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%
111.183863503856153864843862463856373860660.11
211.163925873909173917520.31
单位质量响应值RSD%判断
34531.8435103.231.17数据可信
供试品溶液-24042201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%
5min141118-4111810.62910.872.1910.6310.872.17
243532-4353211.25311.25
341827-4182710.81310.81
441181-4118110.64610.65
542644-4264411.02411.02
641931-4193110.83910.84
10min199484-9948425.71725.881.6725.7825.941.66
297427-9742725.18625.25
3100241-10024125.91325.97
4102143-10214326.40526.46
5101527-10152726.24626.31
699816-9981625.80325.86
15min1128802-12880233.29633.983.0333.5034.183.02
2126434-12643432.68432.89
3133013-13301334.38534.59
4130610-13061033.76433.97
5138060-13806035.69035.90
6131694-13169434.04434.25
20min1150914-15091439.01240.332.5839.4040.722.57
2157224-15722440.64441.03
3153062-15306239.56839.96
4158375-15837540.94141.33
5162059-16205941.89442.30
6154481-15448139.93540.33
30min1175602-17560245.39445.171.8146.0045.791.81
2173090-17309044.74545.35
3173595-17359544.87645.49
4174846-17484645.19945.82
5180340-18034046.61947.26
6171019-17101944.21044.82
45min1173812-17381244.93245.342.7745.7946.212.74
2166547-16654743.05443.91
3177334-17733445.84246.71
4177875-17787545.98246.85
5180475-18047546.65447.55
6176372-17637245.59446.45
60min1179009-17900946.27545.861.9547.3846.981.92
2176836-17683645.71346.81
3180125-18012546.56447.68
4175900-17590045.47246.60
5180963-18096346.78047.94
6171536-17153644.34345.46
极限1170896-17089644.17844.932.7345.5446.302.67
2172878-17287844.69046.04
3166712-16671243.09644.47
4174415-17441545.08846.47
5179052-17905246.28647.70
6178772-17877246.21447.57
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%
111.183870983861983847353833133841203850930.40
211.163844393845383844880.02
单位质量响应值RSD%判断
34444.8134452.330.02数据可信
供试品溶液-24042201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%
5min135611-356119.30410.988.869.3010.988.89
244841-4484111.71511.72
339788-3978810.39510.39
443743-4374311.42811.43
542821-4282111.18711.19
645430-4543011.86911.87
10min185331-8533122.29325.868.6022.3525.928.59
2109841-10984128.69728.76
394107-9410724.58624.64
4103304-10330426.98927.05
598422-9842225.71425.78
6102819-10281926.86226.93
15min1119637-11963731.25633.885.2031.4334.095.21
2136380-13638035.63135.86
3133083-13308334.76934.96
4136409-13640935.63835.85
5125342-12534232.74732.95
6127300-12730033.25833.47
20min1147661-14766138.57839.483.5038.9339.883.51
2160082-16008241.82342.25
3147443-14744338.52138.91
4153090-15309039.99640.41
5152554-15255439.85640.24
6145872-14587238.11038.51
30min1161419-16141942.17244.833.6442.7445.443.62
2168009-16800943.89444.55
3173392-17339245.30045.90
4178743-17874346.69847.33
5176470-17647046.10446.71
6171417-17141744.78445.40
45min1165660-16566043.28045.223.5944.0846.083.56
2168575-16857544.04244.94
3176774-17677446.18447.04
4177721-17772146.43147.32
5181028-18102847.29548.16
6168692-16869244.07244.93
60min1176408-17640846.08846.971.4847.1348.081.50
2180280-18028047.10048.24
3176726-17672646.17147.28
4181017-18101747.29248.44
5181157-18115747.32948.46
6183099-18309947.83648.94
极限1173373-17337345.29546.261.3546.5947.631.37
2176875-17687546.21047.62
3180085-18008547.04948.42
4178872-17887246.73248.15
5175628-17562845.88447.27
6177475-17747546.36747.74
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%
