地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251702107170027717031771703495170330017024710.08
210.311705892170418117050360.08
单位质量响应值RSD%判断
166094.73165376.920.31数据可信
供试品溶液-1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%
5min1647-6470.0390.0450.530.040.0450.78
2709-7090.0430.04
3827-8270.0500.05
4823-8230.0500.05
5672-6720.0410.04
6-0.0000.00
15min1688-6880.0410.0518.960.040.0519.03
2842-8420.0510.05
3758-7580.0460.05
4783-7830.0470.05
51145-11450.0690.07
6901-9010.0540.05
30min1825-8250.0500.0524.180.050.0525.62
21165-11650.0700.07
3697-6970.0420.04
41142-11420.0690.07
5774-7740.0470.05
6690-6900.0420.04
45min1661-6610.0400.048.530.040.0411.92
2679-6790.0410.04
3822-8220.0500.05
4761-7610.0460.05
5703-7030.0420.04
6718-7180.0430.04
60min1642-6420.0390.047.120.040.049.80
2667-6670.0400.04
3757-7570.0460.05
4626-6260.0380.04
5675-6750.0410.04
6651-6510.0390.04
90min1633-6330.0380.0414.580.040.0411.92
2833-8330.0500.05
3607-6070.0370.04
4732-7320.0440.05
5577-5770.0350.04
6603-6030.0360.04
120min1628-6280.0380.048.830.040.049.80
2627-6270.0380.04
3635-6350.0380.04
4775-7750.0470.05
5682-6820.0410.04
6647-6470.0390.04
极限1626-6260.0380.047.850.040.040.00
2638-6380.0380.04
3639-6390.0390.04
4553-5530.0330.04
5555-5550.0330.04
6639-6390.0390.04
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251703785170291817033451703545170461817036420.04
210.311706565170378417051740.12
单位质量响应值RSD%判断
166208.98165390.300.35数据可信
供试品溶液-1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%
5min1637-6370.0380.049.730.040.0411.92
2709-7090.0430.04
3639-6390.0390.04
4771-7710.0460.05
5771-7710.0460.05
6615-6150.0370.04
15min1855-8550.0520.051.940.050.050.00
2837-8370.0500.05
3841-8410.0510.05
4829-8290.0500.05
5831-8310.0500.05
6871-8710.0520.05
30min1740-7400.0450.059.470.050.057.91
2792-7920.0480.05
3885-8850.0530.05
4929-9290.0560.06
5749-7490.0450.05
6770-7700.0460.05
45min1682-6820.0410.059.440.040.0511.07
2760-7600.0460.05
3881-8810.0530.05
4772-7720.0470.05
5694-6940.0420.04
6803-8030.0480.05
60min1714-7140.0430.044.980.040.0511.07
2731-7310.0440.05
3814-8140.0490.05
4707-7070.0430.04
5751-7510.0450.05
6747-7470.0450.05
90min1687-6870.0410.047.950.040.049.80
2762-7620.0460.05
3633-6330.0380.04
4649-6490.0390.04
5677-6770.0410.04
6609-6090.0370.04
120min1733-7330.0440.048.970.050.0511.07
2760-7600.0460.05
3713-7130.0430.05
4800-8000.0480.05
5680-6800.0410.04
6612-6120.0370.04
极限1700-7000.0420.047.540.050.0412.18
2674-6740.0410.04
3731-7310.0440.05
4766-7660.0460.05
5666-6660.0400.04
6621-6210.0370.04
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.251710108170925017103321710122170994117099510.03
210.311708838170684517078420.09
单位质量响应值RSD%判断
166824.49165649.080.50数据可信
供试品溶液-1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%
5min1789-7890.0470.046.600.050.0511.07
2772-7720.0460.05
3797-7970.0480.05
4763-7630.0460.05
5664-6640.0400.04
6711-7110.0430.04
15min1916-9160.0550.0514.120.060.0512.65
2829-8290.0500.05
3864-8640.0520.05
4598-5980.0360.04
5749-7490.0450.05
6764-7640.0460.05
30min1854-8540.0510.0510.200.050.058.45
2812-8120.0490.05
3828-8280.0500.05
4829-8290.0500.05
5638-6380.0380.04
6817-8170.0490.05
45min1678-6780.0410.043.020.040.049.80
2715-7150.0430.04
3684-6840.0410.04
4697-6970.0420.04
5732-7320.0440.05
6690-6900.0410.04
60min1758-7580.0460.0416.070.050.0412.18
2796-7960.0480.05
3865-8650.0520.05
4594-5940.0360.04
5577-5770.0350.04
6662-6620.0400.04
90min1619-6190.0370.049.290.040.0411.92
2704-7040.0420.04
3758-7580.0460.05
4720-7200.0430.05
5662-6620.0400.04
6607-6070.0360.04
120min1668-6680.0400.048.750.040.049.80
2801-8010.0480.05
3659-6590.0400.04
4631-6310.0380.04
5699-6990.0420.04
6650-6500.0390.04
极限1667-6670.0400.046.310.040.0412.18
2639-6390.0380.04
3740-7400.0440.05
4682-6820.0410.04
5751-7510.0450.05
6712-7120.0430.05
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