培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244505254473284465214473284468744477150.36
210.184460784471654466220.18
单位质量响应值RSD%判断
43722.1743872.500.25数据可信
供试品溶液-2023091211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%
5min176095-7609539.01439.704.6139.0139.704.61
277598-7759839.78539.78
383645-8364542.88542.89
477426-7742639.69739.70
572626-7262637.23637.24
677238-7723839.60039.60
10min1141134-14113472.36077.4617.5672.4277.5317.54
2182731-18273193.68793.75
3134651-13465169.03669.11
4182001-18200193.31393.38
5116632-11663259.79859.86
6149389-14938976.59276.66
15min1194549-19454999.74698.492.3099.9398.682.29
2194078-19407899.50599.73
3198061-198061101.547101.73
4185395-18539595.05395.27
5190191-19019197.51297.67
6190296-19029697.56697.76
20min1195934-195934100.45699.392.68100.8199.752.65
2194018-19401899.47499.86
3198749-198749101.899102.26
4183903-18390394.28894.67
5196430-196430100.710101.03
6194110-19411099.52199.88
30min1195914-195914100.44699.302.41100.9799.832.39
2193587-19358799.25399.81
3199090-199090102.074102.60
4185374-18537495.04295.58
5195683-195683100.327100.82
6192458-19245898.67499.20
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244473984469984465064466804465224468210.09
210.184465864471504468680.09
单位质量响应值RSD%判断
43634.8643896.660.43数据可信
供试品溶液-2023091211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%
5min182568-8256842.36439.586.1542.3639.586.15
279919-7991941.00541.00
374865-7486538.41238.41
469751-6975135.78835.79
580548-8054841.32741.33
675163-7516338.56438.56
10min1161006-16100682.60877.7213.3382.6877.7813.32
2171699-17169988.09588.16
3154066-15406679.04879.11
4115045-11504559.02759.09
5163384-16338483.82983.90
6143613-14361373.68573.75
15min1190641-19064197.81397.580.6398.0297.780.61
2190099-19009997.53597.75
3189868-18986897.41797.61
4191529-19152998.26998.43
5188081-18808196.50096.71
6190889-19088997.94198.13
20min1190817-19081797.90498.090.4998.2898.450.48
2191455-19145598.23198.61
3191165-19116598.08298.44
4191930-19193098.47598.80
5189576-18957697.26797.64
6192152-19215298.58998.94
30min1191540-19154098.27597.930.5598.8198.460.54
2191622-19162298.31798.86
3190736-19073697.86298.38
4191385-19138598.19598.68
5188849-18884996.89497.43
6191104-19110498.05198.57
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244434974433264430854427724429524431260.07
210.184449744451674450700.04
单位质量响应值RSD%判断
43274.0243720.040.73数据可信
供试品溶液-2023091311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%
5min1100185-10018551.72147.155.8151.7247.155.81
287002-8700244.91544.92
389956-8995646.44046.44
488732-8873245.80845.81
586882-8688244.85344.85
695207-9520749.15149.15
10min1188779-18877997.45895.992.0397.5496.072.02
2179605-17960592.72292.80
3188576-18857697.35397.43
4188447-18844797.28797.36
5183135-18313594.54494.62
6187070-18707096.57696.66
15min1192300-19230099.27699.821.1999.52100.061.19
2192189-19218999.21999.45
3197069-197069101.738101.98
4194361-194361100.340100.58
5193768-193768100.034100.27
6190397-19039798.29498.54
20min1187571-18757196.83599.261.9897.2599.661.97
2190469-19046998.33198.73
3197432-197432101.925102.33
4194665-194665100.497100.90
5194409-194409100.365100.76
6189087-18908797.61798.02
30min1190314-19031498.25199.061.3898.8399.631.38
2190729-19072998.46599.02
3196722-196722101.559102.14
4191006-19100698.60899.18
5192989-19298999.632100.20
6189510-18951097.83698.41
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244459174460664459034460494457964459460.03
