贝派度酸片项目信息
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BEMA-231010D对照品来源自制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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 2976862977722980812975232976882977500.07
29.932975602977842976720.06
单位质量响应值RSD%判断
30197.7729977.040.52数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min150978-5097816.89616.582.7116.9016.582.73
249061-4906116.26116.26
10min139679-3967913.15115.7823.5713.1815.8123.53
255544-5554418.40918.44
15min143632-4363214.46114.450.0714.5114.510.00
243590-4359014.44714.51
20min1134856-13485644.69746.274.8044.7746.344.81
2144329-14432947.83647.92
30min1133033-13303344.09245.012.8944.2445.162.90
2138578-13857845.93046.09
45min1141653-14165346.94947.010.1947.1747.240.21
2142020-14202047.07147.31
60min1158007-15800752.37054.535.6052.6754.845.59
2171027-17102756.68557.00
极限1167522-16752255.52354.752.0055.9155.151.95
2162859-16285953.97854.39
贝派度酸片项目信息
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BEMA-231010D对照品来源自制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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 2980082978562979072983622975912979450.10
29.932975832977542976680.05
单位质量响应值RSD%判断
30217.5529976.640.57数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1153377-15337750.81952.103.4850.8252.103.48
2161094-16109453.37653.38
10min1156470-15647051.84450.713.1651.9350.803.15
2149638-14963849.58049.67
15min1150095-15009549.73147.945.3049.9048.115.27
2139266-13926646.14346.32
20min1245490-24549081.33982.481.9681.5982.721.95
2252358-25235883.61583.86
30min1244707-24470781.08080.920.2981.4781.300.29
2243722-24372280.75381.14
45min1243609-24360980.71681.401.2081.2481.921.19
2247753-24775382.08982.61
60min1273820-27382090.72691.340.9591.3892.000.95
2277503-27750391.94692.61
极限1273833-27383390.73090.480.4091.5491.290.39
2272319-27231990.22891.04
贝派度酸片项目信息
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BEMA-231010D对照品来源自制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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 2973462972762973912969622976372973220.09
29.932972502972662972580.01
单位质量响应值RSD%判断
30154.3629935.350.52数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1140915-14091546.77145.832.9146.7745.832.91
2135252-13525244.89144.89
10min1142834-14283447.40845.167.0547.4945.247.04
2129285-12928542.91142.99
15min1132156-13215643.86444.040.5844.0244.200.56
2133241-13324144.22444.37
20min1216550-21655071.87573.453.0372.1073.673.02
2226019-22601975.01875.24
30min1219334-21933472.79975.294.6873.1575.644.65
2234330-23433077.77678.12
45min1218353-21835372.47372.570.1972.9473.040.19
2218916-21891672.66073.13
60min1244301-24430181.08583.163.5481.6883.763.52
2256816-25681685.23985.84
极限1245547-24554781.49984.044.2882.2384.784.25
2260869-26086986.58587.32
贝派度酸片项目信息
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BEMA-231010D对照品来源自制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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.86 2974892978402978052978552979702977920.07
29.932974182976372975280.06
单位质量响应值RSD%判断
30202.0329962.540.57数据可信
供试品溶液-2010685批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142001-4200113.92313.178.1113.9213.168.12
237448-3744812.41412.41
10min1101408-10140833.61632.564.5833.6432.584.58
295051-9505131.50931.53
15min1106028-10602835.14831.8614.5935.2331.9414.57
286199-8619928.57528.65
20min1114429-11442937.93337.541.5038.0737.661.53
2112038-11203837.14037.26
30min1232643-23264377.12076.581.0177.3276.771.02
2229363-22936376.03376.22
45min1231973-23197376.89874.754.0777.2375.074.07
2219020-21902072.60472.91
60min1162867-16286753.99054.310.8554.4554.760.81
2164827-16482754.63955.07
极限1277047-27704791.84091.580.4192.3992.120.43
2275466-27546691.31691.84
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