氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661448786144907214479631446683144702414479060.08
210.611451075145169014513820.03
单位质量响应值RSD%判断
135826.08136793.780.51数据可信
长期24月-供试品溶液-2024041521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min112543-125430.8501.0148.230.851.0148.26
22649-26490.1800.18
318409-184091.2471.25
412868-128680.8720.87
522185-221851.5031.50
620596-205961.3961.40
120min132545-325452.2053.0120.962.213.0120.95
236229-362292.4552.46
349488-494883.3533.36
443358-433582.9382.94
558332-583323.9533.96
646276-462763.1363.14
240min178356-783565.3106.7315.645.316.7415.65
294185-941856.3826.39
3113389-1133897.6847.69
485287-852875.7795.79
5110362-1103627.4787.49
6114227-1142277.7407.75
360min1127615-1276158.64811.1312.258.6611.1412.24
2158267-15826710.72510.74
3172877-17287711.71511.73
4164460-16446011.14411.16
5178924-17892412.12412.14
6183045-18304512.40412.42
480min1176677-17667711.97215.1211.4512.0015.1611.45
2212167-21216714.37714.41
3237922-23792216.12216.16
4227743-22774315.43315.46
5243883-24388316.52616.56
6240817-24081716.31916.36
600min1184752-18475212.51915.9311.4912.5615.9811.49
2226968-22696815.38015.43
3250244-25024416.95717.02
4237907-23790716.12116.18
5255634-25563417.32317.38
6254593-25459317.25217.31
720min1227909-22790915.44418.839.8615.5118.919.87
2269151-26915118.23918.31
3291685-29168519.76619.85
4278708-27870818.88618.96
5301625-30162520.43920.53
6298523-29852320.22920.32
840min1286597-28659719.42121.785.8719.5121.885.89
2315899-31589921.40621.51
3333697-33369722.61222.73
4321579-32157921.79121.90
5335044-33504422.70422.82
6335391-33539122.72722.84
960min1326650-32665022.13524.125.2822.2524.265.31
2342810-34281023.23023.36
3371830-37183025.19625.35
4355354-35535424.08024.22
5377013-37701325.54825.70
6361694-36169424.51024.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1351508-35150823.81926.195.3623.9726.365.38
2375183-37518325.42425.59
3400773-40077327.15827.34
4384916-38491626.08326.26
5406560-40656027.55027.74
6399841-39984127.09527.28
1200min1371733-37173325.19027.024.4425.3727.234.47
2385677-38567726.13526.34
3415358-41535828.14628.37
4395202-39520226.78026.99
5414839-41483928.11128.34
6409541-40954127.75227.98
1320min1382965-38296525.95127.804.7526.1728.064.78
2391551-39155126.53326.78
3430696-43069629.18529.46
4409753-40975327.76628.02
5427786-42778628.98829.26
6418994-41899428.39228.66
1440min1403967-40396727.37429.234.3527.6329.524.38
2413148-41314827.99628.28
3447681-44768130.33630.65
4433205-43320529.35529.65
5448754-44875430.40930.73
6441262-44126229.90130.21
极限1421140-42114028.53830.203.6028.8430.543.64
2434781-43478129.46229.79
3465281-46528131.52931.89
4443669-44366930.06430.41
5457494-45749431.00131.37
6451414-45141430.58930.95
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661452431144720014528571450102145194514509070.17
210.611454665145339514540300.07
单位质量响应值RSD%判断
136107.60137043.360.49数据可信
长期24月-供试品溶液-2024041521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min114243-142430.9631.0412.230.961.0412.23
217812-178121.2051.20
314104-141040.9540.95
417327-173271.1721.17
516018-160181.0831.08
613188-131880.8920.89
120min141062-410622.7773.1514.642.783.1614.58
256969-569693.8533.85
352934-529343.5803.58
441545-415452.8102.81
546104-461043.1183.12
641225-412252.7882.79
