PDA Technical Glossary

PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

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Column Load
The solute that is passed through the column for separation. (TR14)
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Column Packing
Preparation of a column that includes the addition of resin slurry into a column to create a bed suitable for its intended use. Characteristics of a packed column bed include bed height and diameter, backpressure, and number of theoretical plates. (TR14)
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Eluate
Solution (effluent) that flows out of the chromatographic column containing the drug substance. [Synonym: collected product fractions] (TR14)
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Elution
Desorption of a drug substance from a chromatographic column. (TR14)
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Flow-through
Effluent that may contain the product that is not retained by chromatography resin during column loading. (TR14)
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Frit
A porous sieve or screen installed at the top and bottom of a column used to retain chromatography resin particles and allow passage of the process stream. [Synonym: sinter] (TR14)
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HETP (Height Equivalent to the Theoretical Plate)
A measurement of column packing efficiency or integrity, calculated from the column height divided by the number of theoretical plates. (TR14)
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Leachable
A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)
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Slurry (noun)
A homogenous distribution of resin particles in a liquid. (TR14)
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Slurry (verb)
To mix resin particles in a liquid to achieve a homogenous liquid suspension. (TR14)
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Transition Analysis
Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)
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Wash
Step in a chromatography cycle designed to flush the column to remove substances acquired during a previous step (often used between the load and elution steps). (TR14)
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