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%
115.004798814797824792304799884796384797040.07
215.084804824819064811940.21
单位质量响应值RSD%判断
31980.2731909.420.16数据可信
供试品溶液-24071701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%
5min1270984-27098450.69448.468.2150.6948.468.20
2246372-24637246.08946.09
3278087-27808752.02252.02
4282727-28272752.89052.89
5246902-24690246.18946.19
6229304-22930442.89742.90
10min1360775-36077567.49166.442.7967.5866.522.79
2346085-34608564.74364.82
3368168-36816868.87468.96
4361139-36113967.55967.65
5342444-34244464.06264.14
6352444-35244465.93366.00
15min1395642-39564274.01474.031.7174.2174.221.71
2387383-38738372.46972.65
3405128-40512875.78875.99
4398948-39894874.63274.83
5388651-38865172.70672.89
6398746-39874674.59474.78
20min1413852-41385277.42077.971.4177.7478.281.42
2409193-40919376.54976.85
3424825-42482579.47379.80
4417281-41728178.06278.39
5413294-41329477.31677.62
6422167-42216778.97679.28
30min1432982-43298280.99982.131.1181.4582.581.11
2434398-43439881.26481.70
3444998-44499883.24783.71
4437606-43760681.86482.32
5441001-44100182.49982.93
6443307-44330782.93183.37
45min1447664-44766483.74684.901.1184.3385.481.11
2450133-45013384.20884.78
3461175-46117586.27386.87
4453683-45368384.87285.46
5452374-45237484.62785.20
6458060-45806085.69186.27
60min1455457-45545785.20486.170.9285.9386.890.92
2457319-45731985.55286.26
3465023-46502386.99387.74
4459424-45942485.94686.68
5460345-46034586.11886.83
6466097-46609787.19487.91
极限1462481-46248186.51888.030.9687.3888.900.95
2471873-47187388.27589.13
3475785-47578589.00689.89
4470462-47046288.01188.89
5469941-46994187.91388.77
6472921-47292188.47189.33
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%
115.004788514787914789714787164790674788790.03
215.084807844809544808690.03
单位质量响应值RSD%判断
31925.2731887.860.09数据可信
供试品溶液-24071702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%
5min1237086-23708644.40546.035.7244.4146.035.72
2234873-23487343.99143.99
3251740-25174047.15047.15
4238560-23856044.68244.68
5240517-24051745.04845.05
6271789-27178950.90550.91
10min1342211-34221164.09564.461.5964.1764.541.60
2343210-34321064.28264.36
3350298-35029865.61065.69
4339808-33980863.64563.72
5338112-33811263.32763.40
6351330-35133065.80365.89
15min1378387-37838770.87171.341.1471.0571.521.14
2381873-38187371.52471.70
3388244-38824472.71772.90
4377204-37720470.64970.83
5376921-37692170.59670.78
6382641-38264171.66771.86
20min1398005-39800574.54575.311.8574.8475.621.85
2402191-40219175.32975.63
3416372-41637277.98578.29
4397794-39779474.50674.80
5396106-39610674.18974.49
6402154-40215475.32275.64
30min1420033-42003378.67178.890.4479.0979.320.44
2424336-42433679.47779.90
3422207-42220779.07879.52
4420900-42090078.83379.26
5419156-41915678.50778.93
6420579-42057978.77379.21
45min1436804-43680481.81282.301.2682.3782.861.26
2442492-44249282.87783.44
3449363-44936384.16484.74
4436420-43642081.74082.29
5436312-43631281.72082.27
6435131-43513181.49982.07
60min1446035-44603583.54184.050.9584.2384.740.95
2451313-45131384.53085.23
3456118-45611885.43086.14
4447823-44782383.87684.57
5446248-44624883.58184.27
6444869-44486983.32384.03
极限1449623-44962384.21384.751.0285.0485.591.02
2457409-45740985.67186.51
3459181-45918186.00386.86
4450937-45093784.45985.29
5449457-44945784.18285.01
6448479-44847983.99984.84
