Pharmacopoeia is a code of law that records drug standards and specifications in a country, while international pharmacopoeias are compiled by recognized international organizations or relevant countries through consultation. Drug standards are an important part of modern drug production and quality management, and are the legal basis for drug production, supply, use and supervision and management departments to follow. The connotation of drug quality includes three aspects: authenticity, purity, and quality.
Drug standards generally include the following: legal name, source, properties, identification, purity inspection, content (potency or activity) determination, category, dosage, specifications, storage, preparation, etc.
Drug standards play a very important role in strengthening the supervision and management of drug quality, ensuring quality, ensuring safe and effective use of drugs, and maintaining people's health.
Pharmacopoeias of various countries (USP-NF, BP, Ph.Eur., ChP, JP) and FDA databases contain detailed information on some drugs, including data on drug ingredients, drug interactions, dosage guidelines, drug safety and effectiveness. This information is crucial for drug R&D and registration personnel.
R&D personnel can query drug standards, drug analysis methods and quality requirements to ensure that the developed drugs meet relevant standards and regulations. This helps speed up the drug development process and ensures the development of high-quality drug products.
For example, the Progesterone Powder we supply meets EP10, USP43, CP2015, and IP2010 standards. Adapalene Powder meets USP, EP, and BP standards.
What is usp?
In 1888, the American Pharmaceutical Association published the first National Formulary, referred to as NF. USP and NF were recognized by the U.S. Food and Drug Act in 1906 and the Food, Drug and Cosmetic Act in 1938. USP provides standards for APIs and preparations, and NF provides standards for excipients.
In 1975, USP and NF were merged and published as USP-NF.
Regulatory agencies around the world, such as the U.S. Food and Drug Administration (US FDA) and the European Medicines Agency (EMA), are continuously strengthening the implementation of strict guidelines and regulations to ensure the safety, efficacy and quality of APIs used in drugs.
Some analysts predict that the peptide API industry will maintain high heat in 2024, including Tirzepatide, Semaglutide, etc. China's peptide API market is showing a rapid development trend. According to statistics, from 2016 to 2021, the annual compound growth rate of China's peptide API market size was 17.5%. The market has put forward higher requirements on the production process, quality control, and ingredient purity of API factories.
China and India occupy an important position in the API market with their cost advantages. China's API industry has a complete range of basic chemical raw materials. Since 2010, China has become the world's largest API production base, which can not only effectively meet domestic demand, but also sell in large quantities to the international market. APIs are exported to nearly 200 countries and regions around the world, and the export volume has been ranked first in the world for many years. In 2020, the output of dozens of bulk chemical products ranked first in the world.
Reference
[1].U.S. Food and Drug Administration. Safeguarding pharmaceutical supply chains in a global economy.
[2].Nusim, S. (Ed.). (2010). Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, Second Edition (2nd ed.). CRC
