We begin at the beginning
Testing raw materials is extremely important since these components will eventually end up in finished products.
When receiving raw materials, Gibraltar Laboratories performs vendor qualification in order to approve suppliers.
In many cases, three lots are tested once per year to verify that the Certificate of Analysis (COA) provided by the vendor is correct. It is important that our sponsor qualify more than one supplier to provide redundancy and business continuity. Then throughout the year each lot is tested to verify the USP Identification requirement.
It is essential to revisit and review the current monograph for changes as revisions are often published, approximately every four months, varying between compendia.
Expertise in both wet and analytical chemistry
Gibraltar Laboratories offers a wide range of services in wet and analytical chemistry.
Our highly trained, expert staff of Ph.D and Master’s-level scientists can perform analysis of compendia release testing for raw materials and drug products (e.g. USP, EP, JP, BP) on a daily basis in order to meet specifications.
Our laboratory equipment includes and allows testing with:
- Gas Chromatography (GC)
- High Performance Liquid Chromatograph (HPLC)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Ultraviolet–Visible Spectroscopy (UV/VIS)
- Atomic Absorption (AA)
- Total Organic Carbon (TOC)
- Polarimeter and Titrations
- Elemental Analyzer (C,H,N)
- Dissolution Apparatus
Gibraltar Laboratories also offers:
- Forced Degradation (Stress) for the detection of impurities or degradation products after exposure to: acid, base, ultraviolet and high temperature.
- Stability Studies with all International Conference of Harmonization (ICH) conditions from real time to accelerated
- Method Development and Validation of Test Methods for Active Drug Substances and Dosage Forms
- Method Transfer Studies
- Dissolution Studies
- Plan and Development of Analytical Cleaning Studies
- Process Validation
- Residual Solvents as USP <467>
Our Chemistry Department performs special projects, as well:
- Container/Closure Integrity Tests for packaged good known as the Methylene Blue Dye Penetration Test
- Spiking Studies using the TOC Analyzer to determine levels of hemoglobin from Medical Devices
- Protein Analysis employing our Elemental Analyzer and Tissue Testing utilizing Chlorohexidine HPLC analysis
Deliveries that meet your schedule
Our Chemistry Department offers you both regular and “RUSH” turnaround options. We have the flexibility and customer-orientation to meet your needs in any way we can.
Contact us today!
To learn more, please call us at (973) 227-6882 or submit a contact form by clicking here.