利伐沙班颗粒片项目信息
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400
标示量(mg)30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%
112.179701649722919697549698889690839702360.13
212.249689509712479700980.17
单位质量响应值RSD%判断
79723.5879256.370.42数据可信
供试品溶液-2023073011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%
5min1281767-28176726.47924.764.2926.4824.764.29
2257851-25785124.23224.23
3258144-25814424.25924.26
4264535-26453524.86024.86
5249089-24908923.40823.41
6269415-26941525.31825.32
10min1312178-31217829.33728.521.7229.3828.561.72
2301767-30176728.35928.40
3300465-30046528.23628.28
4304525-30452528.61828.66
5296859-29685927.89727.94
6305195-30519528.68128.72
15min1320073-32007330.07929.880.7330.1729.970.74
2317560-31756029.84329.93
3316623-31662329.75529.84
4321145-32114530.18030.27
5314797-31479729.58329.67
6317466-31746629.83429.92
20min1325338-32533830.57430.550.7330.7230.690.73
2326526-32652630.68530.82
3324323-32432330.47830.62
4328906-32890630.90931.05
5322434-32243430.30130.44
6323139-32313930.36730.51
30min1330738-33073831.08131.150.5431.2831.340.53
2332358-33235831.23331.42
3333174-33317431.31031.50
4333612-33361231.35131.54
5329360-32936030.95231.14
6329839-32983930.99731.19
45min1334868-33486831.46931.590.5631.7231.830.56
2337754-33775431.74031.98
3338378-33837831.79932.04
4337417-33741731.70931.95
5334342-33434231.42031.66
6334268-33426831.41331.65
60min1336939-33693931.66431.820.5331.9632.120.53
2340138-34013831.96432.26
3340472-34047231.99632.29
4339832-33983231.93632.23
5338041-33804131.76732.06
6336243-33624331.59831.89
极限1337940-33794031.75831.880.5932.1132.230.58
2341094-34109432.05432.40
3341208-34120832.06532.41
4340581-34058132.00632.36
5338166-33816631.77932.12
6336457-33645731.61931.97
利伐沙班颗粒片项目信息
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400
标示量(mg)30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%
112.179686119694619697009693619681179690500.07
212.249681439680189680800.01
单位质量响应值RSD%判断
79626.1379091.500.48数据可信
供试品溶液-2023073011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%
5min1261096-26109624.57725.142.7524.5825.142.75
2262486-26248624.70824.71
3264490-26449024.89724.90
4280308-28030826.38626.39
5270770-27077025.48825.49
6263104-26310424.76624.77
10min1297413-29741327.99628.161.0428.0428.201.05
2298560-29856028.10428.14
3298129-29812928.06328.10
4304948-30494828.70528.75
5300099-30009928.24828.29
6296074-29607427.87027.91
15min1312439-31243929.41029.420.4829.5029.500.48
2313467-31346729.50729.59
3311801-31180129.35029.44
4314006-31400629.55829.65
5313344-31334429.49529.58
6309940-30994029.17529.26
20min1319577-31957730.08230.080.3230.2230.220.32
2320084-32008430.13030.27
3319975-31997530.11930.26
4320074-32007430.12930.27
5320169-32016930.13830.28
6317603-31760329.89630.03
30min1329964-32996431.06030.940.5131.2531.130.52
2328990-32899030.96831.16
3329693-32969331.03431.22
4326390-32639030.72330.91
5330371-33037131.09831.29
6326926-32692630.77430.96
45min1335272-33527231.55931.430.6031.8031.670.60
2334192-33419231.45831.70
3335343-33534331.56631.81
4330786-33078631.13731.38
5335639-33563931.59431.83
6332106-33210631.26131.50
60min1337331-33733131.75331.620.7732.0431.920.77
2337372-33737231.75732.05
3337661-33766131.78432.08
4331652-33165231.21931.51
5337887-33788731.80532.10
6333842-33384231.42531.71
极限1338319-33831931.84631.710.6732.1932.050.66
2338054-33805431.82132.17
3338135-33813531.82932.17
4333078-33307831.35331.70
5338386-33838631.85232.20
6335136-33513631.54731.89
利伐沙班颗粒片项目信息
