贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.239774369784579771329777319791039779720.09
2 11.299777489786649782060.07
单位质量响应值RSD%判断
87085.6686643.580.36数据可信
供试品溶液-24091101批-依折麦布-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%
5min138008-380083.9283.6930.103.933.7030.10
240604-406044.1964.20
350999-509995.2715.27
422281-222812.3032.30
524354-243542.5172.52
638240-382403.9523.95
10min167262-672626.9526.944.177.006.994.28
269379-693797.1707.22
371416-714167.3817.44
466195-661956.8416.87
564178-641786.6336.66
664657-646576.6826.73
15min164358-643586.6516.974.466.777.094.51
269382-693827.1717.30
370769-707697.3147.45
465472-654726.7676.87
564509-645096.6676.77
670310-703107.2677.38
20min171750-717507.4157.162.737.617.362.78
271004-710047.3387.54
369917-699177.2267.45
468003-680037.0287.20
568490-684907.0797.25
666796-667966.9037.10
30min165489-654896.7687.036.247.057.315.95
275140-751407.7668.05
362570-625706.4676.77
467351-673516.9617.22
568022-680227.0307.28
669673-696737.2017.48
45min167682-676826.9957.444.367.357.794.09
274472-744727.6978.07
370900-709007.3287.70
472254-722547.4687.80
576454-764547.9028.23
670180-701807.2537.61
60min156317-563175.8207.019.766.257.459.24
275144-751447.7668.23
364672-646726.6847.14
468716-687167.1027.52
571720-717207.4127.83
670475-704757.2847.72
极限170706-707067.3087.345.057.807.854.79
274704-747047.7218.27
371005-710057.3387.87
471328-713287.3727.87
573834-738347.6318.13
664510-645106.6677.18
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.922499792500212494522495962497522497600.10
2 9.932498412503862501140.16
单位质量响应值RSD%判断
25177.4225187.710.03数据可信
供试品溶液-24091101批-贝派度酸-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%
5min13591-35911.4221.3032.491.421.3032.54
23825-38251.5151.51
34752-47521.8821.88
42003-20030.7930.79
52076-20760.8220.82
63408-34081.3501.35
10min17391-73912.9272.875.792.942.885.96
27527-75272.9813.00
37790-77903.0853.11
47117-71172.8182.83
56600-66002.6142.62
67025-70252.7822.80
15min17696-76963.0483.154.813.103.204.86
28176-81763.2383.29
38376-83763.3173.37
47816-78163.0953.14
57375-73752.9202.96
68236-82363.2613.31
20min18843-88433.5023.362.663.583.442.66
28552-85523.3863.47
38450-84503.3463.44
48563-85633.3913.47
58156-81563.2303.30
68404-84043.3283.41
30min18510-85103.3703.375.563.493.495.38
29175-91753.6333.76
37714-77143.0553.18
48535-85353.3803.49
58461-84613.3503.46
68721-87213.4533.57
45min18609-86093.4093.623.923.573.783.62
29092-90923.6003.76
39239-92393.6593.82
49289-92893.6783.83
59683-96833.8343.98
68966-89663.5503.71
60min17278-72782.8823.429.023.083.618.52
29486-94863.7563.96
38248-82483.2663.47
48871-88713.5133.70
58740-87403.4613.65
69127-91273.6143.81
极限19035-90353.5783.594.213.813.823.94
29355-93553.7043.95
39103-91033.6053.84
49236-92363.6573.89
59291-92913.6793.90
68316-83163.2933.53
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.239777979779659787409768709777139778170.07
2 11.299777989760749769360.13
单位质量响应值RSD%判断
87071.8686531.090.45数据可信
供试品溶液-24091101批-依折麦布-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%
5min139718-397184.1085.2511.084.115.2511.07
252495-524955.4295.43
352442-524425.4245.42
454705-547055.6585.66
554593-545935.6465.65
650689-506895.2435.24
10min172560-725607.5057.215.737.557.275.66
273276-732767.5797.64
371907-719077.4377.50
471223-712237.3667.43
563948-639486.6146.68
665401-654016.7646.82
15min174416-744167.6977.582.237.837.722.20
273571-735717.6097.75
374402-744027.6957.84
472978-729787.5487.69
570153-701537.2567.39
674150-741507.6697.80
20min173052-730527.5567.197.247.777.417.07
271352-713527.3807.61
371641-716417.4107.64
468665-686657.1027.33
559723-597236.1776.39
672603-726037.5097.73
30min171090-710907.3537.401.847.657.701.78
273514-735147.6037.91
370368-703687.2787.59
472727-727277.5227.83
571073-710737.3517.64
670323-703237.2737.58
45min172337-723377.4827.392.427.867.772.41
273426-734267.5947.99
371190-711907.3637.75
471573-715737.4037.79
568301-683017.0647.43
671827-718277.4297.81
60min168023-680237.0357.263.497.507.733.30
272490-724907.4977.98
367789-677897.0117.48
473299-732997.5818.05
571318-713187.3767.82
668371-683717.0717.54
极限169987-699877.2397.353.057.787.902.94
274457-744577.7018.26
369102-691027.1477.70
472870-728707.5378.09
569167-691677.1547.68
670852-708527.3287.87
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.922494362494412495202492742492012493740.06
2 9.932495152493142494140.06
单位质量响应值RSD%判断
25138.5125117.220.06数据可信
供试品溶液-24091101批-贝派度酸-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%
5min1-0.0001.41154.920.001.41154.92
2-0.0000.00
3-0.0000.00
410639-106394.2224.22
510654-106544.2284.23
6-0.0000.00
10min116521-165216.5566.315.526.566.325.45
216545-165456.5666.57
316388-163886.5046.50
416355-163556.4906.54
514930-149305.9255.97
614613-146135.7995.80
15min117934-179347.1177.031.567.197.111.42
217716-177167.0317.10
317983-179837.1377.21
417764-177647.0507.17
517211-172116.8306.94
617660-176607.0087.07
20min118188-181887.2187.2013.037.377.3712.80
217805-178057.0667.22
317679-176797.0167.17
422339-223398.8659.06
514989-149895.9486.14
617908-179087.1077.25
30min118244-182447.2407.321.837.477.571.99
218866-188667.4877.72
317927-179277.1147.34
418697-186977.4207.72
518574-185747.3717.63
618414-184147.3087.53
45min118927-189277.5117.471.817.827.791.57
219248-192487.6397.95
318778-187787.4527.76
418680-186807.4137.79
518249-182497.2427.58
619002-190027.5417.84
60min118349-183497.2827.403.267.687.823.37
219101-191017.5807.98
317962-179627.1287.52
419270-192707.6478.11
519223-192237.6298.05
618046-180467.1627.55
极限118737-187377.4367.532.797.918.022.74
219796-197967.8568.34
318236-182367.2377.71
419241-192417.6368.18
518783-187837.4547.96
619105-191057.5828.05
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