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对照品来源工作对照品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%
19.821674001664741671251669071668951669600.21
29.841679151684561681860.23
单位质量响应值RSD%判断
17002.0417092.070.38数据可信
长期24月-供试品溶液-2023121421批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144747-4474723.56527.7013.4523.5727.7013.44
257599-5759930.33430.33
348266-4826625.41925.42
456068-5606829.52729.53
562383-6238332.85332.85
646534-4653424.50624.51
10min1131329-13132969.16269.188.0569.2969.348.06
2140225-14022573.84774.02
3122943-12294364.74664.89
4127347-12734767.06567.23
5147083-14708377.45977.64
6119277-11927762.81562.95
15min1171845-17184590.49986.665.3691.0187.195.37
2169804-16980489.42590.00
3158839-15883983.65084.15
4157896-15789683.15383.69
5175179-17517992.25592.87
6153711-15371180.94981.43
20min1181665-18166595.67193.742.2396.6994.762.27
2177161-17716193.29994.37
3174895-17489592.10693.07
4175731-17573192.54693.54
5184093-18409396.95098.08
6174500-17450091.89892.83
30min1188792-18879299.42497.631.26100.9799.171.28
2185322-18532297.59799.19
3182608-18260896.16897.64
4182917-18291796.33097.84
5186458-18645898.19599.86
6186224-18622498.07299.52
45min1192130-192130101.18298.271.55103.28100.361.55
2185912-18591297.908100.04
3185155-18515597.50999.52
4184161-18416196.98599.03
5187174-18717498.572100.78
6185116-18511697.48899.48
60min1185094-18509497.47797.961.20100.14100.581.16
2186941-18694198.450101.13
3184704-18470497.27199.82
4183381-18338196.57599.16
5186108-18610898.011100.77
6189793-18979399.951102.48
极限1184858-18485897.35398.091.18100.56101.261.19
2187678-18767898.838102.06
3183926-18392696.86299.96
4184128-18412896.968100.09
5188756-18875699.405102.71
6188187-18818799.106102.19
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2500
标示量(mg)20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%
110.983071293056133051833070083065783063020.29
210.893077123087993082560.25
单位质量响应值RSD%判断
27896.3628306.341.04数据可信
长期24月-供试品溶液-2023121421批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178066-17806652.45367.5518.6152.4567.5518.61
2267359-26735978.75678.76
3194544-19454457.30757.31
4200604-20060459.09259.09
5272951-27295180.40480.40
6262371-26237177.28777.29
10min1287509-28750984.69290.655.1884.9891.025.23
2318520-31852093.82794.26
3306248-30624890.21290.53
4289799-28979985.36685.69
5321485-32148594.70095.15
6322890-32289095.11495.54
15min1308584-30858490.90094.993.4391.6695.873.49
2329747-32974797.13498.09
3323095-32309595.17595.99
4309246-30924691.09591.90
5333161-33316198.14099.11
6331066-33106697.52398.48
20min1315152-31515292.83596.472.6794.1097.882.73
2325646-32564695.92697.42
3328067-32806796.63997.99
4321617-32161794.73996.05
5336933-33693399.251100.77
6337537-33753799.429100.93
30min1325793-32579395.96997.051.3197.7598.991.38
2328131-32813196.65898.69
3330582-33058297.38099.27
4324298-32429895.52997.36
5331996-33199697.79699.87
6335980-33598098.970101.02
45min1327945-32794596.60396.831.1198.9299.311.13
2326014-32601496.03498.60
3332883-33288398.058100.48
4323625-32362595.33197.70
5332538-33253897.956100.57
6329288-32928896.99999.60
60min1322113-32211394.88596.701.7697.7499.721.81
2327958-32795896.60799.71
3332675-33267597.996100.97
4321374-32137494.66897.56
5329588-32958897.087100.24
6335991-33599198.973102.11
极限1323146-32314695.19096.841.4298.57100.401.51
2329719-32971997.126100.76
3328663-32866396.815100.33
4323571-32357195.31598.74
5334146-33414698.430102.13
6333287-33328798.177101.87
