依折麦布阿托伐他汀片项目信息
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%
19.721617381618701618911619601619341618790.06
29.851633421639531636480.27
单位质量响应值RSD%判断
16654.2216614.010.18数据可信
供试品溶液-B25010111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%
5min139738-3973821.44728.3138.4121.4528.3238.42
233301-3330117.97317.97
345976-4597624.81324.81
477930-7793042.05942.06
539853-3985321.50921.51
677978-7797842.08542.09
10min1124963-12496367.44374.4012.8867.5674.5612.93
2129313-12931369.79169.89
3126715-12671568.38968.53
4160541-16054186.64586.88
5124764-12476467.33667.46
6160794-16079486.78187.02
15min1166195-16619589.69692.585.6490.1993.155.72
2167982-16798290.66191.15
3160053-16005386.38186.90
4181617-18161798.02098.73
5168299-16829990.83291.33
6185046-18504699.870100.59
20min1177356-17735695.72097.002.6896.7198.092.78
2179773-17977397.02498.02
3173227-17322793.49194.49
4185266-18526699.989101.25
5177404-17740495.74696.74
6185368-185368100.044101.31
30min1181568-18156897.99398.901.1699.52100.531.24
2185721-185721100.235101.76
3180951-18095197.66099.18
4184680-18468099.673101.49
5181537-18153797.97699.51
6185061-18506199.878101.70
45min1181535-18153597.97599.671.34100.04101.841.38
2187577-187577101.236103.32
3185414-185414100.069102.13
4185755-185755100.253102.62
5181740-18174098.086100.16
6186033-186033100.403102.78
60min1184045-18404599.330100.590.86101.94103.320.80
2187921-187921101.422104.07
3187320-187320101.098103.71
4185875-185875100.318103.24
5187958-187958101.442104.06
6185211-18521199.959102.90
极限1181872-18187298.15799.331.47101.32102.621.39
2186960-186960100.903104.12
3187857-187857101.387104.56
4183388-18338898.975102.46
5181534-18153497.975101.16
6182700-18270098.604102.10
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406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%
110.531443101445151446761445001444341444870.10
210.541457271462911460090.28
单位质量响应值RSD%判断
13721.4613852.850.68数据可信
供试品溶液-B25010111批-阿托伐他汀-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%
5min171612-7161242.99565.1426.3242.9965.1426.32
2124025-12402574.46374.46
3126785-12678576.12076.12
4128432-12843277.10977.11
571792-7179243.10343.10
6128356-12835677.06377.06
10min1130908-13090878.59586.507.1478.8386.867.22
2149784-14978489.92890.34
3153928-15392892.41692.84
4149349-14934989.66790.10
5131068-13106878.69178.93
6149387-14938789.69090.12
15min1145227-14522787.19293.203.3587.8794.053.42
2156953-15695394.23295.15
3160616-16061696.43197.37
4156116-15611693.73094.66
5156580-15658094.00894.68
6155954-15595493.63294.56
20min1150305-15030590.24193.192.8191.4094.552.91
2158442-15844295.12696.56
3161170-16117096.76498.24
4155757-15575793.51494.96
5150247-15024790.20691.40
6155380-15538093.28894.73
30min1154052-15405292.49093.351.8094.1595.231.84
2157372-15737294.48496.45
3160301-16030196.24298.25
4153307-15330792.04394.01
5154364-15436492.67894.38
6153501-15350192.16094.12
45min1154445-15444592.72693.581.6494.9095.981.70
2157708-15770894.68597.18
3160276-16027696.22798.77
4154176-15417692.56595.04
5154597-15459792.81895.03
6154045-15404592.48694.96
60min1156323-15632393.85493.981.4196.5496.901.41
2157061-15706194.29797.31
3160283-16028396.23199.31
4154549-15454992.78995.78
5156867-15686794.18196.91
6154112-15411292.52695.52
极限1154914-15491493.00893.781.2596.2297.221.34
2156870-15687094.18297.72
3159834-15983495.96299.58
4155579-15557993.40796.92
5154631-15463192.83896.09
6155374-15537493.28496.79
依折麦布阿托伐他汀片项目信息
