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%
19.721639581639811639471634981629711636710.27
29.851632341641271636800.39
单位质量响应值RSD%判断
16838.5816617.260.94数据可信
供试品溶液-B24120812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%
5min181854-8185443.93126.7638.1743.9326.7638.17
244637-4463723.95723.96
358854-5885431.58731.59
430109-3010916.16016.16
550797-5079727.26327.26
632898-3289817.65617.66
10min1156998-15699884.26170.5315.8184.5170.6815.86
2119418-11941864.09264.22
3146960-14696078.87479.05
4103976-10397655.80455.89
5144034-14403477.30377.45
6117070-11707062.83262.93
15min1175113-17511393.98388.167.0794.7088.707.15
2151657-15165781.39481.88
3173537-17353793.13793.75
4149383-14938380.17480.57
5173534-17353493.13693.72
6162335-16233587.12587.57
20min1179524-17952496.35194.544.0197.5995.574.08
2167799-16779990.05891.00
3180034-18003496.62497.76
4166625-16662589.42890.27
5183057-18305798.24799.35
6179869-17986996.53697.47
30min1184325-18432598.92798.382.02100.7099.932.08
2177453-17745395.23996.68
3184938-18493899.256100.92
4180149-18014996.68698.03
5185935-18593599.792101.44
6186983-186983100.354101.82
45min1180293-18029396.76399.752.2099.08101.852.17
2182345-18234597.86599.84
3189778-189778101.854104.07
4184320-18432098.925100.80
5189218-189218101.554103.75
6189162-189162101.523103.55
60min1182921-18292198.17498.411.25101.03101.071.33
2181455-18145597.38799.90
3185647-18564799.637102.42
4180146-18014696.68599.11
5184149-18414998.833101.60
6185851-18585199.746102.34
极限1181512-18151297.41899.591.33100.82102.801.25
2184125-18412598.820101.88
3187843-187843100.816104.15
4186364-186364100.022102.99
5185584-18558499.603102.91
6187975-187975100.886104.03
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%
110.532889532885952884312879982887152885380.13
210.542901562904082902820.07
单位质量响应值RSD%判断
27401.5227540.990.36数据可信
供试品溶液-B24120812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%
5min1251587-25158775.80774.216.2775.8174.206.27
2253771-25377176.46576.46
3251547-25154775.79575.79
4252448-25244876.06676.07
5214828-21482864.73164.73
6253466-25346676.37376.37
10min1292468-29246888.12591.033.3888.5591.443.38
2303471-30347191.44091.86
3303872-30387291.56191.98
4305938-30593892.18392.61
5289212-28921287.14487.50
6317629-31762995.70696.13
15min1301873-30187390.95894.493.5391.8795.413.52
2308134-30813492.84593.78
3312082-31208294.03594.96
4322759-32275997.25298.19
5305883-30588392.16793.01
6330810-33081099.678100.63
20min1304707-30470791.81295.863.7393.2397.303.71
2314534-31453494.77396.22
3314416-31441694.73896.19
4321315-32131596.81798.29
5314013-31401394.61695.97
6339762-339762102.375103.88
30min1311520-31152093.86596.512.6395.7998.492.63
2315742-31574295.13797.11
3315138-31513894.95596.93
4326540-32654098.391100.40
5318896-31889696.08897.97
6334036-334036100.650102.73
45min1305369-30536992.01296.642.9294.4699.162.90
2318023-31802395.82598.33
3320019-32001996.42698.93
4325395-32539598.046100.61
5321912-32191296.99699.41
6333753-333753100.564103.20
60min1311912-31191293.98395.432.1596.9498.482.16
2311977-31197794.00397.04
3312809-31280994.25497.30
4317330-31733095.61698.72
5316523-31652395.37398.33
6329770-32977099.364102.56
极限1315727-31572795.13397.222.2498.61100.802.22
2313726-31372694.53098.09
3323197-32319797.384100.95
4322538-32253897.185100.82
5327866-32786698.790102.27
6332894-332894100.305104.05
