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)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%
1 15.199755239754539757949754469747339753900.05
2 15.239758399758089758240.01
单位质量响应值RSD%判断
64212.6464072.490.16数据可信
供试品溶液-2024122521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%
5min1176565-17656516.45017.032.9216.4517.032.92
2177734-17773416.55916.56
3181492-18149216.90916.91
4190633-19063317.76117.76
5184181-18418117.16017.16
6186379-18637917.36417.36
10min1253758-25375823.64224.090.9823.6724.120.99
2258810-25881024.11324.14
3259078-25907824.13824.17
4261222-26122224.33724.37
5258610-25861024.09424.12
6259781-25978124.20324.23
15min1290632-29063227.07727.090.5727.1427.150.57
2292429-29242927.24527.31
3291855-29185527.19127.26
4290978-29097827.11027.18
5287719-28771926.80626.87
6290796-29079627.09327.16
20min1308059-30805928.70128.690.5428.8128.800.54
2309014-30901428.79028.90
3310377-31037728.91729.03
4306825-30682528.58628.70
5305628-30562828.47528.59
6307865-30786528.68328.80
30min1327463-32746330.50930.390.6030.6730.550.59
2326351-32635130.40530.57
3329093-32909330.66130.82
4325878-32587830.36130.52
5323911-32391130.17830.34
6324288-32428830.21330.38
45min1341303-34130331.79831.750.5532.0131.960.55
2342048-34204831.86832.08
3343533-34353332.00632.22
4339192-33919231.60231.82
5339411-33941131.62231.83
6338943-33894331.57831.79
60min1348974-34897432.51332.420.7632.7832.680.75
2351017-35101732.70332.97
3350596-35059632.66432.93
4345299-34529932.17132.44
5345101-34510132.15232.42
6346653-34665332.29732.56
极限1353547-35354732.93932.790.7633.2633.110.76
2355130-35513033.08733.41
3354199-35419933.00033.32
4348654-34865432.48332.80
5350508-35050832.65632.97
6349768-34976832.58732.91
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)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%
1 15.199767579784169780559790029781659780790.09
2 15.239708789700649704710.06
单位质量响应值RSD%判断
64389.6663721.010.74数据可信
供试品溶液-t3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%
5min1181682-18168216.95015.783.9416.9515.783.94
2170293-17029315.88815.89
3167706-16770615.64615.65
4167232-16723215.60215.60
5163658-16365815.26915.27
6163935-16393515.29515.29
10min1259697-25969724.22923.681.2424.2623.711.24
2254745-25474523.76723.79
3253443-25344323.64523.67
4251586-25158623.47223.50
5252434-25243423.55123.58
6251290-25129023.44523.47
15min1290349-29034927.08926.830.6927.1626.900.69
2288720-28872026.93727.00
3287387-28738726.81226.88
4287359-28735926.81026.87
5287356-28735626.80926.87
6284403-28440326.53426.60
20min1307929-30792928.72928.570.6328.8428.680.62
2306479-30647928.59428.70
3305327-30532728.48628.60
4308758-30875828.80628.92
5305531-30553128.50528.61
6303508-30350828.31628.43
30min1328817-32881730.67830.440.6530.8430.600.65
2327899-32789930.59230.75
3325622-32562230.38030.54
4327376-32737630.54330.70
5323405-32340530.17330.33
6324560-32456030.28030.44
45min1343720-34372032.06831.890.4832.2832.100.48
2341910-34191031.89932.11
3341544-34154431.86532.07
4343456-34345632.04332.25
5339773-33977331.70031.91
6340193-34019331.73931.95
60min1350969-35096932.74432.600.5833.0132.860.59
2350467-35046732.69732.96
3349405-34940532.59832.86
4351417-35141732.78633.05
5348572-34857232.52132.78
6345903-34590332.27232.53
极限1355721-35572133.18832.970.6433.5133.280.64
2355007-35500733.12133.44
3353819-35381933.01033.33
4354267-35426733.05233.37
5350041-35004132.65832.97
6351195-35119532.76533.08
