替米沙坦苯磺酸氨氯地平片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237658487662187656487662807674967662980.10
211.297618757624017621380.05
单位质量响应值RSD%判断
68236.6967505.580.77数据可信
供试品溶液-20220105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%
5min1159023-15902321.08820.703.5221.0920.703.51
2159412-15941221.13921.14
3158714-15871421.04721.05
4161335-16133521.39421.39
5148986-14898619.75719.76
6149286-14928619.79719.80
10min1178027-17802723.60823.903.0523.7224.023.04
2189202-18920225.09025.21
3182112-18211224.15024.27
4181495-18149524.06824.19
5177414-17741423.52723.64
6173035-17303522.94623.06
15min1181448-18144824.06124.442.3024.3124.682.30
2188277-18827724.96725.22
3186743-18674324.76425.01
4186441-18644124.72424.98
5185746-18574624.63124.87
6177020-17702023.47423.71
20min1181692-18169224.09424.281.8824.4824.661.82
2177753-17775323.57123.97
3185244-18524424.56524.95
4184554-18455424.47324.86
5181797-18179724.10824.49
6187588-18758824.87625.24
30min1177880-17788023.58824.141.7124.1024.661.69
2181841-18184124.11424.64
3183937-18393724.39224.92
4184604-18460424.48025.01
5178855-17885523.71824.23
6185307-18530724.57325.08
45min1179688-17968823.82824.011.9424.4724.661.85
2181160-18116024.02324.68
3178476-17847623.66724.33
4177648-17764823.55824.22
5181856-18185624.11624.76
6187407-18740724.85225.49
60min1184932-18493224.52323.853.1825.3024.643.06
2175084-17508423.21824.01
3177712-17771223.56624.36
4176499-17649923.40524.20
5175985-17598523.33724.11
6188989-18898925.06125.84
极限1180699-18069923.96223.472.6524.8824.382.55
2172120-17212022.82523.75
3178249-17824923.63724.56
4172250-17225022.84223.76
5174834-17483423.18424.09
6183555-18355524.34125.26
替米沙坦苯磺酸氨氯地平片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237664257640077662277652547643127652450.15
211.297653917628287641100.24
单位质量响应值RSD%判断
68142.9267680.250.49数据可信
供试品溶液-20220107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%
5min1125935-12593516.69016.722.7516.6916.722.75
2129396-12939617.14817.15
3119891-11989115.88915.89
4127815-12781516.93916.94
5125069-12506916.57516.57
6128672-12867217.05217.05
10min1164063-16406321.74321.411.7621.8421.501.76
2161064-16106421.34521.44
3157215-15721520.83520.92
4163204-16320421.62921.72
5164345-16434521.78021.87
6159483-15948321.13621.23
15min1178996-17899623.72223.171.6223.9423.381.61
2173515-17351522.99523.21
3175258-17525823.22623.43
4176713-17671323.41923.63
5170851-17085122.64222.86
6173695-17369523.01923.23
20min1180826-18082623.96423.691.0624.3124.031.05
2178213-17821323.61823.96
3180936-18093623.97924.31
4178861-17886123.70424.05
5177772-17777223.56023.90
6175996-17599623.32423.66
30min1185470-18547024.58023.763.2625.0624.233.20
2184833-18483324.49524.97
3181289-18128924.02624.49
4174103-17410323.07323.55
5170889-17088922.64723.12
6178913-17891323.71124.18
45min1180504-18050423.92223.661.7224.5424.261.69
2180913-18091323.97624.58
3181695-18169524.07924.68
4173852-17385223.04023.64
5176455-17645523.38523.98
6177535-17753523.52824.13
60min1180823-18082323.96423.502.5124.7124.242.44
2174922-17492223.18223.92
3184787-18478724.48925.22
4175298-17529823.23223.96
5174667-17466723.14823.87
6173650-17365023.01323.75
极限1179502-17950223.78923.513.6224.6724.383.52
2183497-18349724.31825.19
3185525-18552524.58725.46
4169908-16990822.51723.38
5174336-17433623.10423.96
6171697-17169722.75423.61
替米沙坦苯磺酸氨氯地平片片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237601307599747599077598127593757598400.04
211.297578937567307573120.11
单位质量响应值RSD%判断
67661.6267078.120.62数据可信
供试品溶液-20220107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%
5min191395-9139512.21011.633.6912.2111.623.70
289045-8904511.89611.90
386505-8650511.55611.56
485362-8536211.40411.40
582059-8205910.96310.96
687742-8774211.72211.72
10min1149180-14918019.92919.264.5120.0019.334.50
2151619-15161920.25520.32
3144842-14484219.35019.41
4133120-13312017.78417.85
5141482-14148218.90118.96
6144979-14497919.36819.43
15min1174839-17483923.35722.532.4323.5422.702.44
2172387-17238723.03023.21
3167508-16750822.37822.55
4165561-16556122.11822.28
5164320-16432021.95222.12
6167325-16732522.35422.53
20min1183459-18345924.50923.503.5224.8223.803.51
2181950-18195024.30724.61
3169676-16967622.66822.96
4171628-17162822.92823.21
5170160-17016022.73223.02
6178541-17854123.85224.15
30min1183180-18318024.47223.842.6324.9224.272.63
2185268-18526824.75125.19
3175457-17545723.44023.86
4175951-17595123.50623.92
5173525-17352523.18223.60
6177351-17735123.69324.12
45min1184908-18490824.70223.503.1725.2824.063.16
2180374-18037424.09724.68
3174560-17456023.32023.87
4172606-17260623.05923.60
5170676-17067622.80123.34
6172205-17220523.00523.57
60min1184695-18469524.67423.693.0225.3924.383.02
2182970-18297024.44425.16
3174500-17450023.31223.99
4176483-17648323.57724.25
5171221-17122122.87423.54
6174081-17408123.25623.94
极限1177506-17750623.71423.292.5324.5724.112.53
2181645-18164524.26725.12
3172195-17219523.00423.82
4169795-16979522.68323.49
5171862-17186222.96023.76
6172940-17294023.10423.92
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