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%
110.006332963206632896304363181632100.18
29.996396963770638700.23
单位质量响应值RSD%判断
6321.006393.390.81数据可信
供试品溶液-H046R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%
5min115960-1596022.52628.2111.7722.5328.2111.76
221798-2179830.76530.77
320814-2081429.37629.38
418405-1840525.97625.98
520930-2093029.54029.54
621999-2199931.04931.05
10min127840-2784039.29347.419.0339.3347.459.03
235044-3504449.46049.51
335152-3515249.61349.66
432623-3262346.04346.09
534912-3491249.27449.32
635963-3596350.75750.81
15min135992-3599250.79858.647.1350.9058.777.14
242718-4271860.29160.42
343291-4329161.10061.23
440451-4045157.09257.21
543018-4301860.71560.85
643828-4382861.85861.99
20min139906-3990656.32265.447.5056.5165.667.50
247521-4752167.07067.30
348212-4821268.04568.28
445020-4502063.54063.76
548293-4829368.16068.39
649250-4925069.51069.75
30min146149-4614965.13473.586.2765.4273.916.27
252145-5214573.59673.94
354099-5409976.35476.70
451143-5114372.18272.50
554385-5438576.75877.10
654878-5487877.45377.81
45min152092-5209273.52180.844.8773.9181.304.88
257576-5757681.26181.73
358345-5834582.34782.82
456638-5663879.93780.38
559204-5920483.55984.03
659832-5983284.44584.93
60min155569-5556978.42984.714.1978.9485.304.21
260023-6002384.71585.32
360870-6087085.91086.52
459129-5912983.45384.03
562018-6201887.53188.14
662508-6250888.22288.85
90min159819-5981984.42789.043.2385.0789.773.25
262395-6239588.06388.81
363274-6327489.30390.06
462611-6261188.36889.08
564824-6482491.49192.25
665580-6558092.55893.33
120min161586-6158686.92190.982.6187.7191.862.63
263889-6388990.17191.06
364679-6467991.28692.19
464405-6440590.90091.76
566134-6613493.34094.25
666080-6608093.26494.19
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162058-6205887.58791.802.7888.5292.832.81
264381-6438190.86691.91
365545-6554592.50993.56
464619-6461991.20292.21
566493-6649393.84794.91
667146-6714694.76895.85
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%
110.006383964057644056404164070640820.32
29.996413663983640600.17
单位质量响应值RSD%判断
6408.206412.410.05数据可信
供试品溶液-H046R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%
5min15432-54327.6038.577.587.608.577.58
26181-61818.6518.65
36323-63238.8508.85
46839-68399.5729.57
56018-60188.4238.42
65948-59488.3258.33
10min112212-1221217.09217.703.1017.1117.713.09
212344-1234417.27717.29
313251-1325118.54718.56
412938-1293818.10918.12
512669-1266917.73217.75
612460-1246017.43917.45
15min117689-1768924.75824.651.5424.8024.701.54
217710-1771024.78824.83
317642-1764224.69224.74
417904-1790425.05925.11
517099-1709923.93223.98
617647-1764724.69924.74
20min121321-2132129.84229.741.7829.9229.821.79
221233-2123329.71829.80
321607-2160730.24230.33
421678-2167830.34130.43
520705-2070528.97929.06
620931-2093129.29629.38
30min126304-2630436.81637.141.6036.9537.271.60
226667-2666737.32437.46
327076-2707637.89738.03
426943-2694337.71037.85
526119-2611936.55736.69
626096-2609636.52536.66
45min131548-3154844.15644.582.5144.3544.772.51
232373-3237345.31045.51
332819-3281945.93546.14
432401-3240145.35045.55
530826-3082643.14543.34
631119-3111943.55543.75
60min135549-3554949.75650.051.3450.0250.321.34
236209-3620950.67950.95
335982-3598250.36250.64
436148-3614850.59450.87
534926-3492648.88449.15
635750-3575050.03750.30
90min140411-4041156.56157.051.4056.9157.411.40
240816-4081657.12857.48
341632-4163258.27058.63
441167-4116757.61957.98
540054-4005456.06156.41
640500-4050056.68557.04
120min143959-4395961.52761.841.2561.9762.281.25
244631-4463162.46762.92
344694-4469462.55563.01
444644-4464462.48562.94
543405-4340560.75161.19
643748-4374861.23161.68
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145181-4518163.23763.681.1263.7864.221.13
245182-4518263.23863.79
346238-4623864.71665.28
446035-4603564.43264.99
545036-4503663.03463.57
645296-4529663.39863.94
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%
