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1000
标示量(mg)10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%
110.413303993309003307513302803305533305770.08
210.483310953308603309780.06
单位质量响应值RSD%判断
31755.7231581.870.39数据可信
供试品溶液-2024010511批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101312-10131228.67730.507.0628.6830.507.05
296413-9641327.29027.29
3107297-10729730.37130.37
4113207-11320732.04432.04
5112325-11232531.79431.79
6115995-11599532.83332.83
10min1137416-13741638.89740.575.1938.9640.645.20
2138517-13851739.20839.27
3135717-13571738.41638.48
4154090-15409043.61643.69
5144388-14438840.87040.94
6149929-14992942.43842.51
15min1164485-16448546.55947.823.5846.7147.983.58
2163403-16340346.25246.40
3165475-16547546.83946.99
4178231-17823150.44950.62
5167534-16753447.42247.58
6174545-17454549.40649.57
20min1183205-18320551.85752.352.5652.1152.622.57
2178235-17823550.45150.70
3182367-18236751.62051.88
4191488-19148854.20254.48
5185834-18583452.60252.87
6188575-18857553.37753.65
30min1200357-20035756.71257.112.1057.0857.492.11
2196893-19689355.73256.09
3197962-19796256.03456.41
4208220-20822058.93859.34
5202883-20288357.42757.81
6204205-20420557.80258.20
45min1212288-21228860.09061.262.4360.5861.772.43
2212338-21233860.10460.59
3211405-21140559.84060.34
4223704-22370463.32163.85
5217444-21744461.54962.06
6221370-22137062.66063.18
60min1221395-22139562.66763.852.2363.3064.502.24
2220925-22092562.53463.15
3220725-22072562.47863.11
4230720-23072065.30765.98
5229948-22994865.08865.74
6229750-22975065.03265.70
极限1230101-23010165.13266.021.9865.9066.811.99
2228380-22838064.64565.40
3228800-22880064.76365.53
4237634-23763467.26468.08
5237699-23769967.28268.08
6236897-23689767.05567.86
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1000
标示量(mg)10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%
110.413306183310293307383309833303953307530.08
210.483319033319693319360.02
单位质量响应值RSD%判断
31772.6231673.280.23数据可信
供试品溶液-2024010511批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106706-10670630.15232.124.5030.1532.124.50
2111928-11192831.62831.63
3109613-10961330.97430.97
4119870-11987033.87233.87
5115863-11586332.74032.74
6118042-11804233.35533.36
10min1151322-15132242.75943.271.7542.8343.341.76
2150445-15044542.51242.58
3150574-15057442.54842.62
4156498-15649844.22244.30
5154381-15438143.62443.70
6155545-15554543.95344.03
15min1173092-17309248.91149.411.5649.0749.581.57
2171961-17196148.59148.76
3172205-17220548.66048.82
4176869-17686949.97850.15
5177437-17743750.13950.31
6177631-17763150.19450.37
20min1185719-18571952.47952.800.9852.7553.080.99
2184691-18469152.18952.46
3185215-18521552.33752.61
4188277-18827753.20253.49
5188824-18882453.35653.64
6188326-18832653.21653.50
30min1203780-20378057.58357.951.0057.9758.341.01
2202890-20289057.33157.72
3203087-20308757.38757.77
4206751-20675158.42258.82
5207531-20753158.64259.04
6206393-20639358.32158.72
45min1219073-21907361.90462.080.9562.4262.600.96
2216688-21668861.23061.75
3218200-21820061.65762.17
4221132-22113262.48663.02
5222316-22231662.82063.35
6220756-22075662.37962.91
60min1227098-22709864.17264.360.8164.8265.020.81
2225702-22570263.77764.43
3226121-22612163.89564.55
4228332-22833264.52065.19
5230594-23059465.15965.83
6228773-22877364.64565.31
极限1234932-23493266.38566.681.0467.1867.491.04
2233232-23323265.90566.70
3233857-23385766.08166.88
4236627-23662766.86467.68
5239703-23970367.73368.55
6237567-23756767.13067.94
