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%
112.034898634898204892364897204865334890340.30
212.084876244872394874320.06
单位质量响应值RSD%判断
40651.2140350.330.53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%
5min1405794-40579474.84668.338.8074.8568.338.80
2329261-32926160.73060.73
3359247-35924766.26166.26
4383667-38366770.76570.76
5340339-34033962.77362.77
6404454-40445474.59974.60
10min1441785-44178581.48478.804.3181.6578.954.32
2402657-40265774.26774.40
3421654-42165477.77177.92
4435309-43530980.29080.45
5411538-41153875.90676.05
6450328-45032883.06083.23
15min1463533-46353385.49683.803.1385.8484.123.15
2436419-43641980.49580.79
3450074-45007483.01383.33
4459957-45995784.83685.17
5441720-44172081.47281.78
6474249-47424987.47287.82
20min1477148-47714888.00786.382.7288.5486.892.73
2453874-45387483.71484.19
3462805-46280585.36185.87
4473040-47304087.24987.77
5456604-45660484.21884.71
6486502-48650289.73290.28
30min1491928-49192890.73389.042.5291.4789.752.53
2470719-47071986.82187.49
3477289-47728988.03388.73
4486939-48693989.81390.53
5469866-46986686.66487.34
6499889-49988992.20192.95
45min1504310-50431093.01790.962.5093.9591.862.52
2481451-48145188.80189.66
3487000-48700089.82490.71
4497174-49717491.70192.62
5479632-47963288.46589.33
6509285-50928593.93494.88
60min1506773-50677393.47191.742.4694.6192.852.48
2485929-48592989.62690.68
3491401-49140190.63691.73
4502635-50263592.70893.83
5483713-48371389.21890.28
6513978-51397894.80095.96
极限1513886-51388694.78392.502.5596.1393.812.56
2490081-49008190.39291.65
3494421-49442191.19392.48
4505350-50535093.20994.54
5487452-48745289.90791.17
6517885-51788595.52196.89
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430060-202202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%
112.034895234896874893994896184898114896080.04
212.084891894892134892010.01
单位质量响应值RSD%判断
40698.9240496.770.36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%
5min1319444-31944458.77856.344.4158.7856.344.42
2317177-31717758.36158.36
3316556-31655658.24758.25
4302123-30212355.59155.59
5287723-28772352.94152.94
6293975-29397554.09254.09
10min1390290-39029071.81471.701.0271.9471.821.03
2394456-39445672.58072.71
3393191-39319172.34872.48
4384126-38412670.68070.80
5389781-38978171.72071.84
6386148-38614871.05271.17
15min1422883-42288377.81177.691.1478.1077.971.14
2427986-42798678.75079.04
3424254-42425478.06378.35
4414739-41473976.31276.59
5424840-42484078.17178.45
6418546-41854677.01377.29
20min1439873-43987380.93780.161.6181.4080.611.61
2445603-44560381.99182.46
3438360-43836080.65981.12
4433838-43383879.82780.28
5427061-42706178.58079.03
6429019-42901978.94079.39
30min1456086-45608683.92083.241.7584.5683.881.75
2465008-46500885.56286.21
3452178-45217883.20183.84
4452496-45249683.26083.89
5442303-44230381.38482.01
6446351-44635182.12982.75
45min1467019-46701985.93285.241.7886.7686.061.78
2476196-47619687.62188.46
3462448-46244885.09185.92
4464313-46431385.43486.25
5452151-45215183.19684.00
6457507-45750784.18284.99
60min1473691-47369187.16086.551.7388.1887.561.73
2481210-48121088.54389.58
3467466-46746686.01487.03
4471691-47169186.79287.79
5456603-45660384.01585.01
6471576-47157686.77087.76
极限1479067-47906788.14987.251.9289.3688.441.91
2487843-48784389.76490.99
3472040-47204086.85688.06
4475908-47590887.56888.76
5461442-46144284.90686.08
6468631-46863186.22987.42
