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10000
标示量(mg)1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%
110.093270732686325893268532635326600.15
210.123274532647326960.22
单位质量响应值RSD%判断
3236.873230.830.14数据可信
供试品溶液-2025072421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%
5min118194-1819450.47846.2013.3550.4846.2113.35
212719-1271935.28835.29
318346-1834650.90050.90
417155-1715547.59547.60
518115-1811550.25950.26
615394-1539442.71042.71
10min124116-2411666.90864.786.5166.9964.866.51
221193-2119358.79958.86
324847-2484768.93669.02
423761-2376165.92366.00
524456-2445667.85267.94
621722-2172260.26660.34
15min126839-2683974.46373.464.6574.6673.644.66
225182-2518269.86670.02
327441-2744176.13376.33
426731-2673174.16374.35
527870-2787077.32477.52
624794-2479468.78968.96
20min128246-2824678.36778.073.5178.6978.373.52
227183-2718375.41775.69
328994-2899480.44280.77
428256-2825678.39478.71
529333-2933381.38381.71
626812-2681274.38874.67
30min129511-2951181.87682.522.8982.3382.962.90
229148-2914880.86981.27
330512-3051284.65485.11
429885-2988582.91483.36
530856-3085685.60886.07
628548-2854879.20579.61
45min130580-3058084.84285.582.8085.4386.152.81
230205-3020583.80284.34
331496-3149687.38487.99
430679-3067985.11785.70
532215-3221589.37889.98
629895-2989582.94283.48
60min130785-3078585.41186.682.5686.1487.402.57
230752-3075285.31985.99
331969-3196988.69689.44
431007-3100786.02786.75
532481-3248190.11690.87
630458-3045884.50485.18
90min131211-3121186.59387.852.1987.4688.712.20
231036-3103686.10786.92
332218-3221889.38790.28
431490-3149087.36788.23
532791-3279190.97791.88
631240-3124086.67387.49
120min131469-3146987.30988.352.3788.3289.362.38
231122-3112286.34687.31
332451-3245190.03391.08
431528-3152887.47288.48
533078-3307891.77392.83
631419-3141987.17088.14
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132105-3210589.07390.511.5390.2391.661.54
232330-3233089.69890.80
333213-3321392.14793.34
432345-3234589.73990.90
533275-3327592.31993.53
632463-3246390.06791.18
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10000
标示量(mg)1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%
110.093275832831328033284132978328420.26
210.123276932800327840.07
单位质量响应值RSD%判断
3254.913239.530.34数据可信
供试品溶液-2025072521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%
5min114513-1451340.10040.986.5540.1040.986.55
214990-1499041.41841.42
314100-1410038.95938.96
414715-1471540.65840.66
514015-1401538.72438.72
616666-1666646.04946.05
10min121961-2196160.67961.544.3260.7561.614.32
221537-2153759.50759.58
321509-2150959.43059.49
422064-2206460.96361.03
522471-2247162.08862.15
624093-2409366.57066.65
15min125590-2559070.70671.073.2970.8771.243.29
224657-2465768.12868.30
325030-2503069.15969.32
425960-2596071.72871.90
526031-2603171.92472.09
627060-2706074.76874.96
20min127578-2757876.19975.912.7576.4876.202.76
226403-2640372.95273.23
326903-2690374.33474.61
427430-2743075.79076.08
528048-2804877.49777.79
628489-2848978.71679.03
30min129806-2980682.35581.551.7582.7781.961.74
228577-2857778.95979.36
329626-2962681.85782.26
429417-2941781.28081.70
530089-3008983.13783.55
629570-2957081.70382.15
45min131126-3112686.00284.831.5986.5585.381.58
229866-2986682.52183.06
330581-3058184.49685.04
431045-3104585.77886.33
531075-3107585.86186.42
630512-3051284.30684.89
60min131962-3196288.31286.491.8689.0187.181.85
230302-3030283.72584.40
331135-3113586.02786.71
431542-3154287.15187.85
531687-3168787.55288.25
631184-3118486.16286.88
90min132809-3280990.65287.992.0091.4988.831.99
231053-3105385.80086.61
331585-3158587.27088.09
432016-3201688.46189.30
532230-3223089.05289.90
631382-3138286.70987.57
120min132537-3253789.90188.251.7490.8989.241.73
231199-3119986.20487.16
331763-3176387.76288.73
432513-3251389.83490.82
532164-3216488.87089.86
631471-3147186.95587.96
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132715-3271590.39288.951.1791.5390.081.17
231663-3166387.48688.58
331942-3194288.25789.37
432316-3231689.29090.43
532432-3243289.61190.75
632080-3208088.63889.79
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10000
标示量(mg)1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%
110.093279232980330093276332869328830.34
210.123334633347333460.01
单位质量响应值RSD%判断
3258.973295.060.78数据可信
供试品溶液-2025072522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%
5min115013-1501341.10536.9713.8741.1136.9713.87
212704-1270434.78334.78
310225-1022527.99628.00
414234-1423438.97238.97
515324-1532441.95741.96
613511-1351136.99336.99
10min121810-2181059.71556.256.2759.7856.316.27
220201-2020155.31055.37
318331-1833150.19050.24
421090-2109057.74457.81
521654-2165459.28859.36
620181-2018155.25555.32
15min125122-2512268.78365.883.5268.9566.043.54
223839-2383965.27165.42
322801-2280162.42862.56
424433-2443366.89767.06
524675-2467567.55967.73
623506-2350664.35964.51
20min127003-2700373.93371.712.1774.2271.982.18
226101-2610171.46471.72
325655-2565570.24370.48
426515-2651572.59772.87
526396-2639672.27172.55
625484-2548469.77470.04
30min128905-2890579.14177.161.8579.5577.551.85
228232-2823277.29877.68
328304-2830477.49677.85
428269-2826977.40077.79
528096-2809676.92677.33
627288-2728874.71475.09
45min129797-2979781.58380.771.6182.1281.281.59
229786-2978681.55382.06
330059-3005982.30182.78
429381-2938180.44480.97
529193-2919379.93080.46
628773-2877378.78079.28
60min130394-3039483.21882.412.1883.8983.062.17
230582-3058283.73384.38
330881-3088184.55185.17
430001-3000182.14282.80
529620-2962081.09981.76
629109-2910979.70080.33
90min130894-3089484.58783.652.4585.4084.432.43
231483-3148386.20086.98
331146-3114685.27786.04
430175-3017582.61883.41
530120-3012082.46883.27
629488-2948880.73781.50
120min131340-3134085.80884.172.7686.7685.102.73
231771-3177186.98887.91
331231-3123185.51086.41
430500-3050083.50884.44
530037-3003782.24083.18
629573-2957380.97081.87
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131503-3150386.25486.051.4087.3587.121.40
232119-3211987.94189.01
331466-3146686.15387.20
431523-3152386.30987.38
531164-3116485.32686.40
630793-3079384.31085.35
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