Lab and analysis
Specification
Definition
The list of tests, methods and acceptance limits a product must meet, agreed between supplier and buyer or set by a standard.
A specification can follow a pharmacopoeia monograph, an industry standard or a custom agreement. Each line names the test (for example appearance, assay, water, heavy metals or particle size), the method and the limit.
Agree the specification before you order, and refer to it in the purchase order. It is the basis for accepting or rejecting a delivery.
Related terms
- COA (certificate of analysis)A batch specific quality document listing the tests performed, the specification limits and the actual results.
- AssayA quantitative test for the content of the main substance, and the result of that test on a certificate of analysis.
- PurityHow much of a material is the stated substance, usually given as a percentage and measured by a defined method.
- Batch number (lot number)A code that identifies a quantity of product made in one production run, used for traceability.
- Pharmacopoeia monographThe official standard for a medicine or ingredient in a pharmacopoeia, listing its tests and acceptance limits.