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%
19.946401564256635066381263920639020.44
210.006501265015650140.01
单位质量响应值RSD%判断
6428.776501.400.80数据可信
供试品溶液-2025072321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%
5min140422-4042256.09954.337.1256.1054.337.12
241281-4128157.29157.29
341380-4138057.42857.43
434277-3427747.57047.57
540094-4009455.64355.64
637426-3742651.94151.94
10min153335-5333574.01974.221.8374.1174.321.84
253859-5385974.74774.84
355231-5523176.65176.75
452668-5266873.09473.17
553238-5323873.88573.98
652566-5256672.95273.04
15min159062-5906281.96782.190.7182.1882.400.70
258855-5885581.68081.90
359303-5930382.30282.53
459522-5952282.60682.81
558735-5873581.51481.73
659837-5983783.04383.25
20min161647-6164785.55586.481.1685.9186.831.15
261595-6159585.48385.84
362354-6235486.53686.90
463533-6353388.17288.51
562095-6209586.17786.53
662643-6264386.93787.28
30min164580-6458089.62590.731.0890.1291.231.07
265808-6580891.33091.83
364882-6488290.04590.55
466210-6621091.88892.37
564805-6480589.93890.43
665989-6598991.58192.07
45min167034-6703493.03193.461.2493.6894.101.23
266519-6651992.31692.97
367165-6716593.21393.87
468626-6862695.24195.88
566639-6663992.48393.13
668059-6805994.45495.10
60min167753-6775394.02994.921.1994.8395.721.17
268027-6802794.40995.21
367941-6794194.29095.10
469120-6912095.92696.72
567841-6784194.15194.95
669692-6969296.72097.52
90min170131-7013197.32996.511.2198.2997.471.20
268483-6848395.04296.00
368854-6885495.55796.52
470290-7029097.55098.51
569047-6904795.82596.78
670426-7042697.73998.70
120min169647-6964796.65897.121.5397.7898.241.51
268821-6882195.51196.63
369166-6916695.99097.12
471387-7138799.072100.19
569667-6966796.68597.80
671208-7120898.82499.95
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169723-6972396.76397.441.2998.0498.731.28
269692-6969296.72098.00
369708-6970896.74298.03
471276-7127698.918100.20
569430-6943096.35697.63
671458-7145899.171100.46
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%
19.946404063600639556384764224639330.37
210.006467264874647730.23
单位质量响应值RSD%判断
6431.896477.300.50数据可信
供试品溶液-2025072321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%
5min132157-3215744.70042.304.1844.7042.304.18
231200-3120043.37043.37
330672-3067242.63642.64
429922-2992241.59341.59
530228-3022842.01842.02
628396-2839639.47239.47
10min146482-4648264.61263.051.7964.6963.121.79
246047-4604764.00864.08
344931-4493162.45662.53
445516-4551663.27063.34
544327-4432761.61761.69
644836-4483662.32462.39
15min153319-5331974.11672.901.6974.3073.081.69
251830-5183072.04672.23
352167-5216772.51572.69
453445-5344574.29174.47
551180-5118071.14371.32
652742-5274273.31473.48
20min156270-5627078.21878.291.4378.5278.591.43
255304-5530476.87577.17
356237-5623778.17278.47
456974-5697479.19779.50
555676-5567677.39277.68
657479-5747979.89980.19
30min160507-6050784.10883.921.9684.5484.351.95
259011-5901182.02882.46
359715-5971583.00783.43
461592-6159285.61686.05
559489-5948982.69383.11
661916-6191686.06686.49
45min162278-6227886.57087.232.0687.1587.802.05
261578-6157885.59786.16
362052-6205286.25586.82
463908-6390888.83589.41
561909-6190986.05786.61
664795-6479590.06890.64
60min163707-6370788.55688.921.7689.2889.641.75
262890-6289087.42088.13
363018-6301887.59888.31
464912-6491290.23190.95
563572-6357288.36889.07
665735-6573591.37592.09
90min165408-6540890.92090.712.0591.7991.572.04
263722-6372288.57789.43
364459-6445989.60190.46
466435-6643592.34893.22
564349-6434989.44890.30
667169-6716993.36894.24
120min165786-6578691.44691.822.2692.4792.832.24
264649-6464989.86590.87
365187-6518790.61391.62
467388-6738893.67394.70
564959-6495990.29691.29
668352-6835295.01396.04
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166636-6663692.62792.711.6693.8093.881.65
265743-6574391.38692.54
366323-6632392.19293.35
467428-6742893.72894.91
565566-6556691.14092.29
668485-6848595.19896.38
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%
19.946485765124650906463364612648630.38
210.006605265860659560.21
单位质量响应值RSD%判断
6525.456595.600.76数据可信
供试品溶液-2025072321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%
5min132485-3248544.42744.1611.6944.4344.1611.68
233592-3359245.94145.94
334553-3455347.25647.26
434452-3445247.11847.12
533909-3390946.37546.37
624740-2474033.83533.84
10min147972-4797265.60864.785.8365.6864.855.84
248822-4882266.77066.85
348579-4857966.43866.52
448871-4887166.83766.92
548168-4816865.87665.95
641784-4178457.14557.20
15min154814-5481474.96574.613.1475.1574.793.16
255402-5540275.76975.96
355391-5539175.75475.94
455299-5529975.62875.82
555328-5532875.66875.86
651090-5109069.87270.02
20min158434-5843479.91680.052.0980.2280.352.10
259681-5968181.62181.94
359404-5940481.24381.56
458814-5881480.43680.75
558607-5860780.15380.47
656234-5623476.90777.18
30min162034-6203484.83985.351.3685.2885.791.38
263141-6314186.35386.80
362902-6290286.02786.48
463111-6311186.31286.76
562334-6233485.25085.70
660937-6093783.33983.74
45min164354-6435488.01288.360.7688.6088.950.77
265365-6536589.39589.99
364665-6466588.43889.03
464946-6494688.82289.42
564314-6431487.95888.55
664017-6401787.55188.09
60min165798-6579889.98790.170.6790.7290.900.68
266594-6659491.07691.82
366175-6617590.50391.24
466091-6609190.38891.13
565439-6543989.49690.23
665501-6550189.58190.26
90min167119-6711991.79491.900.9192.6792.780.92
268099-6809993.13494.03
367222-6722291.93592.83
467643-6764392.51093.40
566495-6649590.94091.83
666622-6662291.11491.94
120min167675-6767592.55493.060.9193.5994.090.92
269212-6921294.65695.71
367865-6786592.81493.86
468216-6821693.29494.34
567520-6752092.34293.38
667769-6776992.68393.66
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167553-6755392.38793.270.8993.5794.460.89
269083-6908394.48095.69
368309-6830993.42194.62
468690-6869093.94295.14
567817-6781792.74893.94
667746-6774692.65193.79
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