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%
1 15.174860204865804868434869204864414865610.08
2 15.124853174857524855340.07
单位质量响应值RSD%判断
32073.9032112.040.09数据可信
供试品溶液-2024123021批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1269751-26975150.23046.978.7350.2346.978.73
2215894-21589440.20140.20
3279054-27905451.96251.96
4251246-25124646.78446.78
5253755-25375547.25147.25
6243715-24371545.38245.38
10min1363239-36323967.63866.404.5367.7266.484.53
2325790-32579060.66560.73
3369527-36952768.80968.90
4367155-36715568.36868.45
5360645-36064567.15567.23
6353102-35310265.75165.83
15min1397701-39770174.05673.961.4274.2574.151.43
2387700-38770072.19372.36
3400575-40057574.59174.79
4404100-40410075.24775.44
5394501-39450173.46073.65
6398509-39850974.20674.39
20min1418383-41838377.90778.130.7578.2378.440.74
2423181-42318178.80079.09
3418553-41855377.93878.26
4423429-42342978.84679.16
5415327-41532777.33877.65
6418503-41850377.92978.24
30min1441988-44198882.30282.280.6082.7582.720.60
2442061-44206182.31682.74
3439970-43997081.92682.38
4446740-44674083.18783.64
5439435-43943581.82782.27
6441012-44101282.12082.56
45min1457430-45743085.17885.260.5985.7685.840.58
2458577-45857785.39185.95
3454522-45452284.63685.23
4462633-46263386.14686.73
5457300-45730085.15385.73
6456789-45678985.05885.63
60min1465865-46586586.74886.690.6087.4887.410.60
2466997-46699786.95987.66
3465063-46506386.59987.33
4469691-46969187.46188.19
5464486-46448686.49287.21
6461291-46129185.89786.61
极限1474495-47449588.35588.300.6989.2389.160.68
2477532-47753288.92189.77
3473070-47307088.09088.97
4477617-47761788.93789.81
5473372-47337288.14689.01
6468986-46898687.32988.19
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%
1 15.174869814867634867324869554873764869610.06
2 15.124867444863284865360.07
单位质量响应值RSD%判断
32100.2632178.310.18数据可信
供试品溶液-2024123021批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1249670-24967046.42447.978.6546.4247.968.65
2293124-29312454.50454.50
3265106-26510649.29449.29
4267604-26760449.75949.76
5242668-24266845.12245.12
6229661-22966142.70342.70
10min1365119-36511967.89167.641.7767.9767.721.78
2370680-37068068.92569.02
3370095-37009568.81668.90
4364235-36423567.72667.81
5357547-35754766.48366.56
6355018-35501866.01266.08
15min1397522-39752273.91673.711.2074.1173.911.21
2397607-39760773.93174.14
3403198-40319874.97175.17
4398151-39815174.03374.23
5392246-39224672.93573.12
6389843-38984372.48872.67
20min1414461-41446177.06577.882.8577.3878.202.84
2415215-41521577.20577.53
3421228-42122878.32478.65
4441445-44144582.08382.40
5412980-41298076.79077.10
6407675-40767575.80376.11
30min1437278-43727881.30881.090.9681.7581.540.97
2435043-43504380.89281.35
3441953-44195382.17782.63
4438476-43847681.53181.99
5434193-43419380.73481.17
6429738-42973879.90680.33
45min1452261-45226184.09483.950.7984.6784.530.79
2449352-44935283.55384.15
3457535-45753585.07485.66
4452891-45289184.21184.80
5448611-44861183.41583.99
6448192-44819283.33783.90
60min1457211-45721185.01485.050.8285.7385.770.82
2455891-45589184.76985.50
3464274-46427486.32887.06
4458020-45802085.16585.90
5453453-45345384.31585.02
6455512-45551284.69885.40
极限1465261-46526186.51186.540.7387.3787.400.74
2463473-46347386.17987.05
3471421-47142187.65688.53
4466836-46683686.80487.68
5461956-46195685.89786.75
6463508-46350886.18587.03