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%
19.721626881636591632281634521636591633370.25
29.851621281627531624400.28
单位质量响应值RSD%判断
16804.2216491.371.33数据可信
供试品溶液-B25010111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%
5min121487-2148711.58816.5027.2811.5916.5027.27
230394-3039416.39216.39
334214-3421418.45218.45
440204-4020421.68221.68
519929-1992910.74810.75
637394-3739420.16720.17
10min186420-8642046.60761.3013.7646.6761.4013.77
2115546-11554662.31562.41
3106914-10691457.66057.76
4127022-12702268.50468.62
5116874-11687463.03163.09
6129250-12925069.70669.82
15min1142189-14218976.68485.866.1677.0186.296.19
2163189-16318988.00988.45
3153571-15357182.82283.24
4164012-16401288.45388.95
5162628-16262887.70788.12
6169578-16957891.45591.95
20min1165832-16583289.43594.493.3890.1895.403.44
2175203-17520394.48895.41
3174326-17432694.01594.90
4176588-17658895.23596.23
5174921-17492194.33695.23
6184372-18437299.433100.44
30min1176835-17683595.36999.252.2596.61100.682.33
2183793-18379399.121100.57
3185096-18509699.824101.23
4185587-185587100.089101.61
5183369-18336998.892100.31
6189497-189497102.197103.76
45min1186037-186037100.331100.941.80102.11102.931.82
2186030-186030100.328102.33
3189679-189679102.295104.26
4185799-185799100.203102.28
5182978-18297898.682100.65
6192499-192499103.816105.94
60min1185208-18520899.884100.651.76102.22103.201.77
2184341-18434199.417101.98
3189147-189147102.009104.54
4183804-18380499.127101.76
5185174-18517499.866102.38
6192075-192075103.588106.29
极限1182280-18228098.305101.052.25101.19104.162.28
2185122-18512299.838102.95
3191783-191783103.430106.53
4185981-185981100.301103.49
5185859-185859100.235103.31
6193165-193165104.175107.46
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406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%
110.531450761458491449361451941451111452330.25
210.541451781451821451800.01
单位质量响应值RSD%判断
13792.3113774.190.10数据可信
供试品溶液-B25010111批-阿托伐他汀-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%
5min1113889-11388968.39565.4415.0768.4065.4415.07
2126882-12688276.19876.20
378614-7861447.21147.21
4116183-11618369.77369.77
5112890-11289067.79567.80
6105346-10534663.26563.26
10min1142943-14294385.84384.755.6086.2285.125.62
2146712-14671288.10788.53
3130863-13086378.58978.85
4141156-14115684.77085.16
5151707-15170791.10691.48
6133390-13339080.10680.46
15min1151632-15163291.06191.183.0691.9292.023.07
2154800-15480092.96493.88
3151795-15179591.15991.86
4150712-15071290.50991.37
5157960-15796094.86295.74
6144097-14409786.53687.33
20min1155879-15587993.61293.681.7594.9795.021.74
2154756-15475692.93794.37
3157993-15799394.88196.09
4155731-15573193.52394.88
5159772-15977295.95097.36
6151857-15185791.19692.47
30min1154441-15444192.74894.331.7694.6396.191.75
2155649-15564993.47495.42
3158180-15818094.99496.73
4158971-15897195.46997.35
5161035-16103596.70898.65
6154172-15417292.58794.37
45min1158930-15893095.44494.920.6197.8497.300.53
2156709-15670994.11096.58
3159014-15901495.49497.75
4158376-15837695.11197.52
5157106-15710694.34996.83
6158200-15820095.00697.30
60min1157316-15731694.47594.700.6097.4097.620.56
2156825-15682594.18097.17
3158071-15807194.92897.72
4156558-15655894.02096.96
5158776-15877695.35298.36
6158611-15861195.25298.08
极限1155698-15569893.50396.422.4296.9699.852.29
2160094-16009496.14399.65
3160615-16061596.45699.77
4159009-15900995.49198.95
5160339-16033996.29099.82
6167529-167529100.608103.96
依折麦布阿托伐他汀片项目信息
