贝派度酸片项目信息
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50
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%
19.852951632951812950212950912951522951220.03
29.862960192958832959510.04
单位质量响应值RSD%判断
29961.6230015.310.13数据可信
制剂处方摸索--供试品溶液-24022301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%
5min11660-16601.1041.1922.001.101.1922.00
22282-22821.5181.52
32219-22191.4761.48
41635-16351.0871.09
51650-16501.0971.10
61259-12590.8370.84
10min14077-40772.7112.466.262.722.476.27
23782-37822.5152.53
33760-37602.5012.52
43569-35692.3742.39
53591-35912.3882.40
63405-34052.2652.27
15min14354-43542.8963.1713.702.943.2113.44
24491-44912.9873.03
34896-48963.2563.30
44507-45072.9973.04
54337-43372.8842.92
66038-60384.0164.05
20min15162-51623.4333.5213.703.513.6013.42
26713-67134.4654.54
35288-52883.5173.60
44974-49743.3083.38
54884-48843.2483.32
64726-47263.1433.22
30min16592-65924.3843.937.774.504.057.48
25575-55753.7083.84
35675-56753.7743.89
46398-63984.2554.36
55526-55263.6753.78
65720-57203.8043.92
45min16196-61964.1214.004.154.284.164.14
26318-63184.2024.37
36127-61274.0754.24
45765-57653.8343.99
55685-56853.7813.93
65980-59803.9774.13
60min15876-58763.9083.983.654.124.183.37
25742-57423.8194.03
36081-60814.0444.25
45747-57473.8224.02
56226-62264.1414.33
66191-61914.1174.32
极限16455-64554.2934.5713.204.544.8112.57
26087-60874.0484.31
37961-79615.2955.55
46976-69764.6394.88
55827-58273.8754.11
67884-78845.2435.49
贝派度酸片项目信息
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50
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%
19.852995402996462998492995552995582996300.05
29.862976192976352976270.01
单位质量响应值RSD%判断
30419.2930185.290.55数据可信
制剂处方摸索--供试品溶液-24022301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%
5min12612-26121.7192.2029.171.722.2029.22
22918-29181.9211.92
35178-51783.4083.41
43106-31062.0442.04
52615-26151.7211.72
63653-36532.4042.40
10min16679-66794.3964.4110.474.424.4310.56
26626-66264.3614.38
38050-80505.2985.34
46400-64004.2124.24
56381-63814.2004.22
66041-60413.9764.00
15min17729-77295.0875.182.075.165.252.02
27783-77835.1235.19
37877-78775.1845.28
47799-77995.1335.20
58182-81825.3855.45
67824-78245.1505.22
20min18723-87235.7415.826.505.875.956.34
28472-84725.5765.70
38489-84895.5875.74
48784-87845.7815.91
58573-85735.6435.77
69980-99806.5696.70
30min19443-94436.2156.221.896.406.411.83
29188-91886.0476.24
39405-94056.1906.41
49393-93936.1826.37
59737-97376.4096.60
69491-94916.2476.45
45min19582-95826.3077.049.446.567.319.12
211599-115997.6347.89
39873-98736.4986.78
410375-103756.8297.09
510571-105716.9587.22
612195-121958.0268.30
60min110133-101336.6696.933.957.007.283.79
210628-106286.9957.34
310027-100276.6006.96
410869-108697.1547.49
510425-104256.8627.20
611093-110937.3017.66
极限110055-100556.6187.318.957.027.738.57
210513-105136.9197.34
310839-108397.1347.56
410534-105346.9337.35
512172-121728.0118.42
612499-124998.2278.67
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