替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.125045705032655039395041105041135039990.10
211.205032955037515035230.07
单位质量响应值RSD%判断
45323.6544957.410.58数据可信
供试品溶液-F95000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%
5min1123936-12393624.71022.876.8024.7122.886.80
2106439-10643921.22221.22
3114037-11403722.73722.74
4113272-11327222.58422.58
5123929-12392924.70924.71
6106766-10676621.28721.29
10min1256598-25659851.16145.477.9851.3045.597.98
2214573-21457342.78242.90
3230958-23095846.04946.17
4225354-22535444.93145.06
5236554-23655447.16447.30
6204157-20415740.70540.82
15min1305108-30510860.83363.234.8661.2563.614.85
2296117-29611759.04059.40
3322900-32290064.38064.76
4329727-32972765.74166.12
5336742-33674267.14067.54
6312194-31219462.24562.59
20min1382884-38288476.34077.181.3677.1077.901.35
2388427-38842777.44578.13
3381505-38150576.06576.80
4396171-39617178.98979.73
5388295-38829577.41978.19
6385159-38515976.79377.48
30min1476482-47648295.00194.452.3196.1895.612.31
2466090-46609092.92994.04
3485097-48509796.71997.88
4480547-48054795.81296.99
5478620-47862095.42896.63
6455507-45550790.81991.94
45min1486234-48623496.94694.981.9298.6696.661.87
2487390-48739097.17698.81
3470865-47086593.88195.58
4477396-47739695.18496.89
5464170-46417092.54794.28
6472147-47214794.13795.76
60min1460010-46001091.71792.582.1693.9794.792.12
2465225-46522592.75794.93
3464486-46448692.61094.83
4483259-48325996.35298.59
5456877-45687791.09293.34
6456173-45617390.95293.10
极限1456544-45654491.02693.912.9493.7996.642.88
2479145-47914595.53298.22
3481908-48190896.08398.82
4476246-47624694.95497.73
5481696-48169696.04198.79
6450460-45046089.81392.46
替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.125027525028095021625018145021245023320.09
211.205043725044055043880.01
单位质量响应值RSD%判断
45173.7445034.640.22数据可信
供试品溶液-F95000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%
5min1107478-10747821.44622.634.3621.4522.634.36
2107268-10726821.40421.40
3117924-11792423.53023.53
4118357-11835723.61723.62
5114294-11429422.80622.81
6115211-11521122.98922.99
10min1216143-21614343.12944.034.3143.2544.154.30
2205425-20542540.99041.11
3218938-21893843.68743.82
4222572-22257244.41244.54
5229355-22935545.76545.89
6231419-23141946.17746.30
15min1297465-29746559.35663.114.5659.7163.484.54
2315259-31525962.90663.25
3333412-33341266.52966.90
4320709-32070963.99464.37
5328943-32894365.63766.02
6301846-30184660.23060.61
20min1392695-39269578.35877.670.6079.0578.400.59
2388418-38841877.50478.20
3386857-38685777.19377.94
4388745-38874577.57078.30
5391521-39152178.12478.87
6387374-38737477.29678.01
30min1464730-46473092.73293.882.2293.8695.032.22
2454786-45478690.74791.87
3480045-48004595.78796.96
4466575-46657593.10094.26
5482513-48251396.28097.46
6474127-47412794.60795.75
45min1487784-48778497.33295.901.8298.9797.571.78
2478517-47851795.48397.11
3471574-47157494.09795.80
4469787-46978793.74195.42
5485235-48523596.82398.54
6490777-49077797.92999.60
60min1457398-45739891.26893.131.3693.4595.341.35
2462392-46239292.26594.43
3471517-47151794.08696.31
4473223-47322394.42696.63
5471492-47149294.08196.33
6464297-46429792.64594.86
极限1459914-45991491.77193.701.9494.4696.421.90
2467654-46765493.31595.99
3480157-48015795.81098.56
4481287-48128796.03598.76
5466562-46656293.09795.87