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%
115.004814764808834806844816664809564811330.09
215.084826584823704825140.05
单位质量响应值RSD%判断
32075.5331996.950.18数据可信
供试品溶液-24071801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%
5min1266126-26612649.64349.390.5849.6449.380.58
2262306-26230648.93048.93
3263983-26398349.24349.24
4266216-26621649.66049.66
5265630-26563049.55049.55
6264259-26425949.29549.29
10min1342653-34265363.91864.260.9964.0064.340.98
2339968-33996863.41763.50
3349698-34969865.23265.31
4346684-34668464.67064.75
5344640-34464064.28964.37
6343332-34333264.04564.13
15min1373758-37375869.72070.291.6769.9170.481.67
2370909-37090969.18969.38
3388604-38860472.49072.68
4373365-37336569.64769.84
5378153-37815370.54070.73
6376022-37602270.14370.33
20min1391095-39109572.95473.060.9573.2673.370.95
2386561-38656172.10972.41
3397764-39776474.19974.51
4390703-39070372.88173.19
5393401-39340173.38573.69
6390559-39055972.85473.16
30min1410239-41023976.52676.631.1976.9577.061.19
2403208-40320875.21475.64
3418512-41851278.06978.50
4411198-41119876.70477.13
5411583-41158376.77677.21
6409982-40998276.47876.90
45min1423318-42331878.96579.141.1679.5279.701.16
2417522-41752277.88478.43
3432583-43258380.69481.26
4422462-42246278.80679.36
5425115-42511579.30179.86
6424648-42464879.21379.77
60min1432664-43266480.70980.551.2281.3981.241.22
2423876-42387679.06979.75
3440128-44012882.10182.80
4429811-42981180.17780.86
5432738-43273880.72381.41
6431680-43168080.52581.21
极限1441401-44140182.33982.190.9683.1683.010.96
2434072-43407280.97181.78
3445486-44548683.10183.94
4438116-43811681.72682.55
5444445-44444582.90683.73
6439952-43995282.06882.89
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%
115.004815414817694817104818914810834815990.07
215.084826294824044825160.04
单位质量响应值RSD%判断
32106.6031997.080.25数据可信
供试品溶液-JPS7157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%
5min1328829-32882961.31060.342.6761.3160.342.67
2333095-33309562.10562.11
3316512-31651259.01359.01
4313903-31390358.52758.53
5332024-33202461.90561.91
6317390-31739059.17759.18
10min1403941-40394175.31475.041.5075.4275.141.50
2410383-41038376.51576.62
3405892-40589275.67875.78
4392851-39285173.24673.34
5399157-39915774.42274.53
6402502-40250275.04675.14
15min1430510-43051080.26879.981.0480.5080.201.05
2436898-43689881.45981.69
3425040-42504079.24879.47
4425025-42502579.24579.46
5427266-42726679.66379.89
6428956-42895679.97880.20
20min1445617-44561783.08582.791.0683.4583.151.06
2452201-45220184.31284.68
3439387-43938781.92382.28
4440132-44013282.06282.41
5442363-44236382.47882.84
6444525-44452582.88183.24
30min1464527-46452786.61086.111.0487.1186.601.04
2469699-46969987.57588.08
3456371-45637185.09085.58
4458845-45884585.55186.04
5459478-45947885.66986.17
6462018-46201886.14386.64
45min1477563-47756389.04188.490.9989.6989.130.99
2481625-48162589.79890.45
3468805-46880587.40888.04
4471486-47148687.90888.54
5472121-47212188.02688.67
6475979-47597988.74689.38
60min1485013-48501390.43089.881.1691.2290.671.15
2490102-49010291.37992.18
3474977-47497788.55989.34
4476801-47680188.89989.68
5481712-48171289.81490.60
6483737-48373790.19290.98
极限1487563-48756390.90590.221.1791.8591.161.17
2491181-49118191.58092.54
3475576-47557688.67089.60
4481285-48128589.73590.66
5480994-48099489.68190.62
6486858-48685890.77491.71
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