氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011474653147565114753331474727147526514751260.03
210.721439908143916814395380.04
单位质量响应值RSD%判断
133980.56134285.260.17数据可信
供试品溶液-2024041521批-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%
240min1254492-25449216.82215.386.6316.8215.386.63
2234124-23412415.47615.48
3231447-23144715.29915.30
4237779-23777915.71815.72
5206564-20656413.65413.65
6231985-23198515.33515.33
480min1401524-40152426.54226.013.4226.5726.033.43
2402915-40291526.63426.66
3378604-37860425.02725.05
4404749-40474926.75526.78
5374146-37414624.73224.75
6398791-39879126.36126.38
720min1538519-53851935.59735.401.2235.6635.461.23
2537388-53738835.52335.59
3541662-54166235.80535.87
4534700-53470035.34535.41
5523062-52306234.57634.63
6537746-53774635.54635.61
1440min1886556-88655658.60360.833.6658.7260.953.65
2955060-95506063.13263.25
3940548-94054862.17262.29
4953923-95392363.05663.17
5881775-88177558.28758.40
6903864-90386459.74759.86
极限1930876-93087661.53363.443.6861.7463.653.68
2991724-99172465.55565.77
3971979-97197964.25064.46
41004877-100487766.42566.64
5916322-91632260.57160.77
6942776-94277662.32062.53
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011469930147023514707721471198147055614705380.04
210.721434368143369014340290.04
单位质量响应值RSD%判断
133563.85133771.360.11数据可信
供试品溶液-2024041521批-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%
240min1239572-23957215.89115.9511.3915.8915.9511.39
2274493-27449318.20818.21
3254758-25475816.89916.90
4257024-25702417.04917.05
5204250-20425013.54813.55
6212304-21230414.08314.08
480min1400363-40036326.55727.218.6726.5827.248.67
2459302-45930230.46730.49
3431479-43147928.62128.65
4427787-42778728.37628.40
5368136-36813624.41924.44
6374458-37445824.83924.86
720min1524235-52423534.77435.786.5734.8435.846.58
2584099-58409938.74538.82
3566452-56645237.57437.64
4558804-55880437.06737.13
5505826-50582633.55333.61
6496829-49682932.95633.01
1440min1790084-79008452.40857.708.5852.5257.828.57
2958955-95895563.61063.74
3888922-88892258.96459.09
4879516-87951658.34058.46
5929573-92957361.66161.77
6772512-77251251.24251.35
极限1824475-82447554.68960.798.4354.8860.998.43
21003753-100375366.58166.81
3952559-95255963.18563.40
4926840-92684061.47961.69
5971017-97101764.41064.61
6819751-81975154.37654.56
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011463353146394314643721465070146359814640670.05
210.721440382144029814403400.01
单位质量响应值RSD%判断
132976.11134360.070.74数据可信
供试品溶液-2024041721批-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%
240min1221232-22123214.67514.825.2114.6814.825.20
2234007-23400715.52315.52
3240021-24002115.92115.92
4210574-21057413.96813.97
5212590-21259014.10214.10
6222100-22210014.73314.73
480min1399447-39944726.49725.985.1426.5226.005.14
2405253-40525326.88226.91
3403244-40324426.74926.77
4384722-38472225.52025.54
5353561-35356123.45323.47
6403485-40348526.76526.79
720min1537833-53783335.67634.035.3835.7434.105.37
2520921-52092134.55534.62
3518554-51855434.39834.46
4499942-49994233.16333.22
5464459-46445930.80930.87
6536695-53669535.60135.66
1440min1874308-87430857.99655.347.2658.1155.457.25
2876016-87601658.10958.22
3849680-84968056.36256.48
4782767-78276751.92452.03
5737076-73707648.89349.00
6885403-88540358.73258.85
极限1913545-91354560.59957.596.7560.8057.786.74
2908110-90811060.23860.44
3882315-88231558.52758.73
4812046-81204653.86654.05
5778631-77863151.64951.83
6914198-91419860.64260.85
