We provide comprehensive analytical services to the Pharmaceutical Industry in a GMP compliant environment. We offer HPLC analysis of pharmaceutical articles ranging from drug substance APIs and intermediates to drug product excipients and finished dosage forms. The extensive experience of our staff allows quick development and validation of analytical methods, including forced degradation studies and identification of resulting degradation products.
We also specialize in Asymmetric Synthesis, which is becoming increasingly important in pharmaceutical industry. We use methods such as resolution of racemates, synthon approach and reactions using chiral substrates/ reagents. A few examples of reactions are Diels â€“ Alder reaction, Sharplessâ€™ epoxidation and dihydroxylation, and reduction of ketones using chiral oxazaborolidines.
Our specifically built pharmaceutical microbiology laboratory is equipped with current technologies to analyze raw materials, active pharmaceutical ingredients, and finished products in accordance with Pharmacopoeial methodologies such as a qualified autoclave, temperature mapped incubators and refrigerators and a HEPA supplied biological safety cabinet. Our MBL staff is fully versed in USP, EP, and JP Pharmacopoeial methodologies and various company specific testing with routine turn around times providing dependable and cost effective testing.
We commit to take the steps necessary to provide the highest quality of services to our clients, through continuous evaluation of all facets of the company and quality systems. A high quality of service will be provided with a minimum turn around time, while complying with regulatory requirements.
We offers a 10-day turnaround time on all raw materials testing. This applies to USP, EP, JP, BP, FCC, ACS, and client-supplied methods. For all compendial purified water testing, We offer a 5-business day turnaround time. Our dedicated group of experienced chemists allows us to offer this exceptional turnaround time. All documentation is extremely detailed, and fully GMP reviewed at test completion. Because of the stringent checks and balances between the laboratory and the Quality Assurance Group, all final results are guaranteed to be accurate and reliable.