Potency and Purity
Beyond Use Dating
Preservative Effectiveness Testing
Sterility Test Validation
Uniformity of Dosage
2327 Chouteau Avenue
Saint Louis, MO 63103
The services provided by DYNALABS are protected by U.S. Patent No. 7,197,405.
Potency and Purity
Potency: A measure of the concentration, strength or activity of a medication. Potency is usually expressed as the amount of active pharmaceutical ingredient (API) within some unit measure of the medication, such as, but not limited to mg/mL, mg/gm, IU/mL, mg/capsule, mg/pellet etc., where the numerator is the amount API, and the denominator is the unit measure of the medication. Specifications for potency are typically expressed as a range, such as but not limited to 90.0 – 110.0% of label value.
Purity: A measure of the pureness of a raw material. Purity is typically express as a percent or activity, and is most often used to determine the factor used to adjust for the amount of impurities within an API raw material. Specifications for Purity are also typically expressed as a range, albeit a narrower one, such as 98.5 – 101.5%
DYNALABS employs a number of technologies for testing potency however; purity measures and stability studies are performed using technologies where the methods can be proven to be stability indicating (eg. HPLC). Our list of potency/purity testing technologies, include but are not limited to, HPLC, LC-MS, GC, UV/VIS, NIR and Titrations.
When testing for potency or purity, the concentration of the API is assigned a value based on prequalified, tightly controlled reference standards. Testing protocols are developed based on guidelines delineated in USP <621> Chromatography and USP <851> Spectrophotometry and Light-Scattering, and are validated according to USP <1225> Validation of Compendial Procedures and ICH Guidelines. The customer is notified immediately of any sample that does not test within acceptable limits.
- aqueous solution