Isolated Intermediate

{
  "id": "MLC-T-ENV-015016",
  "term": "Isolated Intermediate",
  "field": "Environment",
  "definition": "1. Product of a process. An isolated intermediate is usually a product of a chemical synthesis, fermentation, or biological extraction process; several different isolated intermediates may be produced in the manufacture of a finished dosage form of a drug. Precursors, active ingredients, or finished dosage forms are considered isolated intermediates. An isolated intermediate is stored before subsequent processing. Storage occurs at any time the intermediate is placed in equipment used solely for storage, such as drums, totes, day tanks, and storage tanks. The storage of an isolated intermediate marks the end of a process.\n\n2. Product of a process that is stored before subsequent processing. An isolated intermediate is usually a product of a chemical synthesis, fermentation, or biological extraction process. Storage of an isolated intermediate marks the end of a process. Storage occurs at any time the intermediate is placed in equipment used solely for storage. The storage equipment is part of the MCPU that produces the isolated intermediate and is not assigned as specified in § 63.2435(d).\n\n3. Product of a process that is stored before subsequent processing. An isolated intermediate is usually a product of chemical synthesis. Storage of an isolated intermediate marks the end of a process. Storage occurs at any time the intermediate is placed in equipment used solely for storage. [40 CFR 98.128 (CFR 2013)]",
  "references": [
    "40 CFR 63.1251 (CFR 2013)",
    "40 CFR 63.2550 (CFR 2013)",
    "40 CFR 98.418 (CFR 2013)"
  ],
  "url": "https://mlchart.com/terminology/environment/isolated-intermediate/"
}