Stability Studies

Shelf-life is an important component of any consumer product development program.

Comprehensive Stability Testing Services

Santé Laboratories offers comprehensive stability testing services to design, execute, and manage a variety of comprehensive and flexible shelf-life programs covering a wide range of active ingredients and finished products.

Santé Laboratories brings many years of experience in the pharmaceutical, supplement, and cosmetic markets and has managed a diverse portfolio of products and specifications to help you with the following:

  • Develop, qualify, and validate stability-indicating assays to appropriately evaluate and monitor the stability of active ingredients
  • Perform real-time and accelerated aging studies to ensure functionality and potency of ingredients in finished products are not adversely impacted during intended shelf-life and consumer use
  • Perform “super” accelerated aging studies rapidly screen formulations candidates and forecast shelf-life at room temperature to support product development and/or intended use statements for companies like Amazon
  • Perform environment cycling such as freeze-thaw stability testing to support labeling and storage claims
  • PAO (period after opening) determination
  • Assess the compatibility of your formulation in intended packaging to ensure long-term shelf-life.
  • Store and manage stability programs and draft stability protocols, interim, and comprehensive final reports

Advance Your Product Through Microbial Testing

In addition to physical and chemical stability, it’s equally important to ensure your dietary ingredient, dietary supplement, and personal care products can retain their quality, safety, and aesthetics from a microbiological perspective for the labeled lifespan. An effective preservative system to protect your product from microbial ingress and growth is one of the best and most effective formulation strategies to substantiate the safety and overcome the instabilities of your finished products.

Santé Laboratories is equipped with a full-service microbiology center that enables microbial testing of raw materials, dietary ingredient, and finished product testing.  As a result, Santé Laboratories helps you evaluate and advance your product with the following microbiological services:

  • Dedicated Class 100 hoods to compendial or modified version USP <51>, USP <61>, USP <62>, USP <2022> and USP <2023> testing for raw materials and finished products.
  • Modify compendial or develop custom microbial testing methods suitable for difficult to recovery matrices:
    • USP <51> Antimicrobial Effectiveness Testing
    • USP <61> Microbiological Examination for Non-Sterile Products – Enumeration Tests
    • USP <62> Microbiological Examination for Non-Sterile Products – Tests for Specific Microorganisms
    • USP <2022> Microbiological Procedures for Absence of Specified Microorganisms in Nutritional and Dietary Supplements
    • USP <2023> Microbiological Attributes of Non-Sterile Nutritional and Dietary Supplements
  • Rapid Preservative Efficacy Testing (PET) to identify efficacy of preservatives in multiple formulations.
  • Culture and identify microbes using proteotypic mass spectroscopy by MALDI-TOF and 16s sequencing technology.
  • Microbiological examination following compendial and modified versions of USP <2222> and USP <2223>, USP <61> and USP <62>.
  • Several physical formulation characteristics can also be evaluated which include pH, viscosity, appearance, color, and odor. In any study designed by Santé, these properties can be compared against a control formulation and used to monitor.