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%
110.056479864066647366447864749645650.48
210.066570866203659560.54
单位质量响应值RSD%判断
6424.386556.261.44数据可信
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%
5min151885-5188571.73275.985.5571.7375.985.56
257999-5799980.18580.19
352744-5274472.92072.92
452604-5260472.72672.73
559102-5910281.71081.71
655411-5541176.60776.61
10min160090-6009083.07686.394.0483.2086.524.03
263098-6309887.23587.37
359308-5930881.99582.12
462164-6216485.94386.06
565961-6596191.19391.33
664306-6430688.90589.03
15min164025-6402588.51689.732.0488.7790.002.04
264730-6473089.49189.77
363437-6343787.70387.96
464722-6472289.48089.74
567268-6726893.00093.29
665246-6524690.20490.48
20min164592-6459289.30090.891.7989.7191.311.79
265532-6553290.60091.03
364890-6489089.71290.12
465868-6586891.06491.48
567921-6792193.90294.35
665639-6563990.74891.17
30min165139-6513990.05692.001.7790.6192.571.77
265542-6554290.61391.19
367002-6700292.63293.19
466276-6627691.62892.19
568407-6840794.57495.17
666914-6691492.51093.09
45min165917-6591791.13292.271.5291.8493.001.52
265894-6589491.10091.83
366813-6681392.37193.08
466486-6648691.91992.64
568647-6864794.90695.66
666697-6669792.21092.94
60min166185-6618591.50292.781.5492.3693.651.54
266306-6630691.67092.55
366961-6696192.57593.44
466411-6641191.81592.69
568497-6849794.69995.61
668273-6827394.38995.27
90min170169-7016997.01096.270.8598.0297.300.85
269577-6957796.19297.23
369519-6951996.11297.13
468587-6858794.82395.85
570193-7019397.04498.12
669757-6975796.44197.48
120min1-0.0000.00-1.171.202.11
2-0.0001.20
3-0.0001.18
4-0.0001.18
5-0.0001.24
6-0.0001.20
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1-0.0000.00-1.171.202.11
2-0.0001.20
3-0.0001.18
4-0.0001.18
5-0.0001.24
6-0.0001.20
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%
110.056478064550648196475464685647180.17
210.066523464845650400.43
单位质量响应值RSD%判断
6439.606465.210.29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%
5min130950-3095043.03642.496.3443.0442.496.34
227972-2797238.89538.90
332267-3226744.86844.87
432455-3245545.12945.13
531321-3132143.55243.55
628366-2836639.44339.44
10min144216-4421661.48361.713.3861.5561.783.39
242739-4273959.42959.49
346824-4682465.10965.18
444993-4499362.56362.64
544600-4460062.01762.09
642924-4292459.68659.75
15min150373-5037370.04470.472.8270.2270.642.82
249094-4909468.26668.43
353261-5326174.06074.24
450559-5055970.30370.48
550997-5099770.91271.09
649774-4977469.21169.38
20min154491-5449175.77075.713.5376.0676.003.53
252421-5242172.89273.17
358062-5806280.73681.04
454242-5424275.42475.72
554043-5404375.14775.44
653416-5341674.27574.56
30min157210-5721079.55180.371.8579.9780.791.86
257470-5747079.91380.31
359962-5996283.37883.82
457548-5754880.02180.44
557331-5733179.71980.14
657278-5727879.64680.05
45min159462-5946282.68383.211.9283.2383.761.93
258799-5879981.76182.29
362083-6208386.32786.91
459331-5933182.50083.06
559768-5976883.10883.66
659586-5958682.85583.39
60min160118-6011883.59584.691.9484.2885.381.94
260086-6008683.55084.22
363236-6323687.93088.65
460621-6062184.29484.99
560826-6082684.57985.27
660528-6052884.16584.84
90min160846-6084684.60785.542.0085.4386.372.01
261012-6101284.83885.65
363982-6398288.96889.84
460781-6078184.51785.35
561437-6143785.42986.26
661038-6103884.87485.69
120min161475-6147585.48285.882.1586.4586.862.15
260924-6092484.71585.66
364384-6438489.52790.55
460793-6079384.53385.51
561562-6156285.60386.58
661444-6144485.43986.40
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163219-6321987.90788.671.4289.0289.781.43
263351-6335188.09089.18
365561-6556191.16392.33
463264-6326487.96989.08
563782-6378288.69089.81
663412-6341288.17589.27
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%
110.056559265367654976532265230654020.22
210.066545665277653660.20
