依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.331947961950211950251951681951701950360.08
211.381946411948721947560.09
单位质量响应值RSD%判断
17214.1217113.880.42数据可信
长期12月-供试品溶液-2024011621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145442-4544223.76827.0720.3423.7727.0720.34
264443-6444333.70733.71
349278-4927825.77525.77
448001-4800125.10725.11
538790-3879020.28920.29
664579-6457933.77833.78
10min1112893-11289359.04868.2611.7959.1868.4211.80
2149551-14955178.22278.41
3128972-12897267.45867.60
4123718-12371864.71064.85
5119203-11920362.34962.46
6148749-14874977.80377.99
15min1147297-14729777.04382.635.8777.5083.165.91
2169921-16992188.87789.50
3158463-15846382.88483.40
4150316-15031678.62279.12
5154024-15402480.56281.02
6167843-16784387.79088.41
20min1165489-16548986.55888.813.1187.4589.803.18
2177001-17700192.58093.70
3168831-16883188.30789.28
4164347-16434785.96186.90
5167545-16754587.63488.54
6175509-17550991.79992.91
30min1169287-16928788.54591.492.8789.9192.972.91
2178884-17888493.56595.19
3177549-17754992.86694.34
4167775-16777587.75489.17
5177213-17721392.69194.08
6178754-17875493.49795.11
45min1178757-17875793.49893.681.1495.3695.671.19
2179095-17909593.67595.82
3178692-17869293.46495.45
4175901-17590192.00493.91
5180048-18004894.17496.08
6182114-18211495.25497.39
60min1180335-18033594.32494.101.3596.7096.611.37
2180886-18088694.61297.28
3181164-18116494.75797.26
4175026-17502691.54793.96
5181251-18125194.80397.23
6180820-18082094.57797.24
极限1180856-18085694.59694.951.7097.5097.981.68
2181329-18132994.84498.04
3183951-18395196.21599.25
4176318-17631892.22395.14
5185241-18524196.89099.85
6181473-18147394.91998.11
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983095923097463100103099233096263097790.06
210.963094903098893096900.10
单位质量响应值RSD%判断
28213.0228256.390.11数据可信
长期12月-供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1241844-24184470.90074.816.8070.9074.816.80
2277930-27793081.47981.48
3258989-25898975.92675.93
4247819-24781972.65272.65
5233237-23323768.37768.38
6271284-27128479.53179.53
10min1300439-30043988.07890.752.3588.4791.162.37
2317195-31719592.99093.44
3308904-30890490.56090.98
4302528-30252888.69089.09
5310114-31011490.91491.29
6318088-31808893.25293.69
15min1312008-31200891.47093.131.7492.3594.051.75
2324329-32432995.08296.05
3318450-31845093.35894.28
4310211-31021190.94391.84
5321646-32164694.29595.18
6319394-31939493.63594.59
20min1321904-32190494.37194.011.3595.7695.451.35
2325632-32563295.46496.96
3315644-31564492.53693.98
4315468-31546892.48493.89
5324554-32455495.14896.56
6320892-32089294.07495.55
30min1311183-31118391.22892.942.0093.1494.901.99
2321997-32199794.39896.43
3318470-31847093.36495.32
4307790-30779090.23392.15
5324268-32426895.06497.00
6318460-31846093.36195.36
45min1320197-32019793.87093.670.9096.2996.140.90
2319476-31947693.65996.21
3316368-31636892.74895.22
4316154-31615492.68595.10
5323588-32358894.86597.33
6321244-32124494.17796.70
60min1321046-32104694.11993.671.0197.0696.661.00
2321185-32118594.16097.23
3319057-31905793.53696.53
4314150-31415092.09895.03
5323446-32344694.82397.82
6318179-31817993.27996.32
极限1317192-31719292.98993.291.7696.4696.811.73
2319851-31985193.76997.36
3320392-32039293.92897.44
4308715-30871590.50493.95
5325746-32574695.49799.02
6317380-31738093.04596.61
