替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.067602367594427534747550257570307570410.38
211.077532777537527535140.05
单位质量响应值RSD%判断
68448.5568068.110.40数据可信
供试品溶液-2024100621批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185406-8540611.26112.314.8311.2612.314.82
294025-9402512.39712.40
391582-9158212.07512.08
496558-9655812.73112.73
594496-9449612.46012.46
698165-9816512.94312.94
10min1176064-17606423.21524.624.1223.2824.694.12
2184815-18481524.36824.44
3191136-19113625.20225.27
4192876-19287625.43125.50
5180083-18008323.74423.81
6195505-19550525.77825.85
15min1270979-27097935.72936.685.4235.9236.895.41
2296585-29658539.10639.31
3278307-27830736.69636.90
4294442-29444238.82339.04
5257193-25719333.91234.11
6271801-27180135.83836.05
20min1335294-33529444.21047.525.7944.6047.935.76
2372221-37222149.07849.50
3341955-34195545.08845.50
4382744-38274450.46650.89
5348927-34892746.00746.40
6381141-38114150.25550.67
30min1471098-47109862.11666.914.3262.7567.584.31
2518063-51806368.30869.00
3524838-52483869.20169.86
4510600-51060067.32468.03
5492143-49214364.89165.54
6527838-52783869.59770.29
45min1619250-61925081.65083.223.1482.6384.263.13
2651500-65150085.90286.98
3650041-65004185.71086.76
4620810-62081081.85682.94
5602782-60278279.47980.48
6642509-64250984.71785.80
60min1688689-68868990.80690.941.9292.2492.451.89
2672362-67236288.65390.20
3697275-69727591.93893.46
4711037-71103793.75295.29
5685300-68530090.35991.81
6683568-68356890.13191.68
极限1720931-72093195.05794.970.7197.0096.980.65
2722105-72210595.21297.26
3716266-71626694.44296.47
4714682-71468294.23396.29
5728873-72887396.10498.05
6718714-71871494.76596.82
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.067572597566817537777535867528217548250.27
211.077561917538417550160.23
单位质量响应值RSD%判断
68248.1968203.790.05数据可信
供试品溶液-2024100621批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min189710-8971011.83412.082.7911.8312.082.78
289759-8975911.84111.84
396434-9643412.72112.72
491727-9172712.10012.10
590174-9017411.89511.90
691871-9187112.11912.12
10min1185432-18543224.46124.793.9024.5324.863.88
2189935-18993525.05525.12
3181251-18125123.91023.98
4185912-18591224.52424.59
5183478-18347824.20324.27
6201703-20170326.60826.67
15min1284104-28410437.47737.732.9937.6837.942.98
2287162-28716237.88138.09
3293448-29344838.71038.91
4275277-27527736.31336.52
5278587-27858736.75036.95
6297580-29758039.25539.47
20min1382204-38220450.41848.574.4950.8348.984.46
2355443-35544346.88847.30
3390896-39089651.56551.98
4352341-35234146.47946.88
5354100-35410046.71147.12
6374232-37423249.36749.80
30min1531702-53170270.13968.323.4470.8369.003.41
2491636-49163664.85465.53
3540041-54004171.23971.94
4522881-52288168.97669.64
5504437-50443766.54367.21
6516595-51659568.14668.85
45min1628340-62834082.88783.791.0583.9784.861.03
2626460-62646082.63983.68
3637150-63715084.04985.15
4642978-64297884.81885.86
5640730-64073084.52285.56
6635635-63563583.85084.94
60min1637041-63704184.03589.453.6585.5890.983.59
2661074-66107487.20588.70
3692633-69263391.36892.94
4683877-68387790.21391.73
5704658-70465892.95594.46
6689130-68913090.90692.46
极限1725541-72554195.70993.583.1397.7295.603.06
2720264-72026495.01396.99
3700898-70089892.45994.53
4705271-70527193.03695.05
5671392-67139288.56690.59
6732874-73287496.67798.73