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对照品来源工作对照品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%
19.821670031672481671161671861671421671390.06
29.841701291702511701900.06
单位质量响应值RSD%判断
17020.2617295.731.14数据可信
长期24月-供试品溶液-2023121421批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155088-5508828.82523.5021.5028.8323.5021.50
251558-5155826.97826.98
328473-2847314.89914.90
439386-3938620.60920.61
548914-4891425.59525.59
646036-4603624.08924.09
10min1132348-13234869.25263.4710.0369.4163.6010.04
2115131-11513160.24360.39
3100649-10064952.66652.75
4125574-12557465.70865.82
5132876-13287669.52969.67
6121218-12121863.42863.56
15min1166734-16673487.24583.115.6987.7983.605.72
2155090-15509081.15281.64
3144320-14432075.51775.89
4164008-16400885.81986.30
5167752-16775287.77888.31
6155110-15511081.16381.65
20min1179550-17955093.95191.983.1794.9892.923.22
2175641-17564191.90692.84
3165605-16560586.65487.45
4179627-17962793.99194.95
5180182-18018294.28295.30
6174094-17409491.09692.03
30min1185500-18550097.06597.731.2898.6299.191.31
2187437-18743798.07899.52
3183454-18345495.99497.27
4190687-19068799.779101.26
5186540-18654097.60999.15
6187008-18700897.85499.30
45min1188856-18885698.82199.091.36100.91101.091.32
2189270-18927099.037101.03
3189588-18958899.204101.01
4194041-194041101.534103.57
5186306-18630697.48699.57
6188206-18820698.481100.47
60min1187526-18752698.12598.811.20100.76101.361.10
2187817-18781798.277100.82
3192720-192720100.842103.20
4190429-19042999.644102.24
5187074-18707497.888100.51
6187409-18740998.063100.60
极限1186010-18601097.33197.861.11100.52100.961.02
2187191-18719197.949101.04
3189421-18942199.116102.04
4189075-18907598.935102.09
5183881-18388196.21799.38
6186489-18648997.582100.66
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2500
标示量(mg)20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%
110.983065073061903060263060033060973061650.07
210.893095323093863094590.04
单位质量响应值RSD%判断
27883.8828416.801.34数据可信
长期24月-供试品溶液-2023121421批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1259821-25982176.40572.1210.7876.4172.1210.78
2257436-25743675.70475.70
3198199-19819958.28458.28
4257500-25750075.72375.72
5268416-26841678.93378.93
6230034-23003467.64667.65
10min1321137-32113794.43793.822.4494.8694.222.45
2312241-31224191.82092.24
3316575-31657593.09593.42
4332282-33228297.71498.13
5321056-32105694.41394.85
6310888-31088891.42391.80
15min1329911-32991197.01797.961.3197.9798.881.31
2332118-33211897.66698.60
3336234-33623498.87699.72
4340135-340135100.023100.99
5332062-33206297.64998.61
6328267-32826796.53397.42
20min1331038-33103897.34898.681.1998.84100.151.19
2334140-33414098.26099.73
3337227-33722799.168100.56
4342604-342604100.749102.27
5334860-33486098.47299.98
6333532-33353298.08299.50
30min1328093-32809396.48298.851.5798.51100.861.55
2336133-33613398.846100.87
3338392-33839299.511101.45
4343994-343994101.158103.24
5333495-33349598.071100.12
6336666-33666699.003100.97
45min1331688-33168897.53998.591.60100.10101.151.58
2333227-33322797.992100.56
3339273-33927399.770102.26
4344205-344205101.220103.86
5330251-33025197.11799.71
6332955-33295597.912100.43
60min1328936-32893696.73098.111.8399.84101.221.77
2329706-32970696.956100.07
3343936-343936101.141104.19
4338330-33833099.492102.70
5330192-33019297.099100.24
6330679-33067997.243100.30
极限1326357-32635795.97297.081.3599.62100.741.32
2327865-32786596.415100.07
3335677-33567798.712102.32
4335819-33581998.754102.51
5326271-32627195.94699.62
