替米沙坦左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100629-202204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%
111.237608557606217610607603277606767607080.04
211.327581427584297582860.03
单位质量响应值RSD%判断
67738.9166986.400.79数据可信
供试品溶液-2024070521批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181728-18172824.28124.127.0624.2824.127.05
2201737-20173726.95426.95
3187798-18779825.09225.09
4172910-17291023.10223.10
5168647-16864722.53322.53
6170183-17018322.73822.74
10min1313606-31360641.90144.976.6242.0445.116.60
2347854-34785446.47746.63
3368644-36864449.25449.39
4317785-31778542.45942.59
5350698-35069846.85746.98
6320967-32096742.88443.01
15min1412524-41252455.11759.466.7555.4859.856.74
2451550-45155060.33160.74
3473461-47346163.25963.67
4413054-41305455.18855.55
5483723-48372364.63065.02
6435982-43598258.25158.62
20min1486137-48613764.95269.127.1865.6369.847.15
2523952-52395270.00570.75
3522619-52261969.82770.59
4475874-47587463.58164.25
5581423-58142377.68478.43
6514129-51412968.69269.38
30min1561088-56108874.96779.845.5976.0080.935.57
2604993-60499380.83381.96
3580128-58012877.51178.66
4578302-57830277.26778.29
5656403-65640387.70288.88
6604224-60422480.73081.80
45min1621098-62109882.98587.884.8084.4489.424.79
2660190-66019088.20889.79
3640061-64006185.51887.10
4638432-63843285.30086.75
5707667-70766794.55196.21
6679123-67912390.73792.26
60min1661262-66126288.35191.462.8890.2693.492.90
2685473-68547391.58693.66
3665792-66579288.95691.01
4681874-68187491.10593.03
5712942-71294295.25697.44
6699819-69981993.50295.52
90min1701165-70116593.68295.491.2896.0998.021.29
2713684-71368495.35597.93
3707129-70712994.47997.03
4722206-72220696.49398.93
5719233-71923396.09698.81
6724568-72456896.80999.35
120min1-0.0000.00-2.923.073.77
2-0.0003.11
3-0.0003.08
4-0.0002.97
5-0.0003.25
6-0.0003.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-2.923.073.77
2-0.0003.11
3-0.0003.08
4-0.0002.97
5-0.0003.25
6-0.0003.08
替米沙坦左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100629-202204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%
111.237606777611757622757607797620497613910.10
211.327612247640097626160.26
单位质量响应值RSD%判断
67799.7367368.900.46数据可信
供试品溶液-2024070521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%
5min1171728-17172822.86922.9519.9922.8722.9519.99
2160636-16063621.39221.39
3133462-13346217.77317.77
4145362-14536219.35819.36
5227222-22722230.25930.26
6195614-19561426.05026.05
10min1295530-29553039.35541.7318.6839.4841.8618.68
2286317-28631738.12838.25
3236384-23638431.47931.58
4306558-30655840.82440.93
5407830-40783054.31054.48
6347730-34773046.30746.45
15min1391566-39156652.14454.3818.0152.4954.7418.01
2374585-37458549.88350.21
3310391-31039141.33441.61
4418404-41840455.71856.05
5533854-53385471.09271.56
6421183-42118356.08856.49
20min1450141-45014159.94565.2017.6360.5865.8617.63
2440680-44068058.68559.29
3376680-37668050.16250.67
4499730-49973066.54867.19
5618027-61802782.30283.17
6552146-55214673.52874.24
30min1527548-52754870.25375.5214.6171.2276.5514.65
2518541-51854169.05369.99
3467851-46785162.30363.08
4568916-56891675.76276.78
5700332-70033293.26294.58
6619584-61958482.50983.63
45min1585221-58522177.93381.519.3479.2982.969.47
2584284-58428477.80879.13
3534052-53405271.11972.25
4614689-61468981.85783.29
5688557-68855791.69493.53
6665911-66591188.67890.26
60min1627389-62738983.54884.476.7185.3486.376.89
2607055-60705580.84182.59
3573188-57318876.33077.85
4639299-63929985.13487.02
5693640-69364092.37194.72
6665432-66543288.61490.69
90min1530598-53059870.65976.478.0172.9178.838.13
2565452-56545275.30077.50
3541290-54129072.08374.03
4546668-54666872.79975.16
5644492-64449285.82688.69
6616793-61679382.13784.70
120min1-0.0000.00-2.652.7912.39
2-0.0002.62
3-0.0002.35
4-0.0002.77
5-0.0003.34
6-0.0003.02
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-2.652.7912.39
2-0.0002.62
3-0.0002.35
4-0.0002.77
5-0.0003.34
6-0.0003.02
替米沙坦左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100629-202204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%
