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%
111.181862771853961852601854101858981856480.23
211.221864071867621865840.14
单位质量响应值RSD%判断
16605.3716629.590.11数据可信
供试品溶液-2024011621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%
5min113341-133417.2025.6424.767.205.6424.76
212533-125336.7656.77
37217-72173.8963.90
47936-79364.2844.28
59494-94945.1255.12
612211-122116.5926.59
10min118583-1858310.0319.616.1410.079.646.16
218165-181659.8069.84
316409-164098.8588.88
418733-1873310.11210.14
516426-164268.8678.90
618524-185249.99910.04
15min119832-1983210.70610.712.4510.8010.802.44
220009-2000910.80110.89
319776-1977610.67510.75
420650-2065011.14711.23
519172-1917210.34910.43
619636-1963610.60010.69
20min120280-2028010.94710.901.9311.1011.041.93
220223-2022310.91711.07
320417-2041711.02111.15
420648-2064811.14611.29
519502-1950210.52710.66
620095-2009510.84811.00
30min119422-1942210.48410.441.9510.7010.651.92
219096-1909610.30810.52
319363-1936310.45210.64
420030-2003010.81211.02
519209-1920910.36910.56
618952-1895210.23110.44
45min119289-1928910.41210.411.8610.6910.681.77
218889-1888910.19610.47
319677-1967710.62210.87
419750-1975010.66110.93
519110-1911010.31610.57
619003-1900310.25810.53
60min119227-1922710.37910.481.6410.7110.801.59
218972-1897210.24110.57
319510-1951010.53210.84
419865-1986510.72311.05
519314-1931410.42610.73
619641-1964110.60210.93
极限118999-1899910.25610.362.0010.6510.741.87
218898-1889810.20110.58
319653-1965310.60910.98
419519-1951910.53710.92
519350-1935010.44510.81
618679-1867910.08310.47
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%
110.963126693117423110073117113112073116670.21
211.023126913128383127640.04
单位质量响应值RSD%判断
28436.7728381.490.14数据可信
供试品溶液-2024011621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%
5min1140750-14075040.92343.025.8340.9243.025.84
2157581-15758145.81745.82
3145789-14578942.38842.39
4137958-13795840.11240.11
5146714-14671442.65742.66
6158955-15895546.21646.22
10min1239795-23979569.72170.550.7669.9570.790.76
2245331-24533171.33071.58
3243582-24358270.82271.06
4242134-24213470.40170.62
5242831-24283170.60470.84
6242198-24219870.42070.68
15min1275736-27573680.17181.120.9780.7981.760.97
2282543-28254382.15082.80
3279342-27934281.21981.85
4278339-27833980.92881.54
5281586-28158681.87282.50
6276542-27654280.40581.05
20min1292688-29268885.10086.601.2686.1687.681.26
2302554-30255487.96889.08
3301344-30134487.61688.70
4295697-29569785.97487.04
5298854-29885486.89287.98
6295970-29597086.05487.15
30min1303529-30352988.25289.230.7989.7890.800.79
2306151-30615189.01490.61
3305971-30597188.96290.53
4307354-30735489.36490.90
5310882-31088290.39091.96
6307534-30753489.41690.99
45min1318113-31811392.49292.870.4294.5294.930.42
2319521-31952192.90194.99
3321914-32191493.59795.66
4318905-31890592.72294.76
5318628-31862892.64294.71
6319336-31933692.84894.92
60min1324262-32426294.28095.390.6296.8297.970.62
2328397-32839795.48298.09
3328644-32864495.55498.14
4327865-32786595.32797.88
5329833-32983395.90098.48
6329514-32951495.80798.39
极限1327550-32755095.23696.180.9198.3099.280.90
2331901-33190196.50199.64
3333815-33381597.057100.17
4328560-32856095.52998.61
5334449-33444997.242100.36
6328427-32842795.49198.61
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%
111.181859181846801846111849591846441849620.30
211.221849341849101849220.01
单位质量响应值RSD%判断
16544.0116481.460.27数据可信
供试品溶液-2024012021批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17857-78574.2685.2332.784.275.2332.78
212198-121986.6266.63
37414-74144.0284.03
45688-56883.0903.09
513930-139307.5677.57
610690-106905.8075.81
10min116475-164758.9509.247.288.979.277.36
218121-181219.8449.88
315990-159908.6868.71
415562-155628.4548.47
518733-1873310.17610.22
617177-171779.3319.36
15min119287-1928710.47710.592.7710.5510.682.78
220584-2058411.18211.27
319127-1912710.39010.46
419443-1944310.56210.63
519289-1928910.47910.58
619289-1928910.47910.56
20min119517-1951710.60210.772.4110.7310.912.43
220745-2074511.26911.42
319934-1993410.82910.96
419542-1954210.61610.74
519574-1957410.63310.79
619628-1962810.66310.80
30min119176-1917610.41710.631.7210.6110.831.65
219795-1979510.75310.97
319904-1990410.81311.00
419896-1989610.80810.99
519361-1936110.51810.73
619262-1926210.46410.67
45min119429-1942910.55510.482.9810.8010.732.94
220173-2017310.95911.23
319558-1955810.62510.87
418949-1894910.29410.54
519075-1907510.36210.64
618509-1850910.05510.31
60min118773-1877310.19810.362.1610.5110.682.20
219625-1962510.66111.00
319409-1940910.54410.85
418544-1854410.07410.37
519196-1919610.42810.76
618877-1887710.25510.57
极限119306-1930610.48810.492.3910.8510.862.37
220052-2005210.89311.29
319511-1951110.59910.97
419241-1924110.45210.81
519046-1904610.34610.74
618682-1868210.14910.52
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%
110.963112693099993099983100373098643102330.19
