利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.134814414812974814424816204814784814560.03
212.074808794805954807370.05
单位质量响应值RSD%判断
39691.3439829.080.25数据可信
加速6月-供试品溶液-2024010711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%
5min1138904-13890426.09727.564.1626.1027.564.15
2142666-14266626.80426.80
3155674-15567429.24829.25
4150794-15079428.33128.33
5143792-14379227.01527.02
6148314-14831427.86527.86
10min1200578-20057837.68438.241.7537.7438.301.75
2199839-19983937.54537.60
3209530-20953039.36639.43
4203072-20307238.15338.22
5205443-20544338.59838.66
6202628-20262838.06938.13
15min1226344-22634442.52543.121.4142.6743.261.41
2226837-22683742.61742.76
3234756-23475644.10544.26
4229009-22900943.02543.17
5231778-23177843.54643.69
6228191-22819142.87243.02
20min1241511-24151145.37445.921.1745.6146.171.18
2242316-24231645.52645.76
3248878-24887846.75847.01
4244037-24403745.84946.09
5246861-24686146.37946.62
6243053-24305345.66445.91
30min1259611-25961148.77549.210.9349.1149.560.94
2260440-26044048.93149.27
3266053-26605349.98550.34
4261912-26191249.20749.55
5263412-26341249.48949.83
6260248-26024848.89549.24
45min1273318-27331851.35051.740.7551.8052.190.75
2274708-27470851.61152.06
3278904-27890452.40052.87
4275969-27596951.84852.30
5275721-27572151.80252.26
6273597-27359751.40351.85
60min1279467-27946752.50552.980.7253.0653.550.73
2281681-28168152.92153.48
3285568-28556853.65254.23
4282332-28233253.04453.61
5281983-28198352.97853.55
6281043-28104352.80153.37
极限1285540-28554053.64654.000.7254.3254.680.73
2287410-28741053.99854.68
3291281-29128154.72555.43
4287452-28745254.00654.69
5286698-28669853.86454.55
6285999-28599953.73354.42
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.134809264813164807894811384805954809530.06
212.074800224798584799400.03
单位质量响应值RSD%判断
39649.8839763.050.21数据可信
加速6月-供试品溶液-2024010811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%
5min1152257-15225728.64429.773.9928.6429.774.00
2156052-15605229.35829.36
3158593-15859329.83629.84
4162502-16250230.57230.57
5168165-16816531.63731.64
6151780-15178028.55528.55
10min1207899-20789939.11239.721.8539.1839.791.85
2207794-20779439.09239.16
3209706-20970639.45239.52
4213397-21339740.14740.21
5217910-21791040.99641.07
6210094-21009439.52539.59
15min1235376-23537644.28244.431.2944.4344.591.29
2233256-23325643.88344.03
3233194-23319443.87144.02
4237117-23711744.60944.77
5241332-24133245.40245.56
6236857-23685744.56044.71
20min1249970-24997047.02747.151.0847.2847.411.09
2247973-24797346.65146.90
3247872-24787246.63246.88
4251426-25142647.30147.56
5255073-25507347.98748.25
6251570-25157047.32847.58
30min1266918-26691850.21650.380.8950.5750.740.90
2265799-26579950.00550.36
3264789-26478949.81550.17
4268317-26831750.47950.84
5270656-27065650.91951.29
6270236-27023650.84051.20
45min1279871-27987152.65252.670.6353.1253.140.63
2278041-27804152.30852.77
3277912-27791252.28452.75
4280973-28097352.86053.33
5282396-28239653.12753.61
6280503-28050352.77153.24
60min1284157-28415753.45953.740.6354.0454.330.64
2284226-28422653.47254.05
3284093-28409353.44754.03
4286407-28640753.88254.47
5288396-28839654.25654.86
6286659-28665953.92954.52
极限1289553-28955354.47454.700.4955.1755.410.50
2289660-28966054.49455.19
3289880-28988054.53555.24
4291684-29168454.87555.59
5293132-29313255.14755.87
6290625-29062554.67655.38
