Monographs are documents that provide methods and guidelines to verify the identity, potency or strength, purity, and performance of raw materials and ingredients in a product. They detail the parameters expected of specific products to ensure federal and industry requirements for various criteria, described below, are met. Basically, monographs are lists of tests provided by credible and industry-recognized sources to properly authenticate and analyze ingredients.  

Monographs outline tests for the measuring following criteria:  

  1. Identity: Substance is the material that it claims to be 
  2. Strength: Acceptable ranges for the potency of a product  
  3. Contamination: Limits and rages of impurities permitted 
  4. Performance: Predict and demonstrate how a product will be released in the human body or in some cases animals 

Monograph testing is used in a variety of industries, including raw material suppliers, food, beverages, dietary supplements, nutritional products, animal nutrition, and Over The Counter products (OTCs) / low-risk pharmaceuticals.  


What are the benefits of monograph testing? 

There are many benefits to monograph testing, no matter the industry, including compliance with legal and industry expectations, like cGMP or the US Food Safety Modernization Act (FSMA). Using monograph testing to ensure products meet label claims also helps avoid costly investigations and recalls while improving brand reputation with respectable and industry-recognized practices. Ultimately, monograph testing is the right thing to do for customers, employees, and stakeholders! 

More details about the importance of understanding and undergoing monograph testing are provided below:  

  • Compliance: Meet the US Food and Drug Administration (FDA) recommended standards for product purity, identification, potency, and composition with a validated set of tests. Monograph testing provides reliable, reproducible results with the use of standardized and well-developed methods. 
  • Reputation: a more positive reputation is built around properly tested and verified products and brands that value valid testing. Reputations are questioned when a company does not comply with FDA recommendations.  
  • Investigations (not if, when) something happens: When an adverse effect is reported or another situation arises that questions any aspect of a product, it is best to have the tests done beforehand instead of rushing testing after the fact. This provides evidence of safety or allows an investigation into the origin of an issue. It is always best to prevent a costly investigation by testing material before a sale. 
  • The right thing to do: Value the consumer’s safety and trust; even if you think your product is safe, it is always best to make sure.  
  • Other benefits: improved product quality and safety assurance, recall prevention, adulteration detection, legal, insurance, and financial claims prevention  


Where do monographs come from? 

Many recognized industry organizations exist that develop, validate, and optimize tests for specific ingredients which are compiled into monographs.  These organizations are impartial and are only involved in method development, not product development, meaning their suggested tests are truly scientifically acceptable. 

 The most common sources for monographs are: 

Legal requirements for monograph testing in different industries: 

As an example, the US FDA outlines specific monographs for product release on many categories of ingredients and formulated products: 

  • Over the Counter (OTC): OTC products are grouped by therapeutic category, and each category has an OTC monograph. This is essentially a “rule book” establishing conditions for the OTC to be Generally Recognized as Safe and Effective (GRASE). OTC products do not need FDA pre-market approval, however, they must comply with (current) cGMP requirements as outlined in 21 CFR parts 210, 211. 
  • Animal nutrition: The US FDA Center for Veterinary Medicine (CVM) also outlines cGMP requirements for medicated animal feeds including Type A medicated articles (concentrated forms) and Type B and C medicated animal feeds for livestock (beef, pork, poultry, aquatic) as well as companion animals (dogs, cats, etc.). 
  • Raw materials: Raw materials do not require monograph testing in some cases, however, it is good practice to test materials for safety, purity, and efficacy verification. 
  • Dietary supplements: In the dietary supplement industry, it is the manufactures responsibility to test for purity, ID, quality, strength, and composition of their products. The FDA does not pre-approve products for sale, however, they are involved with post-market enforcement with the guidance outlined in 21 CFR part 111 So, monograph testing is important to have beforehand when (not if) a problem arises with a product in the market.  

Amongst all industries, monograph testing provides a validated, standardized approach to test ingredient, dosage, and strength claims, as well as screen for contaminants and other potential issues with unintentional adulteration.  

There are two main types of product testing: 

  1. Compendial: This is just another word for monograph. So, if you see a reference to compendial tests or certifications that means monograph testing is used. As described above, compendial testing includes validated, standardized specifications, and test methods for a specific product, compound, substance, etc. There are many advantages to compendial testing, a main one being the avoidance of validating tests on your own. Additionally, regulatory agencies are familiar with, and typically expect, the outcomes of compendial testing, making the approval and review processes (or any post-distribution follow-ups) more straightforward.  
  1. Non-compendial: This is any testing not specified in a monograph, including in-house and independent lab procedures. While these testing methods are usually scientifically reliable, they do not have the same rigorous validation workflow to ensure between-lab reproducibility. Benefits of non-compendial testing include customized approaches to unique ingredients, flexible problem-solving, and more identification possibilities. 

Monograph testing is an important step before putting a product on the market. No matter the industry, using standardized methods to test composition and purity improves the safety, purity, potency, consistency, and reputation of a product and brand. Trusting an independent lab to perform monograph testing provides non-biased results, however, it is important to carefully choose a lab with open communication, experienced scientists, and reasonable turnaround times that is convenient to work with. Monograph testing may not be legally required for all industries, but is the industry standard for producing the best product possible. 

View Eurofin Monograph pdf