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%
110.971822881827851831481830941826421827910.20
211.031845671853981849820.32
单位质量响应值RSD%判断
16662.8116770.810.46数据可信
长期3月-供试品溶液-2024030121批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167990-6799036.60552.1324.6636.6052.1224.67
268369-6836936.80936.81
3102203-10220355.02555.02
4103591-10359155.77255.77
5111759-11175960.16960.17
6127005-12700568.37868.38
10min1134474-13447472.39981.7410.6572.6082.0310.70
2132005-13200571.07071.27
3148496-14849679.94880.25
4160340-16034086.32586.63
5164989-16498988.82889.16
6170682-17068291.89392.27
15min1160191-16019186.24592.414.4686.8593.164.54
2167771-16777190.32690.92
3167743-16774390.31091.06
4175787-17578794.64195.43
5179219-17921996.48997.32
6179174-17917496.46597.36
20min1174356-17435693.87195.582.2394.9696.842.33
2174503-17450393.95095.05
3173637-17363793.48494.74
4178407-17840796.05297.37
5182047-18204798.01299.38
6182280-18228098.13799.56
30min1179448-17944896.61298.111.7498.2299.901.81
2181093-18109397.49899.12
3178645-17864596.18097.95
4183808-18380898.960100.81
5187192-187192100.782102.69
6183198-18319898.631100.60
45min1174467-17446793.93196.822.3796.0799.152.46
2176972-17697295.27997.44
3177298-17729895.45597.76
4182776-18277698.404100.80
5185713-18571399.985102.45
6181806-18180697.882100.40
60min1179585-17958596.68698.021.7299.35100.901.79
2182206-18220698.097100.79
3178079-17807995.87598.71
4181719-18171997.835100.78
5186860-186860100.603103.63
6183973-18397399.048102.11
极限1180329-18032997.08798.082.19100.29101.502.24
2181122-18112297.514100.75
3177025-17702595.30898.68
4180703-18070397.288100.78
5187200-187200100.786104.37
6186717-186717100.526104.14
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100590-202005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%
110.844226994240024247144245444232794238480.21
210.914288964303844296400.25
单位质量响应值RSD%判断
39100.3739380.380.51数据可信
长期3月-供试品溶液-2024030121批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1175370-17537040.02156.2324.3140.0256.2324.31
2174724-17472439.87439.87
3261206-26120659.61059.61
4260765-26076559.51059.51
5282057-28205764.36964.37
6324194-32419473.98573.98
10min1328495-32849574.96683.249.7775.1983.569.82
2319862-31986272.99673.22
3358410-35841081.79382.12
4381059-38105986.96287.29
5391176-39117689.27189.63
6409621-40962193.48093.89
15min1379265-37926586.55391.523.6787.1992.293.76
2393395-39339589.77790.40
3393839-39383989.87990.66
4407708-40770893.04493.86
5413917-41391794.46195.31
6417933-41793395.37796.31
20min1406140-40614092.68693.101.9293.8194.392.01
2400245-40024591.34192.47
3399746-39974691.22792.51
4407696-40769693.04194.37
5414448-41444894.58295.96
6419516-41951695.73897.20
30min1409099-40909993.36194.061.4595.0095.861.54
2407951-40795193.09994.73
3404559-40455992.32594.12
4414623-41462394.62296.47
5420646-42064695.99697.90
6416100-41610094.95996.95
45min1391719-39171989.39591.782.3291.5594.112.41
2393521-39352189.80691.96
3396418-39641890.46792.77
4408440-40844093.21195.58
5412676-41267694.17896.61
6410354-41035493.64896.17
60min1402837-40283791.93292.391.7294.5895.221.80
2400354-40035491.36594.01
3395835-39583590.33493.14
4404038-40403892.20695.10
5413932-41393294.46497.42
6412171-41217194.06297.10
极限1400490-40049091.39791.922.2094.5695.272.26
2397723-39772390.76593.92
3392386-39238689.54792.86
4398977-39897791.05194.45
5412414-41241494.11897.60
