Research Library

Explore our collection of research articles, guides, and protocol documentation.

Legal & Compliance

What a Certificate of Analysis Documents (and What It Doesn't)

A certificate of analysis is the document most often offered as proof of quality for research chemicals, and the one most often asked to carry more weight than its contents support. This guide separates what the document genuinely establishes — lot-specific identity by mass spectrometry, chromatographic purity, and the line items behind the mass — from what it is simply silent about, including co-eluting impurities, endotoxin, stability past the test date, and whether anyone independent ever checked the numbers.

Research Assistant14 min readOct 12, 2026

Legal & Compliance

Chain-of-Custody Recordkeeping for Laboratory Materials

A certificate of analysis tells you what a laboratory measured. The chain-of-custody record is what establishes that the material measured is the same material that was collected, handled only by named people, and never left unaccounted for. Here is what that record has to contain, how labeling and tamper-evident sealing support it, what 21 CFR Part 58 requires a facility to write down, and what happens to the data when a link in the chain goes missing.

Research Assistant14 min readOct 11, 2026

Legal & Compliance

IACUC and IRB Oversight: The Compliance Context for Research

IRB and IACUC review are jurisdictional questions before they are paperwork questions. This explainer walks through where each committee's authority comes from — the Common Rule, FDA regulations, the Animal Welfare Act, and Public Health Service Policy — how exempt, expedited, and full review differ, what obligations continue after approval, and where laboratory characterization of a research-grade compound actually sits on that map.

Research Assistant13 min readOct 11, 2026

Legal & Compliance

FTC Advertising Substantiation Rules and the Limits of Claims

Read enough research-compound pages and you notice the same careful register everywhere — chemistry described in detail, outcomes described almost not at all. That register is not timidity. It is the shape left behind by the FTC's advertising substantiation rules, which require a marketer to already hold competent and reliable scientific evidence at the moment a claim is published. This explainer walks through what that standard means, how implied claims are read, why cell-culture data cannot carry a consumer claim, and where FDA labeling authority ends and FTC advertising authority begins.

Research Assistant14 min readOct 11, 2026

Legal & Compliance

USP Peptide Monographs and Reference Standards, Explained

A purity percentage only means something relative to a standard — and in pharmaceutical quality control, that standard has a name and a number. This explainer walks through what a USP peptide monograph contains, how USP qualifies the physical reference standards that pair with it, where the legal force of compendial recognition comes from, and what General Chapter 1503 deliberately leaves unspecified for synthetic peptides. It closes on the practical question for anyone sourcing research-grade material: what a quality claim can mean when no monograph exists.

Research Assistant14 min readOct 10, 2026

Legal & Compliance

Good Laboratory Practice (GLP) Basics: A 21 CFR Part 58 Overview

The letters GLP turn up constantly on laboratory paperwork and supplier pages, usually with no explanation of what they govern. 21 CFR Part 58 is the FDA regulation behind them, and it is narrower and stranger than most people assume: a documentation rule written in response to documented fraud, covering how a nonclinical safety study is planned, recorded, and archived. It says nothing about whether a study's conclusions were correct, and nothing at all about the quality of a chemical in a vial.

Research Assistant15 min readOct 10, 2026

Legal & Compliance

GMP vs Research-Grade Manufacturing: The Regulatory Line

The phrase GMP appears constantly in research chemical marketing, usually as though it named a cleaner bin on the same shelf as research-grade. It does not. GMP describes a documented, product-specific quality system scoped to drug products, and the boundary between it and research-grade supply is drawn by intended use rather than by the molecule. Here is where that line actually falls, what a research-use-only label does and does not settle, and what research-grade material still gets characterized for.

Research Assistant14 min readOct 10, 2026

Legal & Compliance

FDA Import Alerts and How Customs Detains Research Chemicals

A research chemical can be held at a U.S. port for weeks without anyone ever opening the container. The hold was decided in advance, against a pattern, by a screening system reading a document the FDA published months earlier. This is a plain-language walk through FDA import alerts: what detention without physical examination actually means, why the agency only needs an appearance of a violation, how Red and Green Lists decide a shipment's fate, which alerts reach peptides specifically, and what the clock looks like once freight is detained.

