利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724628444628454628484626674627264627860.02
211.674621704625864623780.07
单位质量响应值RSD%判断
39486.8639621.080.24数据可信
供试品溶液-2026031021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1389000-38900073.46575.053.8073.4775.053.80
2400606-40060675.65775.66
3372845-37284570.41470.41
4398574-39857475.27375.27
5416453-41645378.65078.65
6406858-40685876.83876.84
10min1457962-45796286.48987.772.6086.6587.932.61
2467831-46783188.35388.52
3445178-44517884.07584.23
4464489-46448987.72287.89
5479315-47931590.52290.70
6473589-47358989.44089.61
15min1491759-49175992.87293.782.3193.2394.142.31
2496552-49655293.77794.14
3479569-47956990.57090.91
4492882-49288293.08493.45
5510613-51061396.43396.81
6507961-50796195.93296.30
20min1506883-50688395.72896.421.8196.2996.991.81
2510809-51080996.47097.04
3497855-49785594.02394.57
4505588-50558895.48496.05
5519714-51971498.15198.74
6522445-52244598.66799.25
30min1519576-51957698.12598.801.3898.9099.591.38
2522959-52295998.76499.55
3517303-51730397.69698.45
4515663-51566397.38698.17
5529699-529699100.037100.85
6533754-533754100.803101.60
45min1525538-52553899.25199.641.42100.24100.651.43
2527367-52736799.597100.60
3520105-52010598.22599.20
4519859-51985998.17999.18
5534863-534863101.012102.04
6537966-537966101.598102.62
60min1526782-52678299.48699.651.40100.70100.881.40
2525041-52504199.157100.39
3520711-52071198.34099.53
4520216-52021698.24699.46
5536158-536158101.257102.51
6536967-536967101.410102.66
极限1531389-531389100.356100.261.35101.79101.701.36
2528831-52883199.873101.32
3522165-52216598.614100.02
4524551-52455199.065100.50
5538566-538566101.712103.19
6539636-539636101.914103.39
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724637514631624629384631774627544631560.09
211.674630644627284628960.06
单位质量响应值RSD%判断
39518.4339665.470.27数据可信
供试品溶液-2026040221批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1372497-37249770.28169.242.7770.2869.242.77
2360360-36036067.99167.99
3385067-38506772.65372.65
4364259-36425968.72768.73
5357973-35797367.54167.54
6361869-36186968.27668.28
10min1446662-44666284.27484.011.2184.4384.161.21
2442961-44296183.57683.73
3453950-45395085.64985.81
4442885-44288583.56183.71
5446925-44692584.32484.47
6438047-43804782.64982.80
15min1470156-47015688.70788.870.8989.0589.210.89
2470469-47046988.76689.10
3474882-47488289.59989.95
4466931-46693188.09888.44
5476986-47698689.99690.33
6466754-46675488.06588.40
20min1479470-47947090.46491.110.8491.0091.650.84
2483967-48396791.31391.85
3483823-48382391.28591.84
4479125-47912590.39990.93
5489981-48998192.44792.98
6480990-48099090.75191.28
30min1489845-48984592.42293.110.8793.1693.850.86
2495226-49522693.43794.17
3492825-49282592.98493.74
4488929-48892992.24992.98
5500793-50079394.48795.23
6493258-49325893.06693.80
45min1492071-49207192.84293.780.9893.7994.730.98
2499496-49949694.24395.19
3496875-49687593.74894.71
4491964-49196492.82193.76
5504915-50491595.26596.22
6497089-49708993.78894.73
60min1494310-49431093.26493.950.8694.4295.110.85
2500642-50064294.45995.61
3496665-49666593.70894.88
4493654-49365493.14094.29
5504939-50493995.27096.43
6497534-49753493.87295.02
极限1498484-49848494.05294.570.7995.4195.930.79
2503376-50337694.97596.34
3500806-50080694.49095.87
4496353-49635393.65095.00
5507658-50765895.78397.16
6500617-50061794.45495.81
