The HypoSpray(R) StatSpray system has been qualified by several regulatory agencies as well as pharmacies and health care providers.

Extensive clinical safety testing has been conducted on the HypoSpray system, including the FDA's rigorous 21-day Cumulative Irritation Test involving 32 subjects and more than 1,300 exposures. The results indicate that the delivery system is non-toxic and non-irritating.

Regulatory agencies such as the FDA, as well as European counterparts like the MHRA and EMA, have reviewed all ingredients and have approved them for trial on seven separate occasions. HypoSpray has registered the product as a Type IV Drug Master File defining a coprocessed Excipient and has filed a Request for Revision with the United States Pharmacopoeia (USP) to add a monograpgh for the system.

Quality manufacturing is a hallmark of HypoSpray with all Contract Manufacturing Organizations meeting strict standards of current Good Manufacturing Practice (cGMP). HypoSpray is working with USP to verify quality at our CMO sites by means of the USP Veriified Program, and once successfully audited and reviewed, HypoSpray StatSpray will carry the USP Verified Excipient logo.

YES.

Given that the HypoSpray DS formula is anhydrous, it falls under the guidelines outlined in USP <795> Pharmaceutical Compounding - Nonsterile Preparations. According to these standards, the Beyond-Use Date (BUD) for such formulations is set at six months from the date of preparation.

According to USP 61 standards, ethanol concentrations exceeding 20% are recognized as potent neutralizing agents. Additionally, Propylene Glycol or Carbonate concentrations surpassing 10% are known to inhibit microbial growth and possess anti-viral properties.

The HSP Solution contains ethanol levels exceeding 20%.

Hypospray solution has been used to formulate:

Testosterone

Progesterone

17 Beta Estradiol

Estriol

Hormone Combinations

Ibuprofen

Acetaminophen

Lidocaine

Tetracaine

Prilocaine

Diclofenac Sodium

Morphine Sulfate

Hydromorphone

Lorazapam

Diazepam

Vitamins B12, C, D, E

Melatonin

Human Insulin

Epinephrine

Hydroxyzine

Cetirizine

Semaglutide

Tirzepetide

Numerous other compounds