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%
1 9.866391663890637546359364102638510.30
2 10.116465464282644680.41
单位质量响应值RSD%判断
6475.766376.661.10数据可信
加速3月-供试品溶液-2025072121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%
5min121304-2130429.74629.815.9629.7529.805.97
222935-2293532.02332.02
320984-2098429.29929.30
420663-2066328.85128.85
519541-1954127.28427.28
622652-2265231.62831.63
10min136454-3645450.89949.982.5650.9550.032.57
236716-3671651.26551.32
335339-3533949.34249.39
434763-3476348.53848.59
534844-3484448.65148.70
636651-3665151.17451.23
15min144200-4420061.71560.401.7661.8560.531.76
243849-4384961.22461.36
342780-4278059.73259.86
442605-4260559.48759.62
542375-4237559.16659.29
643721-4372161.04661.18
20min148764-4876468.08766.911.7168.3267.141.71
248747-4874768.06368.30
346785-4678565.32465.55
448012-4801267.03767.27
547133-4713365.81066.03
648080-4808067.13267.37
30min153670-5367074.93773.601.5375.2973.951.53
252935-5293573.91174.27
351583-5158372.02372.36
453471-5347174.65975.00
552111-5211172.76073.10
652511-5251173.31973.67
45min157149-5714979.79578.771.6480.2779.231.64
256923-5692379.47979.96
355322-5532277.24477.70
457560-5756080.36980.83
555553-5555377.56678.02
655970-5597078.14878.62
60min158399-5839981.54080.931.4082.1581.521.41
258471-5847181.64082.25
356826-5682679.34479.93
458892-5889282.22882.83
557138-5713879.77980.36
658030-5803081.02581.63
90min160030-6003083.81783.111.3484.5683.841.34
259773-5977383.45884.20
358423-5842381.57382.29
460650-6065084.68385.42
559000-5900082.37983.10
659248-5924882.72583.46
120min160612-6061284.63084.000.8285.5184.870.83
260549-6054984.54285.43
359420-5942082.96683.82
460574-6057484.57785.45
559973-5997383.73884.59
659844-5984483.55884.43
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162650-6265087.47587.070.8088.5088.080.80
262932-6293287.86988.90
361762-6176286.23687.23
462770-6277087.64388.66
562202-6220286.85087.85
661839-6183986.34387.36
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%
1 9.866385563928637996350763663637500.27
2 10.116413763973640550.19
单位质量响应值RSD%判断
6465.526335.811.44数据可信
加速3月-供试品溶液-2025072221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%
5min116081-1608122.54427.2514.8522.5427.2514.85
215914-1591422.31022.31
322906-2290632.11232.11
421551-2155130.21230.21
519543-1954327.39727.40
620653-2065328.95328.95
10min131800-3180044.58048.005.3644.6248.045.37
232501-3250145.56345.60
336195-3619550.74150.79
436000-3600050.46850.52
533814-3381447.40347.45
635109-3510949.21949.27
15min141417-4141758.06259.562.4258.1759.692.43
242323-4232359.33259.45
343583-4358361.09961.24
443690-4369061.24961.38
541293-4129357.88858.01
642615-4261559.74259.87
20min147118-4711866.05466.181.8266.2666.401.83
247457-4745766.52966.74
347848-4784867.07867.32
447885-4788567.12967.37
545561-4556163.87164.09
647375-4737566.41566.64
30min151788-5178872.60173.121.5972.9273.461.60
252448-5244873.52673.85
353039-5303974.35574.71
452991-5299174.28874.64
550908-5090871.36771.69
651776-5177672.58472.92
45min156121-5612178.67578.221.0979.1278.681.10
255922-5592278.39678.84
356108-5610878.65779.13
456475-5647579.17279.64
554810-5481076.83877.28
655355-5535577.60278.06
60min157833-5783381.07580.561.4081.6581.151.40
257505-5750580.61681.19
357571-5757180.70881.31
458480-5848081.98382.59
556048-5604878.57379.15
657374-5737480.43281.02
90min159730-5973083.73583.422.0184.4484.142.01
258757-5875782.37183.08
360045-6004584.17684.92
461533-6153386.26287.00
558359-5835981.81382.52
658600-5860082.15182.88
120min161631-6163186.40084.601.6987.2585.461.68
259542-5954283.47184.32
360232-6023284.43985.32
461589-6158986.34187.23
559521-5952183.44284.28
659550-5955083.48384.34
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162303-6230387.34287.141.3888.3388.151.38
262151-6215187.12988.12
362111-6211187.07388.10
463687-6368789.28290.31
561376-6137686.04287.02
661344-6134485.99887.00
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%
1 9.866274662818626796292063616629560.61
2 10.116578065880658300.11
单位质量响应值RSD%判断
6384.996511.371.39数据可信
加速3月-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%
5min116969-1696923.61329.9217.0923.6129.9217.09
220297-2029728.24428.24
324304-2430433.82033.82
419666-1966627.36627.37
527271-2727137.94937.95
620520-2052028.55528.55
10min134338-3433847.78351.999.0247.8252.049.03
234832-3483248.47048.52
340982-4098257.02857.08
436134-3613450.28250.33
542223-4222358.75558.82
635643-3564349.59949.65
15min144093-4409361.35864.095.8361.4864.235.84
244395-4439561.77861.91
349509-4950968.89469.05
444461-4446161.87062.00
549525-4952568.91669.08
644350-4435061.71561.85
20min149341-4934168.66070.283.6268.8870.523.64
249789-4978969.28469.51
352999-5299973.75174.02
449556-4955668.96069.19
552612-5261273.21273.49
648714-4871467.78868.02
30min154711-5471176.13376.922.6576.4777.282.67
254537-5453775.89176.24
357409-5740979.88780.28
454153-5415375.35775.70
556836-5683679.09079.49
654026-5402675.18075.53
45min158785-5878581.80282.082.1782.2682.572.18
259193-5919382.37082.84
361192-6119285.15285.67
458291-5829181.11581.59
559115-5911582.26182.79
657338-5733879.78980.26
60min159157-5915782.32083.881.8682.9284.511.87
260729-6072984.50785.12
362254-6225486.62987.29
459396-5939682.65283.26
559994-5999483.48584.15
660154-6015483.70784.31
90min160715-6071584.48885.551.4385.2286.321.45
262288-6228886.67787.43
362504-6250486.97787.79
460233-6023383.81784.56
561572-6157285.68086.49
661553-6155385.65486.40
120min160532-6053284.23385.822.0385.1186.732.03
262882-6288287.50388.40
363033-6303387.71488.67
460005-6000583.50084.39
561356-6135685.38086.33
662230-6223086.59687.48
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163622-6362288.53388.890.4389.5589.940.46
263910-6391088.93489.98
364380-6438089.58890.69
463654-6365488.57889.60
563865-6386588.87189.96
663851-6385188.85289.88
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