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%
19.721630841637681639671638571636411636630.22
29.851622351630971626660.38
单位质量响应值RSD%判断
16837.7616514.311.38数据可信
供试品溶液-B25010311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%
5min134523-3452318.58734.5661.1918.5934.5661.18
278742-7874242.39542.39
3118059-11805963.56363.56
497625-9762552.56152.56
527667-2766714.89614.90
628578-2857815.38615.39
10min1126727-12672768.23076.4619.1168.3376.6519.21
2161212-16121286.79687.03
3174974-17497494.20694.56
4160990-16099086.67786.97
5108014-10801458.15558.24
6120157-12015764.69264.78
15min1166057-16605789.40591.886.6189.8992.506.77
2176931-17693195.25995.98
3184158-18415899.150100.03
4178694-17869496.20896.98
5153629-15362982.71483.12
6164478-16447888.55589.00
20min1178326-17832696.01096.733.0596.9997.863.23
2179389-17938996.58397.83
3188032-188032101.236102.66
4183341-18334198.710100.02
5172245-17224592.73693.60
6176686-17668695.12796.06
30min1181540-18154097.74198.511.6199.25100.171.78
2183861-18386198.990100.77
3185864-185864100.069102.06
4185559-18555999.905101.76
5183060-18306098.55999.94
6177928-17792895.79697.26
45min1184936-18493699.56999.400.68101.62101.610.78
2184259-18425999.205101.54
3186719-186719100.529103.07
4183396-18339698.740101.15
5185024-18502499.617101.54
6183442-18344298.765100.76
60min1183439-18343998.76398.810.57101.37101.580.47
2181943-18194397.958100.84
3183675-18367598.890101.99
4183122-18312298.593101.55
5185137-18513799.677102.16
6183866-18386698.993101.54
极限1182276-18227698.13798.650.83101.29101.960.79
2182118-18211898.052101.48
3183294-18329498.685102.34
4183583-18358398.841102.35
5186030-186030100.158103.19
6182080-18208098.032101.13
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406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%
110.531455421459231458881458591457181457860.11
210.541448321455061451690.33
单位质量响应值RSD%判断
13844.8213773.150.37数据可信
供试品溶液-B25010311批-阿托伐他汀-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%
5min1122676-12267673.53577.186.7373.5477.186.73
2126575-12657575.87275.87
3138325-13832582.91682.92
4138737-13873783.16383.16
5129377-12937777.55277.55
6116842-11684270.03870.04
10min1150947-15094790.48292.471.7690.8992.901.78
2153557-15355792.04692.47
3154930-15493092.86993.33
4158892-15889295.24495.71
5154738-15473892.75493.18
6152553-15255391.44491.83
15min1158499-15849995.00895.301.4195.9296.241.41
2155740-15574093.35594.29
3157695-15769594.52695.50
4161841-16184197.01298.00
5161084-16108496.55897.50
6159096-15909695.36696.26
20min1160173-16017396.01295.861.8897.4597.331.87
2154132-15413292.39193.84
3159728-15972895.74597.25
4161908-16190897.05298.58
5162332-16233297.30698.79
6161207-16120796.63298.06
30min1159114-15911495.37795.551.3397.3597.551.34
2157328-15732894.30696.27
3158968-15896895.29097.32
4161790-16179096.98199.05
5162037-16203797.12999.15
6157180-15718094.21896.18
45min1158953-15895395.28195.810.7497.7898.340.73
2158119-15811994.78197.27
3160079-16007995.95698.52
4159736-15973695.75098.36
5160936-16093696.46999.03
6161195-16119596.62499.11
60min1157969-15796994.69195.281.0797.7298.351.06
2156933-15693394.07097.08
3157657-15765794.50497.60
4159498-15949895.60798.75
5161103-16110396.56999.67
6160597-16059796.26699.29
极限1156904-15690494.05295.141.0397.6198.741.02
2157662-15766294.50798.04
3157572-15757294.45398.07
4159874-15987495.83399.50
5161136-16113696.589100.22
6159186-15918695.42098.98
依折麦布阿托伐他汀片项目信息
