Nuray Chemicals Pvt. Ltd., is an API Manufacturing Facility necessary for drug formation with state of art Research & Development located at SIDCO Industrial Estate in Tiruvallur District of Tamil Nadu.
Nuray’s expertise lies in developing chemistry requirements of pharmaceutical industries from the synthesis of Impurities, Metabolites, Method Development, Advanced Intermediates and Active Pharmaceutical Ingredients (API’s) for commercial launch. The products (API’s) includes Diazoxide, Thiothixene, L-Methyl Folate and Chlorzoxazone which have been used for physical and mental health development.
The Overall Process of Nuray Chemicals Pvt. Ltd., starts with synthesis of molecules followed by analysis of sample using suitable chromatography techniques. After the analysis procedures, It has been confirmed using various Nuclear Magnetic Resonance (NMR) Techniques such as 1H and C13 NMR. Validation i.e., Checking of desired values is the step next to Confirmation. Finally, the validated sample is transferred to bulk scale for mass production. To complete the overall process, Four Departments are involved viz., Research & Development, Quality Control, Analytical Development and Production.
RESEARCH & DEVELOPMENT DEPARTMENT
Research & Development initiates new projects in assistance with Analytical Development by demanding supply, new molecules and based on Indian Boiler Regulations and International Journals. It performs various reactions under various process conditions. The reactions include reactions in wood vessels for gaseous byproducts, reduction for metal catalysts and under nitrogen atmosphere for hygroscopic compounds. After each stage of observations, Research & Development’s role is to optimize observations and ensure specifications. To do so, It performs three trial batches with small modifications in route of synthesis if needed. After the completion of Molecules Synthesis, Research & Development transfers the batch monitoring record with procedures to Production Department to proceed mass production.
ANALYTICAL DEVELOPMENT DEPARTMENT
Analytical Development Department performs various tests and methods by considering various analysis parameters. The tests that are being carried out by Analytical Development Department include Reaction Monitoring by HPLC, TOT Sulfonamide content and Water content by KF. The analysis parameters that are being considered for sample analysis include speed of stir, absorption index and sample measurement time. Sample Analysis gets completed by reporting results of the sample from peak observations using Empower3 software. Gas Chromatography (GC) is being used for separation of volatile organic compounds. It employs liquid injection and head space analyser to calculate amount of solvent in drugs. Gas Chromatography Mass Spectrometer (GCMS) confirms the structure of volatile organic compounds. Inductively Coupled Plasma Mass Spectrometer (ICPMS) is being used for quantification of heavy metals. High Performance Liquid Chromatography (HPLC) technique is being carried out for routine analysis in separation of impurities whereas Preparative High Performance Liquid Chromatography (PHPLC) is for isolation of impurities.
Wet Analysis is a part of Analytical Development that deals with confirmation of desired by identifying structure and functional group of volatile organic compounds and also by conducting volumetric analysis.
After the completion of Sample Analysis, Analytical Development transfers the methods and procedures being done to Quality Control Department to ensure specifications.
Production Department uses batch reactors including glass lined and stainless steel batch reactors to increase heat transfer by increasing retention time and decreasing flowrate and heat exchanger for exchange of heat from the sample by medium-medium change. Centrifugal Filter is being used to filter product and mother liquor. Mother liquor is then sent for reprocessing if contains product, otherwise it is then discarded.
QUALITY CONTROL DEPARTMENT
Quality Control Department ensures the qualified product which meets desired specifications. Validation process is performed by Quality Control Department, that checks out the product for pH content and density using pH meter and Tap Density Tester and further proceeds to Production or terminates and sent to Rejected Area.
Nuray Chemicals Pvt. Ltd., also consists warehouse for material handling, material dispensing area for dispensing materials selected for commercial purposes and utilities for maintaining adequate conditions of a manufacturing unit.
The products (API's) being manufactured in Nuray Chemicals Pvt. Ltd., are added with excipients to form drugs with long term stabilization which is essential for health to rebuild. The products (API's) are exported to foreign countries for drug formulation.