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%
110.193350233182333663341233260333440.38
210.203316133308332340.32
单位质量响应值RSD%判断
3272.233258.240.31数据可信
供试品溶液-25041502批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114274-1427439.22238.2412.0439.2238.2412.04
214510-1451039.87039.87
310812-1081229.70929.71
413495-1349537.08137.08
514735-1473540.48940.49
615666-1566643.04743.05
10min121140-2114058.08859.124.8358.1559.184.84
221625-2162559.42159.49
319968-1996854.86854.92
421323-2132358.59158.65
521879-2187960.11960.19
623151-2315163.61463.69
15min124654-2465467.74468.833.0367.9168.993.04
224891-2489168.39568.56
324075-2407566.15366.29
425010-2501068.72268.88
525315-2531569.56069.73
626342-2634272.38272.56
20min126601-2660173.09474.632.1773.3774.902.18
226969-2696974.10574.38
326655-2665573.24273.49
427382-2738275.24075.51
527145-2714574.58974.87
628200-2820077.48777.79
30min128794-2879479.12080.371.4279.5280.781.43
229250-2925080.37380.78
329245-2924580.35980.73
429084-2908479.91680.32
529102-2910279.96680.37
630027-3002782.50882.94
45min130431-3043183.61884.941.5384.1585.481.53
230878-3087884.84685.38
330931-3093184.99285.50
431149-3114985.59186.12
530418-3041883.58284.12
631672-3167287.02887.59
60min131480-3148086.50086.711.2287.1787.391.23
231297-3129785.99786.68
331302-3130286.01186.66
431511-3151186.58587.26
531435-3143586.37687.06
632320-3232088.80889.52
90min132203-3220388.48789.180.9989.3090.000.99
232175-3217588.41089.23
332621-3262189.63590.43
432728-3272889.92990.75
532143-3214388.32289.15
632865-3286590.30691.16
120min132874-3287490.33190.671.4091.2991.641.39
232182-3218288.42989.40
332977-3297790.61491.56
433454-3345491.92492.89
533114-3311490.99091.96
633391-3339191.75192.76
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132958-3295890.56191.321.3891.6792.441.37
232677-3267789.78990.91
333214-3321491.26592.36
433994-3399493.40894.53
533082-3308290.90292.03
633469-3346991.96593.13
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%
110.193347633484334903334233383334350.21
210.203397933620338000.76
单位质量响应值RSD%判断
3281.163313.730.70数据可信
供试品溶液-25041901批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110077-1007727.41929.1613.9427.4229.1613.95
212807-1280734.84834.85
311248-1124830.60630.61
49557-955726.00526.00
511788-1178832.07532.08
68821-882124.00224.00
10min118411-1841150.09649.137.6650.1449.187.67
219871-1987154.06954.13
318349-1834949.92849.98
417422-1742247.40547.45
518544-1854450.45850.51
615731-1573142.80442.84
15min122310-2231060.70558.435.9360.8358.565.93
223275-2327563.33163.48
321565-2156558.67858.81
421021-2102157.19857.32
521152-2115257.55457.69
619518-1951853.10853.22
20min124371-2437166.31364.344.6366.5464.574.64
225117-2511768.34368.60
324019-2401965.35665.59
423241-2324163.23963.46
523145-2314562.97763.21
621992-2199259.84060.04
30min127021-2702173.52471.193.5773.8671.523.58
227307-2730774.30274.67
326088-2608870.98571.33
426173-2617371.21771.54
525657-2565769.81370.15
624732-2473267.29667.60
45min128998-2899878.90376.892.8479.3777.352.85
229010-2901078.93679.43
328710-2871078.12078.58
428202-2820276.73777.18
527551-2755174.96675.42
627081-2708173.68774.10
60min130172-3017282.09879.922.5482.6980.502.55
230201-3020182.17782.80
329193-2919379.43480.02
429522-2952280.32980.90
528805-2880578.37878.96
628336-2833677.10277.64
90min131237-3123784.99683.911.4985.7384.621.51
231113-3111384.65885.42
331149-3114984.75685.48
430979-3097984.29485.00
530442-3044282.83283.54
630107-3010781.92182.58
120min132439-3243988.26686.461.6789.1487.321.68
231800-3180086.52887.43
331793-3179386.50987.37
432166-3216687.52388.37
531551-3155185.85086.70
630908-3090884.10084.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132426-3242688.23187.081.5389.2588.081.55
232319-3231987.94088.99
332023-3202387.13488.14
432289-3228987.85888.85
531854-3185486.67587.67
631104-3110484.63485.57
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%
110.193359033660337263370233471336300.31
210.203336833345333560.05
单位质量响应值RSD%判断
3300.293270.200.65数据可信
供试品溶液-25041902批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114090-1409038.48136.857.8538.4836.867.85
214224-1422438.84738.85
312454-1245434.01334.01
414813-1481340.45640.46
512140-1214033.15533.16
613243-1324336.16836.17
10min121867-2186759.72158.462.5459.7858.522.54
221775-2177559.46959.53
321191-2119157.87457.93
421958-2195859.96960.04
520609-2060956.28556.34
621034-2103457.44657.51
15min125356-2535669.24968.161.8869.4168.321.88
225164-2516468.72568.89
325334-2533469.18969.34
425134-2513468.64368.81
524520-2452066.96667.12
624231-2423166.17766.33
20min127347-2734774.68774.111.9474.9774.381.94
227231-2723174.37074.65
327871-2787176.11876.39
427177-2717774.22374.50
526895-2689573.45373.71
626287-2628771.79272.06
30min129070-2907079.39379.611.7379.8080.011.73
229066-2906679.38279.78
329772-2977281.31081.71
429471-2947180.48880.89
529242-2924279.86280.25
628285-2828577.24977.63
45min130654-3065483.71983.581.4784.2584.111.47
230415-3041583.06683.60
331198-3119885.20485.74
430939-3093984.49785.04
530516-3051683.34283.86
629904-2990481.67082.19
60min131504-3150486.04085.441.8586.7286.111.84
230951-3095184.53085.20
332044-3204487.51588.19
431380-3138085.70186.38
531487-3148785.99486.65
630348-3034882.88383.53
90min131880-3188087.06787.441.8087.8988.261.80
231727-3172786.64987.46
332980-3298090.07190.89
432230-3223088.02388.85
532034-3203487.48888.29
631254-3125485.35786.15
120min132188-3218887.90888.591.3388.8789.541.33
232355-3235588.36489.32
333127-3312790.47391.44
432715-3271589.34790.32
532344-3234488.33489.28
631892-3189287.10088.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132476-3247688.69588.701.9689.8189.811.95
232410-3241088.51589.62
333313-3331390.98192.10
432676-3267689.24190.36
532642-3264289.14890.24
631357-3135785.63986.72
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