EL Labs operate as an FDA-inspected, GMP/MIA-certified, quality control laboratory for human and veterinary medicinal APIs, excipients, intermediates, finished products, packaging materials and water. We offer a wide range of physical-chemical, microbiological, and biological services in accordance with ICH guidelines,applicable pharmacopoeia (EU, USP, BP) or manufacturers indications. As a GMP-certified testing site we offer:
- Method validations or verification and analytical method transfers.
- Quality control testing of pharmaceutical raw materials, active substances, and excipients.
- Routine batch testing for the release into the EU market of batches of drugs produced in third countries.
- Stability studies of medicinal products including storage and stability testing.
- Testing of waters for pharmaceutical purposes.
- And more..
A complete list of testing services can be provided upon request, and include the following services for pharmaceutical clients:
- Identification tests – by IR, TLC, HPLC, GC
- API assays by HPLC with multiple detectors (DAD, UV-VIS, RI), GC/FID, GC/MS, UV/VIS, AAS, titration
- Substance content by HPLC, GC, LC-ionex, titration, Kjeldahl
- Related substances identification and quantification by GC/FID, GC/MS, HPLC, LC/MS, TLC
- Residual solvents by GC (organic volatile impurities)
- Physical determinations – pH, viscosity, absorbance and transmittance, density, optical rotation, conductivity,refractive index, melting point, osmolality
- Peroxide value, iodine value, saponification value, free fatty acids
- Dosage uniformity, average weight
- Water content by Karl Fisher, loss on drying, ash
- Elemental impurities and heavy metal limit tests by ICP-AES/OES, ICP-MS, AAS-F, AAS-AMA, AAS-HG, AAS-ETA
- Anions by Ion chromatography
- Solid oral dosage tests, disintegration, dissolution, hardness, friability
- Particulate matter, visible and sub-visible particles
- Particle size, suspension particle morphology by microscopy
- Sterility testing by membrane filtration method (Ph.Eur. 2.6.1)
- Microbial counting of non-sterile drug products and raw materials (TAMC, TYMC)
- Tests on specified microorganisms: Gram-negative bile-tolerant bacteria, E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridia, Candida albicans
- Process environment analysis (cross-contamination, rinse water from cleaning process, swabbing surfaces)
- Aqua Purificata and dialysis waters testing
- Bacterial Endotoxins Testing (BET) by gel cloth or kinetic turbidimetric methods
- And much more..