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1000
标示量(mg)10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%
110.413310623311413313363318253319923314710.13
210.483305843304633305240.03
单位质量响应值RSD%判断
31841.5931538.550.68数据可信
供试品溶液-2024010611批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199437-9943728.12828.6711.4728.1328.6711.46
2105253-10525329.77329.77
379029-7902922.35522.36
4105399-10539929.81429.81
5111586-11158631.56431.56
6107426-10742630.38830.39
10min1146478-14647841.43441.903.8141.5041.963.82
2149214-14921442.20842.27
3137992-13799239.03439.08
4149333-14933342.24242.31
5154573-15457343.72443.79
6151171-15117142.76242.83
15min1145074-14507441.03746.757.1041.1946.917.08
2173532-17353249.08749.25
3163208-16320846.16746.30
4173054-17305448.95249.11
5176339-17633949.88150.05
6160445-16044545.38545.55
20min1178664-17866450.53952.682.2550.7852.942.27
2187816-18781653.12853.40
3184745-18474552.25952.50
4187110-18711052.92853.20
5190775-19077553.96554.24
6188260-18826053.25353.52
30min1197712-19771255.92757.741.7356.2958.121.74
2205528-20552858.13858.53
3202765-20276557.35657.71
4204835-20483557.94258.33
5207487-20748758.69259.09
6206337-20633758.36758.75
45min1213774-21377460.47062.231.7560.9562.741.76
2221127-22112762.55063.07
3217217-21721761.44461.93
4221401-22140162.62863.14
5224413-22441363.48064.01
6222088-22208862.82263.33
60min1222624-22262462.97464.581.3563.5965.221.37
2229571-22957164.93965.59
3227133-22713364.24964.87
4229419-22941964.89665.55
5231273-23127365.42066.09
6229701-22970164.97665.63
极限1231286-23128665.42466.561.0866.1867.341.11
2236473-23647366.89167.69
3233239-23323965.97766.74
4236049-23604966.77167.57
5238238-23823867.39168.21
6236450-23645066.88567.68
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1000
标示量(mg)10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%
110.413314493322253320853321203320763319910.10
210.483352183351613351900.02
单位质量响应值RSD%判断
31891.5531983.780.21数据可信
供试品溶液-2024010611批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108005-10800530.31431.512.3730.3131.512.37
2115647-11564732.45932.46
3110614-11061431.04631.05
4112401-11240131.54831.55
5113493-11349331.85431.85
6113455-11345531.84431.84
10min1148211-14821141.59942.862.0741.6742.932.07
2152982-15298242.93843.01
3149612-14961241.99242.06
4156360-15636043.88643.96
5154551-15455143.37843.45
6154423-15442343.34243.41
15min1168720-16872047.35548.712.1647.5148.872.16
2171869-17186948.23948.41
3170587-17058747.87948.04
4178336-17833650.05450.22
5176706-17670649.59649.76
6175024-17502449.12449.29
20min1182440-18244051.20652.662.2151.4752.932.21
2186265-18626552.27952.55
3184111-18411151.67551.94
4193664-19366454.35654.63
5190209-19020953.38653.66
6188943-18894353.03153.31
30min1199714-19971456.05457.411.9156.4357.801.91
2204045-20404557.27057.66
3200742-20074256.34356.73
4210158-21015858.98659.39
5206360-20636057.92058.32
6206312-20631257.90658.30
45min1215469-21546960.47661.751.6460.9862.271.64
2219103-21910361.49662.01
3216670-21667060.81361.32
4224963-22496363.14163.67
5221516-22151662.17362.70
6222301-22230162.39462.92
60min1224422-22442262.98964.251.5663.6364.901.56
2226863-22686363.67464.33
3226452-22645263.55964.20
4233631-23363165.57466.24
5231860-23186065.07765.74
6230177-23017764.60465.27
极限1233396-23339665.50866.441.4866.2967.241.48
2234745-23474565.88666.68
3233534-23353465.54766.33
4242371-24237168.02768.84
5237822-23782266.75067.56
6238452-23845266.92767.73
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