比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.153831863838113837003833763835503835250.07
2 11.153844113834573839340.18
单位质量响应值RSD%判断
34396.8634433.540.08数据可信
中间条件6月-供试品溶液-2024122121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%
5min1285165-28516574.27673.701.1774.2873.701.17
2284566-28456674.12074.12
3280621-28062173.09273.09
4278493-27849372.53872.54
5281553-28155373.33573.34
6287340-28734074.84274.84
10min1349524-34952491.03990.641.0391.1690.771.03
2348671-34867190.81790.94
3349735-34973591.09491.22
4342348-34234889.17089.29
5345371-34537189.95890.08
6352394-35239491.78791.91
15min1371332-37133296.71996.450.9297.0096.720.92
2371279-37127996.70696.98
3371724-37172496.82297.10
4365327-36532795.15595.42
5367332-36733295.67895.95
6374729-37472997.60497.88
20min1378127-37812798.48998.421.1398.9398.861.13
2377835-37783598.41398.85
3382555-38255599.643100.08
4372295-37229596.97097.40
5373870-37387097.38197.81
6382495-38249599.627100.07
30min1380707-38070799.16199.351.2099.7699.951.20
2380944-38094499.22399.82
3386261-386261100.608101.21
4375412-37541297.78298.37
5378185-37818598.50499.10
6387140-387140100.837101.44
45min1381632-38163299.40299.551.28100.17100.321.28
2382192-38219299.548100.31
3386251-386251100.605101.37
4374700-37470097.59798.35
5379875-37987598.94599.70
6388595-388595101.216101.99
60min1380560-38056099.12399.451.17100.05100.381.17
2381605-38160599.395100.33
3386683-386683100.718101.65
4375713-37571397.86198.78
5379048-37904898.72999.65
6387235-387235100.862101.80
极限1381196-38119699.28999.381.02100.39100.481.03
2382931-38293199.741100.84
3385412-385412100.387101.49
4375801-37580197.88498.96
5378452-37845298.57499.66
6385565-385565100.427101.54
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.153848293849133849983845063843033847100.08
2 11.153827903823103825500.09
单位质量响应值RSD%判断
34503.1434309.420.40数据可信
中间条件6月-供试品溶液-2024122221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%
5min1273373-27337371.22371.781.5871.2271.781.59
2277716-27771672.35572.35
3280022-28002272.95672.96
4278503-27850372.56072.56
5268036-26803669.83369.83
6275348-27534871.73871.74
10min1336958-33695887.79088.541.2387.9188.661.23
2339184-33918488.37088.49
3344563-34456389.77189.89
4342330-34233089.18989.31
5333374-33337486.85686.97
6342568-34256889.25189.37
15min1359183-35918393.58094.261.2893.8594.531.28
2362813-36281394.52694.79
3366895-36689595.58995.86
4361973-36197394.30794.58
5354230-35423092.29092.55
6365695-36569595.27795.54
20min1365995-36599595.35596.311.0195.7896.741.01
2369523-36952396.27496.70
3374377-37437797.53997.97
4371375-37137596.75797.18
5364699-36469995.01795.43
6372080-37208096.94097.37
30min1369659-36965996.30997.211.2996.8997.801.29
2373477-37347797.30497.89
3381481-38148199.39099.98
4372770-37277097.12097.71
5367378-36737895.71596.29
6373917-37391797.41998.01
45min1368394-36839495.98097.171.2796.7297.921.27
2373511-37351197.31398.06
3380175-38017599.04999.81
4374166-37416697.48498.23
5367111-36711195.64696.38
6374416-37441697.54998.30
60min1368424-36842495.98897.221.2396.8998.131.23
2373610-37361097.33998.25
3379310-37931098.82499.75
4374936-37493697.68498.60
5367198-36719895.66896.56
6375440-37544097.81698.73
极限1366766-36676695.55696.931.2996.6298.001.29
2373042-37304297.19198.26
3378903-37890398.71899.81
4372803-37280397.12998.20
5366282-36628295.43096.48
6374349-37434997.53198.61