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%
1 15.174863774863924865054866714869234865740.05
2 15.124867634875414871520.12
单位质量响应值RSD%判断
32074.7532219.050.32数据可信
供试品溶液-2024123021批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1368771-36877168.55470.084.6468.5570.084.64
2372863-37286369.31469.31
3362605-36260567.40767.41
4362624-36262467.41167.41
5407044-40704475.66875.67
6388062-38806272.14072.14
10min1473667-47366788.05488.741.4888.1788.861.48
2473012-47301287.93288.05
3468417-46841787.07887.19
4480900-48090089.39889.51
5488072-48807290.73190.86
6480194-48019489.26789.39
15min1492617-49261791.57692.151.3191.8492.411.32
2493282-49328291.70091.96
3486166-48616690.37790.63
4503712-50371293.63993.90
5501991-50199193.31993.60
6496331-49633192.26792.54
20min1498500-49850092.67093.531.3793.0893.951.37
2501570-50157093.24193.66
3493532-49353291.74692.15
4511714-51171495.12695.54
5509823-50982394.77595.21
6503767-50376793.64994.07
30min1504120-50412093.71594.521.3894.2895.091.38
2508224-50822494.47895.05
3497876-49787692.55493.11
4518389-51838996.36796.94
5511752-51175295.13395.72
6510342-51034294.87195.45
45min1504796-50479693.84095.191.7094.5695.921.70
2511061-51106195.00595.73
3500763-50076393.09193.81
4524936-52493697.58498.32
5513510-51351095.46096.21
6517337-51733796.17296.91
60min1509992-50999294.80695.491.5995.6996.381.59
2511358-51135895.06095.95
3501240-50124093.17994.05
4524892-52489297.57698.48
5515554-51555495.84096.75
6519010-51901096.48397.38
极限1515075-51507595.75196.891.1696.7997.941.16
2521964-52196497.03298.08
3513385-51338595.43796.46
4527760-52776098.10999.17
5527397-52739798.04299.11
6521778-52177896.99798.06
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%
1 15.174850254850814845294845024846454847560.06
2 15.124836604841714839160.08
单位质量响应值RSD%判断
31954.9132005.030.12数据可信
供试品溶液-2024123021批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1379655-37965570.94570.653.9970.9570.663.99
2355450-35545066.42266.42
3373450-37345069.78669.79
4400684-40068474.87574.87
5386118-38611872.15372.15
6373236-37323669.74669.75
10min1494210-49421092.35290.321.9492.4790.441.94
2467152-46715287.29587.41
3479745-47974589.64989.76
4489643-48964391.49891.62
5485320-48532090.69090.81
6484047-48404790.45290.57
15min1509788-50978895.26393.751.2595.5394.021.25
2491849-49184991.91092.17
3498276-49827693.11193.38
4505693-50569394.49794.77
5500977-50097793.61693.89
6503691-50369194.12394.39
20min1517824-51782496.76495.241.1997.2095.671.19
2500503-50050393.52893.94
3506536-50653694.65595.08
4514377-51437796.12096.55
5509260-50926095.16495.59
6509549-50954995.21895.64
30min1520926-52092697.34496.261.1297.9496.841.13
2505782-50578294.51495.08
3511155-51115595.51896.10
4519581-51958197.09397.69
5518075-51807596.81197.40
6515164-51516496.26796.85
45min1522185-52218597.57996.761.2598.3397.501.25
2508069-50806994.94195.66
3516203-51620396.46197.20
4524997-52499798.10598.86
5522062-52206297.55698.30
6513163-51316395.89396.64
60min1525619-52561998.22196.921.4799.1497.821.47
2507903-50790394.91095.79
3513888-51388896.02996.93
4526608-52660898.40699.33
5523181-52318197.76598.68
6514606-51460696.16397.07
极限1523147-52314797.75997.700.6598.8498.770.65
2519672-51967297.11098.15
3521180-52118097.39198.45
4528443-52844398.74999.83
5524781-52478198.06499.14
6519910-51991097.15498.22
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