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.331958791955481952771958561957041956530.13
211.381962371969751966060.27
单位质量响应值RSD%判断
17268.5817276.450.04数据可信
长期12月-供试品溶液-2024011821批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134060-3406017.70322.5829.1917.7022.5829.18
254454-5445428.30328.30
356285-5628529.25429.25
454124-5412428.13128.13
531264-3126416.25016.25
630507-3050715.85615.86
10min1108416-10841656.35061.5612.5556.4561.6912.59
2123546-12354664.21464.37
3142960-14296074.30474.47
4124788-12478864.85965.02
5105767-10576754.97355.06
6105176-10517654.66654.75
15min1142049-14204973.83179.177.0474.2479.647.10
2157738-15773881.98582.50
3169291-16929187.99088.57
4156382-15638281.28181.80
5145696-14569675.72676.12
6142803-14280374.22374.61
20min1159822-15982283.06985.803.9283.8986.703.99
2167977-16797787.30788.28
3175910-17591091.43092.49
4165910-16591086.23387.20
5162751-16275184.59185.41
6158069-15806982.15782.96
30min1172907-17290789.87091.661.9591.1593.042.04
2177218-17721892.11093.56
3182711-18271194.96596.54
4174999-17499990.95792.40
5175857-17585791.40392.69
6174443-17444390.66891.93
45min1180071-18007193.59393.020.8495.3894.910.83
2177586-17758692.30194.27
3180318-18031893.72195.82
4177615-17761592.31794.27
5180582-18058293.85995.65
6177633-17763392.32694.09
60min1180266-18026693.69493.251.2796.0095.661.18
2175039-17503990.97893.46
3179548-17954893.32195.94
4179540-17954093.31795.78
5181644-18164494.41196.73
6180455-18045593.79396.07
极限1179489-17948993.29192.092.3596.1195.022.25
2169038-16903887.85990.84
3178268-17826892.65695.79
4179598-17959893.34796.33
5176754-17675491.86994.71
6179983-17998393.54796.35
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983109083106223104003108713100363105670.12
210.963112573127813120190.35
单位质量响应值RSD%判断
28284.7928468.890.46数据可信
长期12月-供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227848-22784866.46370.217.8166.4670.217.81
2234697-23469768.46168.46
3257570-25757075.13375.13
4268744-26874478.39278.39
5218867-21886763.84363.84
6236501-23650168.98768.99
10min1301996-30199688.09288.381.5488.4688.771.56
2300193-30019387.56687.95
3305683-30568389.16789.58
4311017-31101790.72391.16
5298224-29822486.99287.35
6300802-30080287.74488.13
15min1308542-30854290.00191.431.8090.8692.311.81
2311374-31137490.82791.69
3311616-31161690.89891.81
4323242-32324294.28995.23
5309129-30912990.17391.01
6316788-31678892.40793.28
20min1315434-31543492.01291.721.3893.3793.111.38
2309534-30953490.29191.66
3311249-31124990.79192.21
4322030-32203093.93695.40
5314384-31438491.70693.04
6313949-31394991.57992.96
30min1313061-31306191.32092.541.0793.1994.441.09
2315598-31559892.06093.93
3316897-31689792.43994.36
4323275-32327594.29996.28
5317247-31724792.54194.39
6317343-31734392.56994.46
45min1316283-31628392.25991.921.0494.6494.331.03
2312853-31285391.25993.64
3311774-31177490.94493.38
4319400-31940093.16995.68
5318108-31810892.79295.15
6312238-31223891.08093.49
60min1316410-31641092.29691.811.7995.1994.741.77
2307380-30738089.66292.55
3308815-30881590.08193.02
4322261-32226194.00397.03
5317509-31750992.61795.50
6316091-31609192.20395.12
极限1313072-31307291.32390.352.4594.7393.792.40
2296721-29672186.55389.94
3308215-30821589.90693.35
4316807-31680792.41295.96
5307129-30712989.58992.98
6316581-31658192.34695.77
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源自制对照品使用方法直接使用
