盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.072025782022212016922019562020162020930.17
216.052014902017492016200.10
单位质量响应值RSD%判断
12575.7912561.990.08数据可信
供试品溶液-2024042521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%
5min154077-5407728.77126.0716.7028.7726.0716.69
245648-4564824.28624.29
350932-5093227.09827.10
461033-6103332.47232.47
537567-3756719.98719.99
644728-4472823.79723.80
10min1126648-12664867.38164.167.0667.5464.317.08
2112429-11242959.81659.95
3125377-12537766.70566.86
4131943-13194370.19870.38
5111480-11148059.31159.42
6115742-11574261.57961.71
15min1144000-14400076.61374.963.0477.1575.463.06
2132852-13285270.68271.15
3141846-14184675.46775.99
4144881-14488177.08277.65
5141274-14127475.16375.60
6140519-14051974.76175.24
20min1152700-15270081.24279.792.6782.2080.712.71
2143098-14309876.13376.99
3152621-15262181.20082.14
4153846-15384681.85282.85
5148266-14826678.88379.74
6149295-14929579.43080.32
30min1153322-15332281.57380.312.4282.9881.672.45
2144037-14403776.63377.92
3151737-15173780.73082.12
4154024-15402481.94683.40
5150068-15006879.84281.14
6152477-15247781.12382.45
45min1154868-15486882.39580.232.1384.2682.032.13
2145877-14587777.61279.32
3151230-15123080.46082.30
4149925-14992579.76581.67
5153534-15353481.68683.43
6149315-14931579.44181.22
极限1158095-15809584.11281.742.3086.4383.992.31
2147620-14762078.53980.68
3153520-15352081.67883.97
4154932-15493282.42984.78
5155290-15529082.62084.81
6152313-15231381.03683.26
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.072030522029562028472020812028122027500.20
216.052037882038532038200.03
单位质量响应值RSD%判断
12616.6812699.070.47数据可信
供试品溶液-2024042521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%
5min147512-4751225.10122.5516.5725.1022.5516.57
235326-3532618.66318.66
353781-5378128.41328.41
443647-4364723.05923.06
536610-3661019.34119.34
639271-3927120.74720.75
10min1113563-11356359.99558.558.5060.1358.678.51
298059-9805951.80551.91
3124032-12403265.52665.68
4117097-11709761.86261.99
5103475-10347554.66654.77
6108699-10869957.42657.54
15min1136900-13690072.32472.883.4172.8073.343.45
2132059-13205969.76770.16
3144810-14481076.50377.03
4141961-14196174.99875.47
5137458-13745872.61973.03
6134581-13458171.09971.53
20min1148285-14828578.33977.863.3979.2178.723.43
2140933-14093374.45575.23
3153841-15384181.27482.22
4152090-15209080.34981.24
5145651-14565176.94877.76
6143497-14349775.81076.64
30min1145431-14543176.83178.283.1478.1479.573.16
2140704-14070474.33475.53
3153649-15364981.17382.57
4151009-15100979.77881.11
5150708-15070879.61980.86
6147547-14754777.94979.20
45min1149410-14941078.93379.782.5680.6781.502.60
2145514-14551476.87578.48
3156791-15679182.83384.68
4153694-15369481.19782.97
5150470-15047079.49381.18
6150151-15015179.32581.01
极限1153725-15372581.21381.542.5883.3983.702.62
2148876-14887678.65180.68
3159992-15999284.52486.83
4157601-15760183.26185.49
5151961-15196180.28182.41
6153859-15385981.28483.41
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.072019672025862028612029412024802025670.20
216.052057902051522054710.22
单位质量响应值RSD%判断
12605.2912801.931.10数据可信
供试品溶液-2024042621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%
5min148561-4856125.56422.5010.2925.5622.5010.28
245410-4541023.90523.90
343641-4364122.97422.97
437512-3751219.74719.75
543784-4378423.04923.05
637596-3759619.79119.79
10min1113845-11384559.93157.662.3260.0757.792.33
2107882-10788256.79256.92
3108995-10899557.37857.51
4107168-10716856.41656.53
5111222-11122258.55058.68
6108092-10809256.90257.01
15min1135875-13587571.52870.651.3772.0071.091.37
2132445-13244569.72270.17
3134021-13402170.55271.00
4136104-13610471.64972.07
5135075-13507571.10771.56
6131673-13167369.31669.74
20min1145981-14598176.84875.122.6677.7275.962.64
2139355-13935573.36074.20
3140722-14072274.08074.92
4148785-14878578.32479.15
5141443-14144374.45975.31
6139957-13995773.67774.49
30min1143399-14339975.48976.022.0376.7977.272.00
2144825-14482576.24077.48
3144446-14444676.04077.29
4149035-14903578.45679.71
5144772-14477276.21277.47
6139937-13993773.66674.89
45min1148883-14888378.37677.222.0680.0978.902.03
2147666-14766677.73579.40
3143267-14326775.41977.09
4151042-15104279.51281.20
5144098-14409875.85777.54
6145212-14521276.44378.07
极限1148432-14843278.13878.581.3080.2980.681.27
2148625-14862578.24080.34
3148388-14838878.11580.21
4152972-15297280.52882.66
5147550-14755077.67479.78
6149650-14965078.78080.83
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.072005342013172007772000522001012005560.27
216.052026092044782035440.65
单位质量响应值RSD%判断
12480.1512681.871.14数据可信
供试品溶液-2024042621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%
5min134142-3414218.14820.839.5118.1520.839.50
243348-4334823.04223.04
336055-3605519.16519.17
441392-4139222.00222.00
537840-3784020.11420.11
642365-4236522.51922.52
10min1108929-10892957.90258.194.6658.0058.304.65
2103625-10362555.08355.21
3110782-11078258.88758.99
4104524-10452455.56155.68
5117568-11756862.49462.61
6111362-11136259.19559.32
15min1134174-13417471.32169.862.2971.7470.302.28
2127807-12780767.93768.37
3131042-13104269.65670.09
4127939-12793968.00768.44
5134470-13447071.47971.94
6133087-13308770.74371.20
20min1145137-14513777.14974.862.9277.9775.692.91
2136868-13686872.75373.56
3141162-14116275.03675.86
4135325-13532571.93372.74
5145251-14525177.20978.07
6141236-14123675.07575.92
30min1146378-14637877.80875.362.5379.0676.612.52
2138565-13856573.65574.87
3142110-14211075.54076.78
4136658-13665872.64273.85
5143014-14301476.02077.31
6143923-14392376.50377.77
45min1147153-14715378.22076.402.1279.9078.062.12
2141940-14194075.44977.07
3144083-14408376.58878.25
4138630-13863073.69075.30
5144865-14486577.00478.71
6145674-14567477.43479.12
极限1151166-15116680.35378.921.5582.4781.011.55
2144900-14490077.02379.07
3148682-14868279.03381.12
4147737-14773778.53180.55
5150723-15072380.11882.25
6147640-14764078.47980.60
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