110.006424364224637406375163618639150.47
29.996345063327633880.14
单位质量响应值RSD%判断
6391.506345.150.52数据可信
供试品溶液-H046R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%
5min19909-990913.96113.327.1513.9613.327.15
210468-1046814.74814.75
39579-957913.49613.50
48638-863812.17012.17
59271-927113.06213.06
68876-887612.50512.51
10min119072-1907226.87026.503.1326.8926.523.13
219619-1961927.64127.67
319151-1915126.98227.00
418025-1802525.39525.42
518672-1867226.30726.33
618305-1830525.79025.81
15min125973-2597336.59336.281.5736.6636.341.57
226396-2639637.18937.26
325748-2574836.27636.34
425572-2557236.02836.09
525588-2558836.05036.12
625213-2521335.52235.59
20min130876-3087643.50143.471.5643.6343.601.56
231111-3111143.83243.96
331649-3164944.59044.72
430563-3056343.06043.18
530652-3065243.18543.31
630284-3028442.66742.79
30min137001-3700152.13052.560.8552.3352.760.84
237311-3731152.56752.77
337476-3747652.79953.00
437846-3784653.32153.51
537152-3715252.34352.54
637062-3706252.21652.41
45min143659-4365961.51061.750.9561.8062.040.94
243641-4364161.48561.78
343807-4380761.71962.01
444479-4447962.66662.95
544099-4409962.13062.42
643286-4328660.98561.27
60min147678-4767867.17367.671.0367.5668.061.02
247682-4768267.17867.57
347868-4786867.44067.83
448874-4887468.85869.25
548376-4837668.15668.54
647719-4771967.23067.61
90min153215-5321574.97475.361.2675.4875.861.25
252787-5278774.37174.88
353731-5373175.70176.21
454709-5470977.07977.58
553333-5333375.14075.64
653169-5316974.90975.40
120min156591-5659179.73079.841.3080.3680.461.29
256463-5646379.55080.18
356309-5630979.33379.96
458110-5811081.87082.50
556506-5650679.61080.24
656026-5602678.93479.55
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157841-5784181.49181.661.1882.2582.431.17
257636-5763681.20281.97
358099-5809981.85582.62
459237-5923783.45884.23
557709-5770981.30582.07
657261-5726180.67481.43
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%
110.006357963275634016340163340633990.18
29.996363963568636040.08
单位质量响应值RSD%判断
6339.906366.770.30数据可信
供试品溶液-H046R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%
5min160401-6040185.29888.773.3385.3088.773.33
261200-6120086.42686.43
364703-6470391.37391.37
463849-6384990.16790.17
561526-6152686.88786.89
665477-6547792.46692.47
10min161404-6140486.71492.613.1586.8692.763.15
266415-6641593.79193.93
366757-6675794.27494.43
466158-6615893.42893.58
566082-6608293.32193.47
666674-6667494.15794.31
15min162801-6280188.68794.222.9588.9794.522.95
268159-6815996.25496.55
367839-6783995.80296.11
467090-6709094.74495.05
567372-6737295.14295.44
667065-6706594.70995.02
20min163574-6357489.77995.122.9190.2195.582.91
268862-6886297.24797.71
368740-6874097.07497.54
467230-6723094.94295.41
568106-6810696.17996.64
667610-6761095.47895.95
30min163549-6354989.74495.803.2990.3396.423.28
269724-6972498.46499.09
369257-6925797.80498.44
467608-6760895.47696.10
568542-6854296.79597.41
668362-6836296.54097.17
45min163873-6387390.20196.263.3790.9397.033.36
270527-7052799.598100.38
369359-6935997.94898.74
467788-6778895.73096.51
568959-6895997.38398.16
668459-6845996.67797.47
60min164120-6412090.55096.183.1491.4397.123.13
270393-7039399.409100.36
369131-6913197.62698.58
468046-6804696.09497.03
568879-6887997.27198.21
668086-6808696.15197.10
90min163950-6395090.31096.263.2391.3497.363.23
270407-7040799.428100.55
369117-6911797.60798.73
468323-6832396.48597.59
568758-6875897.10098.20
668440-6844096.65197.76
120min163940-6394090.29696.243.2091.4897.493.20
270320-7032099.305100.59
369070-6907097.54098.82
468435-6843596.64497.91
568753-6875397.09398.36
668356-6835696.53297.80
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163606-6360689.82496.273.3691.1697.693.35
269990-6999098.839100.29
368910-6891097.31498.76
468741-6874197.07698.50
569028-6902897.48198.91
668762-6876297.10598.54
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