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%
110.021736541737001743831735831737231738090.19
210.031748921751611750260.11
单位质量响应值RSD%判断
17346.2117450.250.43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%
5min140350-4035020.80414.8832.2120.8014.8832.21
228427-2842714.65714.66
330140-3014015.54015.54
415057-150577.7637.76
536865-3686519.00719.01
622279-2227911.48711.49
10min184977-8497743.81349.949.1743.9350.029.14
2106135-10613554.72254.80
3105679-10567954.48754.57
4100722-10072251.93151.97
595219-9521949.09449.20
688405-8840545.58145.64
15min1115826-11582659.71971.308.7660.0871.668.71
2150965-15096577.83678.22
3135263-13526369.74070.13
4142181-14218173.30773.64
5143942-14394274.21574.59
6141563-14156372.98973.31
20min1134180-13418069.18282.758.4769.8783.518.43
2167390-16739086.30587.12
3157562-15756281.23882.01
4166814-16681486.00886.75
5170184-17018487.74588.54
6166878-16687886.04186.76
30min1160600-16060082.80488.514.3683.8889.724.38
2176306-17630690.90292.20
3170328-17032887.82089.05
4175085-17508590.27291.49
5181334-18133493.49494.77
6166331-16633185.75986.96
45min1171296-17129688.31992.023.3589.8593.733.33
2174492-17449289.96791.77
3176888-17688891.20292.92
4177044-17704491.28293.00
5183838-18383894.78596.58
6187306-18730696.57398.25
60min1179517-17951792.55794.781.3594.5897.001.42
2186241-18624196.02498.33
3184352-18435295.05097.27
4182479-18247994.08596.31
5185571-18557195.67998.00
6184808-18480895.28597.50
极限1182824-18282494.26395.351.0396.8098.101.07
2184137-18413794.93997.78
3183693-18369394.71197.46
4184447-18444795.09997.85
5187387-18738796.61599.47
6187161-18716196.49999.24
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%
111.173092793097133112303092253091773097250.29
211.113103373124843114100.49
单位质量响应值RSD%判断
27728.2928029.700.77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%
5min180248-8024823.77734.4556.3723.7834.4556.37
2192034-19203456.89856.90
3205097-20509760.76860.77
481622-8162224.18424.18
591025-9102526.97026.97
647628-4762814.11214.11
10min1168122-16812249.81365.2128.3949.9465.4028.46
2284905-28490584.41484.73
3283721-28372184.06384.40
4246612-24661273.06873.20
5204372-20437260.55360.70
6132798-13279839.34739.42
15min1224473-22447366.50977.0520.2566.9277.6020.36
2318067-31806794.24095.02
3311762-31176292.37293.18
4272138-27213880.63281.17
5253591-25359175.13675.62
6180271-18027153.41253.71
20min1256571-25657176.01984.2214.8176.8085.2014.96
2322365-32236595.51396.82
3324075-32407596.02097.34
4305280-30528090.45191.44
5280764-28076483.18784.09
6216477-21647764.14064.73
30min1289672-28967285.82789.2010.3487.0390.6510.53
2321343-32134395.21097.05
3326553-32655396.75498.61
4318345-31834594.32295.81
5306908-30690890.93392.30
6243439-24343972.12873.08
45min1303877-30387790.03592.592.5691.7194.542.83
2312680-31268092.64495.01
3318783-31878394.45296.84
4317867-31786794.18196.20
5320187-32018794.86896.74
6301667-30166789.38190.73
60min1312030-31203092.45194.732.3494.6397.192.68
2327809-32780997.126100.01
3325773-32577396.52399.44
4320066-32006694.83297.37
5323235-32323595.77198.17
6309460-30946091.69093.54
极限1314393-31439393.15195.821.8295.8498.801.68
2321403-32140395.22898.65
3322454-32245495.54098.99
4322688-32268895.60998.67
5328029-32802997.191100.12
6331417-33141798.195100.55
