奥利司他胶囊项目信息
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%
19.923139631307315753120331774314510.72
210.013145531598315260.33
单位质量响应值RSD%判断
3170.463149.450.48数据可信
供试品溶液-25031901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%
5min115273-1527343.36540.117.4243.3740.117.43
214055-1405539.90739.91
313798-1379839.17739.18
414828-1482842.10242.10
512279-1227934.86434.86
614518-1451841.22241.22
10min122128-2212862.82961.022.2662.9061.082.26
221162-2116260.08660.15
321552-2155261.19461.26
421965-2196562.36662.44
520878-2087859.28059.34
621257-2125760.35660.42
15min125395-2539572.10571.031.5372.2871.201.54
224761-2476170.30570.47
325337-2533771.94072.11
425278-2527871.77371.95
524439-2443969.39169.55
624879-2487970.64070.81
20min126691-2669175.78575.910.8376.0876.190.84
226618-2661875.57875.86
326936-2693676.48176.77
427038-2703876.77077.06
526428-2642875.03875.31
626692-2669275.78876.07
30min128816-2881681.81881.170.7382.2481.580.73
228318-2831880.40480.81
328570-2857081.12081.53
428814-2881481.81382.23
528611-2861181.23681.63
628400-2840080.63781.05
45min129959-2995985.06484.530.9785.6285.080.98
229334-2933483.28983.83
329914-2991484.93685.49
430139-3013985.57586.13
529632-2963284.13584.67
629648-2964884.18184.73
60min130454-3045486.46986.620.4787.1787.310.47
230349-3034986.17186.85
330523-3052386.66587.36
430754-3075487.32188.02
530551-3055186.74587.42
630405-3040586.33087.02
极限130868-3086887.64587.611.1488.4988.441.13
230398-3039886.31087.14
331229-3122988.67089.51
431027-3102788.09688.94
531146-3114688.43489.25
630468-3046886.50987.34
奥利司他胶囊项目信息
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%
19.926327363392631936322363271632700.12
210.016251962638625780.14
单位质量响应值RSD%判断
6378.026251.551.42数据可信
供试品溶液-25031701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%
5min119844-1984428.19730.477.5228.2030.477.52
222330-2233031.73031.73
322762-2276232.34432.34
422704-2270432.26132.26
518997-1899726.99426.99
622021-2202131.29131.29
10min133493-3349347.59247.983.1747.6448.033.17
234266-3426648.69048.74
334872-3487249.55149.61
434299-3429948.73748.79
531799-3179945.18545.23
633862-3386248.11648.17
15min140967-4096758.21257.491.5158.3457.621.52
240116-4011657.00357.14
341192-4119258.53258.67
440694-4069457.82457.96
539533-3953356.17456.29
640267-4026757.21757.35
20min145315-4531564.39063.071.3964.6163.291.39
244186-4418662.78663.02
344889-4488963.78564.02
444294-4429462.94063.17
543986-4398662.50262.72
643626-4362661.99062.22
30min149963-4996370.99569.451.6471.3369.781.64
248640-4864069.11569.45
349486-4948670.31770.66
448772-4877269.30369.64
548765-4876569.29369.61
647622-4762267.66968.00
45min153824-5382476.48174.541.8676.9374.991.86
252307-5230774.32674.77
353219-5321975.62276.08
452249-5224974.24374.70
552168-5216874.12874.56
650990-5099072.45472.90
60min156376-5637680.10877.572.1480.6878.142.13
254554-5455477.51978.09
354945-5494578.07478.66
454062-5406276.81977.39
554799-5479977.86778.42
652809-5280975.03975.60
极限157532-5753281.75079.282.0682.4679.982.05
255571-5557178.96479.67
355942-5594279.49180.20
455398-5539878.71879.42
556291-5629179.98780.67
654040-5404076.78877.48
奥利司他胶囊项目信息
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%
19.926321063372630106299962701630580.41
210.016324763328632880.10
单位质量响应值RSD%判断
6356.656322.480.39数据可信
供试品溶液-25031702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%
5min112487-1248717.67223.6012.7617.6723.6012.76
217233-1723324.38924.39
318282-1828225.87425.87
417051-1705124.13224.13
516943-1694323.97923.98
618077-1807725.58425.58
10min123931-2393133.86938.145.6833.9038.185.68
227439-2743938.83338.87
328149-2814939.83839.88
426947-2694738.13738.18
527455-2745538.85638.90
627754-2775439.27939.32
15min130711-3071143.46446.553.4043.5546.653.41
232871-3287146.52146.63
333624-3362447.58747.70
433006-3300646.71246.82
533506-3350647.42047.52
633625-3362547.58847.70
20min134837-3483749.30451.522.2149.4651.702.23
236838-3683852.13652.32
336884-3688452.20152.39
436320-3632051.40251.58
536974-3697452.32852.51
636557-3655751.73851.93
30min139219-3921955.50557.271.7455.7557.541.75
240324-4032457.06957.34
340986-4098658.00658.28
440558-4055857.40057.67
541248-4124858.37758.65
640452-4045257.25057.52
45min142303-4230359.87061.532.0560.2061.892.05
243246-4324661.20561.57
343151-4315161.07061.44
443900-4390062.13062.49
544958-4495863.62764.00
643288-4328861.26461.63
60min145019-4501963.71464.461.5364.1564.921.53
245501-4550164.39664.86
344703-4470363.26763.74
445809-4580964.83265.30
546708-4670866.10466.58
645532-4553264.44064.91
极限147068-4706866.61467.181.4567.1567.751.45
246953-4695366.45167.03
347338-4733866.99667.58
447277-4727766.90967.48
548832-4883269.11069.69
647342-4734267.00167.58
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