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DJ333-221017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(%)99.67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%
19.871618421617971620631620111622821619990.12
29.821619191630861625020.51
单位质量响应值RSD%判断
16413.2716548.070.58数据可信
供试品溶液-2023121421批-依折麦布-pH2.0(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%
5min154534-5453429.68325.5618.7029.6825.5618.70
236272-3627219.74319.74
359703-5970332.49632.50
441088-4108822.36422.36
547305-4730525.74825.75
642878-4287823.33923.34
10min1134523-13452373.22169.623.8773.3969.763.90
2121660-12166066.22066.33
3131615-13161571.63871.82
4127840-12784069.58369.71
5128841-12884170.12870.27
6122925-12292566.90867.04
15min1161679-16167988.00288.142.2288.5788.672.20
2166869-16686990.82791.30
3161835-16183588.08788.67
4161514-16151487.91288.42
5163781-16378189.14689.68
6155929-15592984.87285.37
20min1171264-17126493.21994.071.4394.2895.091.40
2176409-17640996.02097.00
3170820-17082092.97894.05
4174464-17446494.96195.96
5173894-17389494.65195.68
6170120-17012092.59793.57
30min1173375-17337594.36895.301.2595.9596.841.22
2174574-17457495.02196.54
3172771-17277194.03995.62
4178675-17867597.25398.78
5176571-17657196.10897.66
6174575-17457595.02196.51
45min1177705-17770596.72596.371.0398.8398.441.03
2178338-17833897.07099.11
3179418-17941897.65799.76
4176928-17692896.30298.37
5175214-17521495.36997.46
6174711-17471195.09597.11
60min1175650-17565095.60794.891.4798.2597.491.41
2177563-17756396.64899.23
3170088-17008892.57995.23
4173321-17332194.33996.94
5173921-17392194.66597.28
6175432-17543295.48898.03
极限1167716-16771691.28893.752.6394.4696.882.55
2173180-17318094.26297.38
3174265-17426594.85398.02
4176289-17628995.95499.08
5176302-17630295.96199.10
6165632-16563290.15493.23
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100590-202005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%
110.853031823036463036223038243036763035900.08
210.843038733059593049160.49
单位质量响应值RSD%判断
27980.6528128.780.38数据可信
供试品溶液-2023121421批-阿托伐他汀-pH2.0(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%
5min1202445-20244559.60547.3826.0959.6147.3826.09
2106319-10631931.30331.30
3133136-13313639.19939.20
4204172-20417260.11460.11
5186820-18682055.00555.00
6132721-13272139.07739.08
10min1279792-27979282.37878.746.9982.7179.007.04
2232209-23220968.36968.54
3264536-26453677.88678.10
4283428-28342883.44983.78
5276664-27666481.45781.76
6267948-26794878.89179.11
15min1296500-29650087.29887.561.9688.0988.262.03
2291266-29126685.75786.31
3298194-29819487.79688.45
4304237-30423789.57690.37
5303498-30349889.35890.12
6290555-29055585.54786.20
20min1304135-30413589.54590.841.4890.8292.031.52
2306883-30688390.35591.38
3304871-30487189.76290.90
4315605-31560592.92394.22
5312540-31254092.02093.27
6307218-30721890.45391.58
30min1296585-29658587.32389.311.8089.0991.001.82
2300367-30036788.43689.97
3299783-29978388.26489.90
4311618-31161891.74993.56
5306296-30629690.18291.95
6305280-30528089.88391.52
45min1301946-30194688.90189.771.0891.1691.960.99
2308104-30810490.71492.74
3309088-30908891.00493.13
4305840-30584090.04792.37
5301244-30124488.69490.96
6303150-30315089.25591.39
60min1298028-29802887.74788.011.7890.5090.701.68
2305798-30579890.03592.56
3290520-29052085.53788.17
4298082-29808287.76390.58
5297851-29785187.69590.45
6303337-30333789.31191.94
极限1281087-28108782.76086.022.7686.0089.202.69
2294841-29484186.80989.84
3295334-29533486.95490.06
4299990-29999088.32591.63
5298613-29861387.92091.17
6283093-28309383.35086.47