6414833-41483394.67098.23
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%
110.971852101860551862641862271864921860500.27
211.031850461859991855220.37
单位质量响应值RSD%判断
16959.8916819.760.59数据可信
长期3月-供试品溶液-2024030221批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179699-7969942.47047.0515.0942.4747.0515.09
272953-7295338.87538.87
394909-9490950.57550.57
497818-9781852.12552.12
577832-7783241.47541.47
6106581-10658156.79456.79
10min1135363-13536372.13176.547.7172.3776.807.72
2145670-14567077.62477.84
3152421-15242181.22181.50
4145390-14539077.47577.76
5126482-12648267.39967.63
6156497-15649783.39383.71
15min1163862-16386287.31888.474.2587.9589.164.27
2171609-17160991.44692.09
3169274-16927490.20290.93
4169230-16923090.17890.90
5152636-15263681.33681.94
6169576-16957690.36391.14
20min1172706-17270692.03191.832.1593.1593.012.15
2176619-17661994.11695.27
3175704-17570493.62894.86
4172628-17262891.98993.21
5166873-16687388.92289.98
6169462-16946290.30291.58
30min1179000-17900095.38494.931.0797.0296.620.99
2176487-17648794.04595.72
3177739-17773994.71396.47
4179625-17962595.71897.45
5180470-18047096.16897.72
6175545-17554593.54395.33
45min1184843-18484398.49895.462.00100.6697.671.92
2177547-17754794.61096.81
3181085-18108596.49698.78
4177415-17741594.54096.80
5179456-17945695.62797.71
6174474-17447492.97395.27
60min1181700-18170096.82395.501.2399.5398.251.20
2177691-17769194.68797.41
3180090-18009095.96598.78
4181492-18149296.71299.50
5177939-17793994.81997.44
6176406-17640694.00296.82
极限1184162-18416298.13597.221.40101.38100.491.37
2182821-18282197.421100.67
3186446-18644699.352102.70
4179893-17989395.86099.19
5181097-18109796.50299.64
6180226-18022696.03899.38
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100590-202005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%
110.844281814296424304774300474306754298040.24
210.914297154315334306240.30
单位质量响应值RSD%判断
39649.8239470.580.33数据可信
长期3月-供试品溶液-2024030221批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207996-20799647.08351.4514.7447.0851.4514.74
2190155-19015543.04443.04
3243625-24362555.14855.15
4251643-25164356.96356.96
5197345-19734544.67244.67
6273091-27309161.81861.82
10min1326793-32679373.97577.967.5674.2478.257.57
2352441-35244179.78080.02
3365406-36540682.71583.02
4347896-34789678.75179.07
5302005-30200568.36368.61
6371888-37188884.18284.53
15min1384705-38470587.08487.413.8087.7688.133.83
2395581-39558189.54690.23
3392474-39247488.84289.61
4394951-39495189.40390.16
5357242-35724280.86781.50
6391815-39181588.69389.50
20min1398882-39888290.29389.172.2191.4590.382.21
2400976-40097690.76791.95
3400821-40082190.73291.99
4396840-39684089.83191.08
5380715-38071586.18187.26
6385316-38531687.22288.53
30min1408893-40889392.55990.731.6294.2292.431.55
2393729-39372989.12690.81
3399076-39907690.33792.10
4405523-40552391.79693.55
5404271-40427191.51393.07
6393343-39334389.03990.83
45min1413045-41304593.49990.352.0395.6792.551.97
2393657-39365789.11091.29
3403973-40397391.44593.71
4395922-39592289.62391.88
5397274-39727489.92991.99
6390916-39091688.49090.77
60min1402065-40206591.01389.961.1793.7192.661.16
2391963-39196388.72791.40
3399483-39948390.42993.20
4402450-40245091.10193.86
5395907-39590789.62092.18
6392552-39255288.86091.63
极限1407857-40785792.32591.161.4895.5294.361.45
2403335-40333591.30194.47
3411220-41122093.08696.36
4400024-40002490.55193.82
5397862-39786290.06293.12
