The glycerin assay verifies the purity and identity of the starting material used for ozonation. Purity is a property of the raw material, confirmed by conformance to a recognized pharmacopeial monograph — not a vague attribute of the finished product. Using USP-NF (United States Pharmacopeia–National Formulary) grade glycerin links identity, assay/strength, and impurity controls to a recognized compendial standard. Reference: USP-NF General Chapter, Glycerin Monograph
Each lot of glycerin is verified against the USP-NF Glycerin Monograph, which includes identity testing, assay/strength (NLT 99.0%), and impurity controls. Critically, the USP monograph was strengthened to include identity and limit tests for toxic adulterants: ethylene glycol (EG) ≤0.10% and diethylene glycol (DEG) ≤0.10%. We verify purity per lot using the supplier’s Certificate of Analysis (COA) against incoming QC acceptance criteria, providing full chain-of-custody documentation.
The quality of the glycerin base directly affects ozone absorption, retention, and product stability. Lower-grade glycerin (below 99%) may contain water, organic impurities, or residual processing chemicals that degrade ozone stability and reduce shelf life. Anchoring purity to USP grade with lot-level verification directly mitigates historical adulteration risks (EG/DEG contamination incidents) and provides a defensible, auditable basis for consumer-facing purity statements. The 99.7% specification is verified per lot, not a marketing headline. Reference: USP-NF Glycerin Monograph
SimplyO3 uses exclusively USP-grade pharmaceutical glycerin at ≥99.7% purity, which is also certified organic, sourced from verified pharmaceutical suppliers. This exceeds the NLT 99.0% acceptance criteria by a significant margin. Each lot includes supplier COA verification and incoming QC checks for identity, assay, and absence of EG/DEG adulterants.
The combination of high-purity glycerin and extended ozonation gives Glyzine a 90-day unrefrigerated shelf life, up to 18-month refrigerated shelf life, and extended frozen shelf life (2+ years, manufacturer estimate). For scientifically defensible shelf-life claims, an ICH-aligned real-time stability program using at least three primary batches stored at 25°C/60% RH with light protection and first-order kinetic modeling is the recognized standard. Glyzine is kept refrigerated until shipment, so the 90-day clock starts when you receive it. Reference: ICH Q1A(R2); González-González et al. (2022)
Method: USP-NF Glycerin Monograph, verified per supplier COA.
What USP-NF Means: The United States Pharmacopeia–National Formulary is the official compendium of drug substance and excipient standards in the U.S. The Glycerin Monograph specifies: identity testing, assay (NLT 99.0% C₃H₈O₃), and impurity limits including ethylene glycol (EG) ≤0.10% and diethylene glycol (DEG) ≤0.10%. These adulterant limits were strengthened after contamination incidents in which DEG-contaminated glycerin caused fatalities.
Chain of Custody: Each lot of pharmaceutical-grade glycerin arrives with a Certificate of Analysis (COA) from the supplier. We perform incoming QC verification: (1) COA review against acceptance criteria, (2) visual and organoleptic inspection, (3) lot number documentation for full traceability from supplier through finished product to customer.
ICH Q2(R1) on Accuracy: The ICH guideline on analytical method validation states: “The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.” For compendial identity and purity testing, the supplier’s validated assay method (GC or titrimetric per USP) provides the accuracy data in the COA. ICH Guidelines
Our 99.7% Specification: SimplyO3 specifies ≥99.7% glycerin purity, which exceeds the USP minimum of 99.0% by a significant margin. Higher purity means fewer competing reactants during ozonation, better ozone retention, and longer shelf life. The 99.7% figure is a lot-verified measurement, not a marketing claim.