依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.651837801838321838621836261835831837370.07
210.761839841834331837080.22
单位质量响应值RSD%判断
17252.3017073.230.74数据可信
长期6月-供试品溶液-2024030121批-依折麦布-pH7.0(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%
5min180339-8033942.13052.4112.3142.1352.4212.31
2102228-10222853.60953.61
3100542-10054252.72552.72
4118704-11870462.24962.25
5101449-10144953.20053.20
696445-9644550.57650.58
10min1136780-13678071.72882.228.0271.9682.518.03
2164172-16417286.09386.39
3165291-16529186.67986.97
4171250-17125089.80490.15
5152080-15208079.75280.05
6151177-15117779.27879.56
15min1165738-16573886.91493.103.9687.5593.854.00
2181615-18161595.24096.02
3183197-18319796.06996.84
4184298-18429896.64797.49
5174258-17425891.38292.12
6176138-17613892.36893.09
20min1178881-17888193.80696.121.3994.9297.391.45
2182589-18258995.75197.06
3185125-18512597.08198.39
4185301-18530197.17398.55
5182504-18250495.70696.95
6185409-18540997.22998.46
30min1181882-18188295.38097.911.3097.0299.711.35
2187868-18786898.519100.36
3187844-18784498.506100.35
4186712-18671297.91399.83
5188362-18836298.778100.56
6187541-18754198.347100.12
45min1184815-18481596.91898.811.4499.08101.161.45
2189146-18914699.189101.57
3191956-191956100.663103.06
4185867-18586797.47099.94
5188339-18833998.766101.09
6190456-19045699.876102.20
60min1183639-18363996.30197.300.8499.01100.200.87
2187917-18791798.545101.48
3186181-18618197.634100.59
4184985-18498597.007100.01
5186231-18623197.661100.54
6184326-18432696.66299.54
极限1185746-18574697.40696.871.14100.65100.301.09
2182038-18203895.46298.94
3187979-18797998.577102.07
4183624-18362496.29399.84
5183496-18349696.22699.64
6185483-18548397.268100.68
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954254244255264257304251904245564252850.11
211.054261174251674256420.16
单位质量响应值RSD%判断
38838.8138519.640.59数据可信
长期6月-供试品溶液-2024030121批-辛伐他汀-pH7.0(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%
5min1209221-20922148.44059.6611.7948.4459.6611.79
2260938-26093860.41360.41
3265864-26586461.55461.55
4303446-30344670.25570.25
5258543-25854359.85959.86
6248152-24815257.45357.45
10min1332734-33273477.03686.577.5577.3086.907.57
2392280-39228090.82291.16
3395139-39513991.48491.83
4406020-40602094.00394.39
5357856-35785682.85283.18
6359393-35939383.20883.53
15min1390733-39073390.46495.163.2191.1695.973.26
2419070-41907097.02597.86
3424902-42490298.37599.23
4421800-42180097.65798.57
5403161-40316193.34194.13
6406377-40637794.08694.87
20min1412425-41242595.48696.570.8896.6997.910.91
2413036-41303695.62897.01
3420703-42070397.40398.80
4418694-41869496.93898.39
5417047-41704796.55697.87
6420619-42061997.38398.69
30min1410296-41029694.99396.070.6096.7297.950.64
2415593-41559396.22098.13
3415441-41544196.18498.12
4414614-41461495.99397.99
5416799-41679996.49998.35
6416995-41699596.54498.39
45min1411444-41144495.25996.171.3497.5298.581.30
2415428-41542896.18198.63
3421367-42136797.556100.03
4406562-40656294.12996.66
5418031-41803196.78499.17
6419476-41947697.11999.50
60min1407675-40767594.38694.720.5997.1797.670.60
2412588-41258895.52498.50
3410843-41084395.12098.13
4406820-40682094.18897.24
5409965-40996594.91797.84
6406871-40687194.20097.12
极限1410720-41072095.09194.081.1198.4097.551.03
2399384-39938492.46795.98
3410986-41098695.15398.70
4403159-40315993.34196.91
5406141-40614194.03197.48
6407613-40761394.37297.82
