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%
110.001745161746491745921746891746321746160.04
210.011759521763961761740.18
单位质量响应值RSD%判断
17461.6017599.800.56数据可信
供试品溶液-2023120821批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113050-130506.6836.559.206.686.559.21
213612-136126.9716.97
313332-133326.8276.83
413492-134926.9096.91
510471-104715.3625.36
612761-127616.5356.54
10min117237-172378.8278.992.628.869.032.62
217802-178029.1179.16
317689-176899.0599.10
418222-182229.3329.37
517448-174488.9358.97
616911-169118.6608.70
15min117585-175859.0059.021.739.099.101.69
217833-178339.1329.22
317846-178469.1399.23
417023-170238.7188.81
517717-177179.0739.15
617639-176399.0339.12
20min116895-168958.6528.843.068.798.983.05
217897-178979.1659.31
317689-176899.0599.20
416454-164548.4268.56
517395-173958.9089.04
617236-172368.8278.96
30min117055-170558.7348.691.448.928.871.40
216849-168498.6298.82
317036-170368.7248.91
416536-165368.4688.65
517240-172408.8299.01
617069-170698.7418.92
45min116411-164118.4048.683.508.648.923.36
216773-167738.5908.83
316726-167268.5668.80
416506-165068.4538.69
517977-179779.2069.43
617309-173098.8649.10
60min116688-166888.5468.562.098.838.852.00
216503-165038.4518.74
316905-169058.6578.94
416160-161608.2768.56
517110-171108.7629.04
616970-169708.6908.97
极限115883-158838.1348.373.258.468.703.13
215882-158828.1338.47
316810-168108.6098.94
415829-158298.1068.43
516974-169748.6939.02
616661-166618.5328.86
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%
111.211583841588261583481590361587591586710.19
211.241599891603231601560.15
单位质量响应值RSD%判断
14154.4214248.750.47数据可信
供试品溶液-2023120821批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182696-8269648.09937.0022.6848.1037.0022.69
274860-7486043.54143.54
371260-7126041.44741.45
448611-4861128.27428.27
553424-5342431.07331.07
650851-5085129.57729.58
10min1134052-13405277.96971.896.9878.2472.107.02
2125351-12535172.90873.15
3130509-13050975.90876.14
4112192-11219265.25465.41
5114655-11465566.68766.86
6124840-12484072.61172.78
15min1152242-15224288.54982.885.9789.2583.485.98
2138669-13866980.65481.30
3146099-14609984.97685.63
4135222-13522278.64979.17
5131800-13180076.65977.20
6150904-15090487.77188.34
20min1155918-15591890.68786.275.1791.8887.345.19
2145799-14579984.80185.90
3151071-15107187.86888.99
4142763-14276383.03583.99
5137481-13748179.96380.93
6156908-15690891.26392.32
30min1160817-16081793.53688.855.6095.2390.405.57
2144179-14417983.85985.43
3150749-15074987.68089.29
4151448-15144888.08789.50
5144366-14436683.96885.38
6165032-16503295.98897.55
45min1162823-16282394.70391.964.8096.9294.004.76
2150389-15038987.47189.50
3154418-15441889.81491.91
4159042-15904292.50494.41
5151636-15163688.19690.08
6170325-17032599.066101.16
60min1165761-16576196.41292.844.4999.1595.394.49
2151958-15195888.38490.90
3158817-15881792.37394.97
4158244-15824492.04094.46
5152776-15277688.85991.23
6170150-17015098.965101.61
极限1161708-16170894.05594.771.9797.3397.831.98
2158764-15876492.34295.35
3166223-16622396.68199.79
4162357-16235794.43297.36
5161293-16129393.81396.68
6167234-16723497.269100.46
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%
110.001747031751921747951746731747291748180.13
210.011762491768971765730.26
单位质量响应值RSD%判断
17481.8017639.660.64数据可信
供试品溶液-2023120821批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114049-140497.1826.528.647.186.528.66
212966-129666.6296.63
313127-131276.7116.71
411997-119976.1336.13
510963-109635.6055.60
613406-134066.8546.85
10min117754-177549.0768.931.149.128.971.14
217520-175208.9578.99
317212-172128.7998.84
417321-173218.8558.89
517620-176209.0089.04
617418-174188.9058.94
15min117667-176679.0329.010.549.129.100.52
217701-177019.0499.14
317630-176309.0139.10
417631-176319.0149.10
517702-177029.0509.13
617448-174488.9209.01
20min117936-179369.1709.020.989.319.160.97
217625-176259.0119.15
317560-175608.9779.11
417661-176619.0299.16
517656-176569.0269.16
617408-174088.9009.04
30min117741-177419.0708.951.169.269.141.12
217374-173748.8829.07
317281-172818.8359.02
417704-177049.0519.23
517616-176169.0069.19
617336-173368.8639.05
45min117641-176419.0198.872.119.269.112.08
217394-173948.8929.13
