--- type: "WebPage" title: "Analysis of synthetic peptides in the laboratory" description: "You wish to carry out an analysis of synthetic peptides present in your matrices or finished products What is a synthetic peptide? A synthetic peptide is a chain of amino acids (like proteins, but shorter) that is artificially made in..." resource: "https://filab.fr/en/sectors-of-activity/biopharmaceutical/analysis-synthetic-peptides/" tags: ["EN", "pll_68cab007dda5e", "Anaïs DECAUX"] timestamp: "2026-03-12T08:23:50Z" published: "2025-09-17T13:30:51Z" language: "en" author: "Laure Durieux" --- # Analysis of synthetic peptides in the laboratory ## You wish to carry out an analysis of synthetic peptides present in your matrices or finished products ### What is a synthetic peptide? A **synthetic peptide** is a chain of amino acids (like proteins, but shorter) that is **artificially made in a laboratory**, usually by **chemical synthesis** rather than biological means. ### FILAB offers you the analysis of synthetic peptides Peptides are versatile molecules used in various sectors such as pharmaceuticals and cosmetics. Their specificity and effectiveness allow them to play a key role in the development of new treatments or the improvement of skin care. This diversity of applications underscores the considerable potential of peptides and the importance of continuing research in this field. ## Our analysis services on synthetic peptides **Purity control** **Search for impurities and contaminants** **Regulatory support** for your quality files (ICH, pharmacopoeias, ISO, etc.) [Peptide analysis](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/peptide-analysis-biopharmaceutical-services.md) Characterization of active ingredients **Checking the molecular mass** and expected sequence **Stability studies** (thermal, oxidative, hydrolytic stress) [Peptide mapping](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/peptide-analysis-biopharmaceutical-services.md) [Peptide sequening](https://filab.fr/secteur-activite/laboratoire-analyse-biopharmaceutique/sequencage-des-peptides.md) [Validation of analytical methods according to ICH Q2](https://filab.fr/en/our-services/our-expertise-services/life-cycle-of-an-analytical-method-in-the-laboratory/laboratory-analytical-method-validation/validation-of-laboratory-analysis-methods-according-to-the-ich-q2-standard/) ## Our technical means for the analysis of synthetic peptides [### Mass spectrometry](https://filab.fr/en/our-technical-resources/laboratory-analysis-mass-spectrometry.md) [### HS-GC/MS](https://filab.fr/en/our-technical-resources/gas-chromatography-analysis-lab-gc/gc-ms-hs-gc-ms-and-tdu-gc-ms-laboratory.md) [### MALDI-TOF](https://filab.fr/en/our-technical-resources/maldi-tof-laboratory-analysis.md) [### LC-QTOF-MS](https://filab.fr/en/our-technical-resources/laboratory-for-lc-qtof-analysis.md) [### HPLC-MS et HPLC-MS/MS (Orbitrap)](https://filab.fr/en/our-technical-resources/lc-orbitrap-analysis.md) ## Evaluating your synthetic peptides for the US market We support manufacturers developing synthetic peptides based on already approved rDNA peptides, such as **glucagon, liraglutide, nesiritide, teriparatide, or teduglutide**. According to FDA guidance, these products can be submitted as ANDAs (Abbreviated Application) rather than NDAs (Full Application), thereby reducing time and cost to market. ### ANDA/NDA: placing on the American market **Indeed, manufacturers often find themselves faced with a question: should their synthetic peptide-based drug be submitted as an ANDA or as an NDA?** ![](https://filab.fr/wp-content/uploads/2024/03/Banniere-Blog-1024x576.png) An **ANDA** (Abbreviated New Drug Application) is a r**egistration procedure with the FDA (Food and Drug Administration, USA)** allowing a **generic drug** to be placed on the market. An **NDA – New Drug Application** is the official **file submitted to the FDA (Food and Drug Administration, USA)** to obtain marketing authorization (MA) for an **innovative drug**. Thanks to our expertise in **peptide mapping, characterization, and sequencing**, FILAB helps you: - Ensure the equivalence of your synthetic peptide with the reference product - Prepare a robust dossier that complies with FDA requirements ## Why analyze your synthetic peptides? Synthetic peptides are widely used in the **[pharmaceutical](https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals.md), [cosmetic](https://filab.fr/en/sectors-of-activity/laboratory-analysis-cosmetics.md),** and**[biotechnology](https://filab.fr/en/sectors-of-activity/biopharmaceutical.md) sectors**. Their efficacy and safety depend directly on their **purity, sequence, and stability**. Reliable analysis helps ensure the quality of your products, meet regulatory requirements, and accelerate your R&D or industrial projects. ### Why choose FILAB for synthetic peptide analysis - Recognized expertise in **chemical and biochemical analysis**. - **Independent and impartial results**. - **Personalized support**: from one-off analyses to the implementation of monitoring programs. - **Responsiveness** thanks to an integrated laboratory located on a single site. ## FAQ Why analyze a synthetic peptide? Because its purity, sequence, and stability determine its efficacy and safety. Analysis ensures that it meets expected specifications and complies with regulatory standards. What parameters can be checked during an analysis? - **Chemical purity** - **Exact sequence** (peptide identity) - **Molecular mass** - **Impurity profile** (truncations, unintentional modifications) - **Stability under stress** (temperature, oxidation, hydrolysis) - **Concentration and dosage** What are the regulatory issues? - Peptides intended for the pharmaceutical sector must meet ICH and pharmacopoeial (USP, Ph. Eur.) requirements. - In the cosmetics sector, they must comply with Regulation (EC) No. 1223/2009. - Traceability and analytical documentation are essential for marketing. What is the difference between a crude peptide and a purified peptide? - A **crude peptide** still contains impurities related to synthesis. - A **purified peptide** has undergone purification steps (often preparative HPLC) and achieved a higher level of purity (>95% depending on the application).