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.067546257554127536767523577549777542090.17
211.077546427549667548040.04
单位质量响应值RSD%判断
68192.5068184.640.01数据可信
供试品溶液-2024100621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%
5min158798-587987.7617.108.577.767.108.57
247734-477346.3006.30
357140-571407.5427.54
457580-575807.6007.60
550256-502566.6336.63
651306-513066.7726.77
10min1123890-12389016.35215.698.9016.3915.738.90
2101947-10194713.45613.49
3131046-13104617.29617.34
4126347-12634716.67616.72
5117480-11748015.50615.54
6112443-11244314.84114.88
15min1152547-15254720.13420.067.0220.2720.197.02
2132249-13224917.45517.56
3162387-16238721.43321.57
4150691-15069119.88920.02
5159989-15998921.11621.24
6154143-15414320.34520.46
20min1169638-16963822.39021.923.9822.6422.164.01
2152930-15293020.18520.39
3167184-16718422.06622.32
4171081-17108122.58022.83
5168335-16833522.21822.46
6167107-16710722.05622.29
30min1178710-17871023.58723.304.7323.9623.674.70
2164546-16454621.71822.04
3168238-16823822.20522.58
4179164-17916423.64724.02
5184433-18443324.34324.71
6184334-18433424.33024.69
45min1177556-17755623.43524.072.6723.9424.562.61
2184322-18432224.32824.77
3181508-18150823.95724.46
4188445-18844524.87225.37
5186289-18628924.58825.09
6176170-17617023.25223.74
60min1182336-18233624.06623.903.1724.7024.523.11
2179384-17938423.67624.25
3170297-17029722.47723.11
4184618-18461824.36725.01
5185821-18582124.52625.16
6184011-18401124.28724.91
极限1184422-18442224.34124.072.2725.1124.822.21
2181366-18136623.93824.64
3188812-18881224.92125.68
4183343-18334324.19924.97
5177386-17738623.41324.18
6178838-17883823.60424.36
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
111.067468367474247472207464887440107463960.19
211.077484667488737486700.04
单位质量响应值RSD%判断
67486.0867630.530.16数据可信
供试品溶液-2024100621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%
5min151929-519296.9187.006.316.927.006.30
251803-518036.9016.90
353880-538807.1787.18
458385-583857.7787.78
549359-493596.5766.58
649753-497536.6286.63
10min1119940-11994015.97815.642.8516.0215.682.84
2114606-11460615.26815.31
3112606-11260615.00115.04
4116709-11670915.54815.59
5119079-11907915.86415.90
6121316-12131616.16216.20
15min1164194-16419421.87421.264.4422.0021.384.41
2164853-16485321.96122.08
3153718-15371820.47820.60
4150614-15061420.06520.19
5168207-16820722.40822.53
6156005-15600520.78320.91
20min1177860-17786023.69423.592.8223.9423.832.80
2184498-18449824.57924.82
3173216-17321623.07623.31
4170020-17002022.65022.89
5178916-17891623.83524.08
6177784-17778423.68423.93
30min1185274-18527424.68223.852.7625.0624.222.73
2182073-18207324.25524.64
3170577-17057722.72423.09
4179647-17964723.93224.30
5178318-17831823.75524.14
6178170-17817023.73624.11
45min1180271-18027124.01524.211.2124.5324.721.17
2179978-17997823.97624.49
3181268-18126824.14824.64
4185846-18584624.75825.26
5182415-18241524.30124.81
6180676-18067624.06924.57
60min1176096-17609623.45923.863.5624.1124.503.50
2185673-18567324.73525.38
3168814-16881422.48923.11
4181311-18131124.15424.79
5185197-18519724.67225.32
6177515-17751523.64824.29
极限1181252-18125224.14624.021.8124.9324.801.75
2182771-18277124.34825.14
3180920-18092024.10224.85
4182505-18250524.31325.08
5173915-17391523.16923.95
6180655-18065524.06724.84
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