对照品含量(%)99.75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%
111.331977841978341972101966511966741972310.30
211.381953541961731957640.30
单位质量响应值RSD%判断
17407.8617202.460.84数据可信
长期12月-供试品溶液-2024012021批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136265-3626518.81421.8719.8218.8121.8719.82
240214-4021420.86320.86
347192-4719224.48324.48
432145-3214516.67716.68
555720-5572028.90728.91
641361-4136121.45821.46
10min1108466-10846656.27259.2712.8156.3859.3912.81
2119291-11929161.88762.00
3127889-12788966.34866.48
487953-8795345.63045.72
5125623-12562365.17265.33
6116256-11625660.31360.43
15min1157037-15703781.47079.098.0981.8979.558.12
2157829-15782981.88182.34
3160135-16013583.07783.58
4128432-12843266.63066.98
5160847-16084783.44683.97
6150470-15047078.06378.52
20min1170949-17094988.68786.484.8489.5687.374.90
2168614-16861487.47688.39
3170936-17093688.68189.65
4151751-15175178.72879.44
5174045-17404590.29491.28
6163835-16383584.99785.88
30min1178351-17835192.52791.491.3393.8992.861.39
2175965-17596591.29092.69
3176481-17648191.55793.02
4172357-17235789.41890.57
5175901-17590191.25692.74
6179033-17903392.88194.24
45min1180738-18073893.76693.061.2395.6494.941.25
2176146-17614691.38493.29
3178767-17876792.74394.71
4178250-17825092.47594.13
5182508-18250894.68496.68
6179896-17989693.32995.21
60min1183467-18346795.18294.020.9997.5896.411.00
2178960-17896092.84395.26
3182215-18221594.53297.01
4179762-17976293.25995.42
5180380-18038093.58096.10
6182573-18257394.71897.11
极限1180430-18043093.60692.471.0796.5395.391.10
2176957-17695791.80494.74
3177637-17763792.15795.16
4175806-17580691.20793.89
5178050-17805092.37195.41
6180552-18055293.66996.59
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.983137933134293130143127883120163130080.22
210.963103683119703111690.37
单位质量响应值RSD%判断
28507.1028391.330.29数据可信
长期12月-供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1239399-23939969.65463.9711.1369.6563.9711.12
2227078-22707866.06966.07
3250942-25094273.01373.01
4218325-21832563.52363.52
5192040-19204055.87555.88
6191346-19134655.67355.67
10min1320177-32017793.15788.983.3193.5489.343.33
2295458-29545885.96586.33
3316297-31629792.02892.43
4303915-30391588.42688.78
5297830-29783086.65586.97
6301249-30124987.65087.96
15min1325485-32548594.70192.212.7095.6193.062.72
2303438-30343888.28789.13
3325929-32592994.83195.75
4319153-31915392.85993.70
5315273-31527391.73092.52
6312235-31223590.84691.64
20min1330356-33035696.11992.792.9597.5594.162.95
2303469-30346988.29689.63
3323420-32342094.10195.54
4322415-32241593.80895.17
5320962-32096293.38694.69
6312957-31295791.05692.36
30min1331006-33100696.30893.112.6998.2794.992.69
2308177-30817789.66691.49
3320858-32085893.35595.32
4324781-32478194.49796.38
5311536-31153690.64392.46
6323752-32375294.19796.00
45min1330475-33047596.15393.202.4998.6595.592.48
2306358-30635889.13691.46
3321254-32125493.47095.96
4324370-32437094.37796.78
5319546-31954692.97495.30
6319919-31991993.08295.41
60min1334857-33485797.42893.872.63100.4696.782.63
2311352-31135290.58993.41
3326277-32627794.93297.94
4325115-32511594.59497.52
5314841-31484191.60594.44
6323273-32327394.05896.91
极限1327794-32779495.37392.102.1198.9595.542.12
2309444-30944490.03493.36
3316456-31645692.07495.61
4315799-31579991.88395.34
5310462-31046290.33093.68
6319383-31938392.92696.30
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