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%
110.021754911760111765331767011766841762840.30
210.031748321755821752070.31
单位质量响应值RSD%判断
17593.2117468.300.51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%
5min136127-3612718.48622.6226.6718.4922.6226.68
239034-3903419.97419.97
342523-4252321.75921.76
439636-3963620.28220.28
567902-6790234.74534.75
639998-3999820.46720.47
10min1130463-13046366.75770.345.6066.8670.475.64
2134333-13433368.73868.85
3140938-14093872.11772.24
4132782-13278267.94468.06
5151462-15146277.50277.70
6134804-13480468.97969.09
15min1164825-16482584.34085.912.0584.8186.432.10
2168647-16864786.29686.79
3169476-16947686.72087.24
4164960-16496084.40984.90
5173684-17368488.87389.50
6165809-16580984.84485.34
20min1171729-17172987.87389.842.1288.8290.832.16
2174746-17474689.41790.39
3177636-17763690.89691.90
4172396-17239688.21489.17
5181810-18181093.03194.15
6175091-17509189.59390.56
30min1175623-17562389.86690.700.6091.3092.190.59
2177022-17702290.58192.05
3177296-17729690.72292.23
4178885-17888591.53592.98
5177107-17710790.62592.26
6177581-17758190.86792.33
45min1164592-16459284.22190.094.4386.1592.094.38
2178951-17895191.56893.54
3178474-17847491.32493.34
4168407-16840786.17388.13
5181638-18163892.94395.08
6184331-18433194.32196.29
60min1175147-17514789.62291.641.4192.0294.141.46
2179756-17975691.98094.46
3180135-18013592.17494.69
4177573-17757390.86393.30
5182589-18258993.43096.08
6179328-17932891.76194.26
极限1179844-17984492.02592.540.5894.9295.550.64
2180539-18053992.38195.37
3182346-18234693.30696.34
4180193-18019392.20495.15
5181936-18193693.09696.27
6180242-18024292.22995.23
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%
111.173124223135873143973141963138753136950.25
211.113103443131103117270.63
单位质量响应值RSD%判断
28083.7128058.240.07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%
5min173210-7321021.54228.3315.5021.5428.3315.50
287308-8730825.69125.69
3106053-10605331.20731.21
499421-9942129.25529.26
5116118-11611834.16834.17
695491-9549128.09928.10
10min1235959-23595969.43271.262.6369.5571.422.65
2232729-23272968.48168.62
3245225-24522572.15972.33
4244373-24437371.90872.07
5245659-24565972.28672.48
6249072-24907273.29073.45
15min1277439-27743981.63881.981.5082.1482.531.48
2278612-27861281.98382.51
3278249-27824981.87682.45
4276932-27693281.48882.05
5273942-27394280.60981.20
6286370-28637084.26684.83
20min1286317-28631784.25085.471.7685.2186.481.76
2289793-28979385.27386.25
3291244-29124485.70086.73
4287179-28717984.50485.52
5287941-28794184.72885.77
6300202-30020288.33689.37
30min1288361-28836184.85185.802.5186.2887.292.47
2292207-29220785.98387.44
3292639-29263986.11087.62
4293951-29395186.49687.98
5280065-28006582.41083.92
6302357-30235788.97090.49
45min1271462-27146279.87985.854.4381.7887.804.35
2298463-29846387.82489.75
3294269-29426986.59088.57
4283429-28342983.40085.36
5308954-30895490.91192.88
6293873-29387386.47388.49
60min1287319-28731984.54586.812.0186.8989.252.00
2298885-29888587.94890.37
3296867-29686787.35489.82
4292634-29263486.10988.54
5290734-29073485.55088.02
6303619-30361989.34191.84
极限1307522-30752290.49092.321.4893.3095.241.48
2312966-31296692.09295.00
3316064-31606493.00395.95
4317172-31717293.32996.24
5309381-30938191.03793.98
6319382-31938293.98096.97
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