Research Assistant14 min readOct 9, 2026

Legal & Compliance

Are Peptides DEA-Scheduled? The Analogue Act, Explained

Scheduling under the Controlled Substances Act is a question of list membership, and no research peptide is on the list. But absence from the schedules is not the same as absence of regulation. This explainer walks through what the five schedules are built around, why peptides fall outside them, what the 1986 Analogue Act actually reaches, the four-word clause the whole analysis turns on, and the FDA rules that do the real work in this space.

Research Assistant14 min readOct 9, 2026

Legal & Compliance

Reading FDA Warning Letters Sent to Research Peptide Sellers

The FDA has posted a steady run of warning letters to companies selling research peptides online, and they are public documents anyone can read. They are also unusually consistent: four statutory sections, one evidentiary method, and a fifteen-working-day clock. This piece walks through what the letters say, how the agency establishes intended use despite a research-use-only label, where the quoted evidence comes from, and how to read the public database yourself.

Research Assistant13 min readOct 9, 2026

Legal & Compliance

Misbranded vs. Adulterated Under the FDCA: A Plain-Language Primer

Two words turn up constantly in FDA correspondence, and they get used interchangeably by almost everyone who reads it. They are not the same. Adulteration is a finding about the material in the container — its identity, its purity, the conditions under which it was made. Misbranding is a finding about the words around it. This primer walks through the two statutory sections, explains why a website counts as labeling, and shows where a research-use-only statement sits in the analysis.

Research Assistant15 min readOct 8, 2026

Legal & Compliance

The Intended-Use Doctrine: Why a Label Alone Doesn't Decide Status

Two vials can hold the same sequence at the same purity and still sit on opposite sides of a regulatory line. The FDA intended use doctrine explains why: status follows the objective intent a seller demonstrates through labeling, promotion, channel, documentation, and support — not the category name anyone prefers. Here's how the doctrine works, what the 2021 final rule clarified, and why a research-use-only label is a necessary factor rather than a safe harbor.

Research Assistant14 min readOct 8, 2026

Legal & Compliance

Research Use Only (RUO) Labeling: What the FDA Actually Requires

Four words — for research use only — carry more regulatory weight in the research chemical market than almost any other phrase on a label, and almost nobody who reads them knows where they come from. There is a real, codified requirement behind the designation: it names exact wording, it governs a defined category of product, and its scope is far narrower than the market's use of it suggests. Here is what the rule says, what it does not say, and why intended use rather than label text decides how a product is classified.

Research Assistant14 min readOct 8, 2026

Legal & Compliance

How the 'Not for Human Use' Label Carries Legal Weight

Most people read the 'not for human use' line on a research vial one of two ways: as a shield that settles every legal question, or as boilerplate nobody enforces. Both readings miss how the sentence actually works. Its weight is real but entirely derivative — it comes from being a truthful statement of intended use under federal law, which means the words on the carton are only as strong as every other signal around the sale agrees they are.

Research Assistant14 min readOct 7, 2026

Legal & Compliance

ICH Q6B Explained: The International Specification Standard Behind Biotech Peptides

Every trustworthy peptide vial stands on a spec sheet — and that spec sheet traces back to one international guideline. ICH Q6B defines what identity, purity, and potency actually mean for proteins and polypeptides. This explainer unpacks the framework, its universal and specific tests, and why it shapes quality thinking even for research-grade material.

Research Assistant10 min readJun 29, 2026

Legal & Compliance

Research-Grade vs Pharmacy-Grade Peptides: Why the Same Sequence Isn't the Same Product

Two vials with the same peptide name and the same listed purity can still belong to two completely different regulatory worlds. Research-grade and pharmacy-grade describe parallel supply chains with different rules about what gets tested, what gets documented, and who is accountable for what — and the gap shows up in the impurity profile, not the molecular weight.

Research Assistant13 min readMay 18, 2026

Legal & Compliance

FDA 503A Bulks List 2026: PCAC Agenda for Research Peptides

FDA's Pharmacy Compounding Advisory Committee will meet July 23-24, 2026 to discuss whether seven research peptides — BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax, and Epitalon — should be added to the section 503A Bulks List. This research-use-only reference explains what the 503A Bulks List actually is, what's on the July 2026 agenda, the three nomination categories used during evaluation, the PCAC's advisory role versus FDA's final-decision authority, and what the outcomes mean — and don't mean — for research-grade peptide supply.

Research Assistant14 min readMay 4, 2026