217.37
4247436-247436208.867218.08
5234159-234159197.660206.37
6234656-234656198.079206.80
45min1239819-239819202.438203.452.46213.58214.672.46
2243382-243382205.445216.79
3246860-246860208.381219.88
4247509-247509208.929220.46
5233925-233925197.462208.37
6234612-234612198.042208.96
极限1238831-238831201.604203.232.52214.99216.722.51
2243754-243754205.759219.39
3246487-246487208.066221.88
4247508-247508208.928222.78
5233669-233669197.246210.35
6234320-234320197.796210.92
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.341877281882461878991878621876621878790.13
217.421877891878531878210.03
单位质量响应值RSD%判断
10835.0110781.920.35数据可信
供试品溶液-24082901批-左氨氯地平-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%
5min1215565-215565201.478201.940.88201.48201.940.88
2217649-217649203.426203.43
3215397-215397201.321201.32
4214602-214602200.578200.58
5214103-214103200.112200.11
6219032-219032204.718204.72
10min1219331-219331204.998204.280.83207.24206.520.83
2219551-219551205.203207.46
3216934-216934202.758204.99
4217654-217654203.430205.66
5216601-216601202.446204.67
6221304-221304206.842209.12
15min1219038-219038204.724203.900.83209.24208.410.83
2219025-219025204.712209.25
3216858-216858202.686207.18
4216716-216716202.554207.04
5216363-216363202.224206.70
6220937-220937206.499211.07
20min1218444-218444204.169203.510.79210.96210.290.79
2218407-218407204.134210.95
3216247-216247202.115208.86
4216276-216276202.143208.88
5216539-216539202.388209.11
6220549-220549206.136213.00
30min1217962-217962203.718203.570.74212.78212.620.74
2218704-218704204.412213.49
3215846-215846201.741210.73
4216001-216001201.885210.87
5218348-218348204.079213.05
6219987-219987205.611214.77
45min1217796-217796203.563203.250.80214.89214.560.80
2218959-218959204.650216.00
3216412-216412202.270213.50
4215930-215930201.819213.05
5215758-215758201.658212.89
6219939-219939205.566217.01
极限1217735-217735203.506202.870.76217.09216.440.76
2217916-217916203.675217.30
3215662-215662201.569215.05
4215843-215843201.738215.21
5215592-215592201.503214.98
6219605-219605205.254218.98
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.101965131960311963671961131960331962110.12
216.181959851959131959490.03
单位质量响应值RSD%判断
12187.0212110.570.45数据可信
供试品溶液-24082901批-叶酸-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%
5min1234404-234404197.963196.972.10197.96196.972.10
2229254-229254193.613193.61
3231869-231869195.822195.82
4242528-242528204.824204.82
5229903-229903194.162194.16
6231416-231416195.439195.44
10min1242896-242896205.135202.801.99207.33204.991.99
2236385-236385199.636201.79
3237789-237789200.822203.00
4248476-248476209.847212.12
5236231-236231199.506201.66
6239012-239012201.854204.03
15min1243433-243433205.588203.331.83210.07207.771.84
2237015-237015200.168204.54
3238779-238779201.658206.06
4248381-248381209.767214.37
5237170-237170200.299204.67
6239771-239771202.495206.91
20min1243721-243721205.831203.311.90212.59210.011.90
2236967-236967200.127206.72
3238653-238653201.551208.20
4248545-248545209.905216.84
5236997-236997200.153206.75
6239507-239507202.272208.94
30min1243446-243446205.599203.301.84214.65212.261.85
2237618-237618200.677209.49
3238464-238464201.392210.28
4248515-248515209.880219.15
5237195-237195200.320209.14
6239127-239127201.952210.86
45min1243140-243140205.341203.321.79216.68214.541.80
2237134-237134200.268211.32
3238893-238893201.754212.88
4248395-248395209.779221.38
5237600-237600200.662211.71
6239329-239329202.122213.28
极限1243113-243113205.318203.691.73218.93217.171.73
2236839-236839200.019213.29
3238265-238265201.224214.59
4248354-248354209.744223.68
5241281-241281203.771217.05
6239259-239259202.063215.46
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