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%
111.331921261927021913311905051895951912520.65
211.381950951943371947160.28
单位质量响应值RSD%判断
16880.1417110.370.96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%
5min138634-3863420.40919.0931.3320.4119.0831.32
255361-5536129.24529.24
323010-2301012.15512.16
439509-3950920.87120.87
532240-3224017.03117.03
628022-2802214.80314.80
10min1124890-12489065.97461.3913.5766.0961.5013.60
2137237-13723772.49772.66
398283-9828351.91951.99
4127671-12767167.44367.56
5103453-10345354.65054.74
6105717-10571755.84655.93
15min1160178-16017884.61680.657.8785.1081.097.92
2168572-16857289.05089.62
3147229-14722977.77578.13
4159889-15988984.46384.95
5137636-13763672.70873.11
6142465-14246575.25975.65
20min1172986-17298691.38288.254.5792.3389.154.63
2174318-17431892.08593.15
3163365-16336586.29987.09
4174008-17400891.92192.88
5157059-15705982.96883.77
6160668-16066884.87485.69
30min1169516-16951689.54991.281.9291.0192.661.97
2175954-17595492.94994.52
3174775-17477592.32793.59
4176584-17658493.28294.75
5169910-16991089.75791.02
6170032-17003289.82191.10
45min1176803-17680393.39893.391.5095.3595.281.59
2180752-18075295.48497.57
3177486-17748693.75995.54
4177790-17779093.91995.91
5173030-17303091.40593.17
6174865-17486592.37494.16
60min1176811-17681193.40293.760.8595.8896.180.86
2178899-17889994.50597.12
3176416-17641693.19395.49
4176680-17668093.33395.84
5176329-17632993.14895.42
6179851-17985195.00897.30
极限1177452-17745293.74194.711.0996.7397.640.93
2177868-17786893.96197.10
3180585-18058595.39698.21
4177784-17778493.91696.95
5182337-18233796.32199.11
6179718-17971894.93897.76
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%
110.983052903075533053513041683023403049400.63
210.963103493099073101280.11
单位质量响应值RSD%判断
27772.3128296.351.33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%
5min1246481-24648172.78266.789.6972.7866.789.69
2196735-19673558.09358.09
3211014-21101462.30962.31
4253890-25389074.97074.97
5216752-21675264.00464.00
6231975-23197568.49968.50
10min1304231-30423189.83588.832.4590.2489.202.48
2294168-29416886.86487.19
3295028-29502887.11787.46
4313568-31356892.59293.01
5296525-29652587.56087.92
6301500-30150089.02989.41
15min1311773-31177392.06292.001.0692.9792.871.09
2308244-30824491.02091.83
3307328-30732890.75091.58
4315960-31596093.29894.23
5312213-31221392.19293.03
6313913-31391392.69493.57
20min1317432-31743293.73393.532.3395.1594.902.34
2306191-30619190.41491.72
3309400-30940091.36192.70
4324544-32454495.83397.28
5321685-32168594.98996.34
6321167-32116794.83696.23
30min1299496-29949688.43792.523.2190.3794.413.16
2303473-30347389.61191.42
3313995-31399592.71894.56
4319355-31935594.30196.28
5326059-32605996.28098.16
6317488-31748893.75095.67
45min1309165-30916591.29292.991.4993.7295.401.48
2310590-31059091.71394.02
3314466-31446692.85795.21
4318288-31828893.98696.49
5321639-32163994.97597.39
6315391-31539193.13095.57
60min1308694-30869491.15393.112.2794.0996.042.25
2307723-30772390.86693.69
3312070-31207092.15095.02
4316197-31619793.36896.40
5325158-32515896.01498.96
6322118-32211895.11798.07
极限1311391-31139191.94994.081.7895.3997.531.73
2317456-31745693.74097.07
3317968-31796893.89197.28
4317605-31760593.78497.33
5328840-32884097.102100.58
6318470-31847094.04097.52