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400
标示量(mg)30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%
112.179694799696279671019690409663809683250.16
212.249699379687369693360.09
单位质量响应值RSD%判断
79566.5679194.120.34数据可信
供试品溶液-20210818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%
5min1258825-25882524.35724.153.2924.3624.153.29
2264129-26412924.85624.86
3248498-24849823.38523.38
4264440-26444024.88524.88
5244117-24411722.97222.97
6259783-25978324.44724.45
10min1306894-30689428.88028.671.6628.9228.701.66
2307970-30797028.98129.02
3305316-30531628.73228.77
4309391-30939129.11529.16
5295535-29553527.81127.85
6302557-30255728.47228.51
15min1326181-32618130.69530.511.2030.7830.601.20
2325218-32521830.60430.69
3326723-32672330.74630.83
4327859-32785930.85330.94
5317380-31738029.86729.95
6322124-32212430.31330.40
20min1335539-33553931.57631.431.1331.7231.571.13
2334124-33412431.44331.58
3337378-33737831.74931.89
4337871-33787131.79531.94
5329920-32992031.04731.18
6329003-32900330.96131.10
30min1345815-34581532.54332.430.9832.7432.620.98
2343741-34374132.34832.54
3348230-34823032.77032.96
4347917-34791732.74132.93
5342346-34234632.21632.40
6339647-33964731.96232.15
45min1351921-35192133.11733.060.8733.3633.310.87
2350465-35046532.98033.23
3354509-35450933.36133.61
4354232-35423233.33533.58
5350795-35079533.01133.25
6346209-34620932.58032.82
60min1354721-35472133.38133.310.9133.6833.610.91
2353382-35338233.25533.56
3356903-35690333.58633.89
4356268-35626833.52633.83
5354479-35447933.35833.65
6347954-34795432.74433.04
极限1356077-35607733.50833.420.8433.8733.780.84
2354101-35410133.32233.68
3357681-35768133.65934.02
4358398-35839833.72734.09
5354473-35447333.35733.71
6350222-35022232.95733.31
利伐沙班颗粒片项目信息
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400
标示量(mg)30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%
112.179671469668099684869686879685179679290.10
212.249720949741879731400.16
单位质量响应值RSD%判断
79534.0279504.900.03数据可信
供试品溶液-20210818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%
5min1260123-26012324.43624.332.3624.4424.332.36
2264413-26441324.83924.84
3253383-25338323.80323.80
4254198-25419823.87923.88
5254193-25419323.87923.88
6267838-26783825.16125.16
10min1305931-30593128.73928.661.6728.7828.701.66
2312432-31243229.35029.39
3301740-30174028.34528.38
4299405-29940528.12628.17
5301556-30155628.32828.37
6309371-30937129.06229.10
15min1322886-32288630.33230.341.1330.4230.431.13
2328199-32819930.83130.92
3319422-31942230.00630.09
4318525-31852529.92230.01
5323546-32354630.39430.48
6325350-32535030.56330.65
20min1332304-33230431.21631.290.8231.3631.430.82
2335677-33567731.53331.67
3330405-33040531.03831.17
4329616-32961630.96431.10
5335448-33544831.51231.65
6335273-33527331.49531.64
30min1340173-34017331.95632.140.6732.1532.330.67
2343245-34324532.24432.44
3340009-34000931.94032.13
4340498-34049831.98632.17
5345668-34566832.47232.66
6343307-34330732.25032.44
45min1346313-34631332.53232.770.7232.7833.020.72
2349887-34988732.86833.12
3347106-34710632.60732.85
4347309-34730932.62632.87
5353126-35312633.17233.42
6349300-34930032.81333.06
60min1349609-34960932.84233.080.6733.1433.370.67
2352773-35277333.13933.44
3350407-35040732.91733.21
4350529-35052932.92833.22
5355791-35579133.42333.72
6353547-35354733.21233.51
极限1351112-35111232.98333.190.6233.3433.550.61
2353293-35329333.18833.55
3351886-35188633.05633.41
4352213-35221333.08733.44
5357015-35701533.53833.89
6354652-35465233.31633.67
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