各国药典允许调整范围
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各国药典允许调整范围
Adjusting Ph. Eur. Methods
欧洲药典调整范围
1. Mobile phase pH: ± 0.2 units
• pH of 7.6 can be adjusted from 7.4 – 7.8
流动相pH：0.2单位
例如：pH为7.6可以调整为7.4-7.8
2. Concentration of salts in buffer: ± 10 %
• 20 mM Potassium phosphate can be 18 – 22 mM, as long as proper pH is maintained as above
2.缓冲盐浓度：正负10%
20mM磷酸钾可以调整到18-22mM，pH的可调整范围如上。
3. Ratio of components in mobile phase: ± 30 %
The amount(s) of the minor component(s) can be modified by ± 30 % relative or ±2 % absolute. However a change in any component cannot exceed ± 10 % absolute. • 60:40 Acetonitrile/Water could be adjusted to ± 12 % water (= 30 % of 40),
but this exceeds the ±10 % maximum absolute change. Therefore the amount of water can range from 30 % to 50 % in this case.
3.流动相组分的比率：正负30%
较少的组分能改变相对比率正负30%或绝对比率正负2%。但是任何组分的比率改变不能超过绝对比率的正负10%。
60:40乙腈：水可以调整为水的比率正负12%（30%乘以40），但是这超过了绝对比率正负10%。所以水的比率在这里可以在30%到50%的范围里调整。
4. Wavelength of UV-Visible Detector: no deviations permitted
4.紫外可见检测器的波长：不允许偏差
5. Column length: ± 70 %
• 150 x 4.6 mm col umn can be varied ± 105 mm in length
5.柱长：正负70%
150*4.6mm的柱子可以在长度上改变正负105mm。
6. Column inner diameter: ± 25 %
• 150 x 4.6 mm column can be varied ± 1.15 mm in diameter
6.柱内径：正负25%
150*4.6mm柱可以在直径上改变正负1.15mm
7. Particle size: can be reduced as much as 50 %
• 10 μm particles can be switched with 5 μm particles
7.填料粒径：可以减少50%
10微米填料可以改变为5微米填料
8. Flow rate: ± 50 %
• 1 mL/min can be varied from 0.5 to 1.5 mL/min
8.流速：正负50%。
1mL/min可以改变为从0.5-1.5mL/min。
9. Injection volume: can be reduced as long as precision and detection limits are achieved
9.进样量：可以减少到精密度和检测限能够实现的程度。
10. Column temperature: ± 10 % to a maximum of 60°C
10.柱温：正负10%，最高为60度。
11. Gradient elution: Excessive dwell volume of the equipment may significantly alter the resolution, retention time and relative retentions.
11.设备的过多的死体积会大大改变分离度、保留时间和相对保留。
Adjusting USP Methods
1. Mobile phase pH: ± 0.2 units
• pH of 7.6 can be adjusted from 7.4 – 7.8
流动相pH：0.2单位
例如：pH为7.6可以调整为7.4-7.8
2. Concentration of salts in buffer: ± 10 %
• 20 mM Potassium phosphate can be 18 – 22 mM, as long as proper pH is maintained as above
2.缓冲盐浓度：正负10%
20mM磷酸钾可以调整到18-22mM，pH的可调整范围如上。
3. Ratio of components in mobile phase: ± 30 %
• The amount(s) of the minor component(s) can be modified by ± 30 %. However a
change in any component cannot exceed ± 10 % absolute.
• 60:40 Acetonitrile/Water could be adjusted to ± 12 % water (= 30 % of 40),
but this exceeds the ±10 % maximum absolute change. Therefore the amount of water can range from 30 % to 50 % in this case.
3.流动相组分的比率：正负30%
较少的组分能改变相对比率正负30%或绝对比率正负2%。但是任何组分的比率改变不能超过绝对比率的正负10%。
60:40乙腈：水可以调整为水的比率正负12%（30%乘以40），但是这超过了绝对比率正负10%。所以水的比率在这里可以在30%到50%的范围里调整。
4. Wavelength of UV-Visible Detector: no deviations permitted
4.紫外可见检测器的波长：不允许偏差
5. Column length: ± 70 %
• 150 x 4.6 mm column can be varied ± 105 mm in length
5.柱长：正负70%
150*4.6mm的柱子可以在长度上改变正负105mm。
6. Column inner diameter: ± 25 %
• 150 x 4.6 mm column can be varied ± 1.15 mm in diameter
6.柱内径：正负25%
150*4.6mm柱可以在直径上改变正负1.15mm
7. Particle size: can be reduced as much as 50 %
• 10 μm particles can be switched with 5 μm particles
7.填料粒径：可以减少50%
10微米填料可以改变为5微米填料
8. Flow rate: ± 50 %
• 1 mL/min can be varied from 0.5 to 1.5 mL/min
8.流速：正负50%。
1mL/min可以改变为从0.5-1.5mL/min。
9. Injection volume: can be reduced as long as precision and detection limits are achieved
9.进样量：可以减少到精密度和检测限能够实现的程度。