Niagen Bioscience Collaborates with USP to Establish First-Ever USP Monograph for Nicotinamide Riboside Chloride (NRCl), the Patented Form in Niagen®
Niagen Bioscience Collaborates with USP to Establish First-Ever USP Monograph for Nicotinamide Riboside Chloride (NRCl), the Patented Form in Niagen®
Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags
partnership
Key Terms
nicotinamide adenine dinucleotidemedical
Nicotinamide adenine dinucleotide (NAD) is a small molecule that cells use to move energy and chemical signals around, acting like a shuttle or rechargeable battery that helps power metabolism, repair damage, and control how cells respond to stress. Investors care because therapies, diagnostics, or consumer products that change NAD levels can affect disease treatment, aging-related markets, and company valuations, making research results, regulatory news, or product claims material to financial prospects.
united states pharmacopeiaregulatory
United States Pharmacopeia is an independent nonprofit that creates and enforces quality standards for medicines, dietary supplements and ingredients used in health products, acting like an instruction manual or quality checklist that manufacturers and regulators follow. Investors care because meeting or failing these standards affects whether products can be legally sold, influences manufacturing costs, risk of recalls or regulatory action, and therefore can change a company's revenue, reputation and liabilities.
dietary supplement ingredient monographregulatory
A dietary supplement ingredient monograph is a detailed, science-based guide that describes what a specific supplement ingredient is, how to test and measure its purity and strength, safe dosage ranges, and accepted uses. Think of it as a recipe and quality checklist combined: it helps manufacturers and regulators agree on standards, which matters to investors because clear standards lower regulatory and product-quality risk and can speed market acceptance or block problematic products.
pharmacopeial standardregulatory
A pharmacopeial standard is an officially accepted set of tests, measurements and quality rules for a drug or ingredient—like a recipe and checklist that ensures a medicine is what it claims to be and is safe to use. Investors care because meeting or failing these standards affects a product’s ability to gain regulatory approval, avoid recalls, and be manufactured consistently, which directly influences sales, costs and company risk.
identity testingtechnical
Identity testing is the process of confirming that a person, product, or biological sample is who or what it is claimed to be. For investors, this matters because accurate identity checks prevent fraud, ensure regulatory compliance, and protect product safety and quality — like checking a passport before boarding or scanning an ingredient label to be sure you got the right thing.
assay specificationstechnical
Assay specifications are the written limits and performance goals for a laboratory test — like a recipe that spells out how sensitive, accurate and repeatable the test must be. For investors, they matter because clear, achievable specifications determine whether a test can meet regulatory standards, be manufactured consistently, and win customer trust; shortfalls can delay approvals, raise costs, or reduce market value.
impurity limitstechnical
Allowed maximum amounts of unwanted or foreign substances in a manufactured product, typically drugs or chemicals, set by regulators or quality standards. Like a limit on how much grit can be in a sack of flour, impurity limits determine whether a batch is acceptable for sale, safe to use, and legally compliant. For investors, these limits affect regulatory approval, production costs, recall risk and the commercial viability of a product.
microbial requirementstechnical
Microbial requirements are the specific physical and chemical conditions—such as nutrients, temperature, moisture, pH and presence or absence of oxygen—that microorganisms need to survive, grow and reproduce. For investors, they matter because controlling or meeting these needs determines whether beneficial microbes can be used reliably in products or processes, and whether harmful microbes cause contamination, increased costs, production delays or regulatory problems.
See more from StockTitan in Google Search and AI answers.Adds StockTitan as a preferred source · opens Google
NR is the first among NR, NMN, and NAD+ to receive a pharmacopeial quality benchmark, reinforcing Niagen Bioscience’s leadership in NAD+ science and ingredient quality
LOS ANGELES--(BUSINESS WIRE)--
Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announces that Nicotinamide Riboside Chloride (NRCl), the patented form of nicotinamide riboside in the Company’s flagship ingredient, Niagen®, now has a published United States Pharmacopeia (USP) dietary supplement ingredient monograph. This monograph reflects the scientific rigor behind Niagen and establishes a global benchmark for what high-quality NRCl should look like in dietary supplements, limiting adulterants and contaminants.
Rob Fried, Chief Executive Officer of Niagen Bioscience, said, “This monograph is a meaningful development for the broader NAD+ supplement industry because NR now has a published pharmacopeial standard, while NMN and NAD+ do not. It underscores the importance of doing the long-term scientific and technical work required to help define a quality standard.”
USP is an independent, nonprofit organization that develops official quality standards for medicines, food ingredients, and dietary supplements. The U.S. Food & Drug Administration (FDA) and international regulatory bodies use USP standards as a primary reference point for evaluating the quality of a drug or ingredient, including purity, potency, identity, and testing methods.
Aron Erickson, Vice President, Research and Development at Niagen Bioscience, commented, "The monograph for NRCl is based on the scientific data, analytical methods, and specifications that we established for Niagen."
Niagen Bioscience collaborated with USP for six years as the sponsor of the monograph effort, contributing analytical methods, specifications, and testing approaches that helped establish the NRCl standard. The published monograph includes concrete quality requirements for NRCl, including identity testing, assay specifications, impurity limits, contaminant and microbial requirements, and packaging and storage requirements.
The monograph is available in USP’s compendia with a license and is expected to be codified and enforced in October 2026.
For additional information on the quality behind Niagen, visit www.niagenbioscience.com. To learn more about why USP matters for dietary supplements, visit www.aboutnad.com.
About Niagen Bioscience:
Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global leader in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.
The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.
Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.
At the heart of its clinically proven product portfolio is Niagen® (patented nicotinamide riboside, or NR), the most efficient, well-researched, and high-quality NAD+ booster available. Niagen powers the Company’s consumer supplement, Tru Niagen®, the number one NAD+ boosting oral supplement in the United States† (available at www.truniagen.com), and Niagen Plus, featuring pharmaceutical-grade intravenous (IV) and injectable Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription.
Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.
†Based on revenue per largest U.S. e-commerce marketplace (Jan. 2025 – Dec. 2025)
Forward Looking Statements:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects,” “anticipates,” “intends” “estimates,” “plans,” “potential,” “possible,” “probable,” “believes” “seeks,” “may,” “will,” “should,” “could,” “predicts,” “projects,” “continue,” “would” or the negative of such terms or other similar expressions.
Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those described. These risks and uncertainties include, but are not limited to, inflationary conditions and adverse economic conditions; our history of operating losses; the growth and profitability of our product sales; our ability to maintain and grow sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; risks of conducting business in China; including unanticipated developments in and risks related to the Company’s ability to secure adequate quantities of pharmaceutical-grade Niagen in a timely manner; the Company’s ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to compound and distribute pharmaceutical-grade Niagen to clinics; the Company’s ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company’s ability to maintain and enforce the Company’s existing intellectual property and obtain new patents; whether the potential benefits of NRC can be further supported; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities, including with respect to products seeking to compete in our market; mislabeling or other misleading marketing practices by competitors; economic and market instability, including as a result of tariffs or trade conflicts; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and Niagen Bioscience undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
