Specification¶
Definition¶
A specification is a documented set of quality parameters and acceptance criteria that a product must meet to be considered acceptable for its intended use.
Overview¶
Specifications define the quality standards for each peptide product. They establish the required values for purity, identity, appearance, and other quality attributes against which test results are compared on the COA.
Technical Explanation¶
Typical Peptide Specifications:
| Parameter | Example Specification | Method |
|---|---|---|
| Purity (HPLC) | ≥98% | HPLC-UV |
| Identity | Conforms by MS | Mass Spectrometry |
| Appearance | White to off-white powder | Visual inspection |
| Counter-ion Content | Report result | HPLC or IC |
| Water Content | ≤5% | KF or LOD |
| Endotoxin | ≤10 EU/mg | LAL test |
| Microbial Limits | ≤100 CFU/g | Plate count |
Specification vs. COA: - Specification: The standard that must be met - COA: The report showing actual results compared to specifications
Importance in Peptide Documentation¶
Specifications are the reference standard for quality assessment. They are documented in product literature (TDS) and form the basis of COA evaluation. Understanding specifications allows researchers to select appropriate products for their applications.
Related Terms¶
Frequently Asked Questions¶
Q: What happens if a batch doesn't meet specification? A: The batch is rejected (failed) and not released for sale. It may be reprocessed, downgraded, or discarded depending on the nature and extent of the deviation.
Q: Can specifications vary between suppliers? A: Yes. Different suppliers may have different internal specifications. RPL Peptide maintains consistent specifications across all products to ensure reliable quality.