Changes and unification in the latest USP USP weighing regulations

The latest version of the United States Pharmacopoeia was officially released on December 1, 2013. Among them, the Chapter 41 balance chapter has made a lot of changes, which is the most significant change in the relevant chapters in the past 20 years. The change from the chapter name to the specific calculation method has changed accordingly. And the term “minimum weighing” that we first mentioned when we mentioned the USP weighing regulations was no longer mentioned in the new regulations.

Why do you want to make such changes? The author believes that there are two main reasons:

First, the old version of the United States Pharmacopoeia's weighing regulations, although already stipulated in the finer, but the implementation of the operational level is still half a fairy across the sea to show their ability: some users operate according to their own understanding, the vast majority of users are The relevant services are provided by the balance manufacturer, so the level of the manufacturer determines the pass rate of the user to the FDA review. Although manufacturers like Sartorius have strict and rigorous steps to provide users with relevant services and have never been questioned by the FDA, in reality, not all manufacturers have such capabilities and levels, so everyone calls for More specific and detailed regulations have been introduced to guide our work.

Second, various regulations and practices are not uniform, which increases the difficulty and workload for regulatory adaptation: Everyone's daily work will often encounter some weighing regulations. For example, the 2010 edition of the Chinese Pharmacopoeia has "precision weighing" ( Weighing should be accurate to one-thousandth of the weight taken) and “weighing” (weighing should be accurate to one hundredth of the weight taken); the United States Pharmacopoeia used to specify the minimum weighing, It is now stipulated “operating interval” and “weighing starting point”; there are also some metrological regulations that also have clear requirements for accurate weighing. The expressions of these regulations are different, but looking at these regulations, we will find that their commonality is that the requirements of the symmetry uncertainty are constrained from the perspective of relative uncertainty. This provides a main line for us to understand these different regulations. We just need to clarify the methods and requirements for determining the relative uncertainty.

For this change in the US Pharmacopoeia Weighing section, we see that although the repetitive requirements are similar to those of the old Pharmacopoeia's minimum weighing, the two important values ​​have changed: the relative uncertainty has changed from 0.1%. 0.10%, the coverage factor changed from 3 to 2. The readers who have studied it carefully will find that, in fact, the change is not as big as the imagination. The reason for this change is to comply with the clearer and more unified requirements, which reflects the adaptation to the current measurement regulations. Wishes and trends.

Learn USP Weighing Regulations PPT

Learn USP Weighing Regulations Video

Learn about smart, modular Cubis balances that seamlessly integrate into a wide range of workflows

Learn about the Secura series of electronic balances with risk elimination

Follow Sartorius' official Weibo and WeChat to keep up to date with the latest news:

Engine Piston Parts

Engine Piston Parts,Engine Parts ,Car Engine Parts,Parts Of Engine,Piston Engine Parts

ZhouShan HeCheng Machinery Co., LTD. , https://www.hcmarineparts.com