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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.051783191804311809861801941793801798620.58
210.071763901767601765750.15
单位质量响应值RSD%判断
17896.7217534.761.45数据可信
供试品溶液-2024011621批-依折麦布-shui(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%
5min155069-5506927.88728.0120.0027.8928.0020.00
261969-6196931.38131.38
365582-6558233.21133.21
457486-5748629.11129.11
557643-5764329.19029.19
634068-3406817.25217.25
10min1143334-14333472.58474.424.3972.7474.584.40
2143342-14334272.58872.76
3159988-15998881.01881.20
4145782-14578273.82473.99
5144481-14448173.16573.33
6144858-14485873.35673.45
15min1185124-18512493.74791.293.0494.3091.863.03
2179390-17939090.84391.42
3186819-18681994.60595.24
4176859-17685989.56190.13
5171944-17194487.07287.64
6181528-18152891.92692.43
20min1187130-18713094.76294.241.0195.8495.321.01
2183977-18397793.16694.25
3187827-18782795.11596.28
4183631-18363192.99194.06
5186195-18619594.28995.34
6187826-18782695.11596.13
30min1187727-18772795.06594.891.6396.6796.491.57
2188357-18835795.38496.98
3183726-18372693.03994.73
4188397-18839795.40496.99
5184174-18417493.26694.84
6191946-19194697.20198.74
45min1180679-18067991.49692.571.5193.6394.701.47
2182163-18216392.24794.38
3182883-18288392.61294.82
4186679-18667994.53496.65
5179260-17926090.77792.87
6185102-18510293.73695.82
60min1174087-17408788.15889.541.9390.8092.181.85
2173268-17326887.74390.39
3174834-17483488.53691.26
4179655-17965590.97793.62
5177183-17718389.72592.32
6181874-18187492.10194.70
极限1171256-17125686.72486.581.8889.8689.721.81
2169099-16909985.63288.76
3168611-16861185.38488.60
4175145-17514588.69391.84
5167353-16735384.74787.84
6174424-17442488.32891.44
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
110.773237073196783220573206963192903210860.57
210.713140733155343148040.33
单位质量响应值RSD%判断
29813.0029393.461.01数据可信
供试品溶液-2024011621批-阿托伐他汀钙-shui(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%
5min1144775-14477540.39845.1223.6340.4045.1223.63
2139466-13946638.91638.92
3191093-19109353.32253.32
4154239-15423943.03843.04
5222493-22249362.08462.08
6118102-11810232.95532.95
10min1292541-29254181.63086.094.0381.8586.344.07
2305570-30557085.26685.48
3313101-31310187.36787.66
4316305-31630588.26188.50
5326013-32601390.97091.31
6297651-29765183.05683.24
15min1331827-33182792.59292.721.0593.2793.451.03
2334328-33432893.29093.98
3337425-33742594.15494.94
4328470-32847091.65592.38
5328540-32854091.67592.53
6333138-33313892.95893.60
20min1337745-33774594.24494.691.2195.4495.941.21
2341143-34114395.19296.40
3340591-34059195.03896.34
4331821-33182192.59193.83
5342885-34288595.67897.04
6341968-34196895.42296.58
30min1344449-34444996.11496.072.2297.8397.842.12
2353179-35317998.550100.29
3338020-33802094.32096.15
4340193-34019394.92796.68
5336085-33608593.78095.67
6353727-35372798.703100.39
45min1341893-34189395.40196.471.7097.6598.781.61
2351908-35190898.196100.48
3346203-34620396.60498.96
4345375-34537596.37398.65
5336932-33693294.01796.43
6352069-35206998.241100.48
60min1341141-34114195.19196.651.8197.9799.491.74
2348667-34866797.291100.12
3342873-34287395.67498.57
4342804-34280495.65598.47
5344699-34469996.18499.12
6357945-35794599.880102.67
极限1342427-34242795.55095.231.8398.8698.611.72
2345605-34560596.43799.81
3336718-33671893.95797.38
4341278-34127895.22998.58
5332121-33212192.67496.14
6349553-34955397.538100.88
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.051723011718861721351721051718391720530.12
