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

  • The individual requesting removal shall [ submit, in person, a completed ] complete and submit a Re- quest for Removal from Voluntary Self-Exclusion Form as required under subsections [ (b) and ] (c) and (d).

  • Within [**] after the end of each calendar year, Fisiopharma will prepare an annual reconciliation of API Mixture on the reconciliation report form including the calculation of the “Actual Annual Yield” or “AAY” for the Bulk Drug Vials during the calendar year.

  • At its discretion, Zavante may also test, or have tested, any lot of API Mixture supplied to Zavante.

  • Zavante or its designated representative shall have the right to visually inspect each shipment of API Mixture at Ercros’ warehouse for obvious damage and/or shortage (collectively, “Obvious Damage”) prior to shipment, and shall promptly provide Ercros with written notice of any such Obvious Damage.

  • The Purchase Order shall set forth the quantities of API Mixture desired, the desired delivery date and the desired destination for delivery.

  • In addition, Ercros will give Zavante all mutually agreed upon information that will enable Zavante to respond properly to questions or complaints about the API Mixture as set forth in the Quality Agreement.

  • As used herein, the term, “Recall” includes any action (i) by Zavante to recover title to or possession of quantities of the API Mixture or the Product sold or shipped to Third Parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any Regulatory Authorities to detain or destroy any of the API Mixture and/or the Product.

  • The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of API Mixture that complies with the Specifications held at the beginning of the applicable period, less the inventory of API Mixture that complies with the Specifications held at the end of the period.

  • The total amount of API Mixture contained in the Bulk Drug Vials manufactured with the Quantity Dispensed, delivered by Fisiopharma, and not rejected, recalled or returned in accordance with this Agreement due to Fisiopharma’s failure to manufacture the Bulk Drug Vials in accordance with Specifications, cGMP, and other Applicable Laws.

  • For the avoidance of doubt, Ercros shall not supply to Zavante hereunder, and Zavante shall have no obligation to accept, any API Mixture from Ercros manufactured in contravention of this Section 3.2.

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.

  • 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 radioactive waste as defined in Article 3(7) of Council Directive 2011/70/Euratom8;

  • Feed ingredient means each of the constituent materials making up a commercial feed.

  • 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 the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • 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.

  • 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.

  • API means American Petroleum Institute.