利伐沙班颗粒项目信息
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%
112.339769169766559765149761169756749763750.05
212.319793629795409794510.02
单位质量响应值RSD%判断
79186.9479565.480.34数据可信
供试品溶液-2024010511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%
5min1244791-24479123.03722.093.3223.0422.093.32
2224877-22487721.16321.16
3240725-24072522.65422.65
4238482-23848222.44322.44
5231743-23174321.80921.81
6227982-22798221.45521.46
10min1292957-29295727.57027.191.2127.6127.221.21
2282771-28277126.61126.65
3291132-29113227.39827.44
4289749-28974927.26827.31
5288646-28864627.16427.20
6288025-28802527.10627.14
15min1311607-31160729.32529.330.6529.4129.420.65
2308685-30868529.05029.13
3312275-31227529.38829.47
4310961-31096129.26429.35
5311801-31180129.34329.43
6314899-31489929.63529.72
20min1320822-32082230.19230.300.4930.3330.430.48
2321445-32144530.25130.38
3322003-32200330.30330.44
4321581-32158130.26430.40
5320842-32084230.19430.32
6324964-32496430.58230.71
30min1329168-32916830.97831.200.6831.1631.380.67
2333297-33329731.36631.54
3331939-33193931.23931.42
4330447-33044731.09831.28
5329484-32948431.00831.19
6334843-33484331.51231.69
45min1335791-33579131.60131.770.5331.8432.010.52
2339347-33934731.93632.17
3337945-33794531.80432.04
4337633-33763331.77432.01
5335346-33534631.55931.79
6339589-33958931.95832.19
60min1338977-33897731.90132.000.3732.1932.290.37
2341302-34130232.12032.40
3340934-34093432.08532.37
4340029-34002932.00032.29
5338196-33819631.82732.11
6341034-34103432.09432.38
极限1341118-34111832.10232.140.4732.4432.480.47
2343135-34313532.29232.63
3342531-34253132.23532.58
4341194-34119432.11032.45
5338786-33878631.88332.22
6342642-34264232.24632.59
利伐沙班颗粒项目信息
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%
112.339759149753909757089758439757229757150.03
212.319829259829019829130.01
单位质量响应值RSD%判断
79133.4179846.710.64数据可信
供试品溶液-2024010511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%
5min1251469-25146923.63222.672.6323.6322.672.63
2237504-23750422.32022.32
3241633-24163322.70822.71
4243223-24322322.85722.86
5232391-23239121.83921.84
6241165-24116522.66422.66
10min1296042-29604227.82127.091.6827.8627.131.69
2284912-28491226.77526.81
3288656-28865627.12727.16
4291712-29171227.41427.45
5283759-28375926.66726.70
6284659-28465926.75126.79
15min1313050-31305029.41929.061.1829.5029.141.18
2309610-30961029.09629.18
3310221-31022129.15329.24
4312489-31248929.36629.45
5306491-30649128.80328.88
6303573-30357328.52928.61
20min1322636-32263630.32030.090.7830.4530.220.77
2321609-32160930.22330.35
3320251-32025130.09630.23
4322077-32207730.26730.40
5318558-31855829.93730.07
6316154-31615429.71129.84
30min1331406-33140631.14431.100.9931.3331.280.99
2333593-33359331.35031.53
3330739-33073931.08131.26
4335150-33515031.49631.68
5327899-32789930.81530.99
6326578-32657830.69030.87
45min1336628-33662831.63531.690.7631.8731.920.76
2339978-33997831.95032.18
3337796-33779631.74531.98
4340161-34016131.96732.20
5334770-33477031.46031.69
6334109-33410931.39831.63
60min1339811-33981131.93432.000.7732.2232.290.78
2343307-34330732.26332.55
3341558-34155832.09832.38
4343276-34327632.26032.55
5338175-33817531.78032.06
6337091-33709131.67831.96
极限1342403-34240332.17832.130.9032.5232.460.89
2344898-34489832.41232.75
3343412-34341232.27232.61
4344257-34425732.35232.69
5337777-33777731.74332.08
6338336-33833631.79532.13
利伐沙班颗粒项目信息