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.134801684798554799964797564796334798820.05
212.074799914798604799260.02
单位质量响应值RSD%判断
39561.5839761.890.36数据可信
加速6月-供试品溶液-2024010911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%
5min1145081-14508127.32527.765.3227.3327.765.32
2140456-14045626.45426.45
3154602-15460229.11829.12
4149277-14927728.11528.12
5157368-15736829.63929.64
6137489-13748925.89525.90
10min1205852-20585238.77138.432.4338.8338.502.43
2199917-19991737.65337.71
3207340-20734039.05139.12
4203322-20332238.29438.36
5210702-21070239.68439.75
6197253-19725337.15137.21
15min1234946-23494644.25143.851.4244.4044.001.42
2230774-23077443.46543.61
3234388-23438844.14644.30
4231072-23107243.52143.67
5237274-23727444.68944.84
6228335-22833543.00643.15
20min1251211-25121147.31447.110.9547.5647.360.95
2249109-24910946.91847.16
3251392-25139247.34847.60
4248350-24835046.77547.02
5253581-25358147.76048.01
6247151-24715146.54946.79
30min1268492-26849250.56950.520.6550.9250.870.66
2268487-26848750.56850.91
3268667-26866750.60250.96
4266217-26621750.14050.49
5270995-27099551.04051.40
6266499-26649950.19350.53
45min1280776-28077652.88252.920.4953.3553.380.50
2280948-28094852.91553.37
3281038-28103852.93253.40
4279932-27993252.72353.18
5283506-28350653.39753.87
6279648-27964852.67053.12
60min1287615-28761554.17154.110.4054.7554.690.41
2287708-28770854.18854.76
3287159-28715954.08554.67
4285695-28569553.80954.39
5289067-28906754.44455.04
6286597-28659753.97954.55
极限1291448-29144854.89254.970.2855.5955.670.29
2292218-29221855.03755.73
3292046-29204655.00555.71
4291029-29102954.81455.51
5293230-29323055.22855.94
6291211-29121154.84855.54
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.134788784788524785504784334783114786050.06
212.074784334784484784400.01
单位质量响应值RSD%判断
39456.3139638.770.33数据可信
长期6月-供试品溶液-2024010711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%
5min1151960-15196028.70328.122.6828.7028.122.68
2147328-14732827.82827.83
3142365-14236526.89126.89
4149931-14993128.32028.32
5147942-14794227.94427.94
6153677-15367729.02829.03
10min1208376-20837639.36038.122.3239.4238.182.31
2199860-19986037.75137.81
3195468-19546836.92136.98
4202917-20291738.32938.39
5198972-19897237.58337.65
6205358-20535838.79038.85
15min1228536-22853643.16842.651.4943.3242.801.50
2225263-22526342.54942.70
3220358-22035841.62341.76
4226924-22692442.86343.01
5224131-22413142.33642.48
6229671-22967143.38243.53
20min1241812-24181245.67545.381.5045.9245.621.49
2239005-23900545.14545.39
3234435-23443544.28244.52
4241060-24106045.53345.78
5239852-23985245.30545.54
6245313-24531346.33746.58
30min1260057-26005749.12248.631.2649.4748.981.26
2256156-25615648.38548.73
3252082-25208247.61547.95
4257993-25799348.73249.08
5257177-25717748.57848.92
6261270-26127049.35149.70
45min1272971-27297151.56151.031.0652.0251.481.06
2267894-26789450.60251.05
3265932-26593250.23150.67
4270578-27057851.10951.56
5270291-27029151.05551.50
6273250-27325051.61452.07
60min1278828-27882852.66752.270.8553.2452.840.86
2274917-27491751.92852.49
3272994-27299451.56552.12
4277241-27724152.36752.93
5277538-27753852.42352.99
6278975-27897552.69553.27
极限1283414-28341453.53353.300.7654.2253.980.76
2280607-28060753.00353.68
3278706-27870652.64453.31
4282685-28268553.39654.08
5283162-28316253.48654.16
6284502-28450253.73954.43
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