240min178258-782585.2936.4111.145.306.4211.11
2105787-1057877.1557.16
387978-879785.9505.96
495788-957886.4786.48
5105535-1055357.1377.14
695393-953936.4526.46
360min1145608-1456089.84811.336.849.8611.356.85
2173107-17310711.70711.73
3169655-16965511.47411.49
4167164-16716411.30611.32
5178822-17882212.09412.11
6171032-17103211.56711.58
480min1195217-19521713.20315.077.0013.2315.107.00
2225729-22572915.26615.30
3231452-23145215.65315.69
4217378-21737814.70214.73
5240975-24097516.29716.33
6225996-22599615.28415.32
600min1217080-21708014.68115.874.4714.7315.924.47
2241803-24180316.35316.41
3240439-24043916.26116.32
4226592-22659215.32515.38
5243127-24312716.44316.50
6238876-23887616.15616.21
720min1266526-26652618.02618.793.7118.1018.883.71
2277626-27762618.77618.86
3278884-27888418.86118.94
4270257-27025718.27818.36
5296405-29640520.04620.13
6277675-27767518.78018.86
840min1298416-29841620.18221.684.5320.2821.784.52
2319809-31980921.62921.74
3331290-33129022.40622.51
4315720-31572021.35321.46
5340780-34078023.04723.16
6317141-31714121.44921.56
960min1343374-34337423.22324.072.8923.3524.212.90
2357172-35717224.15624.30
3362816-36281624.53824.68
4345536-34553623.36923.51
5370523-37052325.05925.21
6356171-35617124.08824.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1380676-38067625.74626.313.4325.9126.483.42
2390522-39052226.41226.59
3397308-39730826.87127.05
4371992-37199225.15825.33
5409693-40969327.70827.89
6383777-38377725.95526.13
1200min1398573-39857326.95627.412.9427.1627.622.94
2400592-40059227.09327.31
3409654-40965427.70527.93
4389428-38942826.33826.55
5424150-42415028.68628.91
6409228-40922827.67727.89
1320min1407542-40754227.56328.272.4827.8028.522.49
2418920-41892028.33228.59
3416110-41611028.14228.40
4406132-40613227.46727.72
5432375-43237529.24229.51
6426628-42662828.85329.11
1440min1435882-43588229.47929.572.8729.7629.862.86
2422570-42257028.57928.88
3438865-43886529.68129.98
4424339-42433928.69928.99
5454927-45492730.76731.08
6446588-44658830.20330.50
极限1444678-44467830.07430.393.1830.4030.733.17
2450136-45013630.44330.79
3436893-43689329.54829.90
4435427-43542729.44929.78
5474174-47417432.06932.43
6454747-45474730.75531.10
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661459833144811714518901449803145714214533570.35
210.611460892146225714615740.07
单位质量响应值RSD%判断
136337.43137754.380.74数据可信
长期24月-供试品溶液-2024041721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min120432-204321.3771.2114.851.381.2114.70
219532-195321.3161.32
317796-177961.1991.20
413280-132800.8950.90
519807-198071.3351.33
616732-167321.1281.13
120min154094-540943.6463.4211.363.653.4211.39
253594-535943.6123.61
355202-552023.7213.72
439497-394972.6622.66
550752-507523.4213.42
651227-512273.4533.45
240min1105362-1053627.1017.038.217.117.048.20
2105133-1051337.0867.09
3116601-1166017.8597.87
489919-899196.0616.07
5102538-1025386.9116.92
6106034-1060347.1477.15
360min1168978-16897811.38911.213.7511.4111.233.77
2164406-16440611.08111.10
3168429-16842911.35211.37
4155302-15530210.46710.48
5167385-16738511.28211.30
6173848-17384811.71711.74
480min1228194-22819415.38015.352.9015.4215.392.90
2220814-22081414.88314.92
3237993-23799316.04116.08
4227349-22734915.32315.35
5220748-22074814.87814.91
6231581-23158115.60915.64
600min1246041-24604116.58315.996.0216.6416.046.02
