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)0
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2500
标示量(mg)40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%
110.933795773797633793553794793789863794320.08
210.963838633831993835310.13
单位质量响应值RSD%判断
34714.7334993.700.57数据可信
供试品溶液-F11946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%
5min175046-7504619.37921.137.5819.3821.137.57
286155-8615522.24722.25
386958-8695822.45522.45
488929-8892922.96322.96
578387-7838720.24120.24
675599-7559919.52119.52
10min1140783-14078336.35336.815.2736.4636.925.27
2148553-14855338.36038.48
3150264-15026438.80238.93
4142726-14272636.85536.98
5129084-12908433.33233.44
6143799-14379937.13237.24
15min1186141-18614148.06648.417.5348.3848.747.51
2190354-19035449.15449.49
3207727-20772753.64053.98
4188866-18886648.76949.10
5163554-16355442.23342.53
6188312-18831248.62648.94
20min1271363-27136370.07270.172.6170.6570.762.64
2277018-27701871.53272.14
3281295-28129572.63773.28
4271718-27171870.16470.77
5260829-26082967.35267.88
6268164-26816469.24669.83
30min1331768-33176885.67089.192.2986.6490.172.29
2345177-34517789.13290.14
3352803-35280391.10292.14
4352087-35208790.91791.91
5341787-34178788.25789.16
6348817-34881790.07291.04
45min1361100-36110093.24496.191.8594.6997.671.82
2369685-36968595.46196.96
3375468-37546896.95498.50
4372890-37289096.28997.79
5381858-38185898.604100.00
6374162-37416296.61798.09
60min1354959-35495991.65895.292.5193.6297.302.45
2365515-36551594.38496.42
3367058-36705894.78396.87
4371206-37120695.85497.89
5383128-38312898.932100.88
6372245-37224596.12298.13
极限1351438-35143890.74994.522.9193.2297.062.84
2361458-36145893.33795.89
3367323-36732394.85197.46
4362460-36246093.59596.16
5383409-38340999.005101.50
6370104-37010495.56998.11
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)0
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2500
标示量(mg)40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%
110.933802193798993799293796373798313799030.06
210.963791113793093792100.04
单位质量响应值RSD%判断
34757.8234599.450.33数据可信
供试品溶液-F11946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%
5min180803-8080320.97123.466.0620.9723.466.06
292491-9249124.00424.00
395124-9512424.68724.69
495622-9562224.81724.82
588650-8865023.00723.01
689632-8963223.26223.26
10min1162069-16206942.06142.694.2042.1842.824.20
2165869-16586943.04843.18
3164349-16434942.65342.79
4168620-16862043.76143.90
5152753-15275339.64439.77
6173203-17320344.95145.08
15min1219142-21914256.87357.701.3157.2258.071.32
2222423-22242357.72558.10
3226849-22684958.87359.25
4220931-22093157.33857.72
5220083-22008357.11857.47
6224498-22449858.26358.64
20min1269340-26934069.90170.320.7770.5771.000.79
2269064-26906469.82970.52
3272259-27225970.65971.36
4273613-27361371.01071.71
5268863-26886369.77770.44
6272475-27247570.71571.42
30min1347691-34769190.23591.012.0291.2992.092.02
2354596-35459692.02793.11
3358427-35842793.02294.12
4351168-35116891.13892.23
5338250-33825087.78588.84
6353968-35396891.86492.96
45min1383452-38345299.516100.080.89101.07101.660.88
2385141-38514199.955101.55
3383643-38364399.566101.18
4392372-392372101.831103.43
5383811-38381199.609101.15
6385306-38530699.997101.60
60min1375641-37564197.48998.921.1999.60101.061.19
2377410-37741097.948100.10
3382894-38289499.371101.54
4388314-388314100.778102.94
5379972-37997298.613100.71
6382752-38275299.335101.50
极限1371826-37182696.49998.251.5999.15100.941.57
2378471-37847198.223100.92
3374586-37458697.21599.93
4389442-389442101.071103.80
5378390-37839098.202100.84
6378740-37874098.293101.01
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)0
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2500
标示量(mg)40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%
110.933840283825623826323831943839673832770.19
210.963792423827873810140.66
单位质量响应值RSD%判断
35066.5134764.050.62数据可信
供试品溶液-F11946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%
5min129771-297717.6748.8410.197.678.8410.20
237794-377949.7429.74
331272-312728.0618.06
433241-332418.5698.57
538447-384479.9119.91
635145-351459.0599.06
10min157667-5766714.86517.1310.4714.9117.1810.47
269223-6922317.84417.90
362130-6213016.01516.06
462445-6244516.09716.14
576744-7674419.78219.84
670483-7048318.16918.22
15min180362-8036220.71524.748.8520.8424.898.83
292688-9268823.89224.05
3103899-10389926.78226.92
498650-9865025.42925.57
5100936-10093626.01826.18
699374-9937425.61625.77
20min197340-9734025.09131.0012.5925.3331.2812.52
2109976-10997628.34928.63
3139089-13908935.85336.14
4131642-13164233.93434.21
5118114-11811430.44630.76
6125353-12535332.31232.61
30min1137439-13743935.42841.307.2935.8141.767.29
2160440-16044041.35741.80
3167411-16741143.15443.64
4169594-16959443.71744.18
5161854-16185441.72142.20
6164681-16468142.45042.92
45min1169256-16925643.62945.682.7644.2146.362.82
2174339-17433944.94045.61
3179676-17967646.31547.04
4176500-17650045.49746.21
5182084-18208446.93647.65
6181352-18135246.74747.46
60min1168346-16834643.39546.433.4744.2147.373.53
2179255-17925546.20747.13
3183327-18332747.25648.24
4180079-18007946.41947.38
5185314-18531447.76948.74
6184431-18443147.54148.51
极限1168366-16836643.40045.722.8944.4646.912.96
2176021-17602145.37346.55
3177913-17791345.86147.10
4181830-18183046.87148.09
5182680-18268047.09048.33
6177280-17728045.69846.93
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