配吗贝特缓释片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354374143682438994381743604437490.27
210.414340843340433740.12
单位质量响应值RSD%判断
4226.964166.571.02数据可信
供试品溶液-2011707批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
240min1322-3220.6890.5087.660.690.5187.70
2386-3860.8260.83
3-0.0000.00
360min1476-4761.0181.030.871.031.030.56
2484-4841.0351.04
3482-4821.0311.03
480min1518-5181.1081.3220.011.131.3419.36
2579-5791.2391.26
3756-7561.6171.63
600min1657-6571.4051.394.971.441.424.68
2615-6151.3161.35
3679-6791.4521.48
720min1766-7661.6391.657.151.691.696.80
2716-7161.5321.58
3826-8261.7671.81
840min1854-8541.8271.893.951.891.963.91
2874-8741.8701.94
3922-9221.9722.04
960min11016-10162.1732.135.612.262.225.46
2932-9321.9942.08
31038-10382.2202.31
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min11120-11202.3962.392.322.512.502.23
21139-11392.4362.55
31088-10882.3272.44
1200min11162-11622.4862.573.972.622.703.86
21183-11832.5302.67
31253-12532.6802.82
1320min11402-14022.9992.837.143.163.006.76
21219-12192.6072.77
31350-13502.8883.06
1440min11464-14643.1322.965.193.333.154.98
21328-13282.8413.03
31357-13572.9033.10
极限11478-14783.1623.252.443.393.482.24
21551-15513.3183.54
31526-15263.2643.50
配吗贝特缓释片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354289343066432264320442968430710.34
210.414371243922438170.34
单位质量响应值RSD%判断
4161.454209.130.81数据可信
供试品溶液-2011707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%
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
240min1-0.0000.26173.210.000.26173.21
2364-3640.7810.78
3-0.0000.00
360min1447-4470.9590.993.040.960.993.54
2475-4751.0191.03
3462-4620.9910.99
480min1436-4360.9350.9819.550.951.0018.51
2380-3800.8150.84
3555-5551.1901.20
600min1532-5321.1411.0012.061.161.0311.25
2433-4330.9290.96
3436-4360.9350.96
720min1524-5241.1241.112.511.161.152.81
2527-5271.1301.17
3503-5031.0791.11
840min1670-6701.4371.2920.001.481.3418.75
2463-4630.9931.05
3673-6731.4431.49
960min1643-6431.3791.2510.151.441.319.57
2525-5251.1261.19
3578-5781.2401.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min1733-7331.5721.4017.311.651.4716.30
2522-5221.1201.20
3696-6961.4931.57
1200min1719-7191.5421.582.021.641.671.73
2745-7451.5981.69
3744-7441.5961.69
1320min1753-7531.6151.662.171.731.771.82
2782-7821.6771.78
3782-7821.6771.79
1440min1931-9311.9971.8012.312.131.9311.57
2728-7281.5611.69
3862-8621.8491.98
极限1792-7921.6991.662.671.851.812.93
2752-7521.6131.75
3781-7811.6751.83
配吗贝特缓释片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.354225542470421074225742354422890.32
210.414237642713425440.57
单位质量响应值RSD%判断
4085.894086.840.02数据可信
供试品溶液-2011707批-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%
60min17060-706015.50914.765.4515.5114.765.46
26333-633313.91213.91
36766-676614.86314.86
120min111903-1190326.14825.104.0126.3225.264.02
210991-1099124.14424.30
311378-1137824.99425.16
240min118862-1886241.43539.803.7741.9040.243.79
217522-1752238.49138.91
317968-1796839.47139.91
360min123238-2323851.04750.650.9251.9751.530.94
223108-2310850.76251.61
322825-2282550.14051.02
480min127556-2755660.53358.013.7762.0259.453.74
225824-2582456.72858.14
325840-2584056.76358.20
600min129288-2928864.33862.902.0266.5064.992.06
228192-2819261.93063.97
328423-2842362.43764.51
720min131507-3150769.21267.442.3072.0970.232.31
230400-3040066.78069.51
330200-3020066.34169.10
840min133000-3300072.49270.972.1976.1474.522.18
232337-3233771.03574.51
331591-3159169.39772.90
960min133604-3360473.81973.530.8778.2777.860.88
233676-3367673.97778.24
333144-3314472.80877.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1080min135480-3548077.94076.182.0183.2181.332.01
234313-3431375.37680.46
334246-3424675.22980.31
1200min135936-3593678.94177.212.4685.0883.212.41
235287-3528777.51683.44
334225-3422575.18381.10
1320min135837-3583778.72476.902.1085.7483.752.10
234726-3472676.28383.07
334451-3445175.67982.43
1440min134524-3452475.84076.470.8183.7384.170.59
235087-3508777.07684.71
334820-3482076.49084.08
极限134461-3446175.70175.832.2984.4384.382.03
233762-3376274.16682.65
335334-3533477.61986.06
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