2241460-24146016.27416.33
3257228-25722817.33717.40
4216909-21690914.62014.67
5234643-23464315.81515.87
6227091-22709115.30615.36
720min1295052-29505219.88718.924.4819.9719.004.48
2274481-27448118.50018.58
3289951-28995119.54319.63
4278888-27888818.79718.87
5259977-25997717.52317.60
6285933-28593319.27219.35
840min1314991-31499121.23021.552.2821.3421.662.29
2311859-31185921.01921.13
3331758-33175822.36122.48
4316334-31633421.32121.42
5318753-31875321.48421.59
6324496-32449621.87121.98
960min1361707-36170724.37924.242.7624.5224.392.76
2359124-35912424.20524.35
3375774-37577425.32725.48
4350489-35048923.62323.76
5348200-34820023.46923.61
6362809-36280924.45324.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1391618-39161826.39526.202.8326.5826.382.83
2378244-37824425.49425.67
3405861-40586127.35527.54
4384389-38438925.90826.08
5377071-37707125.41525.59
6394843-39484326.61326.79
1200min1403374-40337427.18827.132.5627.4127.342.57
2398447-39844726.85527.07
3421491-42149128.40928.64
4395287-39528726.64226.85
5392616-39261626.46226.67
6403762-40376227.21427.43
1320min1417644-41764428.14927.952.6128.4128.212.62
2409556-40955627.60427.86
3432591-43259129.15729.43
4403896-40389627.22327.47
5405342-40534227.32027.57
6419516-41951628.27628.54
1440min1438183-43818329.53429.222.8829.8429.522.89
2426764-42676428.76429.06
3448907-44890730.25630.57
4414014-41401427.90528.19
5430849-43084929.03929.33
6442864-44286429.84930.15
极限1446571-44657130.09929.922.3030.4530.262.31
2434771-43477129.30429.64
3457808-45780830.85631.22
4433051-43305129.18829.52
5438128-43812829.53029.87
6453176-45317630.54430.89
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661471157146970514651181453872145995014639600.49
210.611477780147705214774160.04
单位质量响应值RSD%判断
137332.08139247.500.98数据可信
长期24月-供试品溶液-2024041721批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min116862-168621.1261.0016.431.131.0016.32
213603-136030.9090.91
312882-128820.8600.86
418449-184491.2321.23
512204-122040.8150.82
615798-157981.0551.06
120min148593-485933.2463.166.193.253.166.16
247386-473863.1653.17
347220-472203.1543.16
450601-506013.3803.38
541870-418702.7972.80
648140-481403.2163.22
240min1109991-1099917.3476.7013.887.356.7013.87
2105744-1057447.0637.07
3103702-1037026.9276.93
4107232-1072327.1637.17
572375-723754.8344.84
6102349-1023496.8366.84
360min1181674-18167412.13511.209.6212.1511.229.60
2163797-16379710.94110.96
3177814-17781411.87711.89
4172062-17206211.49311.51
5137206-1372069.1659.18
6173933-17393311.61811.63
480min1246283-24628316.45115.088.3916.4915.128.40
2230727-23072715.41215.44
3231747-23174715.48015.51
4230732-23073215.41215.45
5189915-18991512.68512.71
6225452-22545215.05915.09
600min1251036-25103616.76815.595.5616.8315.645.56
2246418-24641816.46016.52
3234220-23422015.64515.70
4221705-22170514.80914.87
5220047-22004714.69814.74
6226816-22681615.15015.21
720min1312129-31212920.84918.827.4320.9318.907.42
2296498-29649819.80519.89
3289255-28925519.32119.40
4258377-25837717.25817.34
5263600-26360017.60717.67
6270888-27088818.09418.17
840min1357939-35793923.90921.806.1824.0321.916.19
2339479-33947922.67622.79
3317837-31783721.23021.34
4309091-30909120.64620.75
5304424-30442420.33420.43
6329851-32985122.03322.14
960min1390171-39017126.06224.224.8626.2124.364.86