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%
19.721635811630861629991633251632261632430.14
29.851642011648731645370.29
单位质量响应值RSD%判断
16794.5516704.260.39数据可信
供试品溶液-B24120812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%
5min158744-5874431.48633.2119.8231.4933.2119.82
248707-4870726.10726.11
351714-5171427.71827.72
476981-7698141.26141.26
558596-5859631.40731.41
676993-7699341.26841.27
10min1137583-13758373.74473.5310.3173.9273.7210.34
2121473-12147365.10965.25
3120832-12083264.76564.92
4152966-15296681.98982.22
5137725-13772573.82073.99
6152546-15254681.76481.99
15min1171915-17191592.14589.506.5592.7390.096.58
2154765-15476582.95383.46
3151394-15139481.14681.66
4175941-17594194.30394.99
5172542-17254292.48193.07
6175281-17528193.94994.63
20min1182524-18252497.83294.704.1698.9395.794.20
2166452-16645289.21790.18
3168473-16847390.30091.26
4179528-17952896.22697.43
5183402-18340298.30299.40
6179762-17976296.35197.56
30min1187878-187878100.70199.261.96102.34100.882.04
2181120-18112097.07998.54
3180006-18000696.48297.95
4187688-187688100.599102.34
5187637-187637100.572102.22
6186801-186801100.124101.86
45min1187841-187841100.681100.420.51102.88102.590.60
2186554-18655499.992101.99
3186964-186964100.211102.21
4188508-188508101.039103.34
5186121-18612199.760101.96
6188181-188181100.864103.16
60min1185117-18511799.22199.260.27101.98101.980.35
2184442-18444298.860101.42
3185137-18513799.232101.79
4185354-18535499.348102.21
5185978-18597899.683102.44
6185064-18506499.193102.05
极限1186953-186953100.206100.340.73103.52103.620.83
2185344-18534499.343102.45
3186062-18606299.728102.84
4188947-188947101.274104.69
5187856-187856100.690104.00
6188101-188101100.821104.23
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%
110.532904122893892888842899022891582895490.22
210.542905302923542914420.45
单位质量响应值RSD%判断
27497.5327651.040.40数据可信
供试品溶液-B24120812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%
5min1266204-26620479.91174.686.2479.9174.686.24
2255837-25583776.79976.80
3245649-24564973.74173.74
4230918-23091869.31969.32
5263116-26311678.98478.98
6231007-23100769.34669.35
10min1309680-30968092.96290.803.1193.4191.213.12
2304696-30469691.46691.89
3308663-30866392.65793.07
4290438-29043887.18687.57
5310512-31051293.21293.65
6290829-29082987.30387.69
15min1323762-32376297.19094.543.2998.1595.463.30
2313684-31368494.16495.10
3322204-32220496.72297.65
4302871-30287190.91891.79
5324823-32482397.50898.46
6302256-30225690.73491.60
20min1326034-32603497.87295.013.5899.3796.453.59
2312260-31226093.73795.19
3327544-32754498.32599.79
4303609-30360991.14092.51
5325687-32568797.76799.27
6303832-30383291.20792.58
30min1321087-32108796.38695.751.7798.4397.731.80
2322801-32280196.90198.88
3324463-32446397.40099.41
4312335-31233593.75995.64
5321786-32178696.59698.64
6311395-31139593.47795.36
45min1317919-31791995.43696.711.7598.0299.221.76
2326486-32648698.007100.52
3328684-32868498.667101.22
4316855-31685595.11697.52
5326555-32655598.028100.61
6316502-31650295.01097.41
60min1313535-31353594.11995.391.6397.2398.431.62
2321701-32170196.57199.63
3326403-32640397.982101.08
4315102-31510294.59097.52
5316133-31613394.89998.02
6313774-31377494.19197.12
极限1317993-31799395.45897.231.7399.09100.801.59
2320484-32048496.20599.80
3325890-32589097.828101.47
4329351-32935198.867102.32
5318764-31876495.68999.34
6330899-33089999.332102.78
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%