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011461643146206614624271462166146219514620990.02
210.721435633143633914359860.04
单位质量响应值RSD%判断
132797.37133953.920.62数据可信
供试品溶液-2024041721批-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%
240min1218225-21822514.50714.857.4514.5114.857.44
2206820-20682013.74913.75
3247358-24735816.44416.44
4238178-23817815.83415.83
5223576-22357614.86314.86
6206376-20637613.72013.72
480min1391792-39179226.04626.006.5126.0726.026.50
2360089-36008923.93823.96
3428483-42848328.48528.51
4405798-40579826.97727.00
5394902-39490226.25326.27
6365769-36576924.31624.34
720min1526497-52649735.00134.365.1035.0634.425.10
2479457-47945731.87431.93
3556919-55691937.02337.09
4519642-51964234.54534.61
5520271-52027134.58734.65
6498235-49823533.12233.18
1440min1868740-86874057.75356.655.6557.8756.765.65
2766324-76632450.94451.05
3900812-90081259.88560.01
4828238-82823855.06055.18
5872063-87206357.97458.09
6876467-87646758.26658.37
极限1895623-89562359.54059.035.1459.7459.235.14
2808792-80879253.76753.95
3937862-93786262.34862.56
4864342-86434257.46057.66
5911702-91170260.60960.81
6909592-90959260.46860.66
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011466510146710514673671467725146706614671550.04
210.721438721143808114384010.04
单位质量响应值RSD%判断
133256.58134179.200.49数据可信
供试品溶液-2024041821批-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%
240min1227368-22736815.07615.0113.0515.0815.0113.05
2233624-23362415.49115.49
3180549-18054911.97211.97
4237192-23719215.72815.73
5269043-26904317.84017.84
6210058-21005813.92913.93
480min1388399-38839925.75423.989.3725.7824.009.36
2337059-33705922.35022.37
3315933-31593320.94920.97
4394652-39465226.16926.19
5391136-39113625.93525.96
6342599-34259922.71722.74
720min1536518-53651835.57533.138.9135.6433.188.92
2482511-48251131.99432.05
3429962-42996228.51028.56
4536796-53679635.59435.66
5536988-53698835.60735.67
6474724-47472431.47831.53
1440min1881360-88136058.44156.405.9458.5656.515.94
2870703-87070357.73557.84
3794829-79482952.70452.80
4910111-91011160.34860.46
5863860-86386057.28157.40
6782940-78294051.91552.02
极限1916935-91693560.80059.175.2061.0059.375.21
2911642-91164260.44960.64
3832042-83204255.17155.34
4950178-95017863.00463.21
5903093-90309359.88260.09
6840644-84064455.74155.92
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.011452372145003614495071449336144952614501550.09
210.721439790143814914389700.09
单位质量响应值RSD%判断
131712.53134232.281.34数据可信
供试品溶液-2024041821批-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%
240min1222616-22261614.84513.5211.8514.8513.5211.85
2178861-17886111.92711.93
3181623-18162312.11212.11
4211902-21190214.13114.13
5235794-23579415.72415.72
6185572-18557212.37512.37
480min1376293-37629325.09325.549.7425.1225.569.74
2392042-39204226.14326.16
3317678-31767821.18421.20
4392256-39225626.15826.18
5432590-43259028.84728.87
6387521-38752125.84225.86
720min1518812-51881234.59734.8710.6134.6634.9310.60
2538289-53828935.89635.95
3424373-42437328.29928.35
4533953-53395335.60735.67
5595512-59551239.71239.78
6526575-52657535.11535.17
1440min1857200-85720057.16257.498.0957.2757.608.09
2856228-85622857.09857.21
3732342-73234248.83648.93
4888722-88872259.26459.38
5907701-90770160.53060.66
6930058-93005862.02162.13
极限1900947-90094760.08060.417.6460.2860.617.64
2894552-89455259.65359.85
3777390-77739051.84052.01
4943949-94394962.94763.15
5951927-95192763.47963.70
6966678-96667864.46364.67
点击查看处理图标(自动生成)
 
原始图谱(等待粘贴贴图标)