111.237624997628377624877624987623417625320.03
211.327608317632607620460.23
单位质量响应值RSD%判断
67901.3467318.550.61数据可信
供试品溶液-2024070521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%
5min133690-336904.4854.488.384.484.478.34
232493-324934.3254.33
333008-330084.3944.39
438867-388675.1745.17
530412-304124.0484.05
633238-332384.4254.42
10min186363-8636311.49711.218.9911.5211.248.99
279952-7995210.64310.67
379426-7942610.57310.60
498704-9870413.13913.17
579247-7924710.54910.57
681735-8173510.88010.91
15min1125082-12508216.65116.604.9316.7416.694.95
2119077-11907715.85115.93
3124414-12441416.56216.65
4136107-13610718.11818.22
5123834-12383416.48516.57
6119617-11961715.92316.01
20min1154688-15468820.59220.374.3720.7720.554.40
2148764-14876419.80319.97
3152189-15218920.25920.43
4164850-16485021.94522.15
5152369-15236920.28320.46
6145200-14520019.32919.50
30min1176952-17695223.55623.302.2723.8523.592.29
2173974-17397423.15923.44
3173474-17347423.09323.38
4180510-18051024.02924.35
5176499-17649923.49523.78
6168778-16877822.46822.75
45min1178592-17859223.77424.121.7624.2024.541.69
2184416-18441624.54924.96
3179992-17999223.96024.38
4178138-17813823.71424.17
5185809-18580924.73525.15
6179988-17998823.96024.37
60min1178468-17846823.75723.932.6624.3224.482.60
2180318-18031824.00424.55
3178212-17821223.72324.27
4178672-17867223.78524.37
5188546-18854625.09925.65
6174216-17421623.19123.73
90min1184521-18452124.56324.151.7825.2524.841.74
2178454-17845423.75624.44
3183901-18390124.48125.16
4179892-17989223.94724.67
5184280-18428024.53125.22
6177306-17730623.60324.27
120min1-0.0000.00-0.830.822.13
2-0.0000.81
3-0.0000.82
4-0.0000.85
5-0.0000.83
6-0.0000.80
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.830.822.13
2-0.0000.81
3-0.0000.82
4-0.0000.85
5-0.0000.83
6-0.0000.80
替米沙坦左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100629-202204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%
111.237471917474047468317465867460737468170.07
211.327399157393727396440.06
单位质量响应值RSD%判断
66501.9665339.581.25数据可信
供试品溶液-2024070521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%
5min170805-708059.6688.8716.359.678.8716.37
270579-705799.6379.64
349396-493966.7446.74
457531-575317.8557.86
562640-626408.5538.55
678925-7892510.77610.78
10min1138347-13834718.89017.6418.4718.9417.6918.46
2138956-13895618.97319.03
388538-8853812.08912.13
4114812-11481215.67615.72
5138510-13851018.91218.96
6156055-15605521.30721.37
15min1213941-21394129.21125.7318.6329.3725.8818.61
2184656-18465625.21325.37
3134337-13433718.34218.45
4167035-16703522.80722.94
5197295-19729526.93827.09
6233516-23351631.88432.06
20min1290200-29020039.62333.7521.3339.9434.0421.29
2236678-23667832.31632.61
3170865-17086523.33023.54
4215070-21507029.36529.62
5251886-25188634.39234.69
6318250-31825043.45343.81
30min1395698-39569854.02846.1222.5754.5746.6022.53
2313667-31366742.82843.31
3234647-23464732.03832.37
4303349-30334941.41941.84
5326847-32684744.62745.12
6452491-45249161.78262.38
45min1513040-51304070.05057.9120.3770.8958.6420.35
2375957-37595751.33252.05
3291037-29103739.73840.25
4423187-42318757.78158.43
5420678-42067857.43958.18
6520797-52079771.10972.05
60min1635077-63507786.71265.4823.0787.9466.5423.00
2437286-43728659.70660.71
3319325-31932543.60044.33
4436932-43693259.65860.63
5481561-48156165.75166.81
6567434-56743477.47678.81
90min1674936-67493692.15571.3720.4193.8772.7820.38
2468382-46838263.95265.29
3369814-36981450.49451.47
4475768-47576864.96066.26
5572280-57228078.13879.56
6574900-57490078.49680.26
120min1690729-69072994.31177.1714.0396.5378.9914.07
2579241-57924179.08880.78
3479032-47903265.40666.66
4480457-48045765.60167.26
5594122-59412281.12082.98
6567760-56776077.52179.72
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1694834-69483494.87190.863.9897.6293.104.31
2660732-66073290.21592.34
3617802-61780284.35485.97
4664716-66471690.75992.79
5671823-67182391.72994.04
6682740-68274093.22095.85
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