6395929-39592989.62492.89
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%
110.971841401846811851341854251854621849680.31
211.031873991884381879180.40
单位质量响应值RSD%判断
16861.2617036.990.74数据可信
长期3月-供试品溶液-2024030321批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177961-7796141.39840.2610.7041.4040.2610.71
272704-7270438.60738.61
368692-6869236.47636.48
491105-9110548.37848.38
573619-7361939.09339.09
670779-7077937.58537.58
10min1149915-14991579.60772.239.9079.8472.459.88
2131387-13138769.76869.98
3112347-11234759.65859.86
4135854-13585472.14172.41
5146816-14681677.96278.18
6139796-13979674.23474.44
15min1178503-17850394.78889.265.6195.4689.885.62
2166156-16615688.23188.83
3151425-15142580.40980.94
4170252-17025290.40691.08
5174999-17499992.92793.58
6167169-16716988.76989.39
20min1178014-17801494.52895.073.3195.7396.193.32
2171198-17119890.90992.00
3173560-17356092.16393.14
4182055-18205596.67497.85
5186879-18687999.236100.40
6182480-18248096.90098.01
30min1183594-18359497.49197.892.6399.2299.542.61
2180896-18089696.05997.66
3185520-18552098.514100.01
4183414-18341497.39699.10
5193215-193215102.600104.32
6179458-17945895.29596.95
45min1181908-18190896.59698.163.6198.86100.353.56
2183673-18367397.53399.66
3185697-18569798.608100.65
4187598-18759899.617101.87
5195203-195203103.656105.94
6175029-17502992.94395.13
60min1182577-18257796.95198.252.4599.75100.982.40
2182186-18218696.74499.42
3189176-189176100.455103.04
4184693-18469398.075100.88
5191650-191650101.769104.63
6179803-17980395.47898.18
极限1176925-17692593.95097.102.6897.29100.382.63
2179778-17977895.46598.68
3184687-18468798.072101.22
4184480-18448097.962101.31
5190783-190783101.309104.74
6180461-18046195.82899.06
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100590-202005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%
110.844269444279114293114300224300974288570.33
210.914339804363944351870.40
单位质量响应值RSD%判断
39562.4539888.820.59数据可信
长期3月-供试品溶液-2024030321批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202194-20219445.58044.029.9745.5844.029.97
2186591-18659142.06242.06
3175107-17510739.47339.47
4230869-23086952.04452.04
5190277-19027742.89342.89
6186729-18672942.09342.09
10min1359946-35994681.14173.409.8881.3973.659.86
2315469-31546971.11571.35
3268949-26894960.62860.85
4324571-32457173.16673.46
5350038-35003878.90779.15
6334778-33477875.46775.70
15min1413512-41351293.21687.845.3093.9288.495.32
2383804-38380486.51987.15
3355037-35503780.03480.59
4396863-39686389.46390.16
5405083-40508391.31691.99
6383715-38371586.49987.15
20min1406203-40620391.56892.242.9592.7993.382.96
2391778-39177888.31789.43
3401084-40108490.41491.42
4412987-41298793.09894.29
5425354-42535495.88597.07
6417754-41775494.17295.31
30min1412531-41253192.99593.342.7294.7394.992.68
2405991-40599191.52193.12
3420162-42016294.71596.22
4409234-40923492.25293.96
5433565-43356597.73699.45
6402846-40284690.81292.47
45min1404209-40420991.11993.112.6593.3795.282.61
2409580-40958092.33094.44
3415156-41515693.58795.62
4415768-41576893.72495.95
5432029-43202997.39099.65
6401512-40151290.51192.67
60min1400960-40096090.38676.4948.7493.1479.1847.18
2402310-40231090.69193.31
32220-22200.5003.05
4409289-40928992.26495.01
5422637-42263795.27398.07
6398534-39853489.84092.50
极限1392331-39233188.44191.192.5491.7094.302.48
2396332-39633289.34392.47
3407519-40751991.86594.42
4408923-40892392.18195.44
