Bulk drug refers to the bulk drug used in the production of various preparations, which is a variety of powders, crystals, extracts, etc. prepared by chemical synthesis, plant extraction or biotechnology, but can not be directly taken by patients.
Only when APIs are processed into pharmaceutical preparations can they become medicines for clinical application. According to its source, bulk drugs can be divided into two categories: chemical synthetic drugs and natural chemical drugs.
Chemical synthetic drugs can be divided into inorganic synthetic drugs and organic synthetic drugs. Inorganic synthetic drugs are inorganic compounds (very few are elements). According to their sources, natural chemical drugs can also be divided into biochemical drugs and phytochemical drugs. Antibiotics are generally produced by microbial fermentation, belonging to the category of biochemistry. In recent years, a variety of semi synthetic antibiotics are the products of the combination of biosynthesis and chemical synthesis.
Among the bulk drugs, the varieties, output and output value of organic synthetic drugs account for the largest proportion, and are the main pillar of the chemical pharmaceutical industry. The quality of APIs determines the quality of preparations, so its quality standards are very strict. Countries all over the world have formulated strict national pharmacopoeia standards and quality control methods for its widely used APIs.

01 pharmaceutical intermediates

Picture what are pharmaceutical intermediates?

The so-called pharmaceutical intermediate is a fine chemical product in the production process from pharmaceutical chemical raw materials to APIs or drugs. The synthesis of chemical drugs depends on high-quality pharmaceutical intermediates. According to the regulations of the China food and drug administration, pharmaceutical intermediates can be regarded as pharmaceutical raw materials, and it is not necessary to produce and apply for approval and batch number according to the pharmaceutical rules.
At present, China needs more than 2000 kinds of chemical raw materials and intermediates every year, with a demand of more than 2.5 million tons. After more than 30 years of development, the chemical raw materials and intermediates required by China’s pharmaceutical production can basically be matched, and only a small part needs to be imported. Moreover, because China is rich in resources and the price of raw materials is low, many intermediates have been exported in large quantities.
There are many kinds of pharmaceutical intermediates, mainly including cephalosporin intermediates, amino acid protectants, vitamin intermediates, quinolone intermediates, and other types of intermediates, such as medical disinfectant intermediates, antiepileptic drug intermediates, fluoropyridine intermediates, steroid pharmaceutical intermediates, etc.

02 correlation between API and intermediate

1. The specific substances of the two are different
Pharmaceutical intermediates, also known as organic pharmaceutical intermediates, refer to a semi-finished product, which is a product of some products. The drug substance refers to the active ingredient of a drug, and it is also the basic substance constituting the pharmacological action of a drug. Bulk drug is a kind of drug active substance prepared by chemical synthesis, plant extraction or biotechnology.
2. The manufacture of API must rely on intermediates
Pharmaceutical intermediate is a kind of chemical raw material or chemical product in the process of drug synthesis. It is also an intermediate product in the process of producing API. It is a product in the process of synthesizing API. It is produced in the process step of API. It must undergo the next step of molecular change or refining to become a substance of API. The API can be directly used as a preparation, while the intermediate can only be used to synthesize the next product. Only through the intermediate can the API be manufactured

Post time: Jun-17-2022