211.023101873098273100070.09
单位质量响应值RSD%判断
28305.9328131.310.44数据可信
供试品溶液-2024012021批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144491-14449142.29545.507.2442.3045.507.23
2162322-16232247.51447.51
3145370-14537042.55242.55
4153502-15350244.93344.93
5174204-17420450.99350.99
6152737-15273744.70944.71
10min1239883-23988370.21872.192.3670.4572.442.38
2252164-25216473.81374.08
3244050-24405071.43871.67
4243786-24378671.36071.61
5255230-25523074.71074.99
6244663-24466371.61771.87
15min1279331-27933181.76582.521.3882.3983.171.39
2289150-28915084.63985.31
3278751-27875181.59582.23
4281680-28168082.45383.10
5282905-28290582.81183.51
6279602-27960281.84482.49
20min1293215-29321585.82987.541.4386.9188.651.44
2304790-30479089.21790.36
3298386-29838687.34388.43
4295475-29547586.49187.59
5301927-30192788.37989.54
6300519-30051987.96789.07
30min1302555-30255588.56391.451.8090.1293.051.78
2309627-30962790.63392.27
3312937-31293791.60293.17
4316000-31600092.49994.08
5317413-31741392.91294.56
6316059-31605992.51694.11
45min1321336-32133694.06194.481.2796.1196.581.27
2329642-32964296.49298.64
3321324-32132494.05796.14
4322172-32217294.30596.40
5324584-32458495.01197.18
6317463-31746392.92795.03
60min1317057-31705792.80894.992.3195.3897.622.27
2326240-32624095.49698.18
3325636-32563695.31997.92
4314201-31420191.97294.59
5332631-33263197.367100.06
6331335-33133596.98899.61
极限1329806-32980696.54097.840.8599.63101.000.86
2336046-33604698.367101.58
3331956-33195697.169100.30
4335913-33591398.328101.46
5334566-33456697.933101.17
6337245-33724598.717101.88
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%
111.181883401880331888921891921892481887410.29
211.221899521897951898740.06
单位质量响应值RSD%判断
16882.0216922.820.18数据可信
供试品溶液-2024012021批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19434-94345.0075.8216.395.015.8216.39
212962-129626.8796.88
312674-126746.7266.73
49440-94405.0105.01
59157-91574.8604.86
612104-121046.4246.42
10min117229-172299.1449.584.479.179.624.47
218574-185749.8579.90
318185-181859.6519.69
417805-178059.4499.48
519294-1929410.24010.27
617225-172259.1429.18
15min121023-2102311.15710.623.0711.2410.713.02
220399-2039910.82610.92
319305-1930510.24510.34
419608-1960810.40610.49
519827-1982710.52210.61
619928-1992810.57610.66
20min121278-2127811.29210.663.2811.4310.813.19
220270-2027010.75810.91
319649-1964910.42810.58
420191-2019110.71610.85
519680-1968010.44410.59
619503-1950310.35010.50
30min122656-2265612.02410.666.5012.2310.866.40
219831-1983110.52510.74
319947-1994710.58610.79
419634-1963410.42010.62
519464-1946410.33010.53
618976-1897610.07110.27
45min120956-2095611.12210.534.6411.3910.794.60
220889-2088911.08611.36
319948-1994810.58710.85
419346-1934610.26710.52
518796-187969.97510.23
619108-1910810.14110.40
60min121610-2161011.46910.445.1911.8010.765.10
219341-1934110.26410.60
319927-1992710.57510.90
419367-1936710.27810.59
518823-188239.99010.30
618988-1898810.07710.39
极限122486-2248611.93410.417.3512.3310.787.19
219278-1927810.23110.62
319293-1929310.23910.62
419201-1920110.19010.56
518795-187959.97510.34
618583-185839.86210.23
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%
110.963152323156713166853175813168813164100.30
211.023191403179943185670.26
单位质量响应值RSD%判断
28869.5328908.080.10数据可信
供试品溶液-2024012021批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155436-15543644.44345.264.4944.4445.264.49
2158585-15858545.34345.34
3153764-15376443.96543.96
4155080-15508044.34144.34
5172393-17239349.29149.29
6154533-15453344.18544.18
10min1238907-23890768.30971.183.4868.5671.443.48
2249157-24915771.24071.49
3247585-24758570.79171.03
4247549-24754970.78071.03
5265025-26502575.77776.05
6245559-24555970.21170.46
15min1275221-27522178.69281.021.8979.3281.671.89
2283080-28308080.93981.59
3281802-28180280.57481.21
4281538-28153880.49981.14
5289071-28907182.65283.35
6289540-28954082.78683.42
20min1297055-29705584.93586.501.1286.0087.601.13
2305085-30508587.23188.33
3299971-29997185.76986.85
4303562-30356286.79687.88
5305937-30593787.47588.63
6303638-30363886.81787.91
30min1307619-30761987.95690.421.7689.4992.001.76
2319046-31904691.22392.80
3317815-31781590.87192.43
4313710-31371089.69791.27
5324115-32411592.67294.31
6315075-31507590.08891.67
45min1318150-31815090.96793.191.9892.9995.271.95
2336130-33613096.10898.20
3325490-32549093.06595.13
4320977-32097791.77593.84
5324829-32482992.87695.03
6329936-32993694.33796.41
60min1328862-32886294.03095.291.3096.5697.891.28
2335138-33513895.82498.45
3338215-33821596.70499.29
4327568-32756893.66096.24
5332913-33291395.18897.86
6336873-33687396.32098.92
极限1331692-33169294.83995.231.1797.8998.361.17
2338690-33869096.84099.99
3333361-33336195.31698.44
4327019-32701993.50396.60
5335319-33531995.87699.08
6332374-33237495.03498.17
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