Nutraceutical Stability Testing in Veterinary Formulations 
                     HOW GUIIRES FRL 
CDMO MEETS 
NUTRACEUTIICAL 
STABIILIITY 
TESTIING IIN 
VETERIINARY
A presentation by
Dr. Nancy Agnes, Head, Technical Operations, 
FoodResearchLab
Group: www.foodresearchlab.com 
Email: [email protected]
Introduction
Much has been written since the late 1970s regarding the potential use of foods as medicine 
to support longevity and good health.
Unfortunately, the Food, Drug and Cosmetic (FD&C) Act would classify such goods with a disease-
like claim as medications, therefore food makers were prohibited from taking that approach.
This was altered by the 1992 Nutritional Labelling and Education Act (NLEA), which permitted 
specific health claims to be made on foods.
Only Few food products managed to have fulfilled the strict criteria needed to qualify for a  
health claim.
However, in the veterinary sector, the growth of nutraceuticals has been manifolded. Over the 
past 30 years, the usage of nutraceuticals for veterinary purposes has grown significantly, 
making them a billion-dollar industry.
This pattern indicates a change in the perspectives of veterinarians, manufacturers, and 
animal owners.
Conventional pet food and dietary supplements provide a variety of nutritional options for 
disease management  and  health  promotion,  providing  an  alternative  to  relying  
exclusively  on pharmaceutical or medical goods for disease prevention and treatment.
Thus, need for new nutraceutical formulations and product development have drastically grown 
and ensuring its stability is vital
Stability Testing –  Why is it Needed?
In pharmaceutical industry, stability of active ingredients and manufacturing is
strictly moderated with several regulations.
This is quite absent in case of nutraceutical sector. From a regulatory perspective, 
expiration dates are not necessary on labels for nutraceuticals in the United States.
This has given rise to legitimate worries regarding the effectiveness of nutraceuticals
and their stability over time when utilised in both veterinary and human settings.
Major reasons for shelf-life testing of nutraceuticals are as follows:
1.Concern for the health of the animal affl icted with the medical condition for which 
the product is intended
2.Ensure that the product will be fit for use in terms of all functionally relevant 
aspects
throughout the duration that it is sold, protecting the manufacturer’s reputation in 
the process.
To ensure that a  nutraceutical formulation in veterinary research combines quality, 
efficacy, and  safety,  stability  testing  is  a   must.  It  is  a   sophisticated  series  of  
processes  requiring significant money, time, and scientific skill.
The ability of a  substance or product in a  particular container-closure system to stay 
within specified parameters to maintain its identity, strength, quality, and purity 
throughout the retest or expiration dating periods is known as stability/shelf life for drugs or 
nutraceuticals.
Thus, stability testing assesses how external influences affect the quality of a  
manufactured product or nutraceutical substance, which is used to forecast its shelf life, 
choose the best storage settings, and recommend labelling guidelines.
Roughly 90% of veterinarians in the USA provide innovative ingredients, like 
nutraceuticals, for sale.
Almost thirty percent of pet owners have either used or are thinking about using 
innovative components in their animals, like herbs and botanicals and nutraceuticals.
Although  product  expiration  dates  are  frequently  searched  for  by  consumers,  
nutritional supplements are not currently required by US federal rules to include an 
expiration date.
It  is  the  goal  of  manufacturers  to  achieve  a  minimum  of  two  years  of  stability  for  
their nutraceutical  goods,  which  means  that  if  a   retest  is  conducted  two  
years  after manufacturing.
The substances indicated as “active” on the label will still be able to match the claim 
made on the label.
The best a  consumer can do is look at the label to find out the manufacturing date and 
hope that, with proper storage, the product will remain stable for at least two years.
It is important for manufacturers, veterinarians, and consumers to understand that not 
all nutraceuticals live up to the label.
Factors involved
Numerous factors can impact the stability and concentration of nutraceuticals in both 
their unprocessed and processed forms.
These  include  the  state  of  the  environment,  unstable  chemicals,  interactions  
between matrices, packaging, and other intangible problems.
The  stability  of  a   nutraceutical  product  can  be  affected  by  changes  in  its  
appearance, consistency,  homogeneity  of  content,  clarity  (solution),  moisture  content,  
particle  size  and shape, pH, and package integrity.
Such  physical  alterations  could  result  from  shearing,  freezing,  thawing,  impact,  
vibration, abrasion, and other temperature variations.
Nutraceutical  products  may  undergo  chemical  reactions  such  as  solvolysis,  
oxidation, reduction, racemization, etc.
That result in the formation of degradation products, a  decrease in the potency of the 
active ingredient, and a loss of excipient activity such as antioxidant and antimicrobial 
preservative activity as depicted in below figure

Conclus ion
Many of the tests used in a  stability evaluation will be specific to the product, but they 
will typically fall into one of four categories:
1.sensory/organoleptic evaluation (colour, odour, and taste)
2.chemical analysis (assays for active component levels)
3.physical analysis (taste, hardness, and tablet assessments)
4.microbiological examination (based on assessments of microbiological risks).
The nature and characteristics of the product and the ingredients, the suggested label 
claims, the packaging and expected storage conditions, and the shelf life necessary for 
commercial viability are just a  few of the variables that will determine which tests are 
chosen for any given ingredient or product.
Looking for stability testing of your formulation or innovating on nutraceuticals? Guires 
FRL CDMO is simply an expert at this. Possessing a team of high expertise in variety of 
testing methodologies like genomic/gene expression studies, in vitro bioassays, and 
human clinical testing, we provide consistent and innovative solutions for all your 
requirements related to nutraceutical formulations and its stability.
REFERENCES:
DuBourdieu,  D.  (2019).  Veterinary  Nutraceuticals  Stability  Testing.  Nutraceuticals  in  
Veterinary Medicine, 765-774.
LeDoux, M. A., Appelhans, K. R., Braun, L. A., Dziedziczak, D., Jennings, S., Liu, L., … & Griffiths, J. C. 
(2015). A quality dietary supplement: before you start and after it’s marketed—a conference 
report. European journal of nutrition, 54(Suppl 1), 1-8.
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