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%
110.051713211713961712261712631711571712730.06
210.071704481706851705660.10
单位质量响应值RSD%判断
17042.0916938.030.44数据可信
供试品溶液-2024012021批-依折麦布-pH2.0(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%
5min140050-4005021.14624.218.4421.1524.218.43
248240-4824025.47025.47
346771-4677124.69424.69
442817-4281722.60622.61
546385-4638524.49024.49
650860-5086026.85326.85
10min1132059-13205969.72471.513.2269.8471.643.23
2135951-13595171.77971.92
3138541-13854173.14773.28
4134436-13443670.97971.10
5129810-12981068.53768.67
6141847-14184774.89275.04
15min1168233-16823388.82390.041.5089.3390.571.50
2170860-17086090.21090.75
3168078-16807888.74289.29
4171251-17125190.41790.94
5169777-16977789.63990.16
6175005-17500592.39992.96
20min1181757-18175795.96496.240.7896.9697.270.76
2180055-18005595.06596.11
3181677-18167795.92296.96
4183698-18369896.98998.01
5183698-18369896.98998.00
6182786-18278696.50797.59
30min1176115-17611592.98592.841.7094.5294.411.68
2171580-17158090.59192.16
3175211-17521192.50894.08
4178350-17835094.16595.73
5173974-17397491.85493.41
6179836-17983694.95096.56
45min1180520-18052095.31194.850.6697.3696.930.63
2178390-17839094.18696.26
3179034-17903494.52696.61
4179786-17978694.92397.01
5181466-18146695.81097.87
6178684-17868494.34196.48
60min1173551-17355191.63194.912.5394.2197.522.48
2176624-17662493.25495.85
3177222-17722293.56996.18
4183007-18300796.62499.24
5184349-18434997.33299.93
6183828-18382897.05799.72
极限1181049-18104995.59095.210.6898.6898.340.65
2179945-17994595.00798.12
3178745-17874594.37397.50
4179946-17994695.00898.16
5182300-18230096.25099.39
6179941-17994195.00598.21
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%
110.773076923082063077483077923077343078340.07
210.713060723066783063750.14
单位质量响应值RSD%判断
28582.5428606.440.06数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH2.0(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%
5min1189189-18918954.65057.6619.0954.6557.6619.09
2209609-20960960.54960.55
3244107-24410770.51470.51
4171734-17173449.60849.61
5145901-14590142.14642.15
6237092-23709268.48868.49
10min1300278-30027886.74088.302.1787.0488.622.22
2304846-30484688.06088.40
3313560-31356090.57790.97
4297421-29742185.91586.19
5304750-30475088.03288.27
6313286-31328690.49890.88
15min1320376-32037692.54694.941.3093.3395.751.30
2329558-32955895.19896.02
3329848-32984895.28296.18
4328608-32860894.92495.68
5332343-33234396.00396.73
6331205-33120595.67496.56
20min1332553-33255396.06497.821.5997.3699.161.55
2335178-33517896.82298.18
3342735-34273599.005100.43
4339855-33985598.17399.45
5346541-346541100.104101.36
6334907-33490796.74498.16
30min1312581-31258190.29491.931.5892.1393.811.56
2311183-31118389.89091.78
3320358-32035892.54194.52
4322223-32222393.08094.91
5320553-32055392.59794.41
6322493-32249393.15895.11
45min1317829-31782991.81092.981.6494.1595.371.57
2320123-32012392.47394.86
3323185-32318593.35795.85
4320825-32082592.67695.02
5331734-33173495.82798.15
6317600-31760091.74494.21
60min1301676-30167687.14491.803.3889.9994.713.28
2312342-31234290.22593.13
3315391-31539191.10694.11
4321497-32149792.87095.73
5333505-33350596.33999.20
6322312-32231293.10596.08
极限1313480-31348090.55491.701.5793.8895.111.51
2317788-31778891.79895.21
3316480-31648091.42194.93
4315280-31528091.07494.45
5327100-32710094.48897.88
6314452-31445290.83594.33