111.183780083781053784923783123787243783280.08
211.163843703834503839100.17
单位质量响应值RSD%判断
33839.7134400.541.17数据可信
供试品溶液-2024050921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%
5min135919-359199.4758.878.029.488.878.02
235019-350199.2389.24
333472-334728.8308.83
428500-285007.5187.52
535298-352989.3119.31
633584-335848.8598.86
10min182174-8217421.67723.254.3821.7323.304.37
291046-9104624.01724.07
385169-8516922.46722.52
489017-8901723.48223.52
592663-9266324.44424.50
688667-8866723.39023.44
15min1124349-12434932.80233.892.7532.9834.072.74
2127726-12772633.69333.88
3127132-12713233.53633.71
4131310-13131034.63834.81
5133985-13398535.34435.53
6126348-12634833.33033.51
20min1144251-14425138.05239.252.7838.4139.622.76
2150109-15010939.59839.97
3153021-15302140.36640.73
4149771-14977139.50839.87
5152381-15238140.19740.58
6143238-14323837.78538.15
30min1168892-16889244.55245.422.6445.1246.012.62
2166640-16664043.95844.55
3170119-17011944.87645.46
4178630-17863047.12147.71
5176053-17605346.44147.05
6172793-17279345.58146.16
45min1165960-16596043.77944.962.9744.5945.792.93
2167842-16784244.27545.11
3164955-16495543.51444.35
4171092-17109245.13345.98
5175910-17591046.40447.27
6176786-17678646.63547.46
60min1178400-17840047.06046.881.8248.1247.961.75
2177251-17725146.75747.84
3180333-18033347.57048.65
4178940-17894047.20348.30
5171500-17150045.24046.36
6179799-17979947.42948.52
极限1182181-18218148.05847.872.7249.3849.212.64
2179817-17981747.43448.78
3174404-17440446.00647.35
4186756-18675649.26550.62
5178507-17850747.08948.46
6187037-18703749.33950.69
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%
111.183831823831253841173829473818263830390.22
211.163941183945123943150.08
单位质量响应值RSD%判断
34261.0935332.892.18数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024050921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%
5min128181-281817.2918.5110.847.298.5110.86
233232-332328.5978.60
336012-360129.3169.32
431157-311578.0608.06
530893-308937.9927.99
637844-378449.7909.79
10min180541-8054120.83622.354.9920.8822.404.99
283781-8378121.67521.72
389437-8943723.13823.19
491081-9108123.56323.61
583590-8359021.62521.67
689925-8992523.26423.32
15min1121511-12151131.43533.494.2331.5933.664.24
2125764-12576432.53632.70
3136223-13622335.24135.42
4130430-13043033.74333.92
5128364-12836433.20833.37
6134465-13446534.78734.97
20min1140672-14067236.39239.624.4336.7239.984.42
2150959-15095939.05439.40
3155145-15514540.13740.51
4156883-15688340.58640.95
5159971-15997141.38541.73
6155325-15532540.18340.56
30min1171143-17114344.27545.301.3044.8145.881.32
2178074-17807446.06946.63
3175869-17586945.49846.10
4175739-17573945.46446.05
5174561-17456145.16045.74
6175337-17533745.36045.96
45min1174416-17441645.12246.482.0745.9047.312.09
2176022-17602245.53846.36
3181955-18195547.07347.92
4181159-18115946.86747.71
5180270-18027046.63747.47
6184170-18417047.64648.50
60min1181144-18114446.86346.652.6347.8947.742.56
2184475-18447547.72548.80
3185100-18510047.88649.00
4181617-18161746.98548.09
5176783-17678345.73546.82
6172741-17274144.68945.81
极限1182691-18269147.26347.991.8948.5549.341.86
2184071-18407147.62048.96
3182401-18240147.18848.57
4191582-19158249.56350.93
5187562-18756248.52349.87
6184801-18480147.80949.17
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