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%
112.034907614903394901874903074903554903900.05
212.084931384933224932300.03
单位质量响应值RSD%判断
40763.9240830.300.12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%
5min1321974-32197458.95458.132.3158.9558.132.30
2323717-32371759.27359.27
3318872-31887258.38658.39
4315519-31551957.77257.77
5303750-30375055.61755.62
6321119-32111958.79758.80
10min1382675-38267570.06869.851.2870.2069.981.28
2386223-38622370.71870.85
3383727-38372770.26170.39
4381810-38181069.91070.04
5372119-37211968.13568.26
6382457-38245770.02870.16
15min1405943-40594374.32974.880.9274.6275.170.92
2413113-41311375.64275.93
3410700-41070075.20075.49
4412169-41216975.46975.75
5403483-40348373.87874.15
6408442-40844274.78675.07
20min1419582-41958276.82677.710.8377.2878.160.83
2425537-42553777.91678.37
3426109-42610978.02178.47
4429356-42935678.61679.07
5421297-42129777.14077.58
6424728-42472877.76878.22
30min1433568-43356879.38780.921.1980.0181.551.18
2440521-44052180.66081.29
3441921-44192180.91681.54
4449822-44982282.36382.99
5442245-44224580.97681.59
6443655-44365581.23481.86
45min1444185-44418581.33183.051.2882.1383.861.27
2452061-45206182.77383.58
3455465-45546583.39684.20
4461751-46175184.54785.36
5452380-45238082.83183.62
6455737-45573783.44684.25
60min1449322-44932282.27184.061.2783.2585.051.26
2458382-45838283.93084.92
3459912-45991284.21085.20
4467259-46725985.55686.55
5458578-45857883.96684.94
6461114-46111484.43185.42
极限1454659-45465983.24985.051.2584.4186.221.25
2463973-46397384.95486.13
3467232-46723285.55186.73
4472423-47242386.50187.69
5463887-46388784.93886.10
6464779-46477985.10286.28
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%
112.034906054906354903034907164906334905780.04
212.084879654881364880500.03
单位质量响应值RSD%判断
40779.5540401.490.66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%
5min1310294-31029457.10662.434.4057.1162.434.40
2343223-34322363.16663.17
3348106-34810664.06464.06
4351355-35135564.66264.66
5337684-33768462.14662.15
6344661-34466163.43063.43
10min1378951-37895169.74173.582.6869.8773.722.68
2402106-40210674.00274.14
3404373-40437374.42074.56
4409140-40914075.29775.44
5399477-39947773.51973.66
6404783-40478374.49574.64
15min1412781-41278175.96778.411.7076.2578.711.70
2427227-42722778.62678.93
3427434-42743478.66478.97
4433270-43327079.73880.05
5424498-42449878.12378.42
6431114-43111479.34179.65
20min1434930-43493080.04381.431.0780.4981.901.08
2442743-44274381.48181.96
3443623-44362381.64382.13
4448339-44833982.51183.00
5439545-43954580.89381.37
6445498-44549881.98882.47
30min1461618-46161884.95585.100.5485.5885.760.55
2461940-46194085.01485.67
3463908-46390885.37686.04
4465321-46532185.63686.31
5458200-45820084.32684.98
6463570-46357085.31485.98
45min1477844-47784487.94188.090.7088.7688.930.70
2478193-47819388.00588.85
3479684-47968488.28089.13
4483858-48385889.04889.91
5473551-47355187.15187.99
6478678-47867888.09588.95
60min1487090-48709089.64389.700.8090.6690.740.80
2491766-49176690.50391.55
3487818-48781889.77790.83
4488481-48848189.89990.96
5480217-48021788.37889.41
6489004-48900489.99591.05
极限1494415-49441590.99190.840.5692.2092.080.56
2493821-49382190.88192.13
3493826-49382690.88292.13
4495699-49569991.22792.49
5488290-48829089.86391.10
6495566-49556691.20392.45
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