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%
111.331937651937091935611937211937601937030.05
211.381948541941201944870.27
单位质量响应值RSD%判断
17096.4717090.250.03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%
5min140974-4097421.52021.0723.4621.5221.0723.45
235257-3525718.51718.52
330516-3051616.02716.03
431486-3148616.53716.54
549582-4958226.04126.04
652839-5283927.75127.75
10min1119835-11983562.93863.1112.1463.0663.2312.15
2134171-13417170.46770.57
3106677-10667756.02756.12
4103195-10319554.19854.29
5117223-11722361.56661.71
6139874-13987473.46273.62
15min1154470-15447081.12881.446.8981.6081.916.92
2163679-16367985.96586.46
3144777-14477776.03776.44
4148471-14847177.97878.37
5147115-14711577.26577.75
6171899-17189990.28290.84
20min1164460-16446086.37587.134.3587.2988.054.39
2170937-17093789.77790.75
3156234-15623482.05582.88
4165871-16587187.11687.94
5161188-16118884.65785.57
6176685-17668592.79693.86
30min1167387-16738787.91292.203.7289.3193.603.75
2177139-17713993.03494.50
3170123-17012389.34990.63
4176686-17668692.79694.11
5175799-17579992.33093.72
6186171-18617197.77899.36
45min1176369-17636992.63093.981.8194.5295.901.88
2182812-18281296.01498.00
3174594-17459491.69793.47
4178240-17824093.61295.44
5179416-17941694.23096.13
6182206-18220695.69597.82
60min1175903-17590392.38594.141.7494.7996.581.81
2179546-17954694.29896.82
3176681-17668192.79495.08
4178679-17867993.84396.19
5180022-18002294.54896.97
6184661-18466196.98599.64
极限1178481-17848193.73994.811.6996.6597.771.76
2181396-18139695.27098.31
3176737-17673792.82395.62
4178695-17869593.85196.72
5183237-18323796.23799.18
6184552-18455296.927100.12
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%
110.983085843084843084183082743083433084210.04
210.963097883093383095630.11
单位质量响应值RSD%判断
28089.3428244.800.40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%
5min1234258-23425868.84271.394.5668.8471.394.56
2233842-23384268.71968.72
3239293-23929370.32170.32
4236144-23614469.39669.40
5256200-25620075.29075.29
6257771-25777175.75175.75
10min1295382-29538286.80488.321.6587.1988.711.64
2303103-30310389.07389.45
3293414-29341486.22686.62
4305758-30575889.85390.24
5302094-30209488.77789.19
6303399-30339989.16089.58
15min1305939-30593989.90692.112.4390.7792.992.42
2313935-31393592.25693.13
3302697-30269788.95489.82
4322147-32214794.67095.55
5318119-31811993.48694.40
6317745-31774593.37694.29
20min1308429-30842990.63892.312.9792.0093.702.95
2314388-31438892.38993.78
3300126-30012688.19889.56
4326834-32683496.04797.46
5320649-32064994.22995.66
6314212-31421292.33893.77
30min1303459-30345989.17893.062.9791.0594.972.95
2315752-31575292.79094.69
3307930-30793090.49292.35
4327135-32713596.13598.08
5324141-32414195.25597.21
6321558-32155894.49696.44
45min1316448-31644892.99593.521.6895.3695.951.67
2322928-32292894.89997.32
3311331-31133191.49193.85
4324124-32412495.25097.73
5321257-32125794.40896.89
6313253-31325392.05694.53
60min1316228-31622892.93093.351.0095.8196.301.03
2316755-31675593.08596.03
3313047-31304791.99594.86
4322084-32208494.65197.66
5320152-32015294.08397.09
6317643-31764393.34696.33
极限1319974-31997494.03193.651.7897.4397.121.77
2316494-31649493.00896.47
3308227-30822790.57993.95
4321665-32166594.52898.06
5322539-32253994.78598.32
6323170-32317094.97098.47
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%
