haohan药典中甲醇的理论塔板数测定专用填充柱HH-TBS-III

药品中的残留溶剂系指在原料药或辅料的生产中，以及在制剂制备过程中使用的，但在工艺过程中未能完全去除的有机溶剂。药品中常见的残留溶剂及限度见附表1，除另有规定外，diyi、第二、第三类溶剂的残留限度应符合附表1中的规定；对其他溶剂，应根据生产工艺的特点，制定相应的限度，使其符合产品规范、药品生产质量管理规范（GMP）或其他基本的质量要求。
本法照气相色谱法（通则0521）测定。
系统适用性试验
　　（1）用待测物的色谱峰计算，毛细管色谱柱的理论板数一般不低于5000；填充柱的理论板数一般不低于1000。
　　（2）色谱图中，待测物色谱峰与其相邻色谱峰的分离度应大于1.5。
　　（3）以内标法测定时，对照品溶液连续进样5次，所得待测物与内标物峰面积之比的相对标准偏差（RSD）应不大于5%；若以外标法测定，所得待测物峰面积的RSD应不大于10%。

传统的填充柱想要达到1000以上的理论塔板数，非常困难，为了解决这一难题，　　　
浩瀚色谱（山东）应用技术开发有限公司，研制出《药典0521甲醇的理论塔板数测定专用色谱柱》测定药典中甲醇，丙酮，乙醇等的理论塔板数，甲醇高达30000以上，效果不错。
在安捷伦，岛津，赛默飞，瓦里安，布鲁克，PE等仪器上均可获得满意的结果。　　　　　　　
此柱为浩瀚色谱，经过特殊处理而生产的　　　　　
此柱为浩瀚色谱的特色产品　
 

名称：不锈钢填充柱

规格：3m*1/8

型号：HH-TBS-III

应用：药典0521理论塔板数的测定

适用于：安捷伦，岛津，赛默飞，瓦里安，布鲁克，PE

Residual solvents in drugs refer to organic solvents used in the production of active pharmaceutical ingredients or excipients, as well as in the preparation of formulations, but not completely removed during the manufacturing process. The common residual solvents and their limits in drugs are listed in Appendix 1. Unless otherwise specified, the residual limits for Class I, II, and III solvents should comply with the provisions in Appendix 1; For other solvents, corresponding limits should be established based on the characteristics of the production process to ensure compliance with product specifications, Good Manufacturing Practice (GMP), or other basic quality requirements.
This method is determined by gas chromatography (General Rule 0521).
System Applicability Test
(1) The theoretical number of plates for capillary chromatography columns is generally not less than 5000, calculated based on the chromatographic peak of the analyte; The theoretical number of plates for filling columns is generally not less than 1000.
(2) In the chromatogram, the separation degree between the chromatographic peak of the analyte and its adjacent peaks should be greater than 1.5.
(3) When using the internal standard method for determination, the relative standard deviation (RSD) of the peak area ratio between the analyte and the internal standard obtained by continuously injecting the reference solution 5 times should not exceed 5%; If measured by external standard method, the RSD of the peak area of the analyte obtained should not exceed 10%.
It is very difficult for traditional packed columns to achieve a theoretical tray number of over 1000. To solve this problem
Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has developed a specialized chromatographic column for determining the theoretical plate number of methanol, acetone, ethanol, etc. in Pharmacopoeia 0521. The column has been used to determine the theoretical plate number of methanol, acetone, ethanol, etc. in Pharmacopoeia 0521, with methanol reaching over 30000 and achieving good results.
Satisfactory results can be obtained on instruments such as Agilent, Shimadzu, Thermo Fisher, Varian, Bruker, PE, etc. 
This column is produced through special processing for the Haohan chromatography
This column is a characteristic product of Haohan Chromatography
Name: Stainless Steel Filled Column
Specification: 3m * 1/8
model: HH-TBS-III
Application: Determination of theoretical tray number in Pharmacopoeia 0521
Applicable to: Agilent, Shimadzu, Thermo Fisher, Varian, Brooke, PE