Contract Laboratory Services
Nutraceuticals and Dietary Supplements
Nutraceuticals and Dietary Supplements products must be tested by an independent third-party lab to ensure safety and quality. This is required by most reputable online retailers and by brick-and-mortar stores. In order to meet patient safety requirements, the US FDA recommends that dietary supplement suppliers test at least the following:
- Identity– is it the right drug as indicated on the label?
- Assay – how much drug is there and is it consistent with the labeled amount?
- Impurities – are impurities within established specifications?
When selecting a testing lab, it is critical that you work with someone who prioritizes quality and is able to ensure that their systems ensure data integrity and accuracy. Vici Health Sciences is a pharmaceutical formulation development and testing company and brings the same rigorous standards applied in the development and testing of pharmaceutical products to nutraceutical and dietary supplements testing. Vici’s lab, located in Maryland, USA is cGMP/GLP certified and has a fully independent quality assurance (QA) department to provide the best quality.
Vici regularly provides identification, assay, and purity testing for the following ingredients:
- Cordycepin
- Lion’s mane
- Ashwagandha
- Chaga
- CBD
- CBN
- CBG
- Melatonin
- Honokiol
- 5-HTP
- Methyl paraben
- Propyl paraben
- Benzalkonium chloride
- Sodium
- Potassium chloride
- Magnesium oxide
- Magnesium
- Zinc
- Selenium
- Copper
- Manganese
- Chromium
- Molybdenum
- Chloride
- Potassium
- Cysteine
- Cystine
- Caffeine
- Vitamin A
- Vitamin B6
- Vitamin B12
- Vitamin C
- Vitamin D3
- Vitamin E
- Folic acid
- Thiamin
- Retinol
- Riboflavin
- Niacin
- Biotin
Don't see the test you need? Contact us today and we'll help you find a custom solution for your testing needs.
In addition to testing, Vici Health Sciences is also an expert in formulation development, improving bioavailability, and small batch product manufacturing and packaging. Please contact us for all your formulation development and private label manufacturing needs.
Compounded Drugs Testing
Vici Health Sciences provides affordable and high-quality third-party testing services for compounded products. We are a pharmaceutical service company and operate a cGMP/GLP certified laboratory in Elkridge, Maryland.
Compounded drugs are created to address individual patient needs, especially when commercially available medication does not meet specific requirements. To ensure safety, efficacy, and quality of compounded drug products, FDA and United States Pharmacopeia (USP) testing requirements must be followed. The FDA provides oversight for compounded drugs under sections 503A and 503B of the Federal Food and Drug Cosmetic Act.
503A Compounding
Traditional pharmacies that compound drugs based on prescriptions for individual patients. Typically, non-sterile drug preparations such as oral or topical drugs may be compounded under a 503A license. Testing requirements are more limited when compared to 503B compounding pharmacies. Testing generally focuses on identity (ID), potency (assay), and sometimes stability to support beyond-use dating (BUD).
The regulatory framework for such products must adhere to USP <795> for non-sterile preparations
503B Compounding
These are outsourcing facilities that compound sterile drugs in bulk. Testing requirements are higher than for 503A compounding pharmacies with a strict adherence to Current Good Manufacturing Practices (cGMP) suitable for sterile pharmaceutical manufacturing. Testing requirements include identity, potency, sterility, endotoxin levels, particulate matter, and more.
The regulatory framework for such products must adhere to USP <797> Pharmaceutical Compounding – Sterile Preparations.
Establishing Beyond-Use Dates (BUDs) for compounded drugs requires assessing the drug’s stability, storage conditions, and compatibility with its container-closure system. This involves reviewing scientific literature, performing stability testing, and adhering to USP <795>, <797>, or <800> guidelines. Documented evidence ensures patient safety and compliance with regulatory standards for compounded medications.
At Vici Health Sciences, we provide third party testing services to pharmaceutical compounding companies. We test for:
- Identity – is it the right drug as indicated on the label?
- Assay – how much drug is there and is it consistent with the labeled amount?
- Impurities – are impurities within established specifications?
- Stability Testing Services – for establishing BUD for compounded drugs
- DEA Schedule I-V licensed – to handle compounding testing for DEA controlled products
Contact us
depending on the active ingredient and cost of standardsAs a pharmaceutical testing lab, Vici also provides third party testing services for compounding labs including 503A and 503B manufacturing facilities.
