他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.582378382381972401232387622385662386970.37
212.582389702387672388680.07
单位质量响应值RSD%判断
18974.3218987.920.06数据可信
长期24月-供试品溶液-2022032201批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114618-11461848.27441.1720.8748.2741.1720.87
289236-8923637.58437.58
3128051-12805153.93253.93
481034-8103434.13034.13
574840-7484031.52131.52
698746-9874641.58941.59
10min1173162-17316272.93264.5714.6073.0364.6514.61
2137914-13791458.08658.16
3181866-18186676.59876.71
4146082-14608261.52661.59
5122089-12208951.42151.48
6158695-15869566.83966.92
15min1204755-20475586.23877.5311.7086.4877.7411.71
2170219-17021971.69271.88
3210970-21097088.85689.12
4175100-17510073.74873.94
5154574-15457465.10365.27
6188800-18880079.51879.73
20min1222488-22248893.70786.248.1694.1286.608.19
2195827-19582782.47882.81
3224464-22446494.53994.98
4196977-19697782.96283.30
5181414-18141476.40776.70
6207380-20738087.34487.72
30min1232192-23219297.79494.023.2498.4094.563.29
2216363-21636391.12791.63
3227905-22790595.98896.62
4225353-22535394.91395.42
5212973-21297389.69990.15
6224608-22460894.60095.15
45min1235222-23522299.07097.501.6999.8798.231.70
2224810-22481094.68595.37
3229749-22974996.76597.58
4235153-23515399.04199.74
5231414-23141497.46698.09
6232663-23266397.99298.73
极限1236538-23653899.624100.392.17100.62101.312.11
2232369-23236997.86898.74
3233423-23342398.31299.33
4242187-242187102.003102.90
5245610-245610103.445104.27
6239962-239962101.066102.00
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.582371222363512379542391612379252377030.45
212.582382562395652389100.39
单位质量响应值RSD%判断
18895.3118991.260.36数据可信
长期24月-供试品溶液-2022032201批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1104981-10498144.30438.6212.3344.3038.6212.33
2106517-10651744.95244.95
380263-8026333.87333.87
485196-8519635.95435.95
584636-8463635.71835.72
687506-8750636.92936.93
10min1165819-16581969.97964.967.9870.0765.047.99
2165694-16569469.92670.02
3138469-13846958.43758.50
4160698-16069867.81867.89
5152710-15271064.44764.52
6140225-14022559.17859.25
15min1201229-20122984.92379.226.5685.1579.426.56
2191439-19143980.79181.02
3173773-17377373.33673.52
4196903-19690383.09783.30
5191517-19151780.82481.02
6171394-17139472.33272.52
20min1214862-21486290.67687.154.8991.0787.514.89
2206331-20633187.07687.47
3194987-19498782.28882.62
4217612-21761291.83792.21
5211294-21129489.17089.53
6193889-19388981.82582.16
30min1231555-23155597.72195.143.7698.3095.683.76
2220323-22032392.98193.55
3217037-21703791.59492.09
4237017-237017100.026100.58
5229683-22968396.93197.47
6216971-21697191.56692.07
45min1228088-22808896.25898.432.1997.0399.162.15
2234918-23491899.14099.89
3236937-23693799.992100.67
4226249-22624995.48296.24
5239387-239387101.026101.76
6233868-23386898.69799.38
极限1234210-23421098.84199.831.1099.81100.761.10
2239112-239112100.910101.86
3237029-237029100.031100.91
4236463-23646399.792100.74
5239468-239468101.060102.00
6233011-23301198.33599.22
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.582379372388102391152382872389632386220.21
212.582410412399792405100.32
单位质量响应值RSD%判断
18968.3619118.440.56数据可信
长期24月-供试品溶液-2022032201批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106640-10664044.76846.0419.5844.7746.0419.58
2148319-14831962.26562.27
3109635-10963546.02546.03
4105070-10507044.10944.11
581912-8191234.38734.39
6106459-10645944.69244.69
10min1177358-17735874.45675.029.4974.5575.119.50
2205065-20506586.08786.21
3171625-17162572.04972.14
4163001-16300168.42968.52
5162690-16269068.29868.37
6192414-19241480.77680.87
15min1201034-20103484.39587.557.0084.6387.797.01
2231805-23180597.31397.61
3203048-20304885.24185.48
4192031-19203180.61680.84
5203163-20316385.28985.49
6220196-22019692.43992.69
20min1218310-21831091.64894.155.3992.0594.565.40
2242511-242511101.807102.30
3222289-22228993.31893.72
4206953-20695386.88087.27
5223729-22372993.92394.30
6231767-23176797.29797.73
30min1235589-23558998.90298.921.6599.4999.521.69
2242180-242180101.668102.36
3232730-23273097.70198.29
4231438-23143897.15997.72
5234114-23411498.28298.85
6237714-23771499.794100.42
45min1242274-242274101.708100.441.62102.50101.251.65
2244015-244015102.439103.34
3238091-23809199.952100.74
4233483-23348398.01798.77
5236860-23686099.435100.20
6240851-240851101.111101.94
极限1246198-246198103.355101.371.64104.35102.381.67
2244869-244869102.797103.90
3239575-239575100.575101.56
4235437-23543798.83899.79
5239892-239892100.708101.67
6242899-242899101.970103.00
他达拉非片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数625
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%
112.582424542413742426932421912408142419050.33
212.582381112387872384490.21
单位质量响应值RSD%判断
19229.3318954.611.02数据可信
长期24月-供试品溶液-2022032201批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1116197-11619748.65850.1413.4548.6650.1413.45
2108003-10800345.22745.23
3146537-14653761.36361.36
4128976-12897654.00954.01
5101415-10141542.46842.47
6117227-11722749.08949.09
10min1197423-19742382.67179.524.8182.7779.624.82
2183882-18388277.00177.09
3200395-20039583.91684.04
4194281-19428181.35681.46
5176223-17622373.79473.88
6187150-18715078.37078.47
15min1225438-22543894.40391.542.8694.6791.802.87
2217619-21761991.12991.37
3223123-22312393.43393.72
4221371-22137192.70092.97
5207991-20799187.09787.33
6216116-21611690.49990.75
20min1235566-23556698.64496.762.3399.1097.202.33
2234644-23464498.25898.68
3233839-23383997.92198.40
4232631-23263197.41597.87
5221464-22146492.73993.15
6228184-22818495.55395.99
30min1238139-23813999.72199.780.97100.37100.420.98
2240662-240662100.778101.40
3240462-240462100.694101.37
4239261-239261100.191100.84
5235859-23585998.76799.36
6235282-23528298.52599.15
45min1237512-23751299.459100.540.75100.31101.370.73
2242050-242050101.359102.18
3240954-240954100.900101.77
4240663-240663100.778101.63
5241066-241066100.947101.74
6238268-23826899.775100.60
极限1238695-23869599.954100.640.68101.00101.670.69
2241755-241755101.236102.26
3242890-242890101.711102.79
4239595-239595100.331101.38
5239549-239549100.312101.30
6239445-239445100.268101.29
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