依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.769772097703964559650097654972060.69
210.809550496181958420.50
单位质量响应值RSD%判断
9034.018874.261.27数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1102574-10257497.89493.596.6797.8993.596.67
2104006-10400699.26199.26
393708-9370889.43389.43
4104896-104896100.111100.11
593689-9368989.41589.41
689523-8952385.43985.44
10min1108513-108513103.563103.322.42104.11103.842.43
2109960-109960104.944105.49
3108393-108393103.448103.94
4110574-110574105.529106.09
5108893-108893103.925104.42
6103220-10322098.51198.99
15min1108834-108834103.869102.961.74104.99104.061.74
2110268-110268105.237106.37
3109121-109121104.143105.21
4105990-105990101.155102.30
5107628-107628102.718103.79
6105480-105480100.668101.69
20min1107231-107231102.339101.932.90104.04103.602.89
2109988-109988104.970106.69
3108422-108422103.476105.13
4108045-108045103.116104.82
5106031-106031101.194102.84
6101097-10109796.48598.07
30min1108196-108196103.260100.352.99105.52102.582.98
2107537-107537102.631104.93
3106235-106235101.388103.61
4104672-10467299.897102.17
5104805-104805100.024102.23
699420-9942094.88497.00
45min1107162-107162102.273100.972.63105.11103.762.62
2109824-109824104.814107.69
3106709-106709101.841104.63
4104179-10417999.426102.26
5105203-105203100.404103.17
6101727-10172797.08699.73
60min1106242-106242101.39599.223.45104.80102.573.42
2107405-107405102.505105.96
3106827-106827101.953105.31
4103439-10343998.720102.10
5101649-10164997.012100.33
698206-9820693.72696.91
极限1106446-106446101.59099.573.57105.56103.473.54
2109684-109684104.680108.70
3103753-10375399.020102.94
4103291-10329198.579102.51
5104359-10435999.598103.46
698430-9843093.94097.64
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.778606786661856478603986126861080.43
210.828498685855854200.72
单位质量响应值RSD%判断
7995.177894.640.90数据可信
供试品溶液-2024040921批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12915-29153.3023.4541.453.303.4541.53
25055-50555.7275.73
32813-28133.1873.19
43767-37674.2674.27
51337-13371.5151.51
62394-23942.7122.71
10min15279-52795.9807.5419.746.007.5619.76
27784-77848.8188.85
37377-73778.3578.37
48123-81239.2029.23
56367-63677.2137.22
65011-50115.6775.69
15min16535-65357.4038.5411.047.458.6011.09
28028-80289.0949.18
38235-82359.3299.39
48097-80979.1739.25
57919-79198.9719.02
66411-64117.2637.31
20min15210-52105.9027.4917.455.997.6017.24
27533-75338.5348.67
37453-74538.4438.56
45175-51755.8625.99
56659-66597.5447.64
67643-76438.6588.75
30min15414-54146.1335.9612.666.266.1112.17
24644-46445.2615.44
34283-42834.8525.01
45640-56406.3896.55
55539-55396.2756.42
66060-60606.8657.00
45min14819-48195.4595.716.215.625.896.01
24981-49815.6435.85
35356-53566.0686.26
44564-45645.1705.36
55335-53356.0446.22
65190-51905.8796.05
60min15354-53546.0655.4512.546.265.6611.95
23915-39154.4354.67
34891-48915.5415.76
45571-55716.3116.53
54481-44815.0765.28
64645-46455.2625.47
极限15658-56586.4105.2014.416.635.4413.54
24228-42284.7905.05
34205-42054.7645.02
44233-42334.7955.05
55175-51755.8626.10
64044-40444.5814.82
依折麦布瑞舒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RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.769665197733976099828297201974950.63
210.809568096088958840.31
单位质量响应值RSD%判断
9060.878878.151.45数据可信
供试品溶液-2024040921批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min198950-9895094.27693.114.6494.2893.124.64
2100933-10093396.16696.17
3103562-10356298.67098.67
494758-9475890.28290.28
597371-9737192.77292.77
690809-9080986.52086.52
10min1103963-10396399.052100.232.0799.58100.752.07
2108493-108493103.368103.90
3107294-107294102.226102.77
4103431-10343198.54699.05
5104656-10465699.713100.23
6103378-10337898.49598.98
15min1104211-10421199.289100.681.80100.36101.751.81
2108912-108912103.768104.88
3106160-106160101.146102.26
4105962-105962100.957102.01
5105315-105315100.341101.41
6103439-10343998.55399.58
20min1102857-10285797.999100.852.2599.62102.482.24
2110028-110028104.831106.52
3106474-106474101.445103.12
4105703-105703100.710102.32
5105172-105172100.204101.83
6104872-10487299.918101.49
30min1104387-10438799.456101.612.64101.63103.812.63
2108960-108960103.813106.08
3111064-111064105.818108.06
4106487-106487101.457103.63
5104899-10489999.944102.13
6104098-10409899.181101.31
45min1100905-10090596.139100.023.3598.86102.783.31
2110728-110728105.498108.34
3107285-107285102.218105.05
4103993-10399399.081101.81
5104247-10424799.323102.06
6102728-10272897.876100.56
60min1102559-10255997.71598.943.04100.97102.263.01
2109321-109321104.157107.59
3104916-10491699.960103.36
4104255-10425599.331102.61
5101614-10161496.814100.10
6100417-10041795.67498.90
极限1102972-10297298.10899.392.64101.91103.252.63
2107559-107559102.479106.49
3107197-107197102.134106.09
4102904-10290498.043101.88
5104800-10480099.850103.68
6100445-10044595.70199.46
依折麦布瑞舒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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.778528185442851408505485321852480.18
210.828519384724849580.40
单位质量响应值RSD%判断
7915.327851.940.57数据可信
供试品溶液-2024040921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%
5min13936-39364.4933.4456.134.493.4456.08
22677-26773.0563.06
34925-49255.6235.62
4-0.0000.00
52790-27903.1853.19
63725-37254.2534.25
10min15369-53696.1296.4224.736.156.4424.77
24705-47055.3715.39
38128-81289.2799.31
44723-47235.3925.39
54521-45215.1615.18
66305-63057.1987.22
15min16874-68747.8486.839.017.916.889.04
25628-56286.4256.47
35762-57626.5786.66
45706-57066.5146.54
55512-55126.2936.34
66412-64127.3207.38
20min15795-57956.6166.6410.476.726.7310.04
25879-58796.7126.79
34684-46845.3475.47
46498-64987.4187.48
56115-61156.9817.06
65922-59226.7616.86
30min16304-63047.1976.799.167.346.929.08
26249-62497.1347.25
35699-56996.5066.66
45810-58106.6336.74
55046-50465.7615.88
66555-65557.4837.63
45min16258-62587.1447.084.907.327.254.99
26119-61196.9867.15
36440-64407.3527.54
46036-60366.8917.04
55753-57536.5686.72
66608-66087.5447.73
60min16175-61757.0507.055.247.277.255.22
25972-59726.8187.02
36612-66127.5487.77
45722-57226.5326.71
56455-64557.3697.56
66098-60986.9627.19
极限16442-64427.3547.164.207.617.414.28
26381-63817.2857.52
36301-63017.1937.46
45776-57766.5946.81
56237-62377.1207.35
66513-65137.4357.70
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