2369248-36924824.66424.81
3361988-36198824.17924.32
4351224-35122423.46023.60
5337960-33796022.57422.70
6365384-36538424.40624.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1434726-43472629.03826.495.4029.2326.665.40
2407196-40719627.19927.38
3384397-38439725.67625.85
4383383-38338325.60825.78
5376940-37694025.17825.34
6392723-39272326.23226.41
1200min1439164-43916429.33427.364.6429.5727.584.64
2425473-42547328.42028.64
3396254-39625426.46826.68
4395343-39534326.40726.62
5392413-39241326.21126.41
6409372-40937227.34427.56
1320min1464423-46442331.02128.465.2931.3028.715.29
2439094-43909429.32929.59
3414511-41451127.68727.94
4405382-40538227.07827.33
5407877-40787727.24427.48
6424751-42475128.37128.63
1440min1481549-48154932.16529.585.2932.4929.885.30
2459404-45940430.68631.00
3433503-43350328.95629.25
4418999-41899927.98728.28
5425603-42560328.42828.70
6438444-43844429.28629.59
极限1497811-49781133.25230.554.9633.6330.894.96
2468588-46858831.30031.65
3442841-44284129.58029.92
4435930-43593029.11829.45
5451039-45103930.12730.45
6447795-44779529.91130.25
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661461819146189614636331462066146086114620550.07
210.611475033147274314738880.11
单位质量响应值RSD%判断
137153.38138914.990.91数据可信
长期24月-供试品溶液-2024041821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min119809-198091.3261.1910.041.331.1910.13
216888-168881.1301.13
314803-148030.9910.99
417886-178861.1971.20
519126-191261.2801.28
618438-184381.2341.23
120min151771-517713.4643.425.523.473.425.47
256345-563453.7713.77
348925-489253.2743.28
448797-487973.2653.27
549806-498063.3333.33
651129-511293.4213.42
240min1108765-1087657.2787.3710.007.297.389.95
2129802-1298028.6868.69
397711-977116.5396.55
4104797-1047977.0137.02
5105659-1056597.0717.08
6113818-1138187.6177.62
360min1172166-17216611.52112.035.5411.5412.045.55
2185250-18525012.39712.42
3175750-17575011.76111.78
4166437-16643711.13811.15
5193266-19326612.93312.95
6185346-18534612.40312.42
480min1227757-22775715.24116.004.0615.2816.044.05
2243514-24351416.29616.33
3234058-23405815.66315.70
4233705-23370515.63915.67
5255384-25538417.09017.13
6240205-24020516.07416.11
600min1236222-23622215.80816.975.0515.8717.035.04
2255375-25537517.08917.15
3255502-25550217.09817.16
4241234-24123416.14316.20
5270083-27008318.07418.14
6262795-26279517.58617.65
720min1295129-29512919.75019.984.9819.8320.074.98
2292897-29289719.60019.69
3294744-29474419.72419.81
4279231-27923118.68618.77
5323352-32335221.63821.73
6306170-30617020.48820.58
840min1323430-32343021.64422.683.7421.7622.803.72
2339361-33936122.71022.83
3337948-33794822.61522.73
4326709-32670921.86321.97
5351211-35121123.50323.62
6355008-35500823.75723.87
960min1348402-34840223.31524.824.3623.4624.964.36
2375437-37543725.12425.28
3375486-37548625.12725.27
4357786-35778623.94324.08
5394987-39498726.43226.59
6372987-37298724.96025.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1391851-39185126.22226.983.7026.4027.173.70
2395069-39506926.43726.63
3406549-40654927.20627.39
4385482-38548225.79625.97
5423146-42314628.31628.51
6416980-41698027.90428.10
1200min1402897-40289726.96127.983.4127.1828.213.41
2416564-41656427.87628.11
3423425-42342528.33528.56
4400351-40035126.79127.01
5432424-43242428.93729.18
6433311-43331128.99729.23
1320min1402331-40233126.92328.534.7927.1828.794.78