317081-170818.7328.97
417926-179269.1649.40
517043-170438.7138.94
617064-170648.7248.96
60min117754-177549.0768.623.259.378.913.20
216840-168408.6098.89
316179-161798.2718.55
417201-172018.7949.08
516620-166208.4978.78
616618-166188.4968.78
极限117292-172928.8408.622.359.188.952.30
216866-168668.6238.96
316283-162838.3248.65
417311-173118.8509.18
516629-166298.5018.83
616781-167818.5798.91
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%
111.211585551588521584491585321585941585960.10
211.241601751605251603500.16
单位质量响应值RSD%判断
14147.7314266.010.59数据可信
供试品溶液-2023120821批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186494-8649450.28938.9626.2250.2938.9526.23
243710-4371025.41425.41
353102-5310230.87530.87
464618-6461837.57037.57
566552-6655238.69538.69
687533-8753350.89350.89
10min1137431-13743179.90575.974.0980.1876.184.15
2126276-12627673.41973.56
3126829-12682973.74173.91
4126748-12674873.69473.90
5129275-12927575.16375.38
6137419-13741979.89880.18
15min1153130-15313089.03386.721.7289.7687.361.77
2149315-14931586.81587.36
3147277-14727785.63086.21
4146355-14635585.09485.71
5147767-14776785.91586.55
6151031-15103187.81288.54
20min1160525-16052593.33290.481.9794.5591.602.00
2156594-15659491.04792.08
3153646-15364689.33390.39
4151993-15199388.37289.46
5153952-15395289.51190.62
6156954-15695491.25692.47
30min1162994-16299494.76894.000.6596.5095.620.72
2161870-16187094.11495.65
3160380-16038093.24894.80
4160835-16083593.51395.09
5161237-16123793.74695.35
6162728-16272894.61396.33
45min1166928-16692897.05596.930.9599.3299.080.93
2168120-16812097.74899.81
3164003-16400395.35497.43
4168393-16839397.907100.01
5166571-16657196.84898.98
6166288-16628896.68398.93
60min1167946-16794697.64796.391.74100.4599.071.72
2167281-16728197.26099.86
3160887-16088793.54396.14
4167271-16727197.25599.90
5167700-16770097.504100.17
6163595-16359595.11797.90
极限1168041-16804197.70297.622.03101.05100.841.99
2168382-16838297.900101.04
3161647-16164793.98597.11
4171384-17138499.646102.83
5170380-17038099.062102.27
6167581-16758197.435100.75
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%
110.001752171752481753181753711752421752790.04
210.011750661748611749640.09
单位质量响应值RSD%判断
17527.9017478.920.20数据可信
供试品溶液-2023120822批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114646-146467.5127.286.387.517.286.35
214845-148457.6147.61
314372-143727.3717.37
415080-150807.7357.73
513538-135386.9446.94
612705-127056.5166.52
10min117852-178529.1569.161.829.209.201.81
217938-179389.2009.24
317858-178589.1599.20
417860-178609.1609.20
518306-183069.3899.43
617295-172958.8718.91
15min118442-184429.4599.303.759.559.393.74
218685-186859.5849.68
318424-184249.4509.54
417748-177489.1039.20
518562-185629.5209.61
616914-169148.6758.76
20min118070-180709.2689.222.349.419.362.33
218453-184539.4659.61
317849-178499.1559.30
417783-177839.1219.27
518373-183739.4249.57
617318-173188.8829.02
30min118030-180309.2489.082.469.449.272.44
218128-181289.2989.50
317843-178439.1529.35
416971-169718.7048.90
517819-178199.1399.34
617412-174128.9319.11
45min117807-178079.1338.992.379.389.232.36
217860-178609.1609.41
317863-178639.1629.41
416948-169488.6938.94
517599-175999.0279.27
617062-170628.7518.98
60min117861-178619.1618.842.489.469.132.48
217520-175208.9869.29
317263-172638.8549.15
416859-168598.6478.94
517190-171908.8179.11
616691-166918.5618.84
极限117283-172838.8648.902.049.219.242.04
217712-177129.0859.44
317665-176659.0609.41
416997-169978.7189.06
517553-175539.0039.35
616877-168778.6568.99
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%
111.211587451589541588211588291587161588130.06
211.241585621583551584580.10
单位质量响应值RSD%判断
14167.0814097.690.35数据可信
供试品溶液-2023120822批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191801-9180153.65645.8217.8053.6645.8217.80
279456-7945646.44046.44
370145-7014540.99841.00
493322-9332254.54554.54
579581-7958146.51346.51
656031-5603132.74932.75
10min1137324-13732480.26370.2716.1580.5670.5316.16
2117881-11788168.89969.16
3111644-11164465.25365.48
4135202-13520279.02279.33
5132748-13274877.58877.85
686575-8657550.60150.78
15min1149120-14912087.15776.4116.2987.9077.0616.29
2129013-12901375.40576.05
