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%
111.181858531854301853111850901852531853870.16
211.221872511877441874980.19
单位质量响应值RSD%判断
16582.0216711.050.55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%
5min110234-102345.5154.7928.925.514.7928.88
211270-112706.0736.07
38978-89784.8384.84
411215-112156.0446.04
55028-50282.7092.71
66606-66063.5603.56
10min117699-176999.5388.735.189.578.765.17
215938-159388.5898.62
316221-162218.7418.77
415185-151858.1838.22
515810-158108.5208.53
616326-163268.7988.82
15min119818-1981810.67910.442.4710.7610.512.41
219136-1913610.31210.39
318837-1883710.15110.23
418857-1885710.16210.24
519699-1969910.61510.68
619847-1984710.69510.76
20min120557-2055711.07810.663.5911.2210.793.53
219400-1940010.45410.59
318675-1867510.06410.20
419514-1951410.51610.65
520364-2036410.97411.10
620140-2014010.85310.98
30min120618-2061811.11110.544.7811.3210.744.72
219121-1912110.30410.50
317965-179659.6819.87
419642-1964210.58510.78
520223-2022310.89811.08
619811-1981110.67610.86
45min119511-1951110.51410.493.3910.7810.743.31
219303-1930310.40210.66
318636-1863610.04310.28
418956-1895610.21510.47
520443-2044311.01611.26
619954-1995410.75311.00
60min119892-1989210.71910.305.1211.0410.615.01
218245-182459.83210.14
317875-178759.6329.93
418752-1875210.10510.41
520344-2034410.96311.27
619601-1960110.56310.87
极限120018-2001810.78710.303.3111.1710.663.30
219178-1917810.33510.70
318119-181199.76410.11
418972-1897210.22410.59
519460-1946010.48710.85
618901-1890110.18510.55
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%
110.963107553086623084003081513083303088600.35
211.023114313121433117870.17
单位质量响应值RSD%判断
28180.6628292.830.29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%
5min1151421-15142144.29543.044.5444.2943.044.54
2157440-15744046.05646.06
3147514-14751443.15243.15
4138253-13825340.44340.44
5144381-14438142.23542.24
6143757-14375742.05342.05
10min1241730-24173070.71369.381.2770.9669.621.27
2238695-23869569.82570.08
3234571-23457168.61968.86
4233327-23332768.25568.48
5237073-23707369.35069.59
6237570-23757069.49669.73
15min1277016-27701681.03580.460.4381.6781.090.43
2274868-27486880.40781.05
3275136-27513680.48581.11
4275240-27524080.51581.12
5273364-27336479.96780.59
6274696-27469680.35680.98
20min1295229-29522986.36385.370.8987.4586.440.88
2289995-28999584.83285.92
3291008-29100885.12886.20
4293260-29326085.78786.84
5288174-28817484.29985.36
6293287-29328785.79586.86
30min1314050-31405091.86889.802.0093.4491.341.97
2304903-30490389.19390.75
3297391-29739186.99588.54
4311200-31120091.03592.56
5303739-30373988.85290.38
6310527-31052790.83892.38
45min1314185-31418591.90892.801.2993.9994.851.25
2312084-31208491.29393.35
3319584-31958493.48795.51
4316352-31635292.54294.58
5317590-31759092.90494.93
6323634-32363494.67296.72
60min1326029-32602995.37394.011.1497.9696.571.12
2317304-31730492.82095.38
3316906-31690692.70495.25
4321552-32155294.06396.61
5322296-32229694.28196.82
6324088-32408894.80597.38
极限1329383-32938396.35494.141.7499.4797.231.70
2320987-32098793.89896.98
3321182-32118293.95597.01
4326524-32652495.51798.59
5313403-31340391.67994.75
6319493-31949393.46196.56
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%
111.181859781851461851201851201851261852980.21
211.221866121871631868880.21
单位质量响应值RSD%判断
16574.0616656.680.36数据可信
供试品溶液-2024011821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%
5min114362-143627.7546.6812.147.756.6812.14
213886-138867.4977.50
310842-108425.8535.85
411715-117156.3256.32
510886-108865.8775.88
612554-125546.7786.78
10min118893-1889310.2009.546.2910.249.586.31
218921-1892110.21510.26
317092-170929.2289.26
417739-177399.5779.61
516034-160348.6568.69
617366-173669.3769.41
15min119557-1955710.55810.451.9310.6610.541.96
219911-1991110.75010.85
319281-1928110.40910.49
419446-1944610.49910.59
518922-1892210.21610.30
618980-1898010.24710.34
20min119767-1976710.67210.561.3610.8310.701.40
219844-1984410.71310.87
319336-1933610.43910.58
419758-1975810.66710.81
519383-1938310.46510.60
619234-1923410.38410.53
30min119523-1952310.54010.451.1810.7610.651.15
219229-1922910.38110.60
319734-1973410.65410.85
419156-1915610.34210.55
519229-1922910.38110.58
619227-1922710.38010.58
45min119161-1916110.34510.272.0110.6210.531.91
218416-184169.94210.22
319309-1930910.42510.68
418689-1868910.09010.35
519126-1912610.32610.58
619389-1938910.46810.73
60min119101-1910110.31210.171.0210.6510.491.00
218539-1853910.00910.34
318870-1887010.18810.50
418727-1872710.11010.43
518851-1885110.17710.49
618935-1893510.22310.54
极限119186-1918610.35810.201.4510.7510.581.41
218626-1862610.05610.44
318867-1886710.18610.56
418575-1857510.02810.40
519228-1922810.38110.75
618843-1884310.17310.55
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%
110.963103843067843069453068693069273075820.51
