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%
110.143236832531321533237032035322910.61
210.203253332382324580.33
单位质量响应值RSD%判断
3184.523182.160.06数据可信
中间条件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%
5min125629-2562972.23469.1013.0572.2369.1013.05
221879-2187961.66561.67
319296-1929654.38554.38
426308-2630874.14874.15
527286-2728676.90476.90
626704-2670475.26475.26
10min129826-2982684.06384.936.1084.1885.056.11
228193-2819379.46179.56
327785-2778578.31178.40
431687-3168789.30889.43
532108-3210890.49590.62
631211-3121187.96788.09
15min131358-3135888.38189.513.4788.6489.763.49
230740-3074086.63986.87
330489-3048985.93286.15
432342-3234291.15591.43
533405-3340594.15194.43
632217-3221790.80291.07
20min131843-3184389.74891.621.9890.1692.031.99
231899-3189989.90690.29
332180-3218090.69891.06
433115-3311593.33393.76
533377-3337794.07294.51
632638-3263891.98992.41
30min132292-3229291.01493.001.4491.5793.561.45
232751-3275192.30792.84
333012-3301293.04393.56
433068-3306893.20193.78
533732-3373295.07295.66
633128-3312893.37093.95
45min132502-3250291.60693.411.7292.3194.121.73
232783-3278392.39893.08
332896-3289692.71693.39
433587-3358794.66495.40
534037-3403795.93296.68
633040-3304093.12293.85
60min132795-3279592.43194.141.3993.2995.001.41
233126-3312693.36494.20
333229-3322993.65594.48
433722-3372295.04495.94
534105-3410596.12497.03
633424-3342494.20495.09
极限134399-3439996.95298.632.0097.9799.661.99
234710-3471097.82998.82
334898-3489898.35999.34
434696-3469697.78998.84
534903-3490398.37399.44
636369-36369102.505103.55
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%
110.143217832254322243226732106322060.21
210.203243932398324180.09
单位质量响应值RSD%判断
3176.133178.240.05数据可信
中间条件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%
5min127073-2707376.45270.0411.3276.4570.0411.32
219358-1935854.66554.67
326793-2679375.66175.66
425284-2528471.40071.40
525424-2542471.79571.80
624888-2488870.28270.28
10min132241-3224191.04686.786.3291.1786.906.33
226922-2692276.02576.12
331136-3113687.92588.05
431110-3111087.85287.97
530944-3094487.38387.50
632039-3203990.47590.59
15min133313-3331394.07391.372.9794.3591.632.98
230719-3071986.74886.97
332600-3260092.06092.33
432393-3239391.47591.74
531894-3189490.06690.33
633218-3321893.80594.07
20min133838-3383895.55692.653.2495.9993.063.24
232152-3215290.79591.16
333301-3330194.03994.47
433076-3307693.40493.82
530980-3098087.48587.90
633505-3350594.61595.04
30min134081-3408196.24294.771.5496.8495.341.53
233842-3384295.56796.08
333680-3368095.10995.69
433427-3342794.39594.97
532607-3260792.07992.64
633725-3372595.23795.82
45min134225-3422596.64995.281.5797.4096.001.56
234015-3401596.05596.73
333609-3360994.90995.65
433747-3374795.29996.03
532766-3276692.52893.24
634076-3407696.22896.97
60min133986-3398695.97495.561.2096.8996.451.19
234290-3429096.83297.67
333732-3373295.25696.16
433874-3387495.65796.55
533106-3310693.48994.36
634055-3405596.16897.07
极限134979-3497998.77898.720.8699.8599.760.83
235426-35426100.040101.03
335091-3509199.094100.15
434953-3495398.70499.75
534730-3473098.07599.10
634562-3456297.60098.66
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%
110.143276432728328773291832417327410.61
210.203261732555325860.14
单位质量响应值RSD%判断
3228.903194.710.76数据可信
中间条件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%
5min122252-2225262.16264.6513.1162.1664.6513.11
225054-2505469.99069.99
325434-2543471.05171.05
419977-1997755.80755.81
519446-1944654.32454.32
626693-2669374.56874.57
10min129242-2924281.68984.493.6381.7984.593.64
230961-3096186.49186.61
330867-3086786.22986.35
428623-2862379.96080.05
530309-3030984.67084.76
631457-3145787.87788.00
15min131751-3175188.69890.542.1388.9490.792.13
232142-3214289.79190.05
332648-3264891.20491.47
431719-3171988.60988.84
533536-3353693.68593.92
632656-3265691.22691.50
20min132727-3272791.42592.621.5391.8193.021.52
233194-3319492.72993.14
333015-3301592.22992.64
432623-3262391.13491.51
534019-3401995.03495.42
633350-3335093.16593.59
30min133469-3346993.49893.821.2894.0494.371.26
233537-3353793.68894.25
333202-3320292.75293.32
433510-3351093.61294.14
534419-3441996.15296.70
633365-3336593.20793.79
45min133951-3395194.84495.121.4895.5495.831.47
233726-3372694.21694.94
333779-3377994.36495.09
433783-3378394.37595.06
535053-3505397.92398.63
633997-3399794.97395.71
60min134009-3400995.00695.521.6495.8696.391.62
234064-3406495.16096.04
333834-3383494.51795.40
433941-3394194.81695.66
535322-3532298.67499.54
633989-3398994.95095.84
极限134351-3435195.96297.561.3496.9798.591.33
235106-3510698.07199.11
334689-3468996.90697.94
435123-3512398.11899.12
535655-3565599.604100.64
634616-3461696.70297.75
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