6461902-46190292.16794.90
替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.125029845034485033635029735028975031330.06
211.205054975050925052940.06
单位质量响应值RSD%判断
45245.7745115.540.21数据可信
供试品溶液-F95000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%
5min129009-290095.7795.9114.715.785.9114.68
238077-380777.5857.58
326248-262485.2295.23
430219-302196.0206.02
527556-275565.4895.49
626922-269225.3635.36
10min166894-6689413.32511.9010.7813.3611.9410.77
262486-6248612.44712.49
348962-489629.7539.78
464565-6456512.86112.89
558795-5879511.71211.74
656870-5687011.32911.36
15min191142-9114218.15616.389.2218.2616.489.21
281439-8143916.22316.33
369854-6985413.91514.00
489259-8925917.78017.89
580486-8048616.03316.13
681080-8108016.15116.24
20min1108663-10866321.64620.363.9121.8520.553.93
2100082-10008219.93620.14
397334-9733419.38919.55
4102395-10239520.39720.60
5100165-10016519.95320.14
6104589-10458920.83421.02
30min1113930-11393022.69523.302.4623.0223.602.45
2116211-11621123.14923.46
3115110-11511022.93023.20
4122188-12218824.34024.66
5117702-11770223.44623.74
6116603-11660323.22723.53
45min1113752-11375222.65924.124.0623.1124.553.99
2121658-12165824.23424.68
3117096-11709623.32623.72
4122994-12299424.50024.95
5123602-12360224.62225.05
6127427-12742725.38425.81
60min1108642-10864221.64222.685.1822.2223.245.06
2116391-11639123.18523.76
3110560-11056022.02422.55
4110071-11007121.92622.51
5112813-11281322.47223.03
6124502-12450224.80125.37
极限1112167-11216722.34423.823.6423.0424.513.57
2125268-12526824.95325.66
3117762-11776223.45824.11
4120861-12086124.07624.79
5120691-12069124.04224.73
6120602-12060224.02424.73
替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.125050105035785032655044365054295043440.19
211.205026225017555021880.13
单位质量响应值RSD%判断
45354.6844838.210.81数据可信
供试品溶液-F95000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%
5min125856-258565.1605.5611.965.165.5611.92
233492-334926.6846.68
326181-261815.2255.23
424086-240864.8074.81
529509-295095.8895.89
628177-281775.6245.62
10min164326-6432612.83812.548.1112.8712.578.10
267752-6775213.52213.56
356957-5695711.36711.40
457580-5758011.49211.52
569040-6904013.77913.81
661285-6128512.23112.26
15min190101-9010117.98217.896.8018.0817.996.81
293918-9391818.74418.86
387631-8763117.48917.58
481042-8104216.17416.26
598561-9856119.67119.78
686599-8659917.28317.38
20min1107445-10744521.44421.313.0321.6421.513.06
2110811-11081122.11622.33
3105200-10520020.99621.19
4102257-10225720.40820.59
5109855-10985521.92522.14
6105003-10500320.95621.15
30min1114661-11466122.88422.753.0323.2023.063.02
2114833-11483322.91823.26
3116416-11641623.23423.54
4107467-10746721.44821.74
5113377-11337722.62822.97
6117076-11707623.36623.68
45min1119576-11957623.86523.913.6424.3124.363.55
2115762-11576223.10423.57
3118086-11808623.56724.00
4125993-12599325.14625.56
5124079-12407924.76425.23
6115441-11544123.04023.48
60min1120524-12052424.05423.118.9924.6323.698.77
2119903-11990323.93024.53
3120528-12052824.05524.62
4124229-12422924.79325.35
5113931-11393122.73823.34
695663-9566319.09219.66
极限1123134-12313424.57524.504.9725.2925.204.81
2121945-12194524.33825.07
3132182-13218226.38127.08
4126300-12630025.20725.90
5115076-11507622.96723.70
6117803-11780323.51124.19
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