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%
1 10.053312033211335003306633149332090.52
2 10.083352333163333430.77
单位质量响应值RSD%判断
3304.383307.840.08数据可信
供试品溶液-H147S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%
5min127340-2734074.19573.913.8974.2073.913.89
227080-2708073.49073.49
328165-2816576.43476.43
425382-2538268.88268.88
528354-2835476.94776.95
627088-2708873.51173.51
10min133086-3308689.78990.970.8089.9191.100.81
233613-3361391.21991.34
333566-3356691.09191.22
433355-3335590.51990.63
533852-3385291.86792.00
633663-3366391.35591.48
15min134636-3463693.99594.961.0394.2795.231.02
235379-3537996.01196.29
334506-3450693.64293.92
435164-3516495.42895.69
534957-3495794.86695.15
635304-3530495.80896.08
20min134945-3494594.83495.810.9095.2696.240.90
235459-3545996.22896.66
334857-3485794.59595.03
435576-3557696.54696.97
535536-3553696.43796.88
635450-3545096.20496.64
30min135899-3589997.42397.110.8798.0197.700.86
236083-3608397.92298.52
335274-3527495.72696.32
436058-3605897.85498.44
535591-3559196.58797.19
635787-3578797.11997.71
45min135459-3545996.22897.410.9696.9898.160.95
236065-3606597.87398.63
335663-3566396.78297.53
436352-3635298.65299.40
535681-3568196.83197.59
636140-3614098.07798.83
60min135414-3541496.10697.490.8997.0298.410.88
236103-3610397.97698.90
335883-3588397.37998.29
436274-3627498.44099.35
535734-3573496.97597.90
636146-3614698.09399.01
极限135687-3568796.84798.160.8097.9299.240.79
236510-3651099.081100.17
336364-3636498.68499.76
436280-3628098.45799.53
536082-3608297.91999.00
636102-3610297.97399.06
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%
1 10.053354333165332183307733023332050.62
2 10.083318233599333900.89
单位质量响应值RSD%判断
3303.983312.500.19数据可信
供试品溶液-H147S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%
5min128661-2866177.73071.536.4377.7371.536.43
225899-2589970.23970.24
323466-2346663.64163.64
426669-2666972.32872.33
526884-2688472.91172.91
626673-2667372.33972.34
10min134862-3486294.54891.732.7794.6891.852.77
233400-3340090.58290.70
332227-3222787.40187.51
434529-3452993.64493.76
533833-3383391.75791.88
634095-3409592.46792.59
15min135362-3536295.90495.440.8496.1995.710.84
235124-3512495.25895.53
334677-3467794.04694.30
435551-3555196.41696.69
535192-3519295.44295.72
635238-3523895.56795.84
20min135730-3573096.90296.540.7597.3596.980.75
235126-3512695.26395.69
335505-3550596.29196.70
435791-3579197.06797.50
535857-3585797.24697.68
635579-3557996.49296.93
30min135905-3590597.37697.430.8097.9898.020.80
235519-3551996.32996.91
336333-3633398.53799.11
435837-3583797.19297.79
536161-3616198.07098.67
635802-3580297.09797.69
45min136064-3606497.80797.620.6398.5898.370.62
235694-3569496.80497.55
336112-3611297.93898.67
435875-3587597.29598.06
536335-3633598.54299.30
635884-3588497.31998.08
60min135948-3594897.49397.390.4098.4398.310.40
235663-3566396.72097.63
336054-3605497.78098.68
435827-3582797.16598.09
536010-3601097.66198.58
635958-3595897.52098.44
极限136621-3662199.31898.290.83100.4199.370.82
236333-3633398.53799.61
336212-3621298.20999.27
435784-3578497.04898.13
536457-3645798.87399.96
636051-3605197.77298.85
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%
1 10.053358833224331773333733322333300.48
2 10.083311833226331720.24
单位质量响应值RSD%判断
3316.423290.870.55数据可信
供试品溶液-H149S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%
5min124303-2430366.00467.955.3766.0067.955.37
223487-2348763.78763.79
326085-2608570.84370.84
426188-2618871.12371.12
526381-2638171.64771.65
623678-2367864.30664.31
10min133225-3322590.23491.071.9490.3491.181.94
233133-3313389.98590.09
333636-3363691.35191.47
434771-3477194.43394.55
533426-3342690.78090.90
632995-3299589.61089.72
15min135118-3511895.37696.331.2095.6496.601.21
235386-3538696.10396.36
335118-3511895.37695.65
436250-3625098.45098.73
535618-3561896.73397.00
635336-3533695.96896.22
20min135311-3531195.90097.501.7596.3297.931.75
235787-3578797.19297.61
335921-3592197.55697.99
437093-37093100.739101.18
535484-3548496.37096.80
635816-3581697.27197.69
30min135865-3586597.40498.251.2897.9898.841.28
236168-3616898.22798.81
336304-3630498.59799.19
437035-37035100.582101.19
535813-3581397.26397.86
635884-3588497.45698.03
45min135801-3580197.23098.301.4297.9799.051.42
236163-3616398.21498.96
335862-3586297.39698.15
437181-37181100.978101.75
535921-3592197.55698.31
636234-3623498.40699.15
60min135892-3589297.47897.971.4598.3898.881.45
236012-3601297.80498.71
335919-3591997.55198.47
437085-37085100.718101.66
535564-3556496.58797.50
635969-3596997.68798.59
极限136153-3615398.18698.391.2199.2599.471.21
236083-3608397.99699.07
336258-3625898.47299.55
436995-36995100.473101.58
535642-3564296.79997.88
636246-3624698.43999.51
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%
1 10.053313833237330203336233239331990.39
2 10.083389434033339640.29
单位质量响应值RSD%判断
3303.383369.441.41数据可信
供试品溶液-H149S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%
5min122816-2281661.36265.275.7361.3665.275.73
223592-2359263.44963.45
323875-2387564.21064.21
425772-2577269.31169.31
526218-2621870.51170.51
623337-2333762.76362.76
10min132799-3279988.21089.942.8888.3190.052.89
233617-3361790.41090.52
333505-3350590.10990.22
434600-3460093.05493.17
534193-3419391.95992.08
631931-3193185.87685.98
15min134862-3486293.75895.101.4494.0195.361.45
235553-3555395.61795.87
335473-3547395.40195.66
435954-3595496.69596.97
535689-3568995.98296.25
634628-3462893.12993.38
20min135294-3529494.92096.071.1195.3396.491.11
235841-3584196.39196.81
336054-3605496.96497.38
436264-3626497.52997.96
535505-3550595.48795.92
635366-3536695.11495.52
30min135645-3564595.86496.550.9496.4397.120.95
236182-3618297.30897.88
336107-3610797.10697.68
436295-3629597.61298.21
535701-3570196.01596.60
635470-3547095.39395.95
45min135314-3531494.97496.471.1895.7097.211.18
236016-3601696.86297.60
336238-3623897.45998.20
436414-3641497.93298.69
535654-3565495.88896.64
635584-3558495.70096.42
60min135324-3532495.00196.171.1295.8897.071.13
235914-3591496.58797.49
335911-3591196.57997.48
436401-3640197.89798.82
535598-3559895.73896.65
635403-3540395.21396.09
极限135400-3540095.20596.371.2196.2597.431.22
235918-3591896.59897.66
336255-3625597.50598.57
436349-3634997.75798.84
535790-3579096.25497.32
635287-3528794.90195.94
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