Intermediate intermediate, a material produced in the API process steps that must undergo further molecular changes or refinement to become an API. An intermediate is a compound in the synthesis of an API and is an intermediate product in the synthesis of an API. Intermediates are the key products of the previous process of making API, which are different from the structure of API. Intermediates are only intermediate products in the process of synthesizing API, and do not need to obtain a document number or a drug production license. However, FDA (U.S. Drug Administration) requires that intermediates must be registered.

Active Pharmaceutical Ingredient, or Active Pharmaceutical Ingredient (API), is intended to be used in any substance or mixture of substances in the manufacture of a pharmaceutical product and, when used in the manufacture of a pharmaceutical product, to be an active ingredient of a pharmaceutical product. Raw materials can be used directly to make preparations. A drug substance is a compound that can be safely used in humans for therapeutic diagnosis after sufficient pharmaceutical research.

Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, alleviation of symptoms, management, or prevention of disease, or can affect the function and structure of the body. The API shall apply for registration with the drug regulatory authority (china food and drug administration in China, FDA in the United States, and EMEA in Europe) in accordance with the law, and after obtaining the approval number, it shall be synthesized in a factory that complies with GMP (Good Manufacturing Practice).

The same compound as the API does not obtain the document number or is not manufactured in the GMP plant is not the API.

Pharmaceutical excipients refer to the excipients and additives used in the manufacture and prescription of drugs; they are substances other than active pharmaceutical ingredients that have been reasonably evaluated for safety and are included in pharmaceutical preparations.

In addition to shaping, acting as a carrier and improving stability, pharmaceutical excipients also have important functions such as solubilization, solubilization, slow and controlled release, and are important ingredients that may affect the quality, safety and effectiveness of drugs.

Commonly used accessories are:

1) Diluent (or filler): Increase the weight or volume of the tablet, thereby facilitating tablet compression. Such as starch, sugars, microcrystalline cellulose, inorganic salts, etc.

2) wetting agent: such as distilled water, ethanol.

3) Adhesive: such as starch slurry, hydroxypropyl cellulose, methyl cellulose, hypromellose.

4) Disintegrating agents: dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyethylene pyrrolidone, cross-linked sodium carboxymethyl cellulose, effervescent disintegrating agents (sodium bicarbonate and citric acid, etc.

5) Lubricant: It is the general term of glidant, anti-sticking agent and lubricant (narrow sense), in which glidant is a substance that reduces friction between particles to improve powder fluidity; Anti-sticking agent is a substance that prevents raw and auxiliary materials from adhering to the surface of the punch; Lubricant (narrow sense) is a substance that reduces the friction between the tablet and the hole wall of the die, which is a lubricant in the true sense. Commonly used lubricants include hydrophobic lubricants, such as magnesium stearate, which has a large impact on disintegration or fragmentation; water-soluble lubricants, such as polyethylene glycol and magnesium sulfate lauryl alcohol; glidants, such as micropowder silica gel, talc, hydrogenated vegetable oil, etc.

Preparations (tablets)

The preparation (tablet) is the medicine that the patient often takes is the preparation, in popular terms is the medicine made by adding the raw material medicine to the auxiliary material.

In order to meet the needs of treatment or prevention, according to certain dosage form requirements, can be finally provided to patients with the use of drugs, is the preparation.

The different administration forms that are prepared to meet the needs of diagnosis, treatment or prevention of disease are dosage forms. Commonly used tablets, pills, powder, injection, tincture, solution, extract, ointment and so on.

Formulation specification: refers to the content of the main drug specified in the preparation of the dosage form unit dose. That is, one tablet or one granule contains the main ingredients.