210.071719211716651717930.11
单位质量响应值RSD%判断
17119.7017059.880.25数据可信
供试品溶液-2024011621批-依折麦布-pH4.5(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%
5min136512-3651219.16527.5215.5919.1627.5215.60
256922-5692229.87829.88
354414-5441428.56228.56
452845-5284527.73827.74
554088-5408828.39028.39
659739-5973931.35731.36
10min1144592-14459275.89576.882.1576.0077.032.17
2146593-14659376.94677.11
3144403-14440375.79675.95
4143177-14317775.15375.31
5148259-14825977.82077.98
6151731-15173179.64379.82
15min1170471-17047189.47991.862.1790.0192.442.18
2177605-17760593.22493.82
3178822-17882293.86394.44
4173471-17347191.05491.63
5171129-17112989.82590.41
6178513-17851393.70094.32
20min1185965-18596597.61297.401.5298.6498.491.52
2184574-18457496.88297.99
3185570-18557097.40598.51
4181334-18133495.18196.26
5185822-18582297.53798.63
6190078-19007899.771100.91
30min1193160-193160101.389100.341.06102.96101.971.03
2187421-18742198.376100.03
3190490-19049099.987101.63
4191914-191914100.734102.34
5191941-191941100.749102.38
6191993-191993100.776102.47
45min1189927-18992799.69299.990.48101.82102.180.48
2191475-191475100.504102.70
3189063-18906399.238101.44
4191391-191391100.460102.63
5190530-190530100.008102.20
6190628-190628100.059102.31
60min1188557-18855798.97299.611.61101.66102.351.57
2184501-18450196.84399.60
3189211-18921199.316102.06
4191724-191724100.635103.36
5192342-192342100.959103.71
6192262-192262100.917103.72
极限1190049-19004999.75699.621.45102.99102.921.42
2189947-18994799.702102.99
3185421-18542197.326100.63
4189960-18996099.709102.99
5189307-18930799.366102.67
6194060-194060101.861105.23
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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%
110.773061383061693063733064023063753062910.05
210.713048833055423052120.16
单位质量响应值RSD%判断
28439.2828497.850.15数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH4.5(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%
5min1247276-24727671.74677.866.5771.7577.866.57
2265345-26534576.98976.99
3260627-26062775.62075.62
4260779-26077975.66475.66
5298146-29814686.50686.51
6278008-27800880.66380.66
10min1344531-34453199.964100.461.04100.36100.891.06
2341667-34166799.13399.56
3344482-34448299.950100.37
4346153-346153100.435100.85
5348695-348695101.172101.65
6351855-351855102.089102.54
15min1338938-33893898.34199.361.1699.30100.351.16
2343043-34304399.532100.51
3339891-33989198.61899.59
4343917-34391799.786100.76
5339512-33951298.50899.55
6349436-349436101.387102.40
20min1346339-346339100.48999.811.56101.99101.351.55
2340022-34002298.656100.19
3339492-33949298.502100.03
4339634-33963498.543100.08
5345550-345550100.260101.85
6352941-352941102.404103.98
30min1348593-348593101.14299.561.51103.20101.661.48
2335030-33503097.20799.29
3339683-33968398.557100.63
4346618-346618100.569102.65
5342196-34219699.286101.43
6346655-346655100.580102.73
45min1338946-33894698.34398.190.76100.96100.840.73
2340584-34058498.819101.44
3334696-33469697.11099.73
4341543-34154399.097101.74
5336401-33640197.605100.30
6338239-33823998.138100.84
60min1336194-33619497.54597.721.47100.71100.911.44
2328357-32835795.27198.44
3334712-33471297.115100.27
4341813-34181399.175102.36
5338981-33898198.354101.59
6340730-34073098.861102.11
极限1338219-33821998.13397.631.62101.84101.371.58
2337551-33755197.939101.64
3327886-32788695.13498.83
4337952-33795298.055101.80
5333258-33325896.693100.48
6344005-34400599.811103.61
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