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%
19.721650151655071658231659981664461657580.33
29.851641941652441647190.46
单位质量响应值RSD%判断
17053.2916722.741.39数据可信
供试品溶液-B25010311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%
5min142813-4281322.76126.8335.9522.7626.8335.95
226940-2694014.32214.32
343364-4336423.05423.05
472384-7238438.48238.48
545109-4510923.98223.98
672237-7223738.40438.40
10min1114113-11411360.66768.2018.4760.7968.3518.51
298011-9801152.10752.19
3131698-13169870.01670.14
4155241-15524182.53282.75
5114662-11466260.95961.09
6155943-15594382.90683.12
15min1151174-15117480.37085.927.6980.8386.457.78
2149683-14968379.57879.95
3166494-16649488.51589.03
4175250-17525093.17093.84
5151247-15124780.40980.88
6175883-17588393.50794.18
20min1167180-16718088.88093.194.1889.7994.204.27
2172898-17289891.92092.73
3178575-17857594.93895.95
4181270-18127096.37197.56
5167311-16731188.94989.87
6184543-18454398.11199.30
30min1177693-17769394.46996.052.1295.8797.582.26
2177450-17745094.34095.66
3181629-18162996.56198.10
4184873-18487398.286100.01
5177060-17706094.13295.55
6185341-18534198.535100.27
45min1180027-18002795.71097.531.3597.6499.591.45
2184452-18445298.06299.91
3184890-18489098.295100.37
4185573-18557398.658100.93
5180588-18058896.00897.94
6185167-18516798.442100.73
60min1176961-17696194.08096.852.1596.5499.452.18
2185406-18540698.569100.96
3185537-18553798.639101.26
4183631-18363197.626100.45
5177471-17747194.35196.82
6184028-18402897.837100.67
极限1179345-17934595.34797.341.7298.33100.471.72
2187813-18781399.849102.79
3182701-18270197.131100.30
4184537-18453798.107101.47
5179973-17997395.68198.67
6184155-18415597.904101.28
依折麦布阿托伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202406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%
110.531471711474871477741478011479131476290.21
210.541465071475721470400.52
单位质量响应值RSD%判断
14019.8513950.660.35数据可信
供试品溶液-B25010311批-阿托伐他汀-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%
5min1126724-12672475.00469.4012.3975.0069.4012.38
2121314-12131471.80271.80
3131176-13117677.63977.64
498823-9882358.49058.49
5126434-12643474.83374.83
699093-9909358.65058.65
10min1149785-14978588.65388.422.1489.0788.812.17
2146086-14608686.46486.86
3155060-15506091.77592.21
4147098-14709887.06387.39
5150299-15029988.95889.37
6148058-14805887.63187.96
15min1156130-15613092.40992.911.0093.3293.791.01
2155557-15555792.07092.95
3159902-15990294.64195.58
4156811-15681192.81293.62
5156102-15610292.39293.30
6157358-15735893.13693.95
20min1157578-15757893.26694.861.5394.6996.251.50
2162928-16292896.43297.82
3162334-16233496.08197.55
4158726-15872693.94595.27
5157945-15794593.48394.91
6162101-16210195.94397.27
30min1158181-15818193.62394.511.2695.5696.431.20
2157593-15759393.27595.20
3160249-16024994.84796.85
4161869-16186995.80597.65
5158063-15806393.55395.50
6162095-16209595.93997.80
45min1158273-15827393.67794.781.1796.1497.221.12
2158710-15871093.93696.38
3161265-16126595.44897.98
4162387-16238796.11298.49
5158413-15841393.76096.22
6161756-16175695.73998.13
60min1155604-15560492.09793.991.7895.0896.961.72
2157537-15753793.24196.21
3161680-16168095.69498.75
4160948-16094895.26098.17
5155782-15578292.20395.19
6161261-16126195.44698.37
极限1156817-15681792.81594.221.3896.3197.711.31
2158664-15866493.90997.39
3159144-15914494.19397.78
4161818-16181895.77599.22
5157003-15700392.92596.42
6161687-16168795.69899.16
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