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DJ333-221017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(%)99.67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%
19.871629511640851651441656521657581647180.73
29.821629721643341636530.59
单位质量响应值RSD%判断
16688.7516665.270.10数据可信
供试品溶液-2023121621批-依折麦布-pH2.0(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%
5min164660-6466034.78024.3234.1034.7824.3234.09
233178-3317817.84617.85
345634-4563424.54624.55
449144-4914426.43426.43
556331-5633130.30030.30
622292-2229211.99111.99
10min1131025-13102570.47669.024.1370.6769.164.18
2127078-12707868.35368.45
3134249-13424972.21072.35
4128751-12875169.25369.40
5130128-13012869.99470.16
6118684-11868463.83863.90
15min1163636-16363688.01787.951.3688.6088.471.34
2165813-16581389.18889.67
3163739-16373988.07388.61
4159265-15926585.66686.20
5164329-16432988.39088.95
6164282-16428288.36588.79
20min1174151-17415193.67392.311.6994.7593.321.69
2175360-17536094.32395.30
3167726-16772690.21791.24
4172223-17222392.63693.64
5170929-17092991.94092.99
6169295-16929591.06191.97
30min1175388-17538894.33895.140.8895.9396.660.84
2178040-17804095.76597.26
3175882-17588294.60496.13
4179372-17937296.48198.00
5175817-17581794.56996.13
6176812-17681295.10496.52
45min1177852-17785295.66495.170.6597.7897.220.66
2177570-17757095.51297.54
3176994-17699495.20297.26
4178009-17800995.74897.81
5175033-17503394.14896.23
6176165-17616594.75696.70
60min1171227-17122792.10093.961.4494.7596.541.34
2176390-17639094.87797.44
3174543-17454393.88496.47
4173852-17385293.51296.10
5173593-17359393.37395.98
6178510-17851096.01898.49
极限1173183-17318393.15293.560.9896.3196.660.94
2176086-17608694.71497.80
3173474-17347493.30996.41
4175812-17581294.56797.68
5171669-17166992.33895.46
6173436-17343693.28996.29
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100590-202005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%
110.853055783077623091503099373099973084850.61
210.843061713085623073660.56
单位质量响应值RSD%判断
28431.8028354.800.20数据可信
供试品溶液-2023121621批-阿托伐他汀-pH2.0(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%
5min1129169-12916937.57746.2327.6437.5846.2327.64
2196727-19672757.23157.23
3219770-21977063.93463.93
4164900-16490047.97247.97
5141341-14134141.11841.12
6101607-10160729.55929.56
10min1254898-25489874.15379.344.4374.3679.604.49
2276156-27615680.33880.66
3289957-28995784.35384.71
4279734-27973481.37981.65
5268805-26880578.19978.43
6266776-26677677.60977.77
15min1289847-28984784.32187.311.8784.9488.001.92
2302500-30250088.00288.77
3306416-30641689.14189.96
4298815-29881586.93087.65
5301876-30187687.82088.48
6301228-30122887.63288.23
20min1303728-30372888.35989.391.2589.4590.571.28
2312491-31249190.90892.16
3304431-30443188.56389.88
4310598-31059890.35791.56
5308571-30857189.76890.92
6303762-30376288.36989.45
30min1298213-29821386.75489.501.6588.3391.181.66
2307490-30749089.45391.21
3309025-30902589.90091.71
4312665-31266590.95992.66
5307589-30758989.48291.13
6311020-31102090.48092.05
45min1301414-30141487.68688.880.9089.7591.060.95
2304166-30416688.48690.74
3308151-30815189.64691.96
4308634-30863489.78691.99
5304320-30432088.53190.68
6306424-30642489.14391.22
60min1287545-28754583.65186.942.2386.2089.612.19
2299094-29909487.01189.76
3301338-30133887.66490.47
4298057-29805786.70989.42
5298898-29889886.95489.59
6308159-30815989.64892.22
极限1290628-29062884.54886.231.1387.5689.381.17
2297358-29735886.50689.74
3297562-29756286.56589.86
4300164-30016487.32290.51
5294662-29466285.72188.84
6298105-29810586.72389.79