210.184455144460714457920.09
单位质量响应值RSD%判断
43549.4143790.960.40数据可信
供试品溶液-2023091311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%
5min177198-7719839.69545.2912.4839.7045.3012.47
2108676-10867655.88155.88
382859-8285942.60642.61
487233-8723344.85544.86
582644-8264442.49542.50
689912-8991246.23346.23
10min1136890-13689070.38987.7312.3770.4587.8012.37
2191808-19180898.62898.72
3179950-17995092.53092.60
4177148-17714891.08991.16
5153061-15306178.70478.77
6184831-18483195.04095.12
15min1187993-18799396.66698.341.0696.8598.561.08
2192948-19294899.21499.47
3192818-19281899.14799.37
4192436-19243698.95099.18
5189612-18961297.49897.70
6191734-19173498.58998.82
20min1191306-19130698.36998.960.5398.7199.340.55
2192147-19214798.80299.22
3194079-19407999.795100.19
4191997-19199798.72599.12
5191924-19192498.68799.05
6193255-19325599.37299.77
30min1191381-19138198.40899.251.5798.9299.801.55
2191772-19177298.60999.20
3194862-194862100.198100.75
4190300-19030097.85298.41
5198336-198336101.984102.51
6191509-19150998.47499.04
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244390814387334387434386054386304387580.05
210.184406194413884410040.13
单位质量响应值RSD%判断
42847.4643320.630.78数据可信
供试品溶液-2023090912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%
5min179755-7975541.56945.5511.2641.5745.5511.26
277788-7778840.54440.54
382534-8253443.01743.02
492020-9202047.96147.96
587956-8795645.84345.84
6104352-10435254.38954.39
10min1173234-17323490.29196.113.6290.3696.183.62
2183472-18347295.62795.69
3185944-18594496.91596.99
4181739-18173994.72494.80
5190802-19080299.44799.52
6191194-19119499.65299.74
15min1182973-18297395.36799.272.2995.5999.502.29
2188793-18879398.40098.63
3193263-193263100.730100.96
4189493-18949398.76599.00
5193900-193900101.062101.30
6194314-194314101.278101.53
20min1185368-18536896.61599.681.9296.99100.081.92
2192015-192015100.079100.47
3190953-19095399.52699.93
4189223-18922398.62499.03
5194976-194976101.623102.03
6194930-194930101.599102.02
30min1186225-18622597.06299.892.2797.60100.462.27
2189739-18973998.89399.45
3192295-192295100.225100.79
4188566-18856698.28298.85
5197863-197863103.127103.71
6195189-195189101.734102.33
培哚普利叔丁胺项目信息
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101072-202303对照品来源中检院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1000
标示量(mg)4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%
110.244437124436884435774431544427284433720.10
210.184402684403414403040.02
单位质量响应值RSD%判断
43298.0543251.870.08数据可信
供试品溶液-2023090912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%
5min187293-8729345.29647.5216.1145.3047.5216.11
2118583-11858361.53261.53
394706-9470649.14249.14
480554-8055441.79941.80
591273-9127347.36147.36
677122-7712240.01840.02
10min1185511-18551196.26096.141.7696.3496.221.76
2186902-18690296.98297.08
3187482-18748297.28397.36
4188408-18840897.76397.83
5183929-18392995.43995.52
6179467-17946793.12493.19
15min1189211-18921198.18098.510.9498.4298.750.94
2190420-19042098.80799.07
3191756-19175699.50199.74
4191763-19176399.50499.74
5187367-18736797.22397.46
6188615-18861597.87198.09
20min1188904-18890498.02198.500.9698.4298.900.96
2190268-19026898.72899.16
3190605-19060598.90399.31
4192711-19271199.996100.39
5187367-18736797.22397.62
6189122-18912298.13498.52
30min1189955-18995598.56699.130.5199.1399.700.52
2191837-19183799.543100.14
3191971-19197199.612100.19
4191809-19180999.528100.09
5190793-19079399.00199.56
6189901-18990198.53899.09
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