单位质量响应值RSD%判断
6507.666497.610.11数据可信
供试品溶液-2025072421批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19730-973013.42513.794.6013.4313.794.58
210758-1075814.84414.84
310115-1011513.95613.96
49552-955213.18013.18
510200-1020014.07414.07
69611-961113.26113.26
10min117218-1721823.75724.421.5923.7824.441.59
217693-1769324.41224.44
317538-1753824.19824.22
417971-1797124.79624.82
517892-1789224.68724.71
617858-1785824.64024.66
15min116404-1640422.63429.7112.0022.7029.7711.97
222644-2264431.24331.31
321424-2142429.56029.62
423008-2300831.74631.81
523087-2308731.85531.92
622621-2262131.21231.27
20min125968-2596835.83035.983.2735.9336.093.27
227242-2724237.58837.71
324883-2488334.33334.45
426366-2636636.37936.50
526601-2660136.70336.82
625386-2538635.02735.14
30min130675-3067542.32442.491.3442.4842.661.34
230361-3036141.89142.07
330476-3047642.05042.22
431498-3149843.46043.64
531004-3100442.77842.96
630751-3075142.42942.60
45min134705-3470547.88548.471.2048.1148.721.21
235347-3534748.77149.02
334541-3454147.65847.90
435557-3555749.06049.31
535474-3547448.94649.20
635155-3515548.50648.75
60min138336-3833652.89552.701.7153.2053.021.71
237909-3790952.30552.64
337307-3730751.47551.79
439272-3927254.18654.52
538369-3836952.94053.27
637974-3797452.39552.72
90min141169-4116956.80457.611.5257.2058.021.53
242145-4214558.15058.57
340767-4076756.24956.65
441957-4195757.89158.31
542152-4215258.16058.58
642332-4233258.40858.82
120min144190-4419060.97260.771.8061.4661.281.79
243268-4326859.70060.21
342937-4293759.24359.74
444986-4498662.07062.59
544291-4429161.11161.63
644607-4460761.54762.06
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145445-4544562.70363.131.1163.3063.731.11
245457-4545762.72063.33
345112-4511262.24462.84
446321-4632163.91264.53
546351-4635163.95364.57
645821-4582163.22263.83
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%
110.056479164980649216479964915648810.13
210.066586065824658420.04
单位质量响应值RSD%判断
6455.826544.930.97数据可信
供试品溶液-2025072421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116477-1647722.74321.496.7822.7421.496.78
216278-1627822.46922.47
315655-1565521.60921.61
416413-1641322.65522.65
514707-1470720.30020.30
613904-1390419.19219.19
10min125969-2596935.84534.923.7535.8834.953.75
226224-2622436.19736.23
325469-2546935.15535.19
425853-2585335.68535.72
523901-2390132.99133.02
624357-2435733.62033.65
15min131948-3194844.09843.442.9444.2043.542.95
232450-3245044.79144.89
331807-3180743.90344.00
431985-3198544.14944.25
530447-3044742.02642.12
630183-3018341.66241.75
20min136317-3631750.12949.612.0850.3049.772.09
236578-3657850.48950.66
335946-3594649.61749.78
436536-3653650.43150.60
535662-3566249.22549.38
634595-3459547.75247.91
30min141809-4180957.70957.151.3557.9657.401.36
241907-4190757.84558.10
341061-4106156.67756.93
441804-4180457.70257.96
541387-4138757.12757.37
640473-4047355.86556.10
45min146681-4668164.43463.892.0264.7964.242.01
247703-4770365.84566.20
345422-4542262.69663.04
446142-4614263.69064.04
546633-4663364.36864.70
645156-4515662.32962.66
60min149520-4952068.35368.141.2168.8168.591.21
250004-5000469.02169.48
348912-4891267.51467.96
449711-4971168.61669.07
549659-4965968.54568.99
648410-4841066.82167.25
90min153362-5336273.65673.081.1174.2373.641.12
253426-5342673.74474.32
352765-5276572.83273.39
453228-5322873.47174.04
553032-5303273.20173.76
651855-5185571.57672.12
120min155438-5543876.52275.801.4477.2276.491.45
255558-5555876.68777.39
354368-5436875.04575.73
455412-5541276.48677.18
555157-5515776.13476.81
653567-5356773.93974.60
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156552-5655278.05977.841.1678.8878.651.16
257071-5707178.77679.60
356368-5636877.80578.61
456485-5648577.96778.79
556727-5672778.30179.11
655162-5516276.14176.93
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