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%
112.339792889785079787699790399789049789010.03
212.319962739961789962260.01
单位质量响应值RSD%判断
79391.8180928.191.36数据可信
供试品溶液-2024010611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%
5min1247838-24783823.09821.982.6323.1021.982.63
2231896-23189621.61221.61
3236540-23654022.04522.04
4233786-23378621.78821.79
5230783-23078321.50821.51
6234473-23447321.85221.85
10min1290557-29055727.07926.321.6127.1226.361.62
2279622-27962226.06026.10
3279618-27961826.06026.10
4278852-27885225.98826.02
5284936-28493626.55526.59
6280873-28087326.17726.21
15min1306894-30689428.60228.041.3328.6928.121.33
2300187-30018727.97728.06
3296975-29697527.67727.76
4297700-29770027.74527.82
5304455-30445528.37428.45
6298726-29872627.84027.92
20min1314307-31430729.29328.891.0529.4229.021.04
2309480-30948028.84328.97
3306559-30655928.57028.70
4307326-30732628.64228.77
5313640-31364029.23029.36
6308873-30887328.78628.91
30min1322256-32225630.03329.700.9130.2129.880.91
2318669-31866929.69929.87
3316282-31628229.47729.65
4316604-31660429.50729.68
5322197-32219730.02830.20
6316125-31612529.46229.64
45min1328145-32814530.58230.300.7330.8130.520.73
2324671-32467130.25830.48
3323589-32358930.15830.38
4323204-32320430.12230.34
5327986-32798630.56730.79
6323031-32303130.10630.33
60min1330896-33089630.83930.540.7231.1230.820.72
2327488-32748830.52130.80
3326232-32623230.40430.68
4326281-32628130.40830.68
5330285-33028530.78231.06
6325207-32520730.30830.58
极限1331860-33186030.92830.650.7731.2630.970.77
2327953-32795330.56430.89
3327366-32736630.51030.83
4329870-32987030.74331.07
5330976-33097630.84631.17
6325052-32505230.29430.62
利伐沙班颗粒项目信息
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%
112.339805439810339807669806989802779806630.03
212.319762649761599762120.01
单位质量响应值RSD%判断
79534.7179302.360.21数据可信
供试品溶液-2024010611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%
5min1220890-22089020.77721.412.0120.7821.412.01
2232122-23212221.83321.83
3230631-23063121.69321.69
4226485-22648521.30321.30
5224145-22414521.08321.08
6231682-23168221.79221.79
10min1275271-27527125.89226.030.7425.9326.060.74
2277563-27756326.10726.14
3279432-27943226.28326.32
4277715-27771526.12226.16
5273606-27360625.73525.77
6276786-27678626.03426.07
15min1297276-29727627.96128.020.5628.0428.100.55
2296967-29696727.93228.01
3300368-30036828.25228.33
4299542-29954228.17528.25
5296406-29640627.88027.96
6296755-29675527.91227.99
20min1307311-30731128.90528.980.7829.0329.100.78
2306467-30646728.82628.95
3310916-31091629.24429.37
4311068-31106829.25929.38
5307582-30758228.93129.06
6305178-30517828.70528.83
30min1318558-31855829.96329.920.8730.1430.100.87
2315635-31563529.68829.86
3320200-32020030.11830.29
4320876-32087630.18130.36
5319588-31958830.06030.23
6313909-31390929.52629.70
45min1324391-32439130.51230.490.8730.7330.710.87
2321607-32160730.25030.47
3326348-32634830.69630.92
4325804-32580430.64530.87
5326788-32678830.73730.96
6319905-31990530.09030.31
60min1326815-32681530.74030.720.7431.0131.000.74
2324518-32451830.52430.80
3328711-32871130.91831.20
4327209-32720930.77731.05
5329295-32929530.97331.25
6323040-32304030.38530.66
极限1327963-32796330.84830.800.8631.1731.120.86
2325091-32509130.57830.90
3329751-32975131.01631.34
4328593-32859330.90731.23
5330264-33026431.06431.39
6323059-32305930.38730.71
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