Umang Pharmatech is a contract analytical chemistry laboratory specializing in bioanalytical and metabolism research studies for the pharmaceutical & biotechnology industries using LC/MS/MS, HPLC, and GC. We are committed to performing to the highest standards as an extension of your research and development programs. Since Umang is audited by FDA and all its reputed Clients, you can be assured that when your studies need to be conducted by Good Laboratory Practices (GLP), Good Clinical Practices (GCP), or Good Manufacturing Practices (GMP), they will be done in full compliance with all appropriate regulations.

Umang is structured to best provide you with personalized service. Our staff averages over 20 years of experience in the industry.

Our strong scientific staff can handle the most difficult tasks and strict timelines in a cost-effective manner. Umang’s in houses state-of-the-art analytical equipment suited to fit our clients’ different needs and ensuring smooth technology transfers. Analytical chemists are located in close proximity to our synthetic/process chemists to help complete challenging projects. We can provide analytical support for in-process controls, quality control release testing, and method development/ validation in compliance with FDA cGMP requirements and guideline.

Analytical Development has the following capabilities:

• Analytical method Development and their validation (for precision, accuracy, selectivity or specificity, linearity & range limit of detection, limit of quantization, ruggedness).

• Development / preparation of complete specifications for raw materials (Bulk drugs), finished products, intermediates, excepients, not mentioned in any pharmacopoeia

• Inclusion of in-house tests for strict control of pharmacopoeial materials and products

• Stability study of bulk drugs and formulations under variety of conditions applicable

• Study of effect of solvent, alkalies, acids, excipients on the stability of bulk drugs and formulations.

• Preformulations study of bulk drugs

• Routine services to various groups

• Kinetics and mechanism of degradation of bulk drugs and formulations

• Structure elucidation and characterization of degradation products by UV, IR, Chromatography, DSC, Elemental analysis, Mass, NMR.

• Analysis of active ingredient(s) and metabolite(s) from biological fluids for bioavailability / bioequivalence study

Contact Us for more information on how we can help you.