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Quality Certificates
Quality Certificates
Certificates of Analysis (COA)
Certificates of Analysis (COAs) are issued for each manufactured batch as the formal documentation of product quality and release status. Each COA summarizes testing results against predefined specifications, including identity, purity, assay, related substances, and safety-related parameters where applicable.
At Utide, COAs are prepared under a standardized quality system and aligned with DMF documentation requirements. For peptide APIs within our metabolic and GLP-1 portfolio, such as Semaglutide and Tirzepatide, COAs provide clear, traceable data to support clinical development and commercial supply.
High Performance Liquid Chromatography (HPLC)
High Performance Liquid Chromatography (HPLC) serves as a primary analytical tool for evaluating peptide purity and impurity profiles. Validated chromatographic methods are used to quantify the main component and monitor related substances throughout development and manufacturing.
Utide applies HPLC analysis across a broad range of peptide APIs, including long-acting and multi-agonist molecules such as Retatrutide and Cagrilintide, ensuring consistent impurity control and batch-to-batch reproducibility.
High-resolution Mass Spectrometry Report (MS)
High-resolution mass spectrometry is employed to confirm molecular identity through exact mass determination and structural verification. This analysis provides confidence in correct synthesis and structural integrity, particularly for complex peptide APIs.
For representative products in our portfolio, including GLP-1–based and long-acting metabolic peptides, high-resolution MS reports support identity confirmation as part of routine quality control and DMF-aligned documentation.
Safety Data Sheet (SDS)
he Safety Data Sheet (SDS) provides essential safety and regulatory information for the custom peptides manufactured by Guizhou Utide Biotechnology Co., Ltd. Prepared in accordance with the UN GHS (11th Revised Edition), the SDS outlines the substance’s properties, hazards, safe handling, storage, and emergency measures.
It includes 16 standardized sections covering composition, first-aid, firefighting, accidental release, exposure control, toxicology, ecological impact, and transport guidelines. This document is a critical resource for laboratory staff, manufacturers, logistics personnel, and safety officers to ensure safe use, compliance, and risk management.
Always refer to the SDS before handling the substance to protect personnel, the environment, and regulatory integrity.
Third-Party Test Reports
Third-party test reports from qualified independent laboratories provide additional verification of critical safety-related attributes, such as bacterial endotoxins, sterility (where applicable), and heavy metal content.
Utide collaborates with internationally accredited laboratories to perform third-party testing for peptide APIs, including Semaglutide, tirzepatide, retatrutide and other products in our portfolio, reinforcing product safety assurance and regulatory readiness.