Expanded testing capabilities with developed method for Hydroxychloroquine (HCQ).

Effective April 16, 2020 – Infinity Laboratories has added a validated method for Hydroxychloroquine and is now receiving final product samples for potency testing.

Hydroxychloroquine (HCQ) is an antimalarial drug effective in the treatment of various autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) that is under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19.

(https://ncbi.nlm.nih.gov/pmc/articles/PMC5137978/ and https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html)

Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for method development and extensive testing is performed to display specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows us to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

Important Notice Regarding COVID-19

At Infinity Laboratories, the health and safety of our employees, customers, and communities is a top priority. As the situation regarding COVID-19 continues to evolve, Infinity Laboratories is actively monitoring and adhering to the guidance published by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).

During this time, we wanted to inform you of measures we are taking in order to ensure uninterrupted laboratory service and continued customer support. These measures include:

• LABORATORY VISITS: Restricting non-essential in-person site visits, including audits.
• TRAVEL: Restricting non-essential team member travel.
• OPERATIONS: Running teams in shifts and having some team members work from home.
• LABORATORY NETWORK: Preparing our laboratory network for internal and external subcontract activities should any location be infected.
• VENDORS: Working with our suppliers to ensure laboratory supply chains are not backlogged while also verifying secondary providers.
• CORPORATE EVENTS: Postponing all customer facing sales and marketing activities.

Infinity Laboratories appreciates your business and are committed to serving you through this unprecedented time. We wish you all good health and will keep you updated with any new information. Please feel free to reach out to any of our team members if you have any additional questions.

Additional information and resources about COVID-19:

• Centers for Disease Control and Prevention (CDC) – The CDC is publishing its latest updates, health tips, and country-specific travel information.
• World Health Organization – Coronavirus Q&A, a helpful Q&A addressing many of the common questions about this virus.

Sincerely,

Daniel B. Henderson, MBA
CEO/President
Infinity Laboratories
303.730.7330 (office)
801.243.6643 (mobile) (MTN)
www.infinitylaboratories.com