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)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%
1 15.199771519796159811139804969792489795250.16
2 15.239706679718939712800.09
单位质量响应值RSD%判断
64484.8663774.130.79数据可信
供试品溶液-2024122621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%
5min1206364-20636419.23118.793.0919.2318.793.09
2203514-20351418.96518.97
3203147-20314718.93118.93
4200766-20076618.70918.71
5206149-20614919.21119.21
6189654-18965417.67417.67
10min1266733-26673324.85724.570.9724.8924.600.98
2264327-26432724.63224.66
3263718-26371824.57624.61
4260325-26032524.26024.29
5265925-26592524.78124.81
6261129-26112924.33424.36
15min1294697-29469727.46327.270.6727.5427.340.67
2293403-29340327.34227.41
3294252-29425227.42127.49
4290365-29036527.05927.13
5292813-29281327.28727.36
6290186-29018627.04227.11
20min1310948-31094828.97728.810.5129.1028.930.51
2310609-31060928.94529.06
3309290-30929028.82328.94
4307805-30780528.68428.80
5309325-30932528.82628.94
6306914-30691428.60128.72
30min1329735-32973530.72830.500.6430.9030.670.65
2327306-32730630.50130.67
3329033-32903330.66230.83
4327833-32783330.55130.72
5325529-32552930.33630.50
6324219-32421930.21430.38
45min1342134-34213431.88331.770.4732.1031.990.47
2340916-34091631.77031.99
3342856-34285631.95132.17
4341575-34157531.83132.05
5339132-33913231.60331.82
6339057-33905731.59631.81
60min1348896-34889632.51332.430.4332.7932.700.44
2346112-34611232.25432.52
3349378-34937832.55832.83
4349719-34971932.59032.86
5347273-34727332.36232.63
6346858-34685832.32332.59
极限1353328-35332832.92632.770.3033.2533.100.29
2350594-35059432.67233.00
3351748-35174832.77933.10
4352229-35222932.82433.15
5351531-35153132.75933.08
6350635-35063532.67533.00
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)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%
1 15.199770019772939731449733679736409748890.22
2 15.239696889693649695260.03
单位质量响应值RSD%判断
64179.6663658.960.58数据可信
供试品溶液-t3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%
5min1189542-18954217.72117.771.8817.7217.771.88
2193218-19321818.06518.06
3194814-19481418.21418.21
4190525-19052517.81317.81
5186371-18637117.42517.42
6185935-18593517.38417.38
10min1263239-26323924.61124.620.8024.6424.650.79
2265301-26530124.80424.83
3264692-26469224.74724.78
4265066-26506624.78224.81
5261752-26175224.47224.50
6260097-26009724.31824.35
15min1295558-29555827.63327.511.0327.7027.581.03
2298530-29853027.91127.98
3296265-29626527.69927.77
4292023-29202327.30327.37
5290664-29066427.17527.25
6292313-29231327.33027.40
20min1314075-31407529.36429.160.7029.4829.280.71
2313788-31378829.33729.46
3313823-31382329.34129.46
4310328-31032829.01429.13
5309956-30995628.97929.09
6309563-30956328.94229.06
30min1332264-33226431.06530.910.7831.2331.070.79
2333824-33382431.21131.38
3331642-33164231.00731.17
4330570-33057030.90631.07
5327622-32762230.63130.79
6327451-32745130.61530.78
45min1346666-34666632.41132.190.6932.6332.400.69
2346858-34685832.42932.65
3345460-34546032.29932.52
4342848-34284832.05432.27
5341737-34173731.95132.16
6341986-34198631.97432.19
60min1352078-35207832.91732.890.5033.1933.160.51
2354396-35439633.13433.41
3353217-35321733.02433.30
4350443-35044332.76433.03
5350226-35022632.74433.01
6350422-35042232.76333.03
极限1359079-35907933.57233.370.9333.9033.690.93
2359997-35999733.65833.99
3358003-35800333.47133.80
4354813-35481333.17333.50
5358241-35824133.49433.82
6351172-35117232.83333.15
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