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%
110.051725251725021726631723081722951724590.10
210.071725591726191725890.03
单位质量响应值RSD%判断
17160.1017138.930.09数据可信
供试品溶液-2024012021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%
5min181442-8144242.59935.7816.4142.6035.7816.41
273079-7307938.22538.23
368475-6847535.81735.82
473679-7367938.53938.54
548403-4840325.31825.32
665304-6530434.15834.16
10min1160560-16056083.98380.285.6484.2280.485.63
2149328-14932878.10878.32
3150632-15063278.79078.99
4163356-16335685.44685.66
5157176-15717682.21382.35
6139804-13980473.12773.32
15min1164155-16415585.86487.662.0386.5788.301.98
2170429-17042989.14589.79
3170481-17048189.17389.81
4162952-16295285.23485.92
5170394-17039489.12789.72
6167121-16712187.41588.01
20min1186228-18622897.40996.033.4498.5997.163.41
2183805-18380596.14297.28
3177380-17738092.78193.91
4186539-18653997.57298.73
5192317-192317100.594101.69
6175292-17529291.68992.77
30min1187049-18704997.83997.581.2499.5699.241.24
2185847-18584797.21098.89
3184228-18422896.36398.01
4187044-18704497.83699.54
5190570-19057099.680101.33
6184548-18454896.53198.12
45min1183759-18375996.11898.001.3598.38100.211.31
2189897-18989799.328101.54
3184798-18479896.66198.84
4189282-18928299.007101.25
5188752-18875298.729100.93
6187681-18768198.169100.30
60min1169666-16966688.74690.381.6991.5593.131.65
2171648-17164889.78392.55
3170634-17063489.25391.97
4175611-17561191.85694.65
5177047-17704792.60795.36
6172085-17208590.01292.68
极限1164125-16412585.84888.091.8289.1491.341.76
2171839-17183989.88393.15
3169892-16989288.86492.08
4168733-16873388.25891.57
5170560-17056089.21492.48
6165330-16533086.47889.65
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%
110.773080423081873085563077653079223080940.10
210.713100203110813105500.25
单位质量响应值RSD%判断
28606.6928996.270.96数据可信
供试品溶液-2024012021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%
5min166991-6699119.21353.1537.3719.2153.1637.37
2214520-21452061.52561.53
3238189-23818968.31468.31
4161279-16127946.25546.26
5259825-25982574.51974.52
6171186-17118649.09749.10
10min1254444-25444472.97689.089.8673.0889.389.95
2322364-32236492.45592.80
3331703-33170395.13495.51
4302546-30254686.77187.03
5340296-34029697.59898.01
6312226-31222689.54889.82
15min1318094-31809491.23193.402.3691.7494.192.48
2331230-33123094.99895.85
3329167-32916794.40695.31
4314705-31470590.25991.00
5334257-33425795.86696.82
6326575-32657593.66394.43
20min1331078-33107894.95599.183.2995.97100.483.39
2352482-352482101.093102.48
3342369-34236998.19399.63
4344113-34411398.69399.93
5364295-364295104.481105.97
6340438-34043897.63998.93
30min1344156-34415698.70599.801.46100.25101.661.54
2348407-34840799.925101.87
3342753-34275398.303100.28
4346176-34617699.285101.07
5356970-356970102.380104.45
6349285-349285100.176102.01
45min1345246-34524699.018100.961.55101.11103.381.62
2356826-356826102.339104.84
3345066-34506698.966101.49
4354096-354096101.556103.90
5356597-356597102.273104.91
6354277-354277101.608104.00
60min1342989-34298998.37199.891.85101.02102.861.90
2345229-34522999.013102.08
3342204-34220498.145101.22
4351447-351447100.796103.70
5359301-359301103.049106.26
6348504-34850499.952102.91
极限1337808-33780896.88599.221.78100.08102.761.89
2352547-352547101.112104.73
3346481-34648199.372102.99
4343421-34342198.495101.96
5353456-353456101.373105.15
6342084-34208498.111101.62
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%
