利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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%
112.144759004761414763564766644760954762310.07
212.084760854762214761530.03
单位质量响应值RSD%判断
39228.2539416.640.34数据可信
长期6月-供试品溶液-2024010711批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1325527-32552761.84058.865.7361.8458.865.73
2307566-30756658.42858.43
3275556-27555652.34752.35
4317857-31785760.38360.38
5316647-31664760.15360.15
6316035-31603560.03760.04
10min1390050-39005074.09772.113.9474.2372.243.95
2381610-38161072.49472.62
3349676-34967666.42866.54
4384115-38411572.97073.10
5387652-38765273.64273.78
6384364-38436473.01773.15
15min1419102-41910279.61678.842.2179.9279.142.22
2413491-41349178.55078.84
3397255-39725575.46675.73
4420214-42021479.82880.12
5421703-42170380.11080.41
6418444-41844479.49179.79
20min1434470-43447082.53682.851.5183.0183.311.52
2432210-43221082.10682.57
3425632-42563280.85781.29
4442594-44259484.07984.55
5441567-44156783.88484.36
6440126-44012683.61084.08
30min1450766-45076685.63286.761.3486.2987.411.34
2451501-45150185.77186.42
3451591-45159185.78886.40
4464648-46464888.26988.93
5460729-46072987.52488.19
6460865-46086587.55088.21
45min1465709-46570988.47089.370.9389.3290.210.93
2465676-46567688.46489.30
3469046-46904689.10489.91
4476035-47603590.43291.29
5471823-47182389.63290.49
6474257-47425790.09490.95
60min1473686-47368689.98690.801.1191.0391.841.11
2470541-47054189.38890.42
3476726-47672690.56391.56
4484585-48458592.05693.11
5480625-48062591.30492.36
6481778-48177891.52392.58
极限1480110-48011091.20691.930.9792.4693.170.97
2476889-47688990.59491.83
3483238-48323891.80093.00
4487166-48716692.54693.81
5487879-48787992.68293.94
6488210-48821092.74594.00
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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%
112.144761634760384759654756244754244758430.07
212.084754724757104755910.04
单位质量响应值RSD%判断
39196.2939370.120.32数据可信
长期6月-供试品溶液-2024010811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1321916-32191661.21560.794.3661.2260.794.36
2335704-33570463.83763.84
3302663-30266357.55457.55
4332418-33241863.21263.21
5303816-30381657.77357.77
6321507-32150761.13761.14
10min1394043-39404374.93175.471.9175.0775.611.91
2405989-40598977.20277.34
3387370-38737073.66273.79
4405788-40578877.16477.30
5391931-39193174.52974.66
6396297-39629775.35975.50
15min1426589-42658981.12082.141.3081.4282.441.31
2436328-43632882.97183.28
3425362-42536280.88681.18
4438019-43801983.29383.60
5428900-42890081.55981.85
6436446-43644682.99483.30
20min1445884-44588484.78985.650.6385.2786.140.63
2452129-45212985.97686.47
3450325-45032585.63386.10
4453358-45335886.21086.71
5448509-44850985.28885.76
6452332-45233286.01586.50
30min1466777-46677788.76289.450.8189.4390.120.80
2469367-46936789.25489.94
3473010-47301089.94790.61
4471780-47178089.71390.40
5475605-47560590.44091.11
6465823-46582388.58089.26
45min1480842-48084291.43691.930.6092.3092.800.60
2480831-48083191.43492.32
3488360-48836092.86693.73
4484934-48493492.21493.10
5483574-48357491.95692.82
6482011-48201191.65992.53
60min1487427-48742792.68893.580.9993.7694.660.98
2490027-49002793.18394.27
3497949-49794994.68995.76
4498539-49853994.80195.89
5488890-48889092.96794.04
6489773-48977393.13594.21
极限1492999-49299993.74894.180.6895.0395.470.67
2493366-49336693.81895.12
3501492-50149295.36396.64
4496637-49663794.44095.74
5492840-49284093.71894.99
6494358-49435894.00695.29
