XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561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对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.332773472776392774622776562773852774980.06
210.332781002789212785100.21
单位质量响应值RSD%判断
26863.3126961.280.26数据可信
供试品溶液-第1批-1-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%
5min182047-8204730.48727.8314.6030.4927.8314.61
255181-5518120.50420.50
369739-6973925.91425.91
484943-8494331.56331.56
579419-7941929.51029.51
678052-7805229.00229.00
10min1168231-16823162.51159.7311.1162.5759.7911.12
2129041-12904147.94947.99
3151325-15132556.22956.28
4178395-17839566.28866.35
5170156-17015663.22663.29
6167401-16740162.20362.26
15min1230172-23017285.52782.208.6185.7182.378.62
2187151-18715169.54169.68
3213127-21312779.19379.36
4241886-24188689.88090.08
5227285-22728584.45484.64
6227642-22764284.58784.77
20min1265804-26580498.76793.824.9099.1294.164.92
2229683-22968385.34585.62
3251896-25189693.59993.92
4260549-26054996.81497.19
5253468-25346894.18394.54
6253565-25356594.21994.57
30min1272647-272647101.31099.531.02101.86100.061.05
2264403-26440398.24798.69
3266556-26655699.04799.56
4267281-26728199.31699.88
5268123-26812399.629100.17
6268180-26818099.650100.19
45min1272308-272308101.18499.810.75101.94100.530.77
2267278-26727899.31599.96
3266802-26680299.13899.85
4267506-26750699.400100.17
5268577-26857799.797100.54
6269116-26911699.998100.74
极限1272189-272189101.14099.890.69102.10100.810.72
2267043-26704399.227100.07
3267681-26768199.465100.37
4268509-26850999.772100.74
5267947-26794799.563100.50
6269529-269529100.151101.09
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252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对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1108520158532078545918550898553508540500.17
2108544818604208574500.49
单位质量响应值RSD%判断
85405.0085745.000.29数据可信
供试品溶液-第1批-2-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%
5min1322369-32236937.67135.2411.9737.6735.2411.97
2236069-23606927.58627.59
3284434-28443433.23833.24
4334265-33426539.06139.06
5317543-31754337.10737.11
6314617-31461736.76536.77
10min1581556-58155667.95965.599.5168.0365.669.51
2466764-46676454.54554.60
3531957-53195762.16362.23
4612941-61294171.62671.70
5591061-59106169.07069.14
6583264-58326468.15868.23
15min1751304-75130487.79585.127.1588.0185.327.15
2635413-63541374.25274.42
3704896-70489682.37282.56
4783975-78397591.61391.83
5745649-74564987.13487.35
6749027-74902787.52987.74
20min1841614-84161498.34994.443.8398.7494.813.84
2750797-75079787.73688.05
3806950-80695094.29894.65
4826399-82639996.57196.98
5811147-81114794.78895.17
6812113-81211394.90195.29
30min1852741-85274199.64998.360.77100.2398.920.79
2835779-83577997.66798.15
3836618-83661897.76598.31
4838664-83866498.00498.60
5841133-84113398.29298.87
6845422-84542298.79399.37
45min1849904-84990499.31798.270.65100.1099.030.66
2837596-83759697.87998.56
3835744-83574497.66398.40
4837610-83761097.88198.67
5839939-83993998.15398.93
6844825-84482598.72499.50
极限1850412-85041299.37798.180.70100.3699.140.72
2835932-83593297.68598.56
3835348-83534897.61698.55
4837059-83705997.81698.81
5838424-83842497.97698.94
6843915-84391598.61799.59
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561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对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.332813482814562812762808112813102812400.09
210.332795182795262795220.01
单位质量响应值RSD%判断
27225.5627059.240.44数据可信
供试品溶液-第2批-1-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%
5min178325-7832528.85737.1816.8828.8637.1816.88
2103700-10370038.20638.21
3101605-10160537.43437.43
4119931-11993144.18644.19
5117794-11779443.39943.40
684068-8406830.97330.97
10min1165454-16545460.95874.1013.3861.0274.1713.38
2208882-20888276.95977.03
3201699-20169974.31274.39
4231941-23194185.45485.54
5225124-22512482.94383.03
6173564-17356463.94664.01
15min1221760-22176081.70390.545.8281.8890.765.84
2259387-25938795.56695.80
3252074-25207492.87293.10
4254573-25457393.79394.05
5251380-25138092.61692.87
6235288-23528886.68786.88
20min1246723-24672390.90094.101.9891.2494.502.01
2262253-26225396.62297.04
3256412-25641294.47094.88
4255946-25594694.29894.75
5256871-25687194.63995.08
6254169-25416993.64494.01
30min1251515-25151592.66694.781.4093.1995.371.42
2262621-26262196.75897.37
3256524-25652494.51195.11
4256531-25653194.51495.15
5258241-25824195.14495.77
6258040-25804095.07095.62
45min1252160-25216092.90395.041.3193.6195.821.33
2262383-26238396.67097.48
3257297-25729794.79695.58
4257729-25772994.95595.78
5258745-25874595.33096.15
6259465-25946595.59596.34
极限1253631-25363193.44595.141.3394.3496.111.34
2262855-26285596.84497.85
3255692-25569294.20595.18
4257588-25758894.90395.92
5258425-25842595.21296.22
6261177-26117796.22697.16
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252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对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1108593848586608588738592448589408590200.04
2108587668586938587300.01
单位质量响应值RSD%判断
85902.0085873.000.03数据可信
供试品溶液-第2批-2-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%
5min1338457-33845739.40748.2813.6439.4148.2813.63
2425237-42523749.51149.51
3417776-41777648.64248.64
4481946-48194656.11456.11
5464842-46484254.12254.12
6359850-35985041.89841.90
10min1615905-61590571.71184.1910.8471.7984.2910.85
2747418-74741887.02387.12
3728226-72822684.78884.89
4815964-81596495.00495.12
5785798-78579891.49291.60
6645337-64533775.13775.22
15min1779488-77948890.75798.014.2590.9898.284.27
2877162-877162102.129102.40
3865821-865821100.809101.08
4859495-859495100.072100.37
5845902-84590298.49098.78
6822850-82285095.80696.04
20min1843558-84355898.217100.401.3398.62100.861.34
2875705-875705101.960102.44
3870413-870413101.343101.81
4859702-859702100.096100.60
5857537-85753799.844100.33
6867132-867132100.961101.39
30min1850051-85005198.973100.521.1399.57101.181.13
2873976-873976101.758102.44
3867458-867458100.999101.67
4858742-85874299.985100.69
5856529-85652999.727100.41
6873120-873120101.659102.29
45min1849011-84901198.852100.461.0899.65101.321.08
2872261-872261101.559102.44
3865956-865956100.824101.70
4859875-859875100.116101.02
5857065-85706599.789100.68
6872906-872906101.634102.46
极限1845165-84516598.40499.951.2099.40101.011.20
2870961-870961101.407102.50
3860567-860567100.197101.27
4852617-85261799.271100.37
5851999-85199999.199100.29
6869276-869276101.211102.25
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