Quality and Batch Documentation
Research materials differ not only by compound name, but above all by what is actually known about each batch. This page explains how we test and document batches offered by Pro-Body, as well as what we do not claim, because an accurate description requires both.
Batch Testing
We commission analytical testing from an independent external laboratory. We do not perform these analyses in-house or rely solely on documentation supplied by the manufacturer. We commission the work, and the results are delivered directly to us.
Methods
The analytical scope is selected according to the type of material. In practice, different techniques answer three separate questions.
Purity: High-Performance Liquid Chromatography (HPLC)
HPLC separates a sample into components and shows what proportion of the total recorded peak area is represented by the main peak. It answers the question “how much of the dominant component is present?”
Identity: Liquid Chromatography-Mass Spectrometry (LC-MS)
LC-MS allows the measured molecular mass to be compared with the mass calculated for the declared sequence. It answers “is this the stated compound?”, which is different from the question answered by chromatography alone. Using both analyses is central to confirming the material.
Endotoxins
Endotoxin testing is distinct from sterility testing because endotoxins are heat-stable and may survive procedures that destroy bacteria. A sterile material may still contain endotoxins.
Standard analyses: performed for every tested batch.
Batch Documentation
Each test result is documented in a certificate of analysis assigned to a specific batch. A certificate without a batch number cannot be traced to the package in hand. For this reason, the batch number on the document must match the batch marking on the package.
Our guide How to Read a Certificate of Analysis explains which entries are decisive and which are commonly overinterpreted.
Our article on bacteriostatic water discusses handling after delivery, including solvent selection and storage conditions for a prepared solution.
What We Do Not Claim
This section is intentionally included and is as important as the information above.
- We do not claim compliance with GMP requirements for medicinal products. Research materials are not governed by that framework, and stating otherwise would be inaccurate.
- We do not claim suitability for human use. Analytical documentation describes the physicochemical properties of a batch; it does not change the material’s legal status or constitute marketing authorization.
- We do not claim efficacy or safety. These are established through a registration process that research materials do not undergo.
- A certificate describes the material as tested on a particular date. It does not guarantee the condition of material subsequently stored under unknown conditions.
- Testing does not cover every possible parameter. A certificate documents only the analyses performed. If a parameter is absent, it was not tested; its absence does not mean the result was acceptable.
Pharmaceutical Review
Technical content concerning substance properties, regulatory status and safety profiles is subject to pharmaceutical review. Reviews are conducted by Weronika Krzyżak, Master of Pharmacy, who has 12 years of professional practice and is a member of the Pro-Body team.
Scope of review: the review covers published content only.
Regulatory Status of Materials
Materials in our catalog have varying regulatory statuses, ranging from reagents intended exclusively for research and cosmetic ingredients to substances whose status is disputed in the European Union. We state the status on each product page and do not apply a single framework to the entire catalog, because that would be inaccurate.
Research reagents are not medicinal products, food supplements or foodstuffs and are not intended for use in humans or animals.