Chongqing Liyang Pharmaceutical Development Co., Ltd.
The Differences Between Intermediates, Active Pharmaceutical Ingredients (APIs), Excipients, and Preparations
Release Time:
2025-09-10 00:00
Source:
Intermediate: a substance generated during the pharmaceutical active ingredient (API) manufacturing process, which must undergo further molecular transformations or purification steps before it can be converted into the final API. Intermediates are compounds involved in the synthesis of APIs and serve as critical intermediate products in the overall API production pathway. Although intermediates differ structurally from the final API, they do not require drug registration numbers or pharmaceutical production licenses. However, the U.S. Food and Drug Administration (FDA) mandates that intermediates must still be registered.
Active Pharmaceutical Ingredient (API), the correct term, refers to any substance or mixture of substances intended for incorporation into a medicinal product. When used in pharmaceutical manufacturing, it becomes an active component of the final drug formulation. APIs are directly usable materials that serve as the foundation for preparing finished dosage forms. These compounds have undergone thorough pharmaceutical research and are deemed safe for human use, enabling them to exert therapeutic or diagnostic effects.
The active pharmaceutical ingredient must be registered with the relevant drug regulatory authority in accordance with the law—specifically, the National Medical Products Administration in China, the FDA in the United States, and the EMA in Europe—and obtain an approved registration number before being synthesized in facilities that comply with GMP (Good Manufacturing Practice) standards.
Compounds identical to the active pharmaceutical ingredient (API) are not considered APIs unless they have obtained a drug registration number or are produced in a GMP-compliant facility.
Pharmaceutical excipients refer to the carriers and adjuvants used in the production of pharmaceuticals and formulation preparation; they are substances other than active pharmaceutical ingredients that have undergone reasonable safety assessments and are incorporated into drug formulations.
In addition to serving as excipients, carriers, and stabilizers, pharmaceutical excipients also play crucial roles such as solubilization, co-solubilization, and controlled-release functions. They are essential components that can significantly impact the quality, safety, and efficacy of pharmaceutical products.
A formulation (tablet) is the medication commonly taken by patients. Simply put, it refers to a drug product made by combining active pharmaceutical ingredients with excipients.
A pharmaceutical preparation is a medicine formulated according to specific dosage requirements to meet therapeutic or preventive needs, ultimately intended for patient use.
Different dosage forms prepared to meet the needs of disease diagnosis, treatment, or prevention are known as pharmaceutical formulations. Commonly used ones include tablets, pills, powders, injections, tinctures, solutions, extracts, ointments, and more.
Dosage Form Specification: Refers to the amount of active pharmaceutical ingredient specified in a single dose unit of the dosage form. In other words, it indicates the quantity of the primary component contained within one tablet or one granule.
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Intermediate, a material generated during the active pharmaceutical ingredient (API) manufacturing process that requires further molecular transformation or purification before it can be finalized as an API.
What are the differences between active pharmaceutical ingredients and finished dosage forms?
Active pharmaceutical ingredients (APIs) are the active components of drugs and cannot be used directly for clinical treatment. Pharmaceutical preparations, on the other hand, are drug formulations made by processing APIs with excipients, ready for direct use by patients.
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What are the common types of liquid formulations?
This is a common type of liquid formulation, referring to a homogeneous system in which the drug is uniformly dispersed in the solvent in molecular or ionic form.
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