6328854-32885496.706100.30
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对照品来源工作对照品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%
19.821698121704541701591701291703821701870.15
29.841695831702281699060.27
单位质量响应值RSD%判断
17330.6517266.870.27数据可信
长期24月-供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145945-4594523.84421.8917.8223.8421.8917.82
246580-4658024.17424.17
336731-3673119.06219.06
434901-3490118.11318.11
553286-5328627.65427.65
635635-3563518.49318.49
10min1117826-11782661.14861.449.3961.2861.569.40
2129651-12965167.28567.42
3109121-10912156.63056.74
4106019-10601955.02155.12
5133646-13364669.35869.51
6114084-11408459.20659.31
15min1156367-15636781.15081.735.5781.6282.195.60
2168468-16846887.43087.94
3152930-15293079.36679.79
4145945-14594575.74176.15
5167248-16724886.79787.34
6153923-15392379.88180.31
20min1171752-17175289.13488.753.3690.0689.673.41
2176758-17675891.73292.73
3167817-16781787.09287.95
4163792-16379285.00385.83
5178488-17848892.63093.65
6167470-16747086.91287.79
30min1180841-18084193.85194.581.2995.2795.991.33
2182874-18287494.90696.41
3178714-17871492.74794.09
4183223-18322395.08796.39
5185671-18567196.35897.89
6182191-18219194.55295.91
45min1184473-18447395.73695.950.4897.6897.880.45
2184268-18426895.62997.66
3184758-18475895.88497.74
4186560-18656096.81998.65
5185064-18506496.04398.11
6184160-18416095.57397.46
60min1185816-18581696.43396.050.9398.9098.510.86
2182472-18247294.69797.26
3183727-18372795.34997.74
4186229-18622996.64799.01
5185095-18509596.05998.66
6187093-18709397.09699.51
极限1183330-18333095.14395.600.9498.1598.600.88
2181877-18187794.38997.48
3184333-18433395.66398.59
4184314-18431495.65398.56
5184231-18423195.61098.75
6187166-18716697.133100.09
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2500
标示量(mg)20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%
110.983099683104133103633103353102073102570.06
210.893104793119433112110.34
单位质量响应值RSD%判断
28256.5628577.690.80数据可信
长期24月-供试品溶液-2023121621批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1243539-24353970.94167.908.1170.9467.908.11
2206455-20645560.13960.14
3217510-21751063.35963.36
4235810-23581068.69068.69
5259710-25971075.65175.65
6235500-23550068.59968.60
10min1312000-31200090.88389.284.0491.2889.664.06
2283274-28327482.51582.85
3306688-30668889.33689.69
4309818-30981890.24790.63
5320118-32011893.24893.67
6307137-30713789.46689.85
15min1327637-32763795.43894.392.0296.3495.262.05
2311653-31165390.78291.57
3323268-32326894.16595.01
4324141-32414194.42095.30
5327535-32753595.40896.35
6329910-32991096.10096.98
20min1331396-33139696.53395.221.6397.9696.621.66
2317405-31740592.45793.75
3325577-32557794.83896.21
4325788-32578894.89996.31
5330124-33012496.16297.63
6331081-33108196.44197.85
30min1329950-32995096.11296.191.6398.0898.121.65
2321295-32129593.59195.40
3327518-32751895.40397.30
4333739-33373997.21599.15
5332126-33212696.74698.75
6336631-33663198.058100.01
45min1330263-33026396.20395.701.4398.7098.161.43
2320693-32069393.41595.75
3331355-33135596.52198.95
4331754-33175496.63799.11
5324913-32491394.64497.18
6332271-33227196.78899.28
60min1329816-32981696.07395.611.5099.1198.601.51
2321169-32116993.55496.40
3327548-32754895.41298.38
4329876-32987696.09099.10
5325243-32524394.74197.81
6335706-33570697.788100.82
极限1323819-32381994.32694.841.3697.8998.361.35
2322177-32217793.84897.22
3324356-32435694.48297.98
4326968-32696895.24398.79
5322219-32221993.86097.45
6333861-33386197.251100.82