19.721637031634411634461636411642801637020.21
29.851650761656231653500.24
单位质量响应值RSD%判断
16841.7716786.800.24数据可信
供试品溶液-B24120911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%
5min130269-3026916.16126.9137.9016.1626.9137.90
282089-8208943.82943.83
360594-6059432.35232.35
433485-3348517.87817.88
545449-4544924.26624.27
650547-5054726.98826.99
10min1104036-10403655.54771.1215.4555.6471.2715.49
2157114-15711483.88784.13
3148732-14873279.41179.59
4123559-12355965.97166.07
5119486-11948663.79663.93
6146329-14632978.12878.28
15min1148606-14860679.34488.537.3679.7489.087.43
2176054-17605493.99994.71
3175027-17502793.45194.07
4166342-16634288.81489.28
5153145-15314581.76882.26
6175711-17571193.81694.40
20min1167566-16756689.46794.563.9290.3195.603.98
2178911-17891195.52596.76
3180729-18072996.49597.64
4183294-18329497.86598.82
5169262-16926290.37391.32
6182912-18291297.66198.77
30min1181500-18150096.90798.813.0198.24100.373.01
2184521-18452198.520100.28
3185208-18520898.887100.56
4194833-194833104.026105.53
5178312-17831295.20596.65
6186018-18601899.319100.97
45min1184896-18489698.72099.512.22100.59101.622.20
2181062-18106296.67398.98
3189815-189815101.346103.57
4190131-190131101.515103.60
5182409-18240997.39299.37
6189950-189950101.419103.62
60min1180756-18075696.51098.501.7698.93101.171.85
2184505-18450598.511101.36
3188738-188738100.771103.56
4185689-18568999.144101.79
5180676-18067696.46798.98
6186579-18657999.619102.38
极限1186661-18666199.66299.411.02102.62102.621.00
2183722-18372298.093101.49
3188703-188703100.753104.10
4187552-187552100.138103.33
5184400-18440098.455101.51
6186051-18605199.337102.65
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%
110.532886942881502864852871632874322875850.30
210.542925232933772929500.21
单位质量响应值RSD%判断
27311.0227794.121.24数据可信
供试品溶液-B24120911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%
5min1252555-25255575.87974.876.9675.8874.876.95
2252798-25279875.95275.95
3259298-25929877.90577.90
4256627-25662777.10277.10
5259483-25948377.96177.96
6214371-21437164.40764.41
10min1306029-30602991.94591.994.9392.3792.414.92
2293084-29308488.05688.48
3306507-30650792.08992.52
4334281-334281100.433100.86
5304054-30405491.35291.78
6293123-29312388.06788.43
15min1319828-31982896.09195.103.8997.0296.023.89
2304969-30496991.62792.54
3316605-31660595.12396.07
4339090-339090101.878102.86
5309439-30943992.97093.91
6309229-30922992.90693.75
20min1323090-32309097.07196.054.2898.5497.504.27
2303364-30336491.14492.56
3313287-31328794.12695.60
4343910-343910103.326104.88
5319951-31995196.12897.58
6314505-31450594.49295.85
30min1329439-32943998.97897.084.24100.9899.074.23
2311894-31189493.70795.63
3314124-31412494.37796.37
4348206-348206104.617106.74
5317640-31764095.43497.42
6317470-31747095.38297.27
45min1327068-32706898.26696.643.05100.8299.173.05
2306484-30648492.08294.53
3323419-32341997.17099.69
4335052-335052100.665103.37
5315537-31553794.80297.32
6322376-32237696.85699.27
60min1319985-31998596.13895.912.0699.2498.972.09
2313642-31364294.23297.19
3317959-31795995.52998.59
4330994-33099499.446102.71
5312721-31272193.95697.00
6319987-31998796.13999.09
极限1323157-32315797.09197.222.06100.73100.822.05
2319305-31930595.93499.42
3323488-32348897.191100.78
4332419-33241999.874103.69
5313906-31390694.31297.88
6329224-32922498.914102.40
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%