3119604-11960469.90670.50
4145905-14590585.27886.02
5146405-14640585.57086.26
694332-9433255.13555.60
20min1148571-14857186.83678.1215.4988.0679.1915.50
2130458-13045876.25077.31
3121165-12116570.81871.80
4150292-15029287.84289.06
5151710-15171088.67189.84
699729-9972958.28959.06
30min1151865-15186588.76280.0814.4190.4781.5814.44
2133404-13340477.97279.45
3122228-12222871.43972.81
4151107-15110788.31990.02
5156654-15665491.56193.22
6106819-10681962.43363.53
45min1153734-15373489.85481.5314.3992.0683.4814.41
2134144-13414478.40480.32
3123710-12371072.30674.07
4154659-15465990.39592.59
5160538-16053893.83196.00
6110162-11016264.38765.83
60min1156044-15604491.20481.2714.8093.9183.6814.82
2133293-13329377.90780.26
3122175-12217571.40873.58
4154632-15463290.37993.08
5158775-15877592.80095.49
6109408-10940863.94665.74
极限1158692-15869292.75293.353.1095.9696.203.31
2155752-15575291.03393.82
3157423-15742392.01094.58
4161030-16103094.11897.32
5169030-16903098.794102.00
6156318-15631891.36493.52
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%
110.001759941770061767151760031754091762250.37
210.011763471770161766820.27
单位质量响应值RSD%判断
17622.5017650.550.12数据可信
供试品溶液-2023120822批-依折麦布-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114576-145767.4207.515.297.427.515.28
215267-152677.7717.77
313260-132606.7506.75
415017-150177.6447.64
515245-152457.7607.76
615208-152087.7417.74
10min117966-179669.1459.062.149.199.102.13
218371-183719.3519.39
317531-175318.9248.96
417641-176418.9809.02
517301-173018.8078.85
617958-179589.1419.18
15min117628-176288.9739.061.849.079.151.81
218071-180719.1999.29
318013-180139.1699.26
417799-177999.0609.15
517226-172268.7698.86
618034-180349.1809.27
20min118476-184769.4059.153.499.559.293.46
218710-187109.5249.67
318429-184299.3819.52
417401-174018.8589.00
517293-172938.8038.94
617556-175568.9379.08
30min118039-180399.1828.943.989.389.143.92
217789-177899.0559.25
317910-179109.1179.31
417063-170638.6868.88
516391-163918.3438.53
618212-182129.2709.46
45min117698-176989.0098.843.249.259.083.18
218053-180539.1909.44
317798-177989.0609.30
416880-168808.5928.83
516639-166398.4708.71
617164-171648.7378.98
60min117380-173808.8478.742.839.149.032.76
217312-173128.8129.11
317782-177829.0529.34
416491-164918.3948.68
516685-166858.4938.78
617361-173618.8379.13
极限117389-173898.8528.723.659.209.063.58
217698-176989.0099.36
317933-179339.1289.47
416738-167388.5208.85
516369-163698.3328.66
616702-167028.5028.85
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%
111.211601171606671606821599571591681601180.39
211.241601081604561602820.16
单位质量响应值RSD%判断
14283.5014259.960.12数据可信
供试品溶液-2023120822批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186576-8657650.10741.9230.8850.1141.9230.88
280954-8095446.85446.85
330347-3034717.56417.56
491278-9127852.82952.83
579802-7980246.18746.19
665615-6561537.97637.98
10min1135457-13545778.39868.8012.3578.6869.0312.36
2130696-13069675.64375.90
3114330-11433066.17066.27
4123682-12368271.58371.88
5114711-11471166.39166.65
694356-9435654.61054.82
15min1145387-14538784.14575.5611.8584.8676.1811.82
2140522-14052281.32982.01
3137584-13758479.62980.09
4131815-13181576.29076.98
5125784-12578472.80073.43
6102219-10221959.16159.68
20min1152191-15219188.08379.6012.5489.2680.6312.49
2149646-14964686.61087.74
3148557-14855785.98086.89
4136201-13620178.82979.94
5132220-13222076.52577.55
6106343-10634361.54862.39
30min1158269-15826991.60181.1610.6293.2782.6410.61
2146274-14627484.65986.27
3149463-14946386.50487.89
4138775-13877580.31881.87
5133013-13301376.98478.44
6115592-11559266.90168.09
45min1161710-16171093.59282.3511.7695.7784.2811.72
2152654-15265488.35190.43
3151322-15132287.58089.45
4138862-13886280.36982.37
5134385-13438577.77879.66
6114760-11476066.41967.98
60min1159309-15930992.20382.2210.0794.9084.6010.07
2146920-14692085.03287.61
3151799-15179987.85690.21
4139400-13940080.68083.13
5136728-13672879.13481.45
6118189-11818968.40470.33
极限1166186-16618696.18392.803.1799.3995.643.34
2161326-16132693.37096.42
3164125-16412594.99097.83
4162085-16208593.80996.70
5153957-15395789.10591.86
6154373-15437389.34691.65
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