利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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%
1 10.153233843238503244313234363230113236220.17
2 10.173250443262943256690.28
单位质量响应值RSD%判断
31883.9432022.520.31数据可信
供试品溶液-JPS7149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%
5min1133523-13352337.45836.755.3937.4636.755.39
2125025-12502535.07435.07
3137257-13725738.50638.51
4133753-13375337.52337.52
5136666-13666638.34038.34
6119701-11970133.58033.58
10min1179561-17956150.37349.842.3850.4449.902.39
2174568-17456848.97349.03
3183597-18359751.50651.57
4177750-17775049.86549.93
5179052-17905250.23150.29
6171432-17143248.09348.15
15min1200475-20047556.24155.742.0456.3955.892.04
2195896-19589654.95655.10
3204826-20482657.46157.61
4197002-19700255.26655.41
5200465-20046556.23856.39
6193512-19351254.28754.42
20min1215247-21524760.38559.582.0260.6259.822.02
2210433-21043359.03459.27
3218142-21814261.19761.44
4210092-21009258.93859.18
5214208-21420860.09360.33
6206254-20625457.86258.09
30min1231571-23157164.96464.432.0165.3064.762.01
2227740-22774063.88964.22
3236738-23673866.41466.76
4226662-22666263.58763.92
5231587-23158764.96965.31
6223712-22371262.75963.08
45min1245454-24545468.85968.691.8069.3169.131.81
2243468-24346868.30268.74
3252041-25204170.70771.17
4240948-24094867.59568.04
5247048-24704869.30669.76
6240064-24006467.34767.77
60min1254298-25429871.34071.331.6971.9071.891.69
2252950-25295070.96271.51
3261622-26162273.39473.97
4251115-25111570.44771.00
5256178-25617871.86772.43
6249509-24950969.99670.54
极限1261715-26171573.42173.311.6374.1073.991.63
2261038-26103873.23173.90
3268549-26854975.33876.04
4257274-25727472.17572.85
5262483-26248373.63674.32
6256896-25689672.06972.73
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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%
1 10.154803634813704814764808544814354811000.11
2 10.174833384816364824870.25
单位质量响应值RSD%判断
47399.0147442.180.07数据可信
供试品溶液-JPS7664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%
5min1161595-16159530.54732.264.3130.5532.264.31
2182947-18294734.58334.58
3167837-16783731.72731.73
4166866-16686631.54331.54
5170321-17032132.19632.20
6174459-17445932.97832.98
10min1214488-21448840.54541.512.1540.6041.562.15
2227866-22786643.07443.13
3217321-21732141.08141.13
4217009-21700941.02241.07
5219044-21904441.40641.46
6221740-22174041.91641.97
15min1237335-23733544.86445.501.6544.9845.621.66
2248037-24803746.88747.02
3238027-23802744.99545.12
4238809-23880945.14245.26
5239893-23989345.34745.47
6242023-24202345.75045.87
20min1252104-25210447.65648.031.5147.8548.231.51
2261477-26147749.42749.64
3251278-25127847.50047.70
4252010-25201047.63847.83
5252872-25287247.80148.00
6254795-25479548.16448.37
30min1267505-26750550.56750.961.2650.8451.241.26
2276097-27609752.19152.48
3266840-26684050.44150.72
4268972-26897250.84451.12
5268015-26801550.66350.94
6270098-27009851.05751.34
45min1282046-28204653.31653.470.9653.6753.840.97
2288262-28826254.49154.87
3280800-28080053.08053.44
4281753-28175353.26053.62
5282693-28269353.43853.80
6281698-28169853.25053.62
60min1288592-28859254.55354.880.8555.0055.330.86
2294073-29407355.58956.06
3287389-28738954.32654.77
4289799-28979954.78155.23
5292260-29226055.24655.70
6289665-28966554.75655.21
极限1295432-29543255.84655.710.6056.3856.250.60
2297719-29771956.27856.84
3292905-29290555.36855.91
4294806-29480655.72856.27
5293491-29349155.47956.02
6293780-29378055.53456.08
