他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%
111.141470741147055714711751470978147053614707970.02
210.891428347142798614281660.02
单位质量响应值RSD%判断
132028.46131144.720.48数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min188532-885325.9656.123.755.976.133.73
296282-962826.4886.49
386598-865985.8355.84
492245-922456.2166.22
592016-920166.2006.20
689654-896546.0416.04
120min1318323-31832321.44923.725.7121.4623.735.70
2368968-36896824.86224.87
3355537-35553723.95723.97
4357826-35782624.11124.12
5371958-37195825.06325.07
6339779-33977922.89522.90
240min1671263-67126345.23151.347.3245.2751.387.32
2768224-76822451.76451.81
3786818-78681853.01753.06
4779665-77966552.53552.58
5835167-83516756.27556.32
6730612-73061249.23049.27
360min11070181-107018172.11180.505.7372.2280.625.73
21253925-125392584.49284.62
31228275-122827582.76482.89
41230389-123038982.90683.03
51224099-122409982.48282.61
61160902-116090278.22478.34
480min11509671-1509671101.725101.390.89101.94101.630.88
21511369-1511369101.839102.09
31499832-1499832101.062101.31
41488250-1488250100.281100.53
51493887-1493887100.661100.92
61524974-1524974102.756102.99
极限11514760-1514760102.067101.880.43102.44102.270.43
21511059-1511059101.818102.22
31503886-1503886101.335101.73
41506725-1506725101.526101.93
51512889-1512889101.941102.35
61522383-1522383102.581102.97
他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%
111.141461523146843914677701467947146743814666230.20
210.891424226142352314238740.04
单位质量响应值RSD%判断
131653.77130750.600.49数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min181454-814545.5055.505.845.505.505.83
277057-770575.2075.21
375773-757735.1215.12
482717-827175.5905.59
589093-890936.0216.02
682632-826325.5845.58
120min1358430-35843024.22223.474.9624.2323.474.96
2366317-36631724.75524.76
3315980-31598021.35421.36
4344708-34470823.29523.30
5350014-35001423.65423.66
6348061-34806123.52223.53
240min1742852-74285250.20248.123.3250.2548.173.33
2714304-71430448.27248.32
3671095-67109545.35245.39
4705430-70543047.67347.72
5720815-72081548.71248.76
6718175-71817548.53448.58
360min11159612-115961278.36674.223.4778.4974.343.47
21075033-107503372.65072.77
31052848-105284871.15171.26
41094298-109429873.95274.07
51124131-112413175.96876.09
61083872-108387273.24773.36
480min11478901-147890199.94399.231.37100.1899.461.37
21464041-146404198.93999.17
31431626-143162696.74896.96
41471083-147108399.41599.64
51474674-147467499.65899.89
61490028-1490028100.695100.92
极限11481346-1481346100.108100.371.74100.50100.751.74
21511339-1511339102.135102.51
31440552-144055297.35297.71
41480755-1480755100.069100.44
51487705-1487705100.538100.92
61509633-1509633102.020102.40
他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%
111.141468516146471314697281475497146412114685150.32
210.891407380140999014086850.14
单位质量响应值RSD%判断
131823.61129355.831.34数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min179458-794585.3956.108.465.406.108.43
290528-905286.1476.15
3101289-1012896.8786.88
494900-949006.4446.44
586635-866355.8835.88
686260-862605.8575.86
120min1306716-30671620.82721.935.7920.8321.945.79
2303420-30342020.60320.61
3343746-34374623.34123.35
4346743-34674323.54423.55
5312928-31292821.24821.26
6324076-32407622.00522.01
240min1709028-70902848.14449.016.4148.1849.056.40
2669752-66975245.47745.52
3792697-79269753.82553.87
4761994-76199451.74151.79
5704934-70493447.86647.91
6692274-69227447.00747.05
360min11122516-112251676.22178.654.6576.3378.774.65
21148769-114876978.00378.11
31248885-124888584.80184.93
41191128-119112880.88081.00
51138934-113893477.33577.45
61099651-109965174.66874.78
480min11446904-144690498.247102.842.9798.47103.082.97
21514071-1514071102.808103.03
31529431-1529431103.851104.10
41579257-1579257107.234107.48
51531458-1531458103.988104.22
61486297-1486297100.922101.15
极限11492893-1492893101.370103.021.26101.74103.411.27
21535222-1535222104.244104.62
31517589-1517589103.047103.46
41531497-1531497103.991104.40
51531383-1531383103.983104.37
61494761-1494761101.497101.87
他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%
111.141459555145960914611231461254146100714605100.06
210.891417712141843114180720.04
单位质量响应值RSD%判断
131105.03130217.810.49数据可信
供试品溶液-2024041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min1107035-1070357.2636.1114.277.266.1114.24
299060-990606.7226.72
374205-742055.0355.04
492853-928536.3016.30
576066-760665.1625.16
691103-911036.1826.18
120min1371902-37190225.23722.7411.6425.2522.7511.64
2377561-37756125.62125.63
3295258-29525820.03620.04
4352438-35243823.91623.93
5284993-28499319.33919.35
6328580-32858022.29722.31
240min1783121-78312153.14249.6413.7953.1949.6813.78
2824818-82481855.97156.02
3616985-61698541.86841.91
4814385-81438555.26355.31
5594106-59410640.31540.35
6755546-75554651.27151.31
360min11217330-121733082.60777.2414.7182.7477.3614.70
21275604-127560486.56186.69
3937297-93729763.60463.70
41248102-124810284.69584.82
5910401-91040161.77961.88
61241146-124114684.22384.34
480min11541457-1541457104.60295.3712.05104.8595.6012.05
21515664-1515664102.852103.11
31215736-121573682.49982.69
41495918-1495918101.512101.77
51162330-116233078.87579.06
61501725-1501725101.906102.15
极限11538343-1538343104.39196.629.62104.8097.009.64
21513888-1513888102.731103.15
31274304-127430486.47386.79
41489805-1489805101.097101.50
51224536-122453683.09683.40
61502243-1502243101.941102.34
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