5420908-42090894.88398.21
6401098-40109890.41893.58
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%
110.971883721886481888281883731876791883800.24
211.031882601890221886410.29
单位质量响应值RSD%判断
17172.2917102.540.29数据可信
长期3月-供试品溶液-X024017批-依折麦布-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174703-7470339.23250.6916.7739.2350.6916.78
2111575-11157558.59658.60
397103-9710350.99551.00
4110223-11022357.88657.89
578775-7877541.37041.37
6106702-10670256.03756.04
10min1130468-13046868.51876.019.8368.7476.299.85
2154087-15408780.92281.25
3147484-14748477.45477.74
4162093-16209385.12685.45
5124965-12496565.62865.86
6149283-14928378.39978.71
15min1157091-15709182.49985.985.0183.1086.685.06
2168492-16849288.48789.26
3166977-16697787.69188.40
4175417-17541792.12492.92
5152975-15297580.33880.93
6161359-16135984.74185.49
20min1170177-17017789.37291.533.1090.4392.713.17
2175475-17547592.15493.42
3173210-17321090.96592.17
4182042-18204295.60396.91
5166971-16697187.68888.73
6177800-17780093.37594.59
30min1176151-17615192.50993.831.0494.0695.521.13
2179667-17966794.35696.13
3178317-17831793.64795.35
4181657-18165795.40197.24
5178073-17807393.51895.05
6178152-17815293.56095.30
45min1174691-17469191.74294.751.8793.8196.961.92
2182877-18287796.04198.34
3181340-18134095.23497.46
4184093-18409396.68099.05
5180981-18098195.04697.09
6178582-17858293.78696.04
60min1179817-17981794.43495.111.0497.0197.851.10
2181875-18187595.51598.35
3184094-18409496.68099.44
4181989-18198995.57598.48
5179235-17923594.12996.70
6179620-17962094.33197.11
极限1178266-17826693.62094.620.8996.7297.880.91
2180243-18024394.65898.03
3183063-18306396.13999.43
4179299-17929994.16297.60
5179936-17993694.49797.60
6180161-18016194.61597.92
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100590-202005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%
110.844359884364774369894360914343374359760.23
210.914356284371394363840.25
单位质量响应值RSD%判断
40219.1939998.530.39数据可信
长期3月-供试品溶液-X024017批-辛伐他汀-pH7.0SDS
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197002-19700243.98456.2316.2643.9856.2316.27
2288473-28847364.40764.41
3256661-25666157.30457.30
4286815-28681564.03764.04
5205312-20531245.84045.84
6276786-27678661.79861.80
10min1323606-32360672.25178.839.0972.5079.149.12
2373136-37313683.31083.67
3357493-35749379.81780.14
4394040-39404087.97788.33
5307406-30740668.63468.89
6362735-36273580.98881.33
15min1375856-37585683.91786.064.0684.5686.824.11
2393896-39389687.94588.77
3391839-39183987.48688.25
4407839-40783991.05891.90
5363377-36337781.13181.77
6380003-38000384.84385.64
20min1395315-39531588.26258.9976.8989.3760.2275.23
2402039-40203989.76391.07
3397737-39773788.80290.05
42009-20090.4491.80
5386170-38617086.22087.31
62052-20520.4581.72
30min1402019-40201989.75860.3776.8991.3661.9375.13
2404212-40421290.24892.06
3402723-40272389.91691.66
4409366-40936691.39992.75
52013-20130.4492.02
62011-20110.4491.72
45min12042-20420.45615.38237.402.5617.27210.47
22112-21120.4722.78
32154-21540.4812.72
42134-21340.4762.34
5402655-40265589.90091.47
62179-21790.4871.76
60min12164-21640.4830.491.582.592.4715.23
22247-22470.5022.81
32198-21980.4912.73
42217-22170.4952.36
52175-21750.4862.55
62245-22450.5011.77
极限12186-21860.4880.512.522.592.4915.33
22246-22460.5012.82
32340-23400.5222.77
42236-22360.4992.37
52320-23200.5182.59
62282-22820.5101.78
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