左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718551285584853328548185469854760.11
213.778561585644856300.03
单位质量响应值RSD%判断
6234.576218.590.19数据可信
供试品溶液-2023080921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%
5min164345-6434571.91080.466.0271.9180.466.02
276953-7695386.00086.00
371988-7198880.45180.45
475031-7503183.85283.85
572634-7263481.17381.17
671033-7103379.38479.38
10min182526-8252692.22894.151.4192.9594.951.43
285318-8531895.34996.21
383787-8378793.63894.44
484695-8469594.65295.49
583512-8351293.33094.14
685627-8562795.69496.49
15min183352-8335293.15193.121.6194.7994.871.58
283164-8316492.94194.75
383458-8345893.27095.01
482522-8252292.22494.01
581747-8174791.35893.10
685720-8572095.79897.55
20min181302-8130290.86091.970.9493.4394.640.97
283075-8307592.84295.58
382538-8253892.24294.92
482551-8255192.25694.96
581376-8137690.94393.60
682921-8292192.67095.38
30min180495-8049589.95990.490.9893.4494.080.97
280859-8085990.36594.04
381771-8177191.38594.98
480774-8077490.27093.90
579912-7991289.30792.88
681997-8199791.63795.27
45min176975-7697586.02587.741.2590.4192.241.25
278920-7892088.19892.77
379733-7973389.10793.62
478732-7873287.98892.52
577779-7777986.92391.38
678911-7891188.18892.74
60min177293-7729386.38086.871.0691.6292.240.99
276469-7646985.45990.92
378366-7836687.57992.98
477522-7752286.63692.05
578790-7879088.05393.38
677924-7792487.08592.52
极限174433-7443383.18485.102.0389.2991.351.95
275959-7595984.88991.20
378175-7817587.36693.64
476674-7667485.68891.97
574373-7437383.11789.33
677296-7729686.38492.69
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718590486015860218568785713858680.19
213.778586685775858200.08
单位质量响应值RSD%判断
6263.176232.390.35数据可信
供试品溶液-2023080921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%
5min169326-6932677.21478.021.8477.2178.021.84
271700-7170079.85879.86
368109-6810975.85975.86
471055-7105579.14079.14
569727-6972777.66177.66
670359-7035978.36578.36
10min181621-8162190.90890.480.9191.6891.260.91
281388-8138890.64891.45
379875-7987588.96389.72
481121-8112190.35191.14
582016-8201691.34892.12
681414-8141490.67791.46
15min180697-8069789.87990.070.6991.5691.750.67
281322-8132290.57592.28
381059-8105990.28291.93
480728-8072889.91391.61
579934-7993489.02990.72
681464-8146490.73392.42
20min180189-8018989.31388.740.7491.8991.330.73
280187-8018789.31191.92
378711-7871187.66790.22
479627-7962788.68791.28
580044-8004489.15291.73
679307-7930788.33190.93
30min178124-7812487.01386.031.7390.4989.501.65
277515-7751586.33589.84
378646-7864687.59491.02
477329-7732986.12889.61
574796-7479683.30686.78
677022-7702285.78689.27
45min177498-7749886.31686.550.5190.6690.880.47
277166-7716685.94690.31
377739-7773986.58490.89
477910-7791086.77591.12
578321-7832187.23291.54
677599-7759986.42890.77
60min177186-7718685.96884.061.3691.1789.261.27
274352-7435282.81288.04
375439-7543984.02389.19
474810-7481083.32288.53
576070-7607084.72589.90
674998-7499883.53188.73
极限173891-7389182.29883.211.0088.3689.250.91
273718-7371882.10688.16
375472-7547284.05990.07
474765-7476583.27289.32
575100-7510083.64589.67
675301-7530183.86989.91
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718566185909859188599085718858390.17
213.778750687749876280.20
单位质量响应值RSD%判断
6261.056363.691.15数据可信
供试品溶液-2023081021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%
5min174436-7443682.06287.043.3782.0687.043.37
279145-7914587.25387.25
377648-7764885.60385.60
479661-7966187.82287.82
581942-8194290.33790.34
680889-8088989.17689.18
10min179900-7990088.08691.892.5088.9192.762.50
284220-8422092.84893.72
383116-8311691.63192.49
482790-8279091.27292.15
583798-8379892.38393.29
686255-8625595.09295.98
15min178814-7881486.88990.782.4188.5992.572.42
283202-8320291.72693.53
381871-8187190.25992.03
482482-8248290.93292.72
582956-8295691.45593.28
684755-8475593.43895.28
20min179880-7988088.06490.351.6290.6393.051.65
281866-8186690.25392.97
382410-8241090.85393.53
481054-8105489.35892.06
583067-8306791.57794.32
683446-8344691.99594.77
30min179135-7913587.24288.091.3190.6991.681.30
278801-7880186.87490.49
381416-8141689.75793.34
479232-7923287.34990.94
579963-7996388.15591.81
680863-8086389.14792.84
45min176363-7636384.18686.881.9588.5191.361.95
278426-7842686.46190.95
379711-7971187.87792.36
477898-7789885.87990.35
580286-8028688.51193.05
680156-8015688.36892.96
60min177555-7755585.50185.591.3390.6790.941.31
278315-7831586.33891.69
377686-7768685.64591.00
475802-7580283.56888.89
577587-7758785.53690.96
678857-7885786.93692.41
极限175726-7572683.48484.450.9289.5090.660.97
276315-7631584.13490.35
376120-7612083.91990.13
476596-7659684.44390.61
577380-7738085.30891.59
677479-7747985.41791.76
左氨氯地平片项目信息
介质体积(ml)500取样体积(ml)5补液体积(ml)5
对照品批号100546-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.718716087201874018720687231872400.11
213.778763287646876390.02
单位质量响应值RSD%判断
6363.246364.490.02数据可信
供试品溶液-2023081021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%
5min181347-8134788.95085.194.0888.9585.184.08
280682-8068288.22288.22
379246-7924686.65286.65
473284-7328480.13380.13
577739-7773985.00485.00
675133-7513382.15582.15
10min184025-8402591.87890.073.4992.7790.933.50
284592-8459292.49893.38
384943-8494392.88293.75
477822-7782285.09585.90
582937-8293790.68891.54
679930-7993087.40088.22
15min183356-8335691.14689.473.1792.9591.223.18
283971-8397191.81993.63
384258-8425892.13393.93
478281-7828185.59787.25
582078-8207889.74991.51
678982-7898286.36388.06
20min180850-8085088.40687.402.7691.1390.052.78
282317-8231790.01092.74
380737-8073788.28291.00
477393-7739384.62687.13
581319-8131988.91991.57
676971-7697184.16586.72
30min179972-7997287.44687.041.7191.0590.561.74
280626-8062688.16191.79
380312-8031287.81891.42
479180-7918086.58089.93
580463-8046387.98391.53
677037-7703784.23787.64
45min177773-7777385.04185.552.1689.5289.952.16
280126-8012687.61492.12
380591-8059188.12392.60
476713-7671383.88288.10
577353-7735384.58289.01
676899-7689984.08688.33
60min180126-8012687.61485.361.4192.9490.611.43
277938-7793885.22290.61
378258-7825885.57290.93
477276-7727684.49889.56
577737-7773785.00290.27
677053-7705384.25489.34
极限176577-7657783.73484.081.6189.9490.181.41
274773-7477381.76188.00
377926-7792685.20991.42
478244-7824485.55791.46
576683-7668383.85089.97
677165-7716584.37790.30
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