2426440-42644028.53728.81
3430995-43099528.84229.11
4402512-40251226.93627.19
5449348-44934830.07030.35
6445955-44595529.84330.12
1440min1437501-43750129.27730.073.2429.5830.383.23
2449579-44957930.08530.40
3448106-44810629.98730.30
4429596-42959628.74829.05
5465561-46556131.15531.48
6465520-46552031.15231.47
极限1447164-44716429.92430.793.4030.2731.153.40
2456875-45687530.57330.93
3459747-45974730.76631.12
4440563-44056329.48229.82
5476223-47622331.86832.24
6480109-48010932.12832.50
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.661472405147178414696941467155146866714699410.15
210.611467869146575614668120.11
单位质量响应值RSD%判断
137893.15138248.070.19数据可信
长期24月-供试品溶液-2024041821批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min110290-102900.6881.2025.400.691.2025.40
223409-234091.5661.57
319246-192461.2881.29
416160-161601.0811.08
517574-175741.1761.18
621220-212201.4201.42
120min134386-343862.3003.1917.562.303.1917.55
243937-439372.9392.94
346925-469253.1393.14
447655-476553.1883.19
556936-569363.8093.81
656222-562223.7613.76
240min191992-919926.1546.757.036.166.757.02
2101467-1014676.7886.79
3105951-1059517.0887.09
492436-924366.1846.19
5104879-1048797.0167.02
6108547-1085477.2627.27
360min1158055-15805510.57411.285.0310.5911.305.03
2161029-16102910.77310.79
3178830-17883011.96311.98
4164650-16465011.01511.03
5175035-17503511.71011.73
6174009-17400911.64111.66
480min1218725-21872514.63215.062.4314.6615.102.43
2225451-22545115.08215.12
3232524-23252415.55515.59
4222092-22209214.85814.89
5221407-22140714.81214.85
6230580-23058015.42515.46
600min1236377-23637715.81316.373.3015.8616.423.30
2252944-25294416.92216.98
3241365-24136516.14716.21
4241819-24181916.17716.23
5239018-23901815.99016.05
6256392-25639217.15217.21
720min1285813-28581319.12019.012.9419.2019.092.93
2293610-29361019.64219.72
3280937-28093718.79418.88
4271351-27135118.15318.23
5280579-28057918.77018.85
6292489-29248919.56719.65
840min1337248-33724822.56121.972.8722.6722.082.85
2339953-33995322.74222.85
3332612-33261222.25122.36
4323446-32344621.63821.74
5317144-31714421.21621.33
6320467-32046721.43921.55
960min1362824-36282424.27224.272.8624.4124.422.84
2378231-37823125.30325.45
3361059-36105924.15424.30
4355476-35547623.78123.92
5349241-34924123.36423.51
6370313-37031324.77324.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1392075-39207526.22926.421.8326.4026.601.83
2407516-40751627.26227.44
3395160-39516026.43626.62
4390297-39029726.11026.28
5386959-38695925.88726.06
6398009-39800926.62626.81
1200min1410703-41070327.47527.461.7527.6927.681.75
2422078-42207828.23628.46
3408541-40854127.33127.55
4409193-40919327.37427.59
5399806-39980626.74626.96
6412143-41214327.57227.80
1320min1422220-42222028.24628.002.5628.5028.262.54
2430626-43062628.80829.07
3417143-41714327.90628.17
4404212-40421227.04127.30
5408605-40860527.33527.59
6428761-42876128.68328.95
1440min1442279-44227929.58829.381.8329.8829.681.82
2450437-45043730.13430.44
3436392-43639229.19429.50
4434251-43425129.05129.35
5427895-42789528.62528.92
6444066-44406629.70730.02
极限1450251-45025130.12129.951.4130.4630.291.41
2453950-45395030.36930.72
3447018-44701829.90530.25
4443151-44315129.64629.98
5437987-43798729.30129.64
6453743-45374330.35530.71
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