111.331940161937581928031923431921711930180.44
211.381941621942511942060.04
单位质量响应值RSD%判断
17036.0117065.550.13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%
5min148995-4899525.79720.4626.8225.8020.4626.83
250667-5066726.67726.68
328504-2850415.00815.01
425419-2541913.38413.38
537425-3742519.70519.70
642094-4209422.16322.16
10min1126764-12676466.74358.758.6066.8958.878.62
2112190-11219059.07059.22
398474-9847451.84851.93
4111263-11126358.58258.66
5105185-10518555.38255.49
6115638-11563860.88561.01
15min1153728-15372880.94076.923.4381.4577.363.45
2142428-14242874.99175.47
3143285-14328575.44275.81
4146556-14655677.16477.56
5140596-14059674.02674.44
6149989-14998978.97279.43
20min1169868-16986889.43885.432.4990.4086.302.51
2158968-15896883.69984.59
3160301-16030184.40185.19
4163547-16354786.11086.94
5160697-16069784.61085.44
6160139-16013984.31685.22
30min1174186-17418691.71290.951.2593.1792.301.23
2169126-16912689.04890.41
3173327-17332791.25992.52
4171499-17149990.29791.60
5175154-17515492.22193.52
6173186-17318691.18592.55
45min1183479-18347996.60592.502.4598.5794.352.45
2174720-17472091.99393.85
3175196-17519692.24394.01
4172874-17287491.02192.83
5176808-17680893.09294.90
6171077-17107790.07591.95
60min1178756-17875694.11894.271.0596.6296.630.99
2176125-17612592.73395.10
3180503-18050395.03897.32
4180364-18036494.96597.28
5180844-18084495.21797.55
6177681-17768193.55295.93
极限1179652-17965294.59094.091.4497.6296.981.38
2177151-17715193.27396.15
3182026-18202695.84098.65
4178491-17849193.97896.82
5180217-18021794.88797.74
6174679-17467991.97194.87
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%
110.983084053073563058013054713049513063970.47
210.963088063097023092540.21
单位质量响应值RSD%判断
27905.0128216.610.79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%
5min1237606-23760670.09165.0812.0470.0965.0812.04
2217185-21718564.06764.07
3205870-20587060.73060.73
4176276-17627652.00052.00
5242734-24273471.60471.60
6244118-24411872.01272.01
10min1305739-30573990.19088.722.6390.5889.082.67
2297653-29765387.80588.16
3292053-29205386.15386.49
4293494-29349486.57886.87
5302661-30266189.28289.68
6312846-31284692.28792.69
15min1307302-30730290.65191.661.7591.5492.511.77
2310851-31085191.69892.54
3310253-31025391.52292.34
4305336-30533690.07190.84
5309664-30966491.34892.24
6320928-32092894.67195.58
20min1315082-31508292.94692.600.9194.3493.960.94
2312523-31252392.19193.54
3310095-31009591.47592.80
4314319-31431992.72193.99
5312930-31293092.31193.71
6318554-31855493.97095.41
30min1309712-30971291.36293.222.0493.2795.102.05
2312997-31299792.33194.20
3315682-31568293.12394.96
4311498-31149891.88993.67
5318839-31883994.05495.97
6327433-32743396.59098.55
45min1322253-32225395.06192.981.5097.4895.381.51
2317292-31729293.59895.98
3312237-31223792.10794.46
4309085-30908591.17793.47
5312773-31277392.26594.70
6317514-31751493.66496.16
60min1312802-31280292.27494.471.5495.2297.381.52
2319328-31932894.19997.10
3320186-32018694.45297.31
4321214-32121494.75597.56
5319742-31974294.32197.27
6328220-32822096.82299.84
极限1313850-31385092.58393.730.9796.0497.170.93
2318271-31827193.88797.31
3322479-32247995.12898.51
4317134-31713493.55196.88
5315330-31533093.01996.49
6319448-31944894.23497.79
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