Terms, A to Z.
The terms that come up most when evaluating a peptide supplier, a certificate of analysis or a facility. Each definition is written for business buyers, not as medical information.
API
Active pharmaceutical ingredient. The raw peptide or compound before it is formulated and filled into vials.
Assay
A measurement of how much of the target compound is present, usually reported against the label claim. Also called potency.
Aseptic filling
Filling sterile product into sterile containers in a controlled environment so that no microorganisms are introduced.
Bacterial endotoxin
Toxic components of the outer membrane of certain bacteria. Tested by the LAL method described in USP <85>.
Certificate of analysis (COA)
A lab report listing the tests run on one specific lot, the specification for each and the result. See how to read a peptide COA.
cGMP
Current Good Manufacturing Practice. The quality system requirements for how products are manufactured, documented and controlled.
Clean bench
A workstation that supplies filtered, unidirectional airflow over the work surface. Also called a laminar flow hood or cabinet.
Fill weight
The amount of compound placed in each vial. Underfill is a common reason a vial fails assay.
HPLC
High-performance liquid chromatography. The standard method for confirming a peptide’s identity and measuring purity and assay.
Identity
A test that confirms the vial contains the compound named on the label.
ISO 14644-1
The international standard that classifies cleanrooms by the number of airborne particles allowed per cubic meter.
ISO 5 / ISO 7
Cleanroom classes. ISO 5 allows up to 3,520 particles of 0.5 microns or larger per cubic meter; ISO 7 allows up to 352,000.
ISO/IEC 17025
The accreditation standard for testing and calibration laboratories. An accredited lab has been independently assessed for competence.
LAL
Limulus amebocyte lysate. The reagent used to detect bacterial endotoxin.
Lot (batch)
A quantity of product made in one production run under the same conditions. Each lot gets its own number and its own COA.
Lyophilization
Freeze-drying. Water is removed from the product under vacuum at low temperature, leaving a stable powder in the vial.
Media fill
A validation run in which growth medium replaces product in the aseptic filling process, then is incubated to confirm nothing grows.
Purity
The share of the material that is the target compound, as opposed to related impurities, usually measured by HPLC.
Research use only (RUO)
Products supplied for laboratory research, not for human consumption or clinical, diagnostic or therapeutic use.
SOP
Standard operating procedure. A written, controlled instruction for performing a task the same way every time.
Sterility test
A test that checks a finished product for viable microorganisms.
Third-party testing
Testing performed by an independent laboratory that did not manufacture the product.
White label
Finished product manufactured by a supplier and sold under another company’s brand. See white label peptides.