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724607884600924610494614474599434606640.14
211.674603344604684604010.03
单位质量响应值RSD%判断
39305.8039451.670.27数据可信
供试品溶液-2026031021批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1380094-38009472.10373.851.5672.1073.841.56
2383158-38315872.68472.68
3393077-39307774.56674.57
4394221-39422174.78374.78
5392788-39278874.51174.51
6392338-39233874.42574.43
10min1441048-44104883.66586.061.7583.8386.221.75
2456520-45652086.60086.76
3446970-44697084.78984.95
4457064-45706486.70486.87
5461811-46181187.60487.77
6458601-45860186.99587.16
15min1466371-46637188.46990.381.5288.8290.741.51
2473976-47397689.91290.27
3470562-47056289.26489.62
4481320-48132091.30591.66
5483736-48373691.76392.12
6482761-48276191.57891.94
20min1475668-47566890.23392.261.5190.7892.821.51
2483465-48346591.71292.27
3481166-48116691.27691.83
4492452-49245293.41793.98
5493252-49325293.56894.13
6492144-49214493.35893.92
30min1489344-48934492.82794.291.2493.5795.051.24
2493525-49352593.62094.38
3491963-49196393.32494.08
4503526-50352695.51796.29
5500946-50094695.02895.80
6502924-50292495.40396.17
45min1495499-49549993.99595.201.4594.9496.171.45
2496544-49654494.19395.16
3494421-49442193.79094.75
4511681-51168197.06498.05
5507172-50717296.20997.19
6505830-50583095.95496.94
60min1493916-49391693.69495.351.6194.8596.541.61
2496664-49666494.21695.39
3495827-49582794.05795.23
4512085-51208597.14198.34
5507114-50711496.19897.40
6510320-51032096.80698.00
极限1498442-49844294.55396.101.4895.9297.491.48
2500616-50061694.96596.35
3500439-50043994.93296.31
4514337-51433797.56898.98
5511876-51187697.10198.51
6513861-51386197.47898.89
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724601684596334603514599644602644600760.07
211.674603214600954602080.04
单位质量响应值RSD%判断
39255.6339435.130.33数据可信
供试品溶液-2026040221批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1373752-37375270.96072.163.1370.9672.163.13
2367830-36783069.83569.84
3374276-37427671.05971.06
4378433-37843371.84971.85
5401558-40155876.23976.24
6384514-38451473.00373.00
10min1434732-43473282.53783.071.2182.7083.241.21
2436417-43641782.85783.01
3435570-43557082.69682.85
4434678-43467882.52782.69
5448213-44821385.09785.27
6435766-43576682.73482.90
15min1460111-46011187.35687.131.2487.7087.481.24
2459577-45957787.25487.59
3462044-46204487.72388.06
4451678-45167885.75586.10
5466937-46693788.65289.01
6453242-45324286.05286.40
20min1469144-46914489.07189.340.9989.6189.880.99
2471200-47120089.46189.99
3471579-47157989.53390.07
4463959-46395988.08688.62
5478216-47821690.79391.35
6469381-46938189.11689.65
30min1481147-48114791.35091.540.8092.0892.280.80
2484040-48404091.89992.63
3483483-48348391.79392.53
4476025-47602590.37791.11
5487365-48736592.53093.29
6480871-48087191.29792.03
45min1485355-48535592.14992.410.9193.0893.350.91
2489495-48949592.93593.87
3489800-48980092.99293.93
4479628-47962891.06191.99
5491564-49156493.32794.29
6484583-48458392.00292.94
60min1487951-48795192.64192.720.8093.7893.870.80
2489674-48967492.96994.11
3492560-49256093.51694.66
4481824-48182491.47892.61
5491582-49158293.33194.50
6486645-48664592.39393.54
极限1494232-49423293.83493.910.5295.1895.260.53
2494462-49446293.87895.23
3496033-49603394.17695.53
4490848-49084893.19194.53
5498563-49856394.65696.03
6493631-49363193.72095.07
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724613534619494615174616364618034616520.06
