Neotron Pharma SpA

About Neotron Pharma SpA

Neotron is a global player in the Analytical sector for Chemical, Biochemical, Microbiological, Physical and Sensory on Food products, Feeding, Supplements, Food Contact Materials (FCM), Cosmetics and on Pharmaceutical products.
Neotron has a business unit dedicated to the testing activities for the Pharmaceutical sector authorized by AIFA, GMP,  FDA and the Ministry of Health.Thanks to our know-how formed through years of practice in analytical chemistry, we decided to  create a laboratory that operates according to GMP standards.
For this area we are able to offer a wide analysis portfolio on different matrices: DRUGS, API, EXCIPIENTS, PACKAGING PRIMARY MATERIALS

Certifications
  • IT
  • 2016
    On CPhI since
  • 3
    Certificates
  • 500 - 999
    Employees
Contract Service
Contact info

Products from Neotron Pharma SpA

  • Nitrosamine impurities

    Product Nitrosamine impurities

    Neotron Pharma, on request of several customers, has provided an effective methodological approach for Nitrosamine alerts management to support the pharmaceutical industry. Currently the laboratory is able to perform screening and validation activities for more than 11 Nitrosamine residues in API, FP and excipients. If your risk-assessment has highlighted other nitrosamines not present in our commercial package, the laboratory will be able to find them from our STD suppliers and fine-tune them in our analytical methods.   
  • Elemental Impurities

    Product Elemental Impurities

    In light of the growing interest of the pharmaceutical world on the issue of determining Elemental Impurities in accordance with tables 1, 2a, 2b and 3 of the ICHQ3D, Neotron Pharma laboratory, thanks to its decades of experience in the analysis of metals, has developed a series of analytical proposals to better support you on your API, FP or excipients. 
  • Extractables & Leachables

    Product Extractables & Leachables

    There are many contaminants that could be released inside a drug during the production process or by contact with the packaging material. Neotron Pharma will be able to support you from the study of Extractables, to the toxicological evaluation up to the control of the Leachables. What distinguishes us is the ability to customize these studies according to the real needs of the customer.
  • Pharmacopea Analysis

    Product Pharmacopea Analysis

    Neotron SpA provides wide range of analytical control according to EP, USP, JP, BP, CHP. 
    Contact us to ask for tests in relation to your monograph of interest.
  • Pyrrolizidine Alkaloids

    Product Pyrrolizidine Alkaloids

    Neotron Pharma has an HPLC-MSMS method for the determination of 28 pyrrolizidine alkaloids on different matrices. We currently collaborate with numerous herbals producers for these routine checks for both the Pharma and Food markets
  • Contaminants

    Product Contaminants

    Neotron Pharma, thanks to its many years of experience in the Food department, is able to quantify the presence of contaminants such as Pesticides, Aflatoxins, Mycotoxins under GMP regime. This type of analysis can be fundamental for all those suppliers of raw materials and Erbal intended for the supplement market who want to monitor their products thus having a COA that can be used in the Pharma and Food sector.
  • Method Validation

    Product Method Validation

    Neotron Pharma is able to validate analytical methods developed internally or transmitted by the customer using top of the range equipment such as:
    - HPLC-UV / DAD / MSMS
    - GC-FID / ECD / MSMS (even in Headspace)
    - ICP-MS / AAS / AES / OES
    - Post-column derivatization
    - Particle size
    - and many more ...
  • R&D service

    Product R&D service

    Neotron Pharma is able to offer you a research and development service. The research and development laboratory, operating under the ISO regime, will be able to develop customized methods for the customer in faster times and with lower costs. Subsequently, the customer will be able to validate the GMP method to perform the analyzes or possibly request the analytical transfer to their laboratories.
  • Residual solvents

    Product Residual solvents

    Neotron Pharma is able to perform screening tests in accordance with USP <467> for solvent classes 1,2,3, validation activities for methods transmitted by the customer or to develop customized methods for particular solvents.
  • Stability tests according to ICH

    Product Stability tests according to ICH

    Neotron Pharma provides Stability tests according to ICH standards (zones I, II, IV). We can carry out stability studies in their entirety (storage + analysis) or provide only storage service. The conditions we can offer are listed below:

    - 40°C ± 2°C , 75% ± 5% U.R. 
    - 30°C ± 2°C   65% ± 5% U.R. 
    - 25°C ± 2°C   60% ± 5% U.R. 
    - 30°C ± 2°C   75% ± 5% U.R.  
    - 1 Chamber for light stress test
  • Narcotic Substances

    Product Narcotic Substances

    Neotron Pharma is able to perform all the analytical techniques requested by the customer on APIs or finished products subject to restrictions