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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%
112.144747444746444742834742364740254743860.07
212.084748974751494750230.04
单位质量响应值RSD%判断
39076.2839323.100.45数据可信
加速6月-供试品溶液-2024010711批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1328005-32800562.50659.525.1662.5159.525.16
2332815-33281563.42363.42
3317633-31763360.53060.53
4302799-30279957.70357.70
5294854-29485456.18956.19
6297885-29788556.76656.77
10min1390206-39020674.35972.823.1874.5072.953.18
2395349-39534975.34075.48
3388618-38861874.05774.19
4383920-38392073.16273.29
5364659-36465969.49169.62
6370029-37002970.51470.64
15min1415854-41585479.24778.622.0579.5578.922.05
2420805-42080580.19180.50
3417739-41773979.60679.91
4416554-41655479.38079.67
5399046-39904676.04476.32
6405486-40548677.27177.55
20min1432362-43236282.39381.851.3382.8782.321.34
2435698-43569883.02983.52
3432550-43255082.42982.90
4431103-43110382.15382.62
5420212-42021280.07880.53
6425291-42529181.04581.50
30min1450079-45007985.76985.540.7086.4386.190.72
2451279-45127985.99886.67
3452260-45226086.18586.84
4449485-44948585.65686.31
5444558-44455884.71785.34
6445495-44549584.89685.53
45min1462434-46243488.12488.150.5388.9888.990.54
2465228-46522888.65689.52
3465256-46525688.66189.51
4462746-46274688.18389.02
5459877-45987787.63688.45
6459766-45976687.61588.44
60min1471561-47156189.86389.560.6890.9190.600.69
2472325-47232590.00891.07
3472516-47251690.04591.09
4471725-47172589.89490.93
5465502-46550288.70889.72
6466349-46634988.87089.89
极限1475722-47572290.65690.650.6791.9191.880.68
2478078-47807891.10592.36
3479778-47977891.42992.68
4476420-47642090.78992.02
5471796-47179689.90891.11
6472318-47231890.00791.22
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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%
112.144777674779444778724773824773354776600.06
212.084744694744424744560.01
单位质量响应值RSD%判断
39345.9639276.160.13数据可信
加速6月-供试品溶液-2024010811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283073-28307353.79057.234.4453.7957.234.44
2307038-30703858.34458.34
3317550-31755060.34260.34
4298381-29838156.69956.70
5311721-31172159.23459.23
6289248-28924854.96454.96
10min1374829-37482971.22673.022.1671.3573.152.16
2392917-39291774.66374.79
3392099-39209974.50874.64
4383645-38364572.90173.03
5387976-38797673.72473.86
6374131-37413171.09371.22
15min1413919-41391978.65479.901.1978.9380.191.19
2426975-42697581.13581.43
3425127-42512780.78481.08
4420476-42047679.90080.19
5419862-41986279.78380.08
6416455-41645579.13679.42
20min1439597-43959783.53483.930.6983.9984.400.69
2445583-44558384.67185.15
3444150-44415084.39984.88
4442861-44286184.15484.62
5437641-43764183.16283.63
6440220-44022083.65284.11
30min1465236-46523688.40688.050.7089.0488.700.68
2461401-46140187.67788.34
3465196-46519688.39889.06
4465691-46569188.49289.14
5457626-45762686.95987.62
6464914-46491488.34488.99
45min1478128-47812890.85590.560.7191.6991.410.69
2473769-47376990.02790.89
3478154-47815490.86091.72
4480750-48075091.35492.20
5471550-47155089.60590.46
6477189-47718990.67791.52
60min1489804-48980493.07492.101.0194.1193.160.99
2481094-48109491.41992.48
3487086-48708692.55893.62
4487209-48720992.58193.63
5476706-47670690.58591.64
6486320-48632092.41293.45
极限1491324-49132493.36392.790.9594.6194.040.93
2484925-48492592.14793.41
3488063-48806392.74394.01
4491274-49127493.35394.61
5481016-48101691.40492.66
6493151-49315193.71094.96
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