Third-Party 7x Tested
Every ProTecPep production batch undergoes seven independent quality tests covering identity, net content, purity, conformity, sterility, endotoxins, and heavy metals. This comprehensive testing protocol supports consistent quality, analytical accuracy, and complete batch-specific transparency.
Batch-Specific Certificates of Analysis
Each production lot is independently analyzed by an ISO/IEC 17025-accredited laboratory and issued its own Certificate of Analysis (COA). Current and archived COAs provide complete lot-specific traceability and verification of the reported analytical results.
99%+ Purity Standard
Purity is measured using High-Performance Liquid Chromatography (HPLC). Every batch must meet ProTecPep’s 99%+ purity specification and all established identity and conformity requirements before it is approved for release.
What We Test
Identity
Identity testing confirms that the compound matches the product label. Mass spectrometry and HPLC retention analysis are used to evaluate molecular identity and confirm the correct compound.
Net Content
Net-content testing verifies the measured quantity of material contained in each vial against the labeled amount, supporting accurate and consistent laboratory preparation.
Purity
HPLC analysis measures the percentage of the intended compound relative to impurities, related substances, and synthesis byproducts. Each batch must meet the established 99%+ purity specification before release.
Conformity
Conformity testing confirms that the product’s appearance, solubility, analytical results, and other measured characteristics fall within established acceptance criteria.
Sterility
Sterility testing evaluates the finished lyophilized product for viable microorganisms, including bacteria, yeast, and mold.
Endotoxins
The Limulus Amebocyte Lysate (LAL) assay measures bacterial endotoxin levels and confirms that each batch remains within established specifications.
Heavy Metals
Heavy-metal analysis screens for elemental impurities, including lead, arsenic, cadmium, and mercury, using validated analytical methods.
Our Quality Verification Process
Every ProTecPep batch follows a structured verification process designed to support consistency, traceability, and analytical integrity.
Testing begins with identity and net-content verification, followed by purity, conformity, microbiological, endotoxin, and heavy-metal analysis. All results are then reviewed against predefined specifications.
A batch-specific Certificate of Analysis is issued only after the complete analytical record has been reviewed and the production lot has met all applicable release requirements.
Dedicated Customer Support
Our team is available by phone, text, or email to answer questions about our products, laboratory testing, Certificates of Analysis, or order status.