110.051731891728511725071723561719501725710.28
210.071707801705791706800.09
单位质量响应值RSD%判断
17171.2416949.350.92数据可信
供试品溶液-2024012021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%
5min137279-3727919.60223.7614.3719.6023.7614.37
243589-4358922.92022.92
348573-4857325.54125.54
454945-5494528.89128.89
539343-3934320.68720.69
647389-4738924.91824.92
10min1142125-14212574.73270.257.6974.8470.387.68
2121200-12120063.73063.86
3145080-14508076.28676.43
4135501-13550171.24971.41
5121093-12109363.67363.79
6136571-13657171.81271.95
15min1168153-16815388.41988.353.2088.9488.873.19
2173810-17381091.39391.87
3174618-17461891.81892.38
4163808-16380886.13486.69
5161175-16117584.74985.22
6166569-16656987.58688.12
20min1175488-17548892.27592.622.7193.2993.632.68
2181821-18182195.60596.59
3178034-17803493.61494.69
4168573-16857388.63989.67
5173324-17332491.13892.08
6179566-17956694.42095.44
30min1182894-18289496.17097.521.9397.7099.051.92
2186033-18603397.82099.34
3184812-18481297.17898.77
4183368-18336896.41997.95
5183331-18333196.39997.85
6192369-192369101.152102.70
45min1184618-18461897.07697.152.4599.1499.222.39
2187201-18720198.434100.50
3180435-18043594.87797.01
4178951-17895194.09696.16
5186209-18620997.91399.89
6191183-191183100.528102.64
60min1187631-18763198.66099.511.14101.26102.121.15
2189369-18936999.574102.18
3188858-18885899.306101.97
4189292-18929299.534102.12
5187129-18712998.397100.92
6193222-193222101.600104.27
极限1186452-18645298.04199.401.69101.19102.561.60
2189510-18951099.649102.81
3188284-18828499.004102.22
4186896-18689698.274101.41
5195135-195135102.606105.68
6187928-18792898.817102.05
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%
110.773096713093483090083085633080963089370.21
210.713051193054003052600.07
单位质量响应值RSD%判断
28684.9628502.330.46数据可信
供试品溶液-2024012021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%
5min1239767-23976769.26375.756.5469.2675.756.54
2277606-27760680.19480.19
3277795-27779580.24980.25
4255218-25521873.72773.73
5276288-27628879.81479.81
6246755-24675571.28271.28
10min1325043-32504393.89896.902.4294.2897.322.42
2340215-34021598.28198.73
3327134-32713494.50294.95
4333872-33387296.44896.86
5341183-34118398.56099.00
6345136-34513699.702100.10
15min1341088-34108898.53398.721.3999.4499.681.39
2346615-346615100.130101.12
3343788-34378899.313100.28
4333504-33350496.34297.29
5340047-34004798.23299.22
6345381-34538199.773100.72
20min1332701-33270196.11096.862.5497.5698.362.52
2340995-34099598.506100.05
3334228-33422896.55198.07
4320504-32050492.58794.07
5338389-33838997.75399.29
6344907-34490799.636101.14
30min1333450-33345096.32697.692.1298.3199.742.10
2336999-33699997.35299.45
3337111-33711197.38499.44
4331364-33136495.72497.72
5338328-33832897.73699.82
6351776-351776101.620103.68
45min1332741-33274196.12295.942.6498.6498.532.60
2335972-33597297.05599.69
3326432-32643294.29996.90
4318153-31815391.90894.43
5336193-33619397.11999.74
6343188-34318899.140101.76
60min1337319-33731997.44497.961.25100.50101.081.25
2339688-33968898.129101.30
3341293-34129398.592101.72
4335989-33598997.060100.10
5334288-33428896.56999.73
6346074-34607499.973103.15
极限1335409-33540996.89297.741.57100.49101.411.55
2339397-33939798.044101.76
3339519-33951998.080101.75
4332249-33224995.98099.56
5347654-347654100.430104.13
6335881-33588197.029100.76
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