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.153834753837703834383833573831373834350.06
2 11.153837313837543837420.01
单位质量响应值RSD%判断
34388.7934416.320.06数据可信
中间条件6月-供试品溶液-2024122321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%
5min1264023-26402368.79469.541.0568.7969.541.05
2266810-26681069.52169.52
3271674-27167470.78870.79
4266442-26644269.42569.42
5267964-26796469.82169.82
6264351-26435168.88068.88
10min1341567-34156788.99989.140.8189.1189.250.82
2339931-33993188.57388.69
3346984-34698490.41190.53
4339416-33941688.43988.55
5341273-34127388.92389.04
6343369-34336989.46989.58
15min1361614-36161494.22394.930.7594.4995.190.75
2363368-36336894.68094.94
3369323-36932396.23296.50
4363115-36311594.61494.88
5363239-36323994.64694.91
6365268-36526895.17595.44
20min1370587-37058796.56197.010.9296.9897.430.92
2369856-36985696.37096.79
3378933-37893398.73699.16
4371561-37156196.81597.24
5370183-37018396.45696.88
6372705-37270597.11397.54
30min1374090-37409097.47497.600.5898.0598.180.58
2373940-37394097.43598.02
3374778-37477897.65398.25
4371322-37132296.75297.33
5375211-37521197.76698.35
6378002-37800298.49399.08
45min1374359-37435997.54498.080.8898.2998.830.88
2375062-37506297.72798.47
3382180-38218099.582100.34
4374405-37440597.55698.30
5373890-37389097.42298.17
6378576-37857698.64399.39
60min1375017-37501797.71598.280.9298.6299.190.92
2374739-37473997.64398.55
3383034-38303499.804100.73
4374719-37471997.63898.54
5375820-37582097.92498.83
6379755-37975598.95099.86
极限1375701-37570197.89398.241.1198.9699.311.10
2375781-37578197.91498.98
3383733-38373399.986101.07
4373814-37381497.40298.47
5372831-37283197.14698.22
6380256-38025699.080100.16
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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 11.153833213835833831183835903831953833610.06
2 11.153831973822343827160.18
单位质量响应值RSD%判断
34382.1534324.300.12数据可信
中间条件6月-供试品溶液-3176A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%
5min1235004-23500461.32160.252.2661.3260.252.26
2226708-22670859.15659.16
3222597-22259758.08458.08
4234037-23403761.06961.07
5235650-23565061.49061.49
6231332-23133260.36360.36
10min1320810-32081083.71182.201.3783.8182.301.37
2311632-31163281.31681.41
3311952-31195281.40081.50
4316708-31670882.64182.74
5318634-31863483.14383.25
6310303-31030380.96981.07
15min1351594-35159491.74489.281.8591.9989.521.85
2335164-33516487.45687.69
3340920-34092088.95889.19
4344997-34499790.02290.26
5344848-34484889.98390.22
6335431-33543187.52687.76
20min1364447-36444795.09792.151.9395.4992.541.92
2347325-34732590.63091.01
3352759-35275992.04892.43
4353892-35389292.34392.73
5355358-35535892.72693.12
6345203-34520390.07690.46
30min1376364-37636498.20794.512.3198.7695.052.31
2354873-35487392.59993.13
3360918-36091894.17794.71
4364277-36427795.05395.60
5363927-36392794.96295.51
6352887-35288792.08192.61
45min1385539-385539100.60195.972.83101.3296.672.82
2359289-35928993.75294.44
3365949-36594995.48996.18
4368746-36874696.21996.92
5371160-37116096.84997.55
6356080-35608092.91493.60
60min1390322-390322101.84996.653.03102.7397.513.01
2362066-36206694.47695.32
3367100-36710095.79096.64
4371152-37115296.84797.71
5373161-37316197.37198.24
6358548-35854893.55894.40
极限1395579-395579103.22197.403.38104.2898.423.36
2363808-36380894.93195.93
3367928-36792896.00697.02
4371873-37187397.03598.06
5379064-37906498.91299.94
6361433-36143394.31195.31
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