Purity, Strength, Composition
You want to assure your customers that your products contain exactly what is on your label. Physical and Chemical raw material and products insure a uniform and quality finished supplement. Exact Scientific Services, Inc has multiple ways of helping you with this.
Specifications should be established for each component of a product. The specification is used to ensure that the quality of the dietary supplement has an expected target, that it is met, and then monitored. Specifications should establish that each component used meets the requirement for physical properties such as particle size, bulk density and capsule weight. For specific properties you will want to look items like loss on drying, rancidity (peroxide value), water activity and pH. This properties will affect the shelf stability, look and smell of the product.
Generally, ingredients should meet USP, NF or Food Chemical Codex standards.
We have the capability to look at each specification using different instruments that meet the requirements. Dietary supplements for which a monograph is provided in the USP, NF or FCC have established compliance guidelines for purity, strength and composition.
Monographs have different sections to help establish specification criteria. These may include but are not limited to:
- Definition – Component definition.
- Identity – Methods, analysis, and acceptable criteria
- Composition – Analyte(s) and the method, analysis and acceptable criteria for them.
- Impurities – Tests for heavy metals, pesticides, residual solvents, microbiological, aflatoxins, and others.
- Specific Tests – Limit tests, Loss on drying, ash, acid-insoluble ash, specific rotation are examples of specific tests based on the component.
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