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%
112.339952469959099960559962779965279960030.05
212.319973939975429974680.02
单位质量响应值RSD%判断
80778.8381029.080.22数据可信
供试品溶液-2024010612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%
5min1245654-24565422.68222.571.4422.6822.561.45
2247726-24772622.87322.87
3246611-24661122.77022.77
4244678-24467822.59222.59
5244022-24402222.53122.53
6237769-23776921.95421.95
10min1290354-29035426.80926.761.0726.8526.801.07
2292201-29220126.97927.02
3292080-29208026.96827.01
4288140-28814026.60526.64
5291907-29190726.95226.99
6284423-28442326.26126.30
15min1307410-30741028.38428.330.9928.4728.420.99
2309529-30952928.57928.66
3308915-30891528.52328.61
4305195-30519528.17928.26
5308524-30852428.48728.57
6301552-30155227.84327.92
20min1315799-31579929.15829.120.9029.2929.250.91
2317983-31798329.36029.49
3317152-31715229.28329.41
4314319-31431929.02229.15
5317051-31705129.27429.40
6310263-31026328.64728.77
30min1321606-32160629.69529.820.8129.8730.000.81
2326570-32657030.15330.33
3323861-32386129.90330.08
4322666-32266629.79229.97
5324296-32429629.94330.12
6318950-31895029.44929.62
45min1327291-32729130.21930.310.6330.4530.540.64
2330955-33095530.55830.79
3329105-32910530.38730.62
4326836-32683630.17730.40
5330129-33012930.48130.71
6325627-32562730.06630.29
60min1328773-32877330.35630.530.8030.6330.800.80
2334368-33436830.87331.15
3330744-33074430.53830.82
4328979-32897930.37530.65
5333156-33315630.76131.04
6327841-32784130.27030.54
极限1331462-33146230.60530.680.7030.9331.010.71
2335129-33512930.94331.28
3333673-33367330.80931.14
4330191-33019130.48730.82
5333951-33395130.83431.17
6329324-32932430.40730.73
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%
112.339984419980829979459978089971939978940.05
212.319977299979519978400.02
单位质量响应值RSD%判断
80932.2081059.300.12数据可信
供试品溶液-2024010612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%
5min1245240-24524022.61822.982.2222.6222.982.22
2248490-24849022.91822.92
3255250-25525023.54123.54
4256381-25638123.64523.65
5246620-24662022.74522.75
6242791-24279122.39222.39
10min1288579-28857926.61526.901.7726.6526.941.78
2296305-29630527.32727.37
3296218-29621827.31927.36
4296542-29654227.34927.39
5286524-28652426.42526.46
6286083-28608326.38526.42
15min1309084-30908428.50628.651.4828.5928.731.48
2317385-31738529.27229.36
3313065-31306528.87328.96
4312089-31208928.78328.87
5304349-30434928.06928.15
6307601-30760128.36928.45
20min1319482-31948229.46529.581.4429.5929.701.45
2327941-32794130.24530.38
3321993-32199329.69629.83
4321763-32176329.67529.81
5313856-31385628.94629.07
6319061-31906129.42629.55
30min1330801-33080130.50930.501.2330.6930.681.23
2337165-33716531.09631.28
3331753-33175330.59730.78
4330122-33012230.44630.63
5324568-32456829.93430.11
6329834-32983430.42030.60
45min1336558-33655831.04031.071.0431.2731.301.04
2342194-34219431.56031.79
3338287-33828731.19931.43
4336315-33631531.01731.25
5331360-33136030.56030.79
6336857-33685731.06731.30
60min1340253-34025331.38131.370.9731.6631.650.97
2344963-34496331.81532.10
3341118-34111831.46031.75
4338982-33898231.26331.55
5334812-33481230.87931.16
6340554-34055431.40831.69
极限1340932-34093231.44331.440.8731.7831.780.86
2344832-34483231.80332.14
3342364-34236431.57531.91
4340123-34012331.36931.71
5335909-33590930.98031.31
6341226-34122631.47031.80
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%
