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%
110.043250332791328213245232756326650.54
210.193310232807329540.64
单位质量响应值RSD%判断
3253.493233.950.43数据可信
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%
5min127554-2755476.21564.2211.8976.2164.2211.89
220950-2095057.94857.95
321582-2158259.69659.70
423842-2384265.94765.95
520393-2039356.40756.41
624977-2497769.08769.09
10min132361-3236189.51185.263.7589.6485.363.76
229575-2957581.80581.90
329987-2998782.94583.04
431253-3125386.44686.56
529920-2992082.75982.85
631845-3184588.08488.20
15min133601-3360192.94191.281.7993.2291.531.80
232318-3231889.39289.63
333184-3318491.78792.03
433304-3330492.11992.37
532203-3220389.07489.31
633395-3339592.37192.63
20min133872-3387293.69093.720.9494.1294.120.94
233728-3372893.29293.67
334089-3408994.29194.68
434342-3434294.99195.40
533413-3341392.42192.80
633849-3384993.62794.04
30min134415-3441595.19295.410.7795.7895.970.77
234598-3459895.69996.24
334342-3434294.99195.54
434979-3497996.75297.32
534271-3427194.79495.33
634355-3435595.02695.60
45min134765-3476596.16196.280.7696.9197.000.76
234835-3483596.35497.05
334619-3461995.75796.46
435275-3527597.57198.30
534858-3485896.41897.11
634507-3450795.44796.18
60min134562-3456295.59996.620.7096.5197.500.68
235002-3500296.81697.67
334966-3496696.71797.58
435253-3525397.51098.40
535054-3505496.96097.81
634756-3475696.13697.03
极限135447-3544798.04797.820.6399.1198.860.63
235102-3510297.09398.11
335493-3549398.17499.20
435638-3563898.57599.63
535430-3543098.00099.01
635090-3509097.05998.11
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%
110.043362433679335413350433132334960.65
210.193374733814337800.15
单位质量响应值RSD%判断
3336.253315.010.46数据可信
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%
5min124527-2452766.17161.597.7966.1761.597.79
223437-2343763.23063.23
320406-2040655.05355.05
422279-2227960.10660.11
521416-2141657.77857.78
624917-2491767.22367.22
10min131245-3124584.29682.624.4484.4182.724.44
230991-3099183.61083.72
328315-2831576.39176.48
430414-3041482.05482.15
530345-3034581.86781.96
632423-3242387.47487.59
15min133497-3349790.37189.082.9790.6289.322.97
233492-3349290.35890.60
331100-3110083.90484.12
433057-3305789.18489.42
533151-3315189.43889.67
633811-3381191.21891.48
20min134207-3420792.28790.912.1792.6991.302.18
233950-3395091.59391.99
332243-3224386.98887.35
433909-3390991.48391.87
533731-3373191.00291.38
634130-3413092.07992.49
30min134859-3485994.04692.561.2394.6093.101.25
234272-3427292.46293.01
333614-3361490.68791.19
434254-3425492.41392.95
534246-3424692.39292.93
634615-3461593.38793.95
45min134816-3481693.93093.300.8494.6494.000.85
234589-3458993.31794.02
334110-3411092.02592.68
434470-3447092.99693.69
534940-3494094.26494.95
634581-3458193.29694.01
60min135349-3534995.36894.030.8696.2494.880.86
234721-3472193.67394.53
334756-3475693.76894.58
435067-3506794.60795.45
534523-3452393.13993.98
634709-3470993.64194.52
极限135262-3526295.13394.980.7796.1695.990.75
235378-3537895.44696.46
335604-3560496.05697.02
435072-3507294.62095.63
534844-3484494.00595.01
635067-3506794.60795.64
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%
110.046630766874662106643266250664150.41
210.196869468400685470.31
单位质量响应值RSD%判断
6615.046726.891.19数据可信
供试品溶液-2025072321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%
5min147445-4744563.81666.168.8363.8266.168.83
241875-4187556.32456.32
351938-5193869.85969.86
449980-4998067.22567.23
554619-5461973.46573.46
649249-4924966.24266.24
10min160232-6023281.01584.154.0581.1284.264.06
258810-5881079.10279.20
365139-6513987.61587.73
463413-6341385.29385.41
564811-6481187.17487.30
662971-6297184.69984.81
15min165705-6570588.37690.022.0088.6290.272.01
264930-6493087.33487.56
367924-6792491.36191.62
467197-6719790.38390.64
568382-6838291.97792.24
667415-6741590.67690.93
20min168057-6805791.54092.241.3491.9392.641.35
267086-6708690.23490.60
369113-6911392.96093.37
468895-6889592.66793.07
569708-6970893.76094.18
668613-6861392.28792.69
30min170441-7044194.74693.950.7595.2994.500.75
268952-6895292.74393.27
369685-6968593.72994.30
470001-7000194.15494.71
569789-6978993.86994.45
670227-7022794.45895.01
45min170514-7051494.84494.630.5695.5495.340.57
269694-6969493.74194.42
370557-7055794.90295.63
470069-7006994.24694.96
570708-7070895.10595.84
670579-7057994.93295.65
60min170631-7063195.00294.820.5695.8695.690.58
269880-6988093.99294.82
370407-7040794.70095.58
470393-7039394.68295.55
571085-7108595.61296.50
670584-7058494.93895.81
极限171433-7143396.08095.920.5597.1096.950.55
270907-7090795.37396.36
371293-7129395.89296.93
470870-7087095.32396.35
571507-7150796.18097.23
671894-7189496.70097.73
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%
110.046601666349669896712766987666940.73
210.196921869067691420.16
单位质量响应值RSD%判断
6642.836785.281.51数据可信
供试品溶液-2025072321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%
5min145193-4519360.39965.979.7060.4065.979.70
244393-4439359.33059.33
348184-4818464.39664.40
457536-5753676.89576.89
551450-5145068.76168.76
649424-4942466.05466.05
10min160519-6051980.88284.824.0980.9884.934.10
261368-6136882.01682.12
363190-6319084.45184.56
467948-6794890.81090.94
563944-6394485.45985.57
663822-6382285.29685.41
15min166480-6648088.84890.451.6889.0890.711.69
266811-6681189.29189.53
367149-6714989.74289.99
469599-6959993.01793.30
568135-6813591.06091.32
667918-6791890.77091.02
20min168931-6893192.12492.530.5892.5192.930.59
269684-6968493.13093.51
368858-6885892.02692.42
469716-6971693.17393.61
568887-6888792.06592.47
669336-6933692.66593.07
30min169595-6959593.01193.530.6493.5594.080.64
270544-7054494.28094.82
369747-6974793.21593.77
470507-7050794.23094.82
569540-6954092.93893.50
669948-6994893.48394.04
45min169872-6987293.38293.950.7794.0794.660.78
270848-7084894.68695.38
369860-6986093.36694.07
471000-7100094.88995.64
569777-6977793.25593.97
670420-7042094.11494.83
60min170330-7033093.99494.300.7494.8495.170.75
270779-7077994.59495.45
370203-7020393.82494.69
471517-7151795.58096.49
570170-7017093.78094.65
670357-7035794.03094.90
极限170526-7052694.25694.830.5695.2695.850.56
271346-7134695.35296.36
371108-7110895.03396.05
471398-7139895.42196.49
570520-7052094.24895.28
670814-7081494.64195.67
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