Excipient definition

Excipient means [***].
Excipient means any substance that instead of conferring a drug product action:– assists in giving a pharmaceutical form to a drug product;– protects, supports and improves stability, bioavailability and tolerance of a medicinal product;– assists in drug product identification,
Excipient means a substance intended to be used as is or in the manufacture of a medicinal product for a specific function, but does not exert pharmacological activity;

Examples of Excipient in a sentence

  • Preformation Concepts – Drug Excipient interactions - different methods, kinetics of stability, Stability testing.

  • Excipient with known effectEach mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.

  • Excipient with known effect: Each tablet contains 20 mg of sodium.

  • Excipient with known effect:Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).

  • Excipient with known effectEach tablet contains 63 mg lactose (as monohydrate).


More Definitions of Excipient

Excipient means a substance that is used as a diluent or vehicle for the Modified Protein and is part of the Bulk Product to formulate the Product, including, but not limited to albumin.
Excipient means any substance other than the API used in formulating the Compounded Bulk.
Excipient means an inactive ingredient, as defined in Title 21 of the U.S. Code of Federal Regulations Part 201.
Excipient means any substance, other than the API, used in formulating the Product.
Excipient means any components other than APIs that are commonly used in a pharmaceutical product. These components may include vehicles and additives, such as dyes, flavors, binders, emollients, fillers, lubricants, and preservatives. "Firm" means any business within the customs territory of China or within the United States that is engaged in the manufacture (including processing) and distribution (including export) of Drugs, Excipients, and Medical Devices. "HHS/FDA Requirements" means any U.S. laws, regulations or other requirements, including any amendment adopted after the date of entry into force of this Agreement, concerning Drugs, Excipients, and Medical Devices that are administered or enforced by HHS/FDA. "SFDA Requirements" means any Chinese laws, regulations or other requirements, including any amendment adopted after the date of entry into force of this Agreement, concerning Drugs, Excipients, and Medical Devices that are administered or enforced by SFDA. "Medical Device" means any instrument, apparatus, machine, implant, in vitro reagent, or similar or related article, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans, or intended to affect the structure or any function of the human body, and which is not a drug. "SFDA-Registered Firm" means a Firm that SFDA has determined meets SFDA Requirements and that is registered with SFDA. "HHS/FDA Registered Firm" means a firm that complies with U.S. registration and listing requirements and that is registered with HHS/FDA. "Facility" means any Firm´s site within the customs territory of China or in the United States that is engaged in manufacturing, producing, processing, packing, testing, holding, transporting, distributing, or exporting Drugs, Excipients, and Medical Devices.
Excipient means any constituent of a medicinal product other than the active substance or packaging material,
Excipient means any constituent of a medicinal product other than the active substance and the packaging material;”,