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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%
1 10.154805014810474800314795734799704802240.12
2 10.174823964826684825320.04
单位质量响应值RSD%判断
47312.7147446.610.20数据可信
供试品溶液-JPS7157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%
5min1173110-17311032.75233.353.2932.7533.343.29
2186437-18643735.27335.27
3175451-17545133.19533.19
4169620-16962032.09132.09
5178600-17860033.79033.79
6174266-17426632.97032.97
10min1217538-21753841.15741.782.2741.2141.842.27
2230482-23048243.60643.66
3220218-22021841.66441.72
4219828-21982841.59041.64
5220534-22053441.72441.78
6216408-21640840.94341.00
15min1241372-24137245.66646.242.2345.7946.362.23
2254649-25464948.17848.31
3243551-24355146.07946.20
4245675-24567546.48146.60
5241456-24145645.68245.81
6239678-23967845.34645.47
20min1255274-25527448.29748.882.0548.5049.082.05
2268490-26849050.79751.01
3256733-25673348.57348.77
4259197-25919749.03949.24
5256532-25653248.53548.74
6253762-25376248.01148.21
30min1271823-27182351.42851.931.8051.7152.221.80
2282927-28292753.52953.82
3275053-27505352.03952.32
4276700-27670052.35052.63
5271098-27109851.29151.57
6269374-26937450.96451.24
45min1283719-28371953.67854.181.5054.0454.551.51
2293777-29377755.58155.97
3284998-28499853.92054.29
4289014-28901454.68055.05
5284480-28448053.82254.19
6282221-28222153.39553.76
60min1291210-29121055.09655.431.4055.5555.891.41
2299831-29983156.72757.20
3292512-29251255.34255.80
4295551-29555155.91756.38
5289824-28982454.83355.29
6288847-28884754.64955.10
极限1295302-29530255.87056.211.2456.4256.761.25
2303772-30377257.47258.05
3295577-29557755.92256.47
4298709-29870956.51457.07
5295775-29577555.95956.51
6293440-29344055.51856.06
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所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%
1 10.154850454832634839964834684836124838770.15
2 10.174801544802134801840.01
单位质量响应值RSD%判断
47672.6147215.730.69数据可信
供试品溶液-2024112221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%
5min1164507-16450731.08230.795.0331.0830.795.03
2166244-16624431.41131.41
3176064-17606433.26633.27
4152686-15268628.84928.85
5161898-16189830.58930.59
6156386-15638629.54829.55
10min1232548-23254843.93843.583.5543.9943.633.55
2236805-23680544.74244.79
3240215-24021545.38745.44
4217328-21732841.06241.11
5231170-23117043.67843.73
6225733-22573342.65042.70
15min1260651-26065149.24849.042.3549.3749.162.36
2264783-26478350.02950.16
3266739-26673950.39850.53
4250517-25051747.33347.45
5259823-25982349.09249.22
6254674-25467448.11948.24
20min1275476-27547652.04952.081.5352.2652.291.54
2279272-27927252.76652.98
3281840-28184053.25153.47
4271999-27199951.39251.59
5274396-27439651.84552.05
6270987-27098751.20151.40
30min1293142-29314255.38755.301.1755.6855.591.17
2294393-29439355.62355.92
3297973-29797356.30056.60
4291068-29106854.99555.28
5291511-29151155.07955.37
6287909-28790954.39854.68
45min1303685-30368557.37957.560.9657.7757.950.97
2305629-30562957.74658.14
3309209-30920958.42358.82
4304971-30497157.62257.99
5304300-30430057.49557.88
6300203-30020356.72157.10
60min1309181-30918158.41758.760.9258.9059.240.93
2312536-31253659.05159.54
3315044-31504459.52560.02
4312349-31234959.01659.48
5309909-30990958.55559.03
6307031-30703158.01158.48
极限1313929-31392959.31459.490.7559.8960.070.75
2315552-31555259.62160.21
3318655-31865560.20760.80
4314888-31488859.49660.06
5314654-31465459.45160.03
6311464-31146458.84959.42
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