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DJ333-221017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(%)99.67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%
19.871619761624601631061632111635271628560.39
29.821626671636161631420.42
单位质量响应值RSD%判断
16500.1016613.240.49数据可信
供试品溶液-2023121621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%
5min132402-3240217.55512.7925.2117.5612.7925.22
217575-175759.5229.52
316283-162838.8228.82
424942-2494213.51413.51
524067-2406713.04013.04
626359-2635914.28114.28
10min1100963-10096354.70242.6926.0154.8042.7625.99
248000-4800026.00626.06
379003-7900342.80442.85
484361-8436145.70745.78
562564-6256433.89733.97
697881-9788153.03253.11
15min1148932-14893280.69164.2227.5581.0964.5327.52
276841-7684141.63241.83
3126598-12659868.59168.88
4124143-12414367.26167.59
581521-8152144.16844.43
6153184-15318482.99583.37
20min1164261-16426188.99773.3024.4089.8573.9724.40
292608-9260850.17550.60
3152671-15267182.71783.39
4141499-14149976.66477.37
595751-9575151.87852.38
6164967-16496789.37990.21
30min1167264-16726490.62483.7112.4791.9784.7812.61
2136444-13644473.92574.63
3164019-16401988.86689.99
4158731-15873186.00087.13
5125563-12556368.03068.82
6174977-17497794.80396.13
45min1172566-17256693.49692.272.8495.3493.803.05
2169935-16993592.07193.19
3174253-17425394.41096.03
4169967-16996792.08893.69
5161210-16121087.34488.52
6173843-17384394.18896.05
60min1170540-17054092.39994.651.9294.7796.701.94
2174814-17481494.71496.34
3175665-17566595.17597.32
4172272-17227293.33795.45
5174533-17453394.56296.22
6180334-18033497.705100.09
极限1175098-17509894.86896.071.1797.7598.650.94
2180536-18053697.81499.97
3176618-17661895.69298.37
4179052-17905297.01099.65
5176892-17689295.84098.02
6175733-17573395.21298.14
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100590-202005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%
110.853040683047013055653060373061653053070.30
210.843048093063103055600.35
单位质量响应值RSD%判断
28138.8928188.190.13数据可信
供试品溶液-2023121621批-阿托伐他汀-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%
5min1177310-17731052.00343.9030.5152.0043.9030.50
2107997-10799731.67431.67
3158849-15884946.58846.59
4222869-22286965.36565.36
5107083-10708331.40631.41
6123918-12391836.34436.34
10min1256158-25615875.12863.2315.8775.4263.4815.92
2192061-19206156.32956.51
3214751-21475162.98463.24
4258095-25809575.69676.06
5178470-17847052.34352.52
6194048-19404856.91257.11
15min1270691-27069179.39071.069.9580.1071.6510.02
2240353-24035370.49270.98
3222408-22240865.22965.84
4273532-27353280.22381.01
5222733-22273365.32565.79
6223938-22393865.67866.20
20min1275661-27566180.84874.817.7982.0075.807.86
2261779-26177976.77677.66
3236128-23612869.25370.22
4278697-27869781.73882.97
5245124-24512471.89272.72
6232983-23298368.33169.21
30min1271648-27164879.67179.457.2281.2780.857.13
2293814-29381486.17287.48
3237745-23774569.72871.08
4281547-28154782.57484.26
5279476-27947681.96783.19
6261089-26108976.57477.84
45min1278981-27898181.82284.388.8983.8686.228.69
2319125-31912593.59595.38
3250240-25024073.39275.14
4289324-28932484.85587.00
5313120-31312091.83493.52
6275385-27538580.76782.45
60min1276852-27685281.19786.059.1983.6988.368.96
2320556-32055694.01596.32
3253747-25374774.42176.57
4293043-29304385.94688.56
5325666-32566695.51497.71
6290439-29043985.18287.32
极限1321938-32193894.42093.731.9197.3796.522.03
2325921-32592195.58898.42
3315734-31573492.60195.17
4325148-32514895.36298.45
5318778-31877893.49496.22
6309905-30990590.89193.50