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对照品来源工作对照品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%
19.821692471690471691381697111697651693820.20
29.841699121716361707740.72
单位质量响应值RSD%判断
17248.6817355.080.44数据可信
长期24月-供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123377-2337712.13021.7335.4412.1321.7335.44
261827-6182732.08132.08
344748-4474823.21923.22
433424-3342417.34317.34
555637-5563728.86928.87
632288-3228816.75416.75
10min1105833-10583354.91563.2011.0754.9863.3211.11
2138357-13835771.79171.97
3133452-13345269.24569.37
4110118-11011857.13857.23
5128859-12885966.86267.02
6114226-11422659.26959.36
15min1155935-15593580.91183.623.3681.2884.103.42
2168238-16823887.29587.87
3161918-16191884.01684.53
4153707-15370779.75580.17
5162801-16280184.47485.01
6164375-16437585.29185.71
20min1176480-17648091.57291.281.7392.3992.221.75
2179753-17975393.27094.33
3173083-17308389.80990.79
4172046-17204689.27190.13
5175483-17548391.05492.06
6178709-17870992.72893.62
30min1184938-18493895.96095.851.3197.2997.291.33
2187384-18738497.23098.81
3181241-18124194.04295.52
4182486-18248694.68896.04
5185663-18566396.33797.84
6186656-18665696.85298.26
45min1188225-18822597.66695.731.3699.5397.701.34
2185125-18512596.05898.18
3182472-18247294.68196.68
4181009-18100993.92295.80
5184780-18478095.87897.92
6185326-18532696.16298.11
60min1187554-18755497.31896.561.3799.7299.071.36
2187938-18793897.517100.17
3182378-18237894.63297.16
4183693-18369395.31497.72
5186283-18628396.65899.23
6188768-18876897.948100.43
极限1187013-18701397.03796.251.2199.9899.291.12
2182657-18265794.77797.97
3183079-18307994.99698.05
4186844-18684496.94999.88
5188093-18809397.598100.71
6185283-18528396.13999.17
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2500
标示量(mg)20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%
110.983099753093873100733101963105863100430.15
210.893109733146963128340.85
单位质量响应值RSD%判断
28237.0728726.721.22数据可信
长期24月-供试品溶液-2023121621批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1180567-18056752.48064.9113.9252.4864.9113.92
2276387-27638780.33080.33
3229658-22965866.74866.75
4221154-22115464.27764.28
5211822-21182261.56461.56
6220397-22039764.05764.06
10min1306900-30690089.19890.102.2889.4990.462.29
2316292-31629291.92892.37
3316646-31664692.03092.40
4298901-29890186.87387.23
5306721-30672189.14689.49
6314540-31454091.41891.77
15min1322412-32241293.70694.221.9694.4995.081.95
2323237-32323793.94694.90
3326238-32623894.81895.70
4313066-31306690.99091.83
5329669-32966995.81596.65
6330387-33038796.02496.89
20min1331915-33191596.46895.651.3997.7897.031.36
2325965-32596594.73996.22
3329213-32921395.68397.09
4321821-32182193.53594.88
5334500-33450097.22098.59
6331098-33109896.23197.63
30min1330292-33029295.99796.171.2997.8498.091.28
2328911-32891195.59597.60
3331186-33118696.25698.20
4324590-32459094.33996.20
5337351-33735198.04899.96
6333019-33301996.78998.72
45min1330951-33095196.18895.201.5298.5797.651.50
2328233-32823395.39897.93
3326951-32695195.02697.50
4318403-31840392.54194.93
5332739-33273996.70899.16
6328088-32808895.35697.83
60min1329813-32981395.85795.461.2798.7798.441.25
2327961-32796195.31998.39
3324611-32461194.34597.35
4322820-32282093.82596.73
5333615-33361596.96299.95
6331816-33181696.43999.44
极限1327463-32746395.17495.251.4798.6298.761.40
2321229-32122993.36296.96
3327104-32710495.07098.60
4327915-32791595.30698.73
5336186-33618697.710101.24
6326513-32651394.89898.43
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