API Mixture definition

API Mixture means a blend of fosfomycin sodium and succinic acid to obtain intravenous quality, according to the API Mixture Specifications.
API Mixture means the blend of fosfomycin sodium and succinic acid intended for use in preparing an intravenous formulation purchased by Zavante from Ercros.

Examples of API Mixture in a sentence

  • This objective will be supported by the delivery to Zavante from Ercros and ERN of technical documentation, expertise and know-how for the API and API Mixture, and regarding Product manufacturing.

Related to API Mixture

  • Oily mixture means a mixture with any oil content.

  • Mixture means a mixture or solution composed of two or more substances;

  • Inert ingredient means an ingredient which is not an active ingredient.

  • Additives means non-hydrocarbon compounds added to or blended with a product to modify its properties;

  • Chemical agent shall mean any compound which, when suitably disseminated, produces incapacitating, damaging or lethal effects on people, animals, plants or material property.

  • combustible waste means non-biodegradable, non- recyclable, non-reusable, non-hazardous solid waste having minimum calorific value exceeding 1500 kcal/kg and excluding chlorinated materials like plastic, wood pulp, etc.;

  • Semisolid means a product that, at room temperature, will not pour, but will spread or deform easily, including but not limited to gels, pastes, and greases.

  • Radionuclide means a radioactive element or a radioactive isotope.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Radioactive Products or Waste means any radioactive material produced in, or any material made radioactive by exposure to the radiation incidental to the production or utilization of nuclear fuel, but does not include radioisotopes which have reached the final stage of fabrication so as to be usable for any scientific, medical, agricultural, commercial or industrial purpose.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Isomer means all enantiomers and diastereomers.

  • Radioactive waste means any waste which contains radioactive material in concentrations which exceed those listed in 10 CFR Part 20, Appendix B, Table II, Column 2.

  • Contaminant means any waste, pollutant, hazardous substance, toxic substance, hazardous waste, special waste, petroleum or petroleum-derived substance or waste, asbestos in any form or condition, polychlorinated biphenyls (“PCBs”), or any constituent of any such substance or waste.

  • Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • Substances means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Oxides of nitrogen means the sum of the volume mixing ratio (ppbv) of nitrogen monoxide (nitric oxide) and nitrogen dioxide expressed in units of mass concentration of nitrogen dioxide (µg/m3);

  • Hydrofluorocarbons means compounds that only contain hydrogen, fluorine, and carbon.

  • Chemicals means substances applied to forest lands or timber including pesticides, fertilizers, and other forest chemicals.

  • Nitrogen oxides means nitric oxide and nitrogen dioxide, expressed as nitrogen dioxide (NO2);

  • Beam scattering foil means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

  • Petroleum product means gasoline, gasoline−alcohol fuel blends, kerosene, fuel oil, burner oil, diesel fuel oil or used motor oil.

  • Cannabinoid concentrate means a substance obtained by separating cannabinoids from marijuana by:

  • Soil texture means proportion by weight of sand, silt, and clay in a soil.