harley medical


Hartley Pharmacy employs extensive end-product testing
for the detection of bacteria, endotoxins (pyrogens), and
concentration. We apply the following methods to certify
our solutions:

HPLC (High Performance Liquid Chromatography):
HPLC determines the exact concentration of our sterile products in milligrams per milliliter (mg/ml). This precise method is applied to ascertain our staff’s compounding accuracy.

Endotoxin Detection:
Hartley employs a FDA-approved method to determine the endotoxin concentration within our sterile compounded products. We use equipment and procedures utilizing the Limulus Amoebocyte Lysate (LAL)—a method accepted by large-scale manufacturers—to assay our parenteral compounds to quantify the endotoxin levels. This technique is far more advanced than rudimentary shortsighted products on the market. Our technologically advanced instruments have the ability to detect endotoxins to a level of 0.001 Endotoxin Units per milliliter.

Sterility & Fungal Testing:
Boards of Pharmacy and USP <797> mandate sterility testing. We integrate a robust testing program at Hartley Pharmacy to eliminate the possibility of contaminations. Routine and random testing is actively conducted to provide the purest compounded products. Fungal testing, although not mandated by any governing body, is also routinely implemented.