Analytical Services
Our team of well-trained and highly qualified professionals performs testing for all phases of product development from conception to market. Whether our customer needs raw material or finished product testing, wet chemistry or instrumental analysis, or release testing, Qualimax LLC has the necessary experience and knowledge to deliver timely and accurate results.
Qualimax LLC maintains a large array of analytical instrumentation capable of performing a wide variety of procedures too numerous to comprehensively list here. Below is a list of selected tests we perform. If you do not see the procedure that meets your needs, please contact us for more information.
Liquid Chromatography
Qualimax LLC offers a wide variety of HPLC capabilities. We assay both raw material and finished products with this type of testing, and examine peak purity, impurities and degradation products during stability and validation studies. Detectors we use include UV (Ultraviolet), Vis (Visible), RI (Refractive Index) and PDA (Photo Diode Array). We can deploy a nearly limitless combination of columns, mobile phases, gradients and detectors to separate and quantitate analytes.
Gas Chromatography
Qualimax LLC has an extensive array of GC capabilities. Because of our extensive experience and capabilities, customers rely on us for all of their compendial testing, client specific methods and method validations. We have several systems that accommodate packed (glass and metal) and capillary columns; and we offer a limitless variety of column types and packings.
Compendial Analysis
Qualimax LLC performs tests from a variety of compendia. These include USP/NF, EP, JP, BP, FCC, ACS, and AOAC. It is not uncommon for our customers to require alternative methods to compendial procedures. Not only Qualimax LLC has the capacity to perform these alternative methods, but we also provide method development and validation services.
Wet Chemical Analysis
In addition to modern analytical instrumentation, we offer many types of well-known wet chemical analyses that the various industries still widely perform and rely upon. Often, modern instrumentation cannot ascertain results that many specific wet chemical tests provide. Despite our investments in the most modern and up-to-date technology and methodologies, Qualimax LLC is firmly committed to maintaining the equipment, knowledge and experienced staff to provide wet chemical analyses for our clients.
Method Development/Validation
QUALIMAX LLC has extensive experience providing both method development and validation services. Most often we are asked to develop a method for the analysis of an active in a finished product. Because HPLC instrumentation lends itself to automation, high sample volumes and accuracy at low levels, we typically prefer an HPLC procedure for method development because it allows for the separation of components, as well as taking full advantage of the Photo Diode Array Detector (DAD) to establish peak purity. In some cases, because of the nature of the analyte, we apply other testing techniques, such as Gas Chromatography.
For validation guidelines we use sources such as the ICH (International Conference on Harmonization), EP (European Pharmacopoeia) and USP (United States Pharmacopeia). These guidelines specify the typical analytical characteristics of data elements for validation testing. Depending on the particular test method and purpose (assay, impurity, degradation product, limit test, etc.), validations include accuracy, precision, specificity, detection limit, linearity, range and robustness.
Cleaning Validation
QUALIMAX LLC has extensive experience adapting HPLC, GC, and TOC technologies to meet the particular needs of our customers’ protocols for cleaning validations, such as specificity and limit of detection.
Preservative Testing (Presence or Absence)
QUALIMAX LLC tests for presence and/or absence of varied preservatives in different formulations. Below is a list of diverse preservatives tested by Qualimax LLC:
- Benzoic Acid
- Benzyl Alcohol
- Butylparaben
- Chlorphenesin
- Dehydroacetic Acid
- Ethylparaben
- Isobutyl Paraben
- Methylparaben
- Methylparaben
- Phenoxyethanol
- Potassium Sorbate
- Propylparaben
- Salicylic Acid
- Sodium Benzoate
- Sodium Dehydroacetate
- Sodium Methylparaben
- Sodium Salicylate
- Sorbic Acid
- Triclosan
- Zinc Salicylate
Additional Tests
- Color testing
- FTIR
- Identification
- LOD
- Melting range
- Optical/Specific Rotation
- pH
- Refractive Index
- Sieve Analysis
- Thin Layer Chromotography
- Titrations
- UV-Vis
- viscosity
