Analytical Solution (A Division of ALS Testing Lab) | Analytical Solutions | A part of ALS Limited

OUR NAVI MUMBAI LAB ACCREDIATIONS:Approved By US-FDA, inspected 10th Times till Date, (Last Audit Was Nov 2025-EIR Received)Health Canada (Last Audit Was Marc 2024)Gulf Health Council (GCC) (Last Audit Was Aug 2022)Granzer Pharmaceutical Services Gmbh (QP audit from Europe) 2023Foods & Drug Administration, India (Regular Schedule)Iso 9001 (Regular Schedule) OUR CAPABILITIES: We have dedicated Manpower & instruments like Vertical wise (E & L, Nitrosamine and In Vitro). Please find attached Molecules ListWe will work on the FTE Model in case the company proposes. ANALYTICAL SERVICES: Extractable & Leachable Study: more than 350 studies completed, for all types of products including peptide molecules (Glass Delamination Third Party).Method development & Validation: more than 2500 validations completed for various doses forms with suitable techniques.Nitrosamine Evaluation: More than 400 Studies completed one of the most favored labs for Nitrosamine & Genotoxic evaluation.Ion Chromatography Evaluation: Pioneer in India, studies all critical products including Gentamycin, Neomycin, Beta cyclodextrin etc.LC-HRMS support- Identification & Characterization of Unknown peaks with structure, IUPAC name & Tox assessment.Elemental analysis- trace level analysis of almost all dosage forms.Pharmacopeial Analysis: all pharmacopeial method analysis for batch release purpose.Analytical Support for Product Design.Particle Size Distribution Studies (New Malvern 3000 Mastersizer)Toxicological assessment by prediction soft-ware Case-Ultra.ICP-MS, ICP-OES.XRD Analysis (ALS Bangalore).Biological and Peptide Characterization (ALS Hyderabad). IN VITRO-BIO SERVICES: In-Vitro Release Testing (IVRT) for Topical Formulations using Synthetic Membrane (Completed 3 Projects)In-Vitro Permeation Testing (IVPT) for Topical Formulations using Human Cadaver Skin. (Ongoing 1 Projects)Few Examples of IVRT-IVPT Studies (Gel, Lotions, Ointment and Cream): Adapalene, Acyclovir, Clindamycin phosphate, Calcipotriene, Dapsone, Diclofenac sodium, Ivermectin, Mupirocin, Penciclovir, Silver sulfadiazine, Sirolimus, Tacrolimus, TazaroteneIn-Vitro Equilibrium and Kinetic Binding Study: Started since 2008, more than 40 studies completed, filled & most of them approved. (Completed 45 Projects)Few Examples of Binding Studies: Cholestyramine HCl, Colesevelam HCl, Colestipol. Sucralfate Suspension and Tablet, Sevelamer Carbonate, Sevelamer HCl, Sucroferric oxyhydroxide, Ferric citrate, Lanthanum carbonateIn Vitro Feeding Tube: Testing require Drug Product which was Administration through feeding tube studies. (Completed 6 Projects)Few Examples Feeding Tube Studies: Dexlansoprazole, Lansoprazole, Apixaban, Rivaroxaban, Gefitinib, Ticagrelor, Mycophenolate Mofetil, Baclofen, Carglumic acid, Baricitinib, Esomeprazole magnesium, Pantoprazole sodium, Omeprazole magnesium.We are waiting for valuable enquiries from your end.