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.651836541837261832851835081837081835760.11
210.761854351857241855800.12
单位质量响应值RSD%判断
17237.1817247.210.05数据可信
长期6月-供试品溶液-2024030221批-依折麦布-pH7.0(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%
5min174217-7421738.73938.587.5338.7438.597.53
283010-8301043.32943.33
372374-7237437.77737.78
469848-6984836.45936.46
576838-7683840.10840.11
667241-6724135.09835.10
10min1130217-13021767.97071.674.1368.1971.894.13
2144139-14413975.23775.48
3142331-14233174.29374.50
4131666-13166668.72668.93
5135989-13598970.98371.21
6139528-13952872.83073.03
15min1169867-16986788.66689.561.0489.2690.171.05
2173886-17388690.76491.42
3170382-17038288.93589.56
4170030-17003088.75189.34
5171809-17180989.68090.30
6173475-17347590.55091.15
20min1181961-18196194.97995.270.8096.0696.380.81
2183535-18353595.80196.96
3183383-18338395.72196.84
4180258-18025894.09095.17
5181792-18179294.89196.01
6184199-18419996.14797.25
30min1183762-18376295.91995.592.2597.5397.232.19
2179100-17910093.48695.18
3179199-17919993.53795.19
4188417-18841798.34999.95
5180814-18081494.38096.02
6187500-18750097.87099.51
45min1185162-18516296.65097.411.6798.8099.581.62
2182889-18288995.46497.68
3184958-18495896.54498.71
4191909-191909100.172102.32
5186795-18679597.50299.67
6187944-18794498.102100.28
60min1185813-18581396.99097.361.5899.67100.081.54
2184913-18491396.52099.26
3182380-18238095.19897.90
4188019-18801998.141100.84
5187014-18701497.617100.33
6191045-19104599.721102.45
极限1184114-18411496.10397.181.4199.32100.431.36
2184626-18462696.37099.65
3190973-19097399.683102.92
4184516-18451696.31399.56
5187324-18732497.778101.03
6185500-18550096.826100.11
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954260634250884255484261694260754257890.11
211.054302654310644306640.14
单位质量响应值RSD%判断
38884.8438974.120.17数据可信
长期6月-供试品溶液-2024030221批-辛伐他汀-pH7.0(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%
5min1193781-19378144.57644.907.2244.5844.907.22
2217454-21745450.02150.02
3193647-19364744.54544.54
4182887-18288742.07042.07
5204197-20419746.97246.97
6179122-17912241.20441.20
10min1315985-31598572.68776.203.9872.9376.453.98
2348338-34833880.12980.41
3341189-34118978.48478.73
4316517-31651772.80973.04
5329408-32940875.77476.04
6336057-33605777.30477.53
15min1398849-39884991.74892.020.7492.4092.700.76
2404205-40420592.98093.70
3398028-39802891.55992.24
4396081-39608191.11191.75
5401119-40111992.27092.95
6401990-40199092.47093.13
20min1415941-41594195.68095.910.7596.8497.090.77
2420047-42004796.62497.86
3419608-41960896.52397.72
4412496-41249694.88796.03
5414415-41441595.32996.52
6419093-41909396.40597.58
30min1410726-41072694.48094.001.9496.1795.721.88
2401704-40170492.40594.18
3399436-39943691.88393.61
4418586-41858696.28897.96
5404814-40481493.12094.84
6416610-41661095.83397.54
45min1410812-41081294.50094.871.7396.7297.111.67
2402743-40274392.64494.93
3408975-40897594.07796.32
4424250-42425097.59199.80
5414602-41460295.37297.61
6413082-41308295.02297.26
60min1411112-41111294.56994.441.1997.3197.201.16
2409151-40915194.11896.92
3401998-40199892.47295.23
4411671-41167194.69797.45
5412531-41253194.89597.67
6416741-41674195.86498.63
极限1407099-40709993.64694.151.5496.9197.441.48
2407340-40734093.70197.03
3420614-42061496.755100.03
4405015-40501593.16696.44
5412245-41224594.82998.13
6403512-40351292.82196.12
