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430060-202202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%
112.034954184950824943754945554945514947960.09
212.084886844887824887330.02
单位质量响应值RSD%判断
41130.1740458.031.17数据可信
长期36月-供试品溶液-20210818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%
5min1373266-37326668.35565.835.7368.3665.835.73
2366769-36676967.16567.17
3357363-35736365.44365.44
4367019-36701967.21167.21
5373285-37328568.35968.36
6319183-31918358.45158.45
10min1443402-44340281.19978.393.6081.3578.533.60
2432407-43240779.18579.33
3424592-42459277.75477.90
4437977-43797780.20580.35
5430337-43033778.80678.96
6399539-39953973.16673.30
15min1468082-46808285.71983.582.7586.0583.902.75
2462578-46257884.71185.04
3446368-44636881.74282.06
4467728-46772885.65485.98
5456896-45689683.67084.00
6436887-43688780.00680.30
20min1481184-48118488.11886.222.6088.6486.722.60
2478432-47843287.61488.13
3456394-45639483.57884.08
4483453-48345388.53389.05
5469002-46900285.88786.40
6456382-45638283.57684.05
30min1495805-49580590.79588.892.7991.5189.592.79
2496029-49602990.83691.54
3467657-46765785.64186.33
4498251-49825191.24391.96
5483806-48380688.59889.30
6470919-47091986.23886.89
45min1505263-50526392.52790.512.7593.4591.412.75
2504130-50413092.32093.23
3476620-47662087.28288.16
4507757-50775792.98493.90
5491680-49168090.04090.94
6480040-48004087.90888.76
60min1516662-51666294.61591.602.9995.7492.702.99
2509741-50974193.34794.46
3482921-48292188.43689.51
4512299-51229993.81694.94
5496525-49652590.92792.03
6482999-48299988.45089.49
极限1515717-51571794.44292.212.9295.7893.512.92
2513934-51393494.11595.44
3485429-48542988.89590.16
4517982-51798294.85796.19
5501411-50141191.82293.12
6486815-48681589.14990.39
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430060-202202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%
112.034888584883824893374891974893674890280.09
212.084906604910364908480.06
单位质量响应值RSD%判断
40650.7140633.110.04数据可信
长期36月-供试品溶液-20210819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%
5min1287871-28787152.91158.656.8252.9158.646.82
2299242-29924255.00155.00
3330680-33068060.77960.78
4319094-31909458.65058.65
5345236-34523663.45563.45
6332336-33233661.08361.08
10min1354253-35425365.11270.794.7265.2370.924.72
2374721-37472168.87469.00
3386167-38616770.97871.11
4394617-39461772.53172.66
5403922-40392274.24174.38
6397055-39705572.97973.11
15min1391866-39186672.02576.283.1472.2976.573.15
2411829-41182975.69475.97
3412985-41298575.90776.20
4422450-42245077.64677.94
5428760-42876078.80679.11
6422301-42230177.61977.92
20min1415064-41506476.28979.422.2676.7179.882.27
2431253-43125379.26479.71
3428484-42848478.75679.22
4436835-43683580.29080.75
5442436-44243681.32081.80
6438501-43850180.59781.07
30min1436069-43606980.15082.411.5480.7483.051.56
2449722-44972282.65983.28
3446740-44674082.11182.75
4450124-45012482.73383.38
5456952-45695283.98884.65
6450695-45069582.83883.49
45min1448693-44869382.47084.611.4083.2485.431.41
2464365-46436585.35086.15
3458914-45891484.34985.17
4460321-46032184.60785.43
5467148-46714885.86286.71
6462674-46267485.04085.87
60min1454536-45453683.54485.711.4384.5086.721.45
2469553-46955386.30487.30
3464765-46476585.42486.43
4466280-46628085.70286.72
5474430-47443087.20088.24
6468505-46850586.11187.13
极限1460575-46057584.65486.701.3985.7987.901.40
2476556-47655687.59188.78
3469103-46910386.22187.42
4471100-47110086.58887.79
5478937-47893788.02989.26
6473957-47395787.11388.33
