多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.143234732502322523239932536324070.36
210.203247632547325120.16
单位质量响应值RSD%判断
3195.963187.450.19数据可信
加速6月-供试品溶液-2025072421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%
5min117783-1778349.98955.569.0149.9955.569.01
221985-2198561.80161.80
321260-2126059.76359.76
417616-1761649.52049.52
520113-2011356.53956.54
619823-1982355.72455.72
10min126217-2621773.69879.916.5073.7880.016.50
229810-2981083.79883.90
329184-2918482.03882.14
425964-2596472.98773.07
529263-2926382.26082.35
630132-3013284.70384.80
15min129545-2954583.05387.573.8483.2687.803.85
231556-3155688.70688.95
331754-3175489.26389.50
429880-2988083.99584.20
531505-3150588.56388.79
632669-3266991.83592.07
20min131344-3134488.11091.142.8088.4591.512.81
232648-3264891.77692.17
333113-3311393.08393.47
431368-3136888.17888.52
532503-3250391.36891.75
633558-3355894.33494.72
30min132060-3206090.12392.931.8890.6193.451.90
233174-3317493.25593.80
333412-3341293.92494.46
432570-3257091.55792.05
533417-3341793.93894.47
633708-3370894.75695.30
45min132210-3221090.54593.241.6691.1993.921.67
233354-3335493.76194.46
333431-3343193.97794.67
433138-3313893.15393.80
533033-3303392.85893.55
633847-3384795.14695.85
60min132622-3262291.70393.701.2092.5094.541.22
233654-3365494.60495.46
333456-3345694.04794.90
433295-3329593.59594.39
533235-3323593.42694.27
633736-3373694.83495.70
极限135009-3500998.41397.590.9399.3698.580.90
234608-3460897.28698.30
334186-3418696.09997.11
435034-3503498.48399.44
534596-3459697.25298.25
634865-3486598.00899.03
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.143282432524324383256532603325910.45
210.203272032520326200.44
单位质量响应值RSD%判断
3214.103198.040.36数据可信
加速6月-供试品溶液-2025072521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%
5min117294-1729448.39757.6512.1248.4057.6512.12
222732-2273263.61563.62
322453-2245362.83462.83
419021-1902153.23053.23
518890-1889052.86352.86
623213-2321364.96164.96
10min126678-2667874.65879.985.6674.7480.075.67
229792-2979283.37383.48
329024-2902481.22381.33
426948-2694875.41475.50
528217-2821778.96579.05
630813-3081386.23086.34
15min129708-2970883.13886.832.9383.3487.062.94
231868-3186889.18289.43
330492-3049285.33285.57
430907-3090786.49386.71
531002-3100286.75986.98
632196-3219690.10090.35
20min132117-3211789.87990.282.4890.2290.662.49
232938-3293892.17792.57
331152-3115287.17987.56
431846-3184689.12189.48
532111-3211189.86290.23
633398-3339893.46493.87
30min133297-3329793.18192.531.5593.6793.061.55
233212-3321292.94393.49
332660-3266091.39991.93
432928-3292892.14992.66
532425-3242590.74191.26
633866-3386694.77495.33
45min133655-3365594.18393.631.9994.8394.301.99
233908-3390894.89195.59
332430-3243090.75591.43
433839-3383994.69895.36
532835-3283591.88892.55
634069-3406995.34296.06
60min133614-3361494.06893.531.8394.8794.361.82
233856-3385694.74695.61
332341-3234190.50691.34
433740-3374094.42195.24
533066-3306692.53593.35
633908-3390894.89195.77
极限134988-3498897.91497.301.2798.8898.291.27
234997-3499797.93998.96
333887-3388794.83295.81
434859-3485997.55398.53
534842-3484297.50598.48
635040-3504098.05999.09
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.143303632565326643240932750326850.72
210.203317233200331860.06
单位质量响应值RSD%判断
3223.373253.530.66数据可信
加速6月-供试品溶液-2025072522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%
5min123153-2315364.14758.439.1264.1558.449.12
222922-2292263.50763.51
320481-2048156.74456.74
422092-2209261.20761.21
518552-1855251.39951.40
619348-1934853.60553.60
10min131514-3151487.31182.494.5987.4282.594.60
230559-3055984.66584.77
329737-2973782.38882.48
430494-3049484.48584.59
528233-2823378.22178.31
628103-2810377.86177.95
15min132928-3292891.22989.701.2991.4889.941.30
232646-3264690.44790.69
332332-3233289.57789.81
432555-3255590.19590.44
531910-3191088.40888.62
631891-3189188.35688.57
20min133758-3375893.52893.120.9293.9393.510.91
233112-3311291.73892.14
333580-3358093.03593.42
433535-3353592.91093.30
533632-3363293.17993.54
634057-3405794.35794.72
30min134145-3414594.60094.580.9095.1695.120.88
233779-3377993.58694.14
334050-3405094.33794.87
433867-3386793.83094.38
534417-3441795.35495.87
634562-3456295.75696.28
45min134285-3428594.98895.600.6995.7196.290.67
234423-3442395.37196.08
334417-3441795.35496.05
434347-3434795.16095.86
534927-3492796.76797.44
634625-3462595.93096.61
60min134375-3437595.23895.690.8596.1196.540.83
234281-3428194.97795.84
334519-3451995.63796.49
434339-3433995.13896.00
535068-3506897.15898.00
634639-3463995.96996.81
极限134782-3478296.36596.750.5397.4097.760.53
234731-3473196.22497.25
335211-3521197.55498.57
435010-3501096.99798.02
534994-3499496.95397.95
634788-3478896.38297.38
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