211.023096533104393100460.18
单位质量响应值RSD%判断
28064.0528134.850.18数据可信
供试品溶液-2024011821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%
5min1151200-15120044.44644.646.1344.4544.646.13
2164349-16434948.31148.31
3142740-14274041.95941.96
4158160-15816046.49246.49
5139867-13986741.11541.11
6154866-15486645.52445.52
10min1240766-24076670.77570.271.9171.0270.521.92
2243578-24357871.60171.87
3232121-23212168.23368.47
4238810-23881070.20070.46
5235551-23555169.24269.47
6243565-24356571.59871.85
15min1264951-26495177.88480.472.0278.5281.112.03
2280583-28058382.47983.15
3272366-27236680.06480.68
4273806-27380680.48781.14
5272172-27217280.00780.62
6278665-27866581.91582.57
20min1282786-28278683.12785.831.9984.2086.911.99
2300002-30000288.18889.31
3288696-28869684.86485.92
4292626-29262686.01987.11
5293165-29316586.17887.24
6294516-29451686.57587.68
30min1299785-29978588.12490.451.4289.6692.021.43
2311650-31165091.61293.23
3308397-30839790.65592.18
4308147-30814790.58292.16
5306663-30666390.14691.68
6311578-31157891.59093.18
45min1307293-30729390.33193.031.8792.3595.101.85
2318308-31830893.56995.69
3315785-31578592.82794.86
4312876-31287691.97294.05
5320664-32066494.26196.30
6323929-32392995.22197.32
60min1311061-31106191.43893.791.4993.9696.371.49
2322285-32228594.73897.38
3317253-31725393.25995.81
4318199-31819993.53796.12
5321088-32108894.38696.95
6324502-32450295.38998.01
极限1317903-31790393.45094.821.3296.4897.921.31
2324970-32497095.52798.70
3319714-31971493.98297.05
4319250-31925093.84696.95
5328855-32885596.66999.75
6324591-32459195.41698.57
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%
111.181884781878491876281869201871051875960.34
211.221848441855201851820.26
单位质量响应值RSD%判断
16779.6116504.631.17数据可信
供试品溶液-2024011821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%
5min113510-135107.2836.7610.147.286.7610.10
213172-131727.1007.10
312036-120366.4886.49
412734-127346.8646.86
513600-136007.3317.33
610233-102335.5165.52
10min118469-184699.9569.755.0110.009.785.02
218081-180819.7479.79
318230-182309.8279.86
418142-181429.7799.82
519145-1914510.32010.36
616412-164128.8478.88
15min119756-1975610.64910.451.8610.7510.541.90
219444-1944410.48110.57
319289-1928910.39810.49
418903-1890310.19010.28
519797-1979710.67210.77
619076-1907610.28310.36
20min119747-1974710.64510.441.5010.8010.591.54
219332-1933210.42110.57
319292-1929210.39910.55
419128-1912810.31110.46
519682-1968210.61010.77
619032-1903210.25910.40
30min119476-1947610.49910.411.0810.7110.621.06
219232-1923210.36710.58
319256-1925610.38010.59
418977-1897710.23010.44
519565-1956510.54610.76
619384-1938410.44910.64
45min119223-1922310.36210.093.0810.6310.353.04
219011-1901110.24810.52
318605-1860510.02910.29
417623-176239.5009.76
519026-1902610.25610.53
618804-1880410.13610.39
60min118778-1877810.12210.121.6610.4510.441.65
219323-1932310.41610.74
318566-1856610.00810.33
418418-184189.92810.24
518841-1884110.15610.49
618693-1869310.07610.38
极限118648-1864810.05210.041.0510.4410.421.10
218899-1889910.18710.57
318402-184029.92010.29
418601-1860110.02710.40
518773-1877310.12010.51
618415-184159.92710.29
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%
110.963105483111433107513100503098213104630.18
211.023066223077113071660.26
单位质量响应值RSD%判断
28326.9227873.501.15数据可信
供试品溶液-2024011821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%
5min1166755-16675549.02045.274.8649.0245.274.86
2143558-14355842.20142.20
3155551-15555145.72745.73
4152837-15283744.92944.93
5152697-15269744.88844.89
6152618-15261844.86544.86
10min1240474-24047470.69170.421.3270.9670.671.32
2237002-23700269.67169.91
3243123-24312371.47071.72
4236931-23693169.65069.90
5243192-24319271.49071.74
6236502-23650269.52469.77
15min1276211-27621181.19780.370.8381.8681.010.83
2272604-27260480.13780.76
3274797-27479780.78181.43
4269596-26959679.25279.89
5273196-27319680.31180.96
6273889-27388980.51481.15
20min1290114-29011485.28484.350.8486.4085.440.85
2285180-28518083.83484.90
3289482-28948285.09886.20
4284533-28453383.64384.72
5287242-28724284.44085.53
6285142-28514283.82284.91
30min1306138-30613889.99589.860.8291.5891.420.82
2301582-30158288.65590.19
3307867-30786790.50392.08
4304000-30400089.36690.91
5306273-30627390.03491.60
6308150-30815090.58692.13
45min1317661-31766193.38291.951.0795.4794.001.05
2314344-31434492.40794.43
3310715-31071591.34093.42
4309292-30929290.92292.96
5309892-30989291.09893.16
6314787-31478792.53794.59
60min1314866-31486692.56093.221.3295.1795.791.27
2323048-32304894.96697.50
3319980-31998094.06496.65
4313930-31393092.28594.83
5312114-31211491.75194.32
6318747-31874793.70196.27
极限1316895-31689593.15793.861.0996.2896.941.06
2324496-32449695.39198.46
3320689-32068994.27297.38
4316437-31643793.02296.08
5315718-31571892.81195.89
6321441-32144194.49397.58
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