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.651848771844871841311837481835011841490.31
210.761853561855311854440.07
单位质量响应值RSD%判断
17290.9917234.570.24数据可信
长期6月-供试品溶液-2024030321批-依折麦布-pH7.0(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%
5min172059-7205937.56841.9413.9337.5741.9413.94
297759-9775950.96750.97
369787-6978736.38436.38
490185-9018547.01847.02
579409-7940941.40041.40
673506-7350638.32338.32
10min1146270-14627076.25873.505.0976.4773.735.11
2151854-15185479.17079.45
3132370-13237069.01269.21
4140888-14088873.45373.71
5139393-13939372.67372.90
6135127-13512770.44970.66
15min1180441-18044194.07490.482.8194.7191.122.82
2178540-17854093.08393.81
3169533-16953388.38788.97
4171090-17109089.19989.87
5168678-16867887.94188.57
6172958-17295890.17290.78
20min1182658-18265895.23095.180.8196.3896.320.81
2183148-18314895.48596.73
3184589-18458996.23697.31
4183290-18329095.55996.72
5180799-18079994.26095.38
6180910-18091094.31895.42
30min1185777-18577796.85696.092.1898.5497.772.14
2185745-18574596.83998.61
3190244-19024499.185100.80
4183161-18316195.49297.19
5178219-17821992.91594.56
6182734-18273495.26996.90
45min1186331-18633197.14496.591.4399.3798.801.41
2184633-18463396.25998.57
3189082-18908298.579100.74
4186636-18663697.30399.53
5181665-18166594.71296.87
6183281-18328195.55497.71
60min1187220-18722097.60896.401.07100.3799.141.07
2184531-18453196.20699.05
3185421-18542196.67099.38
4186616-18661697.293100.06
5181801-18180194.78397.47
6183807-18380795.82998.52
极限1185034-18503496.46896.431.6699.7799.701.63
2184628-18462896.25799.63
3188211-18821198.125101.37
4188291-18829198.166101.47
5183282-18328295.55598.77
6180265-18026593.98297.20
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954283684276274271344262034249784268620.31
211.054297654300544299100.05
单位质量响应值RSD%判断
38982.8338905.880.14数据可信
长期6月-供试品溶液-2024030321批-辛伐他汀-pH7.0(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%
5min1184711-18471142.47346.6013.6242.4746.6013.62
2245281-24528156.40156.40
3174265-17426540.07140.07
4225732-22573251.90651.91
5201357-20135746.30146.30
6184553-18455342.43742.44
10min1346746-34674679.73276.884.8079.9777.144.82
2358653-35865382.47082.78
3314461-31446172.30872.53
4332022-33202276.34676.63
5331489-33148976.22476.48
6322780-32278074.22174.46
15min1416577-41657795.78992.502.4696.4793.192.47
2411649-41164994.65695.43
3394050-39405090.60991.23
4396131-39613191.08891.80
5392725-39272590.30590.99
6402532-40253292.56093.21
20min1413369-41336995.05295.450.4196.2696.640.40
2416118-41611895.68496.98
3417602-41760296.02597.15
4415682-41568295.58396.80
5414241-41424195.25296.43
6413513-41351395.08596.25
30min1415275-41527595.49094.981.8397.2396.711.80
2416843-41684395.85097.68
3423988-42398897.49399.15
4411516-41151694.62696.38
5401800-40180092.39194.10
6408969-40896994.04095.73
45min1413019-41301994.97194.641.2997.2496.901.27
2411118-41111894.53496.90
3418974-41897496.34098.54
4415019-41501995.43197.71
5405217-40521793.17795.40
6406051-40605193.36995.58
60min1411878-41187894.70994.130.8297.5196.910.83
2409701-40970194.20897.09
3409295-40929594.11596.85
4413879-41387995.16997.97
5404631-40463193.04295.78
6406749-40674993.52996.26
极限1409223-40922394.09893.861.5997.4297.171.56
2408623-40862393.96097.37
3412342-41234294.81598.08
4415660-41566095.57898.91
5406626-40662693.50196.76
6396651-39665191.20794.46
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