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DJ333-221017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(%)99.67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%
19.871621101631591640571648341649341638190.73
29.821607931615901611920.35
单位质量响应值RSD%判断
16597.6716414.660.79数据可信
供试品溶液-2023121621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%
5min151356-5135627.91019.2924.4327.9119.2924.43
234844-3484418.93718.94
333253-3325318.07218.07
429780-2978016.18416.18
526397-2639714.34614.35
637330-3733020.28820.29
10min1137783-13778374.88166.229.7775.0466.329.80
2123524-12352467.13167.24
3120706-12070665.60065.70
4119866-11986665.14365.23
5101523-10152355.17555.25
6127626-12762669.36169.47
15min1164011-16401189.13583.903.6889.7184.373.72
2157876-15787685.80186.28
3152391-15239182.82083.28
4152773-15277383.02783.48
5148226-14822680.55680.94
6150977-15097782.05182.55
20min1169249-16924991.98189.332.7593.0590.272.80
2163446-16344688.82889.78
3164220-16422089.24890.17
4162936-16293688.55189.46
5157180-15718085.42286.26
6169219-16921991.96592.92
30min1176594-17659495.97394.122.3197.5595.562.34
2171452-17145293.17994.63
3170811-17081192.83094.25
4175054-17505495.13696.54
5167341-16734190.94592.25
6177831-17783196.64598.11
45min1174287-17428794.71993.980.8496.8395.940.89
2173447-17344794.26396.23
3172233-17223393.60395.54
4174690-17469094.93896.87
5170955-17095592.90994.72
6171996-17199693.47495.48
60min1176482-17648295.91293.711.5498.5596.191.59
2172582-17258293.79396.28
3172276-17227693.62796.08
4173736-17373694.42096.88
5168630-16863091.64593.97
6170859-17085992.85695.38
极限1180729-18072998.22094.442.25101.3997.442.29
2173125-17312594.08897.10
3173791-17379194.45097.43
4172589-17258993.79796.78
5168701-16870191.68494.52
6173674-17367494.38697.42
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100590-202005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%
110.853045453063643077393093643090133074050.65
210.843006933023423015180.39
单位质量响应值RSD%判断
28332.2627815.311.31数据可信
供试品溶液-2023121621批-阿托伐他汀-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%
5min1175264-17526451.57145.0912.0951.5745.0912.08
2167191-16719149.19649.20
3155006-15500645.61045.61
4144495-14449542.51842.52
5122399-12239936.01636.02
6155015-15501545.61345.61
10min1230573-23057367.84662.346.2268.1362.596.19
2195880-19588057.63857.91
3207676-20767661.10961.36
4204321-20432160.12160.36
5224946-22494666.19066.39
6207824-20782461.15261.41
15min1239001-23900170.32664.538.1270.9965.128.07
2210078-21007861.81562.41
3211946-21194662.36562.96
4205586-20558660.49461.06
5244746-24474672.01672.58
6204424-20442460.15260.74
20min1236395-23639569.55965.856.9270.6166.806.88
2208851-20885161.45462.39
3218889-21888964.40865.35
4209610-20961061.67862.58
5247952-24795272.96073.93
6221032-22103265.03965.97
30min1241181-24118170.96767.936.9272.4169.256.87
2213904-21390462.94164.22
3223838-22383865.86467.16
4220696-22069664.94066.19
5257679-25767975.82277.20
6227824-22782467.03768.33
45min1237272-23727269.81767.957.3471.6569.647.26
2216439-21643963.68765.32
3227155-22715566.84068.50
4221896-22189665.29366.90
5262220-26222077.15878.95
6220489-22048964.87966.54
60min1241116-24111670.94868.387.0173.1770.466.95
2217602-21760264.02966.01
3230474-23047467.81769.85
4223857-22385765.87067.84
5260889-26088976.76678.99
6220476-22047664.87566.90
极限1315830-31583092.93391.401.0695.5593.861.05
2309210-30921090.98593.32
3312224-31222491.87294.28
4310751-31075191.43893.78
5306078-30607890.06392.71
6309663-30966391.11893.50
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