Arunkumar N
M.Pharm | Executive – Analytical R&D | Method Development & Validation |Stability|Complex Injectables |Extractable and Leachables|HPLC, GC, IVRT, Empower | USFDA, ICH Compliance.
- Role
- Executive at Syngene International Limited
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Arunkumar N
I am currently working as a Senior Research Associate at Syngene International Limited…
Experience
Executive
Oct 2024 — Present · Hyderabad, IN
At Biological E. Limited, I serve as an Executive in the Analytical Research & Development department, where I focus on analytical method development and validation for parenteral formulations.Key Responsibilities & Achievements:Developed and validated robust analytical methods using HPLC and GC for injectable dosage forms.Performed analysis for injectable suspensions including assay, related substances, benzyl alcohol content, particle size, and dissolution studies for stability batches.Conducted stability data compilation, vendor evaluation, and API qualification.Executed cleaning method validation and analytical reference number allocation.Drafted SOPs, calibration protocols, and managed critical equipment such as HPLC, analytical balances, and pH meters.Ensured documentation compliance with GLP, GMP, and regulatory standards (USFDA, ICH).
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