211.674635554625264630400.16
单位质量响应值RSD%判断
39390.1039677.810.52数据可信
供试品溶液-2026030522批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1396079-39607974.84175.871.4774.8475.871.47
2405212-40521276.56676.57
3393055-39305574.26974.27
4402510-40251076.05676.06
5403550-40355076.25276.25
6408749-40874977.23577.23
10min1448920-44892084.82585.120.7484.9985.280.73
2448402-44840284.72784.90
3450029-45002985.03585.20
4456468-45646886.25186.42
5447324-44732484.52484.69
6451654-45165485.34285.51
15min1469418-46941888.69888.730.7389.0589.090.73
2466441-46644188.13688.49
3469381-46938188.69189.05
4475877-47587789.91990.28
5466618-46661888.16988.53
6469935-46993588.79689.16
20min1479145-47914590.53690.500.8391.0991.060.83
2475409-47540989.83090.38
3479731-47973190.64791.20
4486179-48617991.86592.43
5475673-47567389.88090.43
6477637-47763790.25190.81
30min1488166-48816692.24192.160.8092.9992.920.80
2485679-48567991.77192.52
3488742-48874292.35093.10
4494673-49467393.47094.24
5483435-48343591.34792.10
6485847-48584791.80392.56
45min1493192-49319293.19192.870.9794.1593.830.97
2486338-48633891.89692.85
3492813-49281393.11994.08
4498949-49894994.27895.25
5486453-48645391.91792.87
6491088-49108892.79393.76
60min1492598-49259893.07892.841.0194.2494.011.00
2487652-48765292.14493.31
3492736-49273693.10494.27
4499417-49941794.36795.55
5485165-48516591.67492.83
6490448-49044892.67293.84
极限1496798-49679893.87293.470.8395.2494.840.83
2491348-49134892.84294.21
3495498-49549893.62695.00
4500612-50061294.59395.98
5489031-48903192.40493.77
6494618-49461893.46094.84
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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800
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%
111.724614964619604614484617274619274617120.06
211.674607034613734610380.11
单位质量响应值RSD%判断
39395.2239506.260.20数据可信
供试品溶液-2026030522批-pH4.5(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1420720-42072079.66478.711.9879.6678.711.98
2406861-40686177.03977.04
3416527-41652778.87078.87
4428038-42803881.04981.05
5415227-41522778.62378.62
6406748-40674877.01877.02
10min1455042-45504286.16285.602.1886.3485.782.18
2444174-44417484.10584.28
3452013-45201385.58985.76
4469622-46962288.92389.10
5449418-44941885.09785.27
6442251-44225183.74083.91
15min1471143-47114389.21188.502.3089.5888.862.29
2459548-45954887.01687.37
3465860-46586088.21188.58
4486677-48667792.15392.53
5464292-46429287.91488.28
6456744-45674486.48586.84
20min1478201-47820190.54889.842.3791.1190.402.37
2465134-46513488.07388.62
3474564-47456489.85990.42
4494181-49418193.57394.16
5471880-47188089.35189.91
6462872-46287287.64588.19
30min1489177-48917792.62691.482.5993.3992.242.59
2475074-47507489.95590.70
3478971-47897190.69391.45
4504862-50486295.59696.39
5481429-48142991.15991.92
6469394-46939488.88089.62
45min1487691-48769192.34591.972.2593.3292.932.25
2478752-47875290.65291.60
3485411-48541191.91392.88
4505866-50586695.78696.79
5481643-48164391.19992.16
6474834-47483489.91090.85
60min1488862-48886292.56692.232.1893.7593.402.19
2487333-48733392.27793.43
3485440-48544091.91893.09
4505620-50562095.73996.96
5481701-48170191.21092.37
6473474-47347489.65390.79
极限1492849-49284993.32192.682.1594.7194.062.15
2484074-48407491.66093.01
3489074-48907492.60693.98
4507643-50764396.12297.55
5486890-48689092.19393.56
6476350-47635090.19791.54
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