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430060-202202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%
112.034936494936294938774936494939174937440.03
212.084925414924414924910.02
单位质量响应值RSD%判断
41042.7340769.120.48数据可信
长期36月-供试品溶液-20210820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%
5min1274332-27433250.09751.407.0750.1051.407.06
2292248-29224853.36953.37
3249737-24973745.60645.61
4294879-29487953.85053.85
5304797-30479755.66155.66
6272678-27267849.79549.80
10min1371103-37110367.76967.236.4867.8867.346.47
2380864-38086469.55269.67
3362258-36225866.15466.26
4323490-32349059.07559.19
5381185-38118569.61169.73
6389951-38995171.21171.32
15min1407636-40763674.44174.133.1174.7074.403.11
2412388-41238875.30975.58
3404569-40456973.88174.13
4381701-38170169.70569.96
5412563-41256375.34175.62
6416794-41679476.11376.38
20min1426483-42648377.88377.601.8978.3178.031.90
2428718-42871878.29178.73
3427631-42763178.09278.50
4408701-40870174.63575.04
5429130-42913078.36678.81
6429063-42906378.35478.79
30min1447377-44737781.69881.231.2082.3081.831.21
2446686-44668681.57282.19
3451048-45104882.36982.95
4435353-43535379.50380.07
5445465-44546581.34981.97
6443005-44300580.90081.51
45min1455302-45530283.14683.140.5983.9383.930.59
2459204-45920483.85884.65
3456054-45605483.28384.05
4451425-45142582.43883.19
5456317-45631783.33184.13
6453486-45348682.81483.61
60min1461184-46118484.22084.190.4085.1985.150.42
2463555-46355584.65385.63
3460997-46099784.18685.14
4458062-45806283.65084.58
5462016-46201684.37285.36
6460157-46015784.03285.01
极限1465800-46580085.06385.090.2686.2286.240.26
2468107-46810785.48486.65
3465625-46562585.03186.17
4465719-46571985.04886.17
5465937-46593785.08886.26
6464502-46450284.82685.99
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430060-202202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%
112.034935134930684939354933554932984934340.07
212.084953924949584951750.07
单位质量响应值RSD%判断
41016.9640991.310.05数据可信
长期36月-供试品溶液-JPS4394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%
5min1317830-31783057.90151.3120.5657.9051.3120.56
2270002-27000249.18849.19
3169354-16935430.85230.85
4320273-32027358.34658.35
5307134-30713455.95355.95
6305345-30534555.62755.63
10min1392328-39232871.47372.774.1471.6072.884.13
2408810-40881074.47674.58
3406287-40628774.01674.08
4407024-40702474.15074.28
5413183-41318375.27275.40
6368912-36891267.20767.33
15min1422037-42203776.88577.066.8577.1777.346.82
2437918-43791879.77880.05
3436236-43623679.47279.71
4436429-43642979.50779.80
5440006-44000680.15980.45
6365385-36538566.56566.84
20min1451057-45105782.17281.104.4682.6381.554.45
2454379-45437982.77783.23
3452949-45294982.51782.93
4452140-45214082.36982.84
5455641-45564183.00783.48
6404807-40480773.74674.17
30min1467105-46710585.09684.773.4585.7485.403.44
2473986-47398686.34986.99
3472869-47286986.14686.74
4471340-47134085.86786.52
5473679-47367986.29386.95
6433045-43304578.89179.48
45min1484158-48415888.20287.712.7989.0388.522.80
2487137-48713788.74589.57
3487771-48777188.86189.64
4486734-48673488.67289.52
5488701-48870189.03089.88
6454225-45422582.74983.51
60min1490336-49033689.32889.122.9090.3590.132.91
2497438-49743890.62291.65
3496015-49601590.36291.34
4494881-49488190.15691.20
5495845-49584590.33191.38
6460700-46070083.92984.87
极限1494659-49465990.11590.622.1491.3491.832.15
2503138-50313891.66092.89
3504033-50403391.82393.01
4502610-50261091.56492.81
5503123-50312391.65792.90
6476977-47697786.89488.02
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