WHAT DOES PHARMACEUTICAL GRADE MEAN?
Pharmaceutical grade means that the product has been manufactured under GMP conditions and is safe, pure and effective. Under GMP (Good Manufacturing Practices) every step of the process is documented by using established SOPs (Standard Operating Procedures). This includes training, equipment, raw materials, facilities, and final release criteria. Everything can be traced back to the date, time, person, lot number, and piece of equipment used.
The term “pharmaceutical-grade omega-3 oil” is a set of specifications regarding the amounts of the various fatty acids contained in the oil after processing. These specifications are defined in a pharmacopeia, which is a compendium of specifications (also called monographs) for all types of organic and inorganic substances that people use for health or medicinal purposes. Omega-3 specifications are defined in the european pharmacopeia and our omega-3 products conform to or exceed those standards thereby making them “pharmaceutical-grade” by definition. The key to verifying this is the amount of EPA and DHA (the 2 most important acids) in a gram of omega-3 oil. It can vary a lot from one brand to another. Our products contain more than sufficient levels. Also important to understand is that some brands produce their oils with additives to manipulate the levels of EPA and DHA artificially. Our lab in Iceland produces a completely natural product. In addition, our lab in Iceland uses a p
Pharmaceutical grade raw material used to make dietary supplements has been tested and has passed the tests using procedures designated in a pharmaceutical monograph. Compliance to the specifications of the US Pharmacopeia monographs designate what can be called USP material. There can be a range of purity given for test results of api pharmaceutical grade materials, such as 97-102%.