112.331001394100166710012261002103100096010014700.05
212.311020375102017610202760.02
单位质量响应值RSD%判断
81222.2282881.881.44数据可信
供试品溶液-2024010911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%
5min1261309-26130923.79224.072.4023.7924.072.39
2255004-25500423.21823.22
3271050-27105024.67924.68
4261454-26145423.80523.81
5266277-26627724.24424.24
6271182-27118224.69124.69
10min1296975-29697527.03927.060.9927.0827.100.99
2293095-29309526.68626.72
3301828-30182827.48127.52
4295764-29576426.92926.97
5296875-29687527.03027.07
6298668-29866827.19327.23
15min1311031-31103128.31928.360.5928.4028.450.59
2309925-30992528.21828.30
3314233-31423328.61128.70
4313229-31322928.51928.60
5309741-30974128.20228.29
6310874-31087428.30528.39
20min1318633-31863329.01128.970.4729.1429.100.46
2318884-31888429.03429.16
3320156-32015629.15029.28
4317893-31789328.94429.08
5315788-31578828.75228.88
6317539-31753928.91229.05
30min1327389-32738929.80829.630.6729.9929.810.66
2327299-32729929.80029.98
3326747-32674729.75029.93
4325511-32551129.63729.82
5322186-32218629.33529.52
6323480-32348029.45329.63
45min1332479-33247930.27230.090.6630.5030.320.65
2332202-33220230.24730.47
3331974-33197430.22630.46
4330367-33036730.08030.31
5328033-32803329.86730.10
6327650-32765029.83230.06
60min1334150-33415030.42430.290.5930.7030.580.59
2334848-33484830.48830.77
3333690-33369030.38230.67
4332968-33296830.31630.60
5330612-33061230.10230.38
6330052-33005230.05130.33
极限1335570-33557030.55330.370.5930.8830.700.58
2335890-33589030.58230.91
3334312-33431230.43930.77
4332616-33261630.28430.61
5331613-33161330.19330.52
6331537-33153730.18630.52
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%
112.331003822100374210037171003398100289210035140.04
212.311007331100303810051840.31
单位质量响应值RSD%判断
81388.0081655.890.24数据可信
供试品溶液-2024010911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%
5min1248904-24890422.80822.201.7022.8122.201.71
2242684-24268422.23822.24
3240645-24064522.05122.05
4244641-24464122.41722.42
5239862-23986221.97921.98
6237119-23711921.72821.73
10min1290496-29049626.61926.401.1826.6626.431.18
2290907-29090726.65626.69
3290028-29002826.57626.61
4289117-28911726.49226.53
5285340-28534026.14626.18
6282478-28247825.88425.92
15min1305777-30577728.01927.860.8928.1027.940.89
2306118-30611828.05028.13
3305509-30550927.99428.08
4304665-30466527.91728.00
5303181-30318127.78127.86
6299005-29900527.39827.48
20min1313076-31307628.68828.550.6928.8228.680.69
2312838-31283828.66628.79
3313446-31344628.72228.85
4311654-31165428.55728.69
5310540-31054028.45528.58
6307765-30776528.20128.33
30min1319203-31920329.24929.220.4729.4329.400.48
2319020-31902029.23229.41
3321333-32133329.44429.62
4318964-31896429.22729.40
5318322-31832229.16829.34
6316714-31671429.02129.19
45min1324862-32486229.76829.710.4729.9929.940.47
2324428-32442829.72829.95
3326548-32654829.92230.15
4323275-32327529.62229.85
5324449-32444929.73029.95
6322072-32207229.51229.73
60min1327439-32743930.00429.950.3130.2830.220.31
2326495-32649529.91730.19
3328204-32820430.07430.35
4326791-32679129.94530.22
5326851-32685129.95030.22
6325203-32520329.79930.07
极限1327263-32726329.98829.930.4230.3130.250.42
2327232-32723229.98530.31
3328692-32869230.11930.44
4325223-32522329.80130.12
5326276-32627629.89730.22
6325273-32527329.80530.12
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