19.721630581637181634171635191632111633850.16
29.851624181621451622820.12
单位质量响应值RSD%判断
16809.1616475.331.42数据可信
供试品溶液-B24120911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%
5min161051-6105132.93733.6219.4932.9433.6219.49
276363-7636341.19741.20
358036-5803631.31031.31
448649-4864926.24626.25
577537-7753741.83141.83
652254-5225428.19128.19
10min1139380-13938075.19574.4310.5275.3874.6210.54
2153155-15315582.62682.86
3137345-13734574.09774.27
4121651-12165165.63065.78
5154753-15475383.48883.72
6121490-12149065.54365.70
15min1172755-17275593.20090.376.9693.8090.976.99
2175398-17539894.62695.31
3175105-17510594.46895.05
4154566-15456683.38883.90
5176517-17651795.23095.93
6150688-15068881.29581.82
20min1185873-185873100.27896.194.65101.4097.304.68
2179436-17943696.80598.02
3184810-18481099.704100.81
4166362-16636289.75190.73
5183526-18352699.011100.24
6169824-16982491.61992.59
30min1188106-188106101.482100.681.88103.16102.321.90
2187459-187459101.133102.88
3187597-187597101.208102.87
4189857-189857102.427103.90
5186925-186925100.845102.62
6179780-17978096.99098.47
45min1188039-188039101.446101.780.68103.69103.970.77
2189302-189302102.127104.44
3189816-189816102.405104.63
4187245-187245101.018103.06
5190134-190134102.576104.91
6187356-187356101.078103.10
60min1185532-185532100.094100.981.73102.90103.741.62
2185235-18523599.933102.81
3188776-188776101.844104.64
4184953-18495399.781102.38
5185468-185468100.059102.96
6193110-193110104.182106.76
极限1188639-188639101.770102.111.48105.13105.431.44
2190300-190300102.666106.10
3189134-189134102.037105.40
4185102-18510299.862103.02
5188690-188690101.797105.26
6193741-193741104.522107.68
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%
110.532903752908702905962896882887792900620.29
210.542902902888722895810.35
单位质量响应值RSD%判断
27546.2527474.480.19数据可信
供试品溶液-B24120911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%
5min1278371-27837183.75775.807.4183.7675.807.41
2229908-22990869.17669.18
3263361-26336179.24179.24
4257580-25758077.50277.50
5232187-23218769.86169.86
6250116-25011675.25675.26
10min1312655-31265594.07391.433.1194.5491.863.12
2291714-29171487.77288.16
3309508-30950893.12693.57
4304852-30485291.72592.16
5292758-29275888.08688.47
6311802-31180293.81694.23
15min1325060-32506097.80594.923.4898.7995.853.49
2301623-30162390.75391.63
3328132-32813298.73099.69
4312526-31252694.03494.97
5304579-30457991.64392.52
6320969-32096996.57497.51
20min1329330-32933099.09095.793.62100.6297.243.62
2302575-30257591.04092.42
3326795-32679598.32799.83
4312361-31236193.98495.45
5310011-31001193.27794.66
6329057-32905799.008100.48
30min1322476-32247697.02896.593.1299.1198.583.10
2310574-31057493.44795.33
3321288-32128896.67098.72
4337401-337401101.518103.50
5310441-31044193.40795.31
6324036-32403697.49799.52
45min1317650-31765095.57697.472.0598.20100.002.05
2317099-31709995.41097.81
3331415-33141599.717102.31
4328194-32819498.748101.30
5319285-31928596.06898.49
6330025-33002599.299101.87
60min1316944-31694495.36396.482.8798.5299.552.83
2314167-31416794.52897.46
3319112-31911296.01699.16
4321225-32122596.65199.75
5314017-31401794.48397.44
6338524-338524101.856104.98
极限1321445-32144596.71898.121.68100.40101.731.54
2334520-334520100.652104.11
3321450-32145096.719100.40
4321833-32183396.834100.47
5330075-33007599.314102.80
6327412-32741298.513102.20
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