1. Different definitions
1) Chemical raw materials: refers to the raw materials used to produce various preparations. They are the active ingredients in the preparations. They are various powders, crystals, and infusions prepared by chemical synthesis, plant extraction, or biotechnology for medicinal purposes. ointments, etc., but substances that the patient cannot take directly.
2) Chemical drug preparation: The process of adding raw materials and excipients (starch, glucose, etc.) is called preparation (making medicine). After the preparation process, the raw materials become capsules, injections, etc., which are so-called pharmaceutical preparations.
2. Different ingredients
1) Chemical drug substance: Any substance or mixture of substances intended to be used in the manufacture of drugs, and when used in pharmaceuticals, becomes an active ingredient of the drug. Such substances have pharmacological activity or other direct effects in the diagnosis, treatment, symptom relief, treatment or prevention of diseases, or can affect the function or structure of the body.
2) Chemical preparations: Before conducting the stability test of pharmaceutical preparations, the content of reactants or decomposition products should be selected. However, the method of measuring drugs is usually used, because the content of decomposition products can be distinguished from reactants or decomposition products. But the method of measuring drugs is usually chosen.
Because decomposition products are often complex, sometimes decomposition products may immediately decompose again, making accurate measurement inconvenient.
3. Different regulatory requirements
1) Chemical original drug: the active ingredient of the drug. Only when raw materials are processed into pharmaceutical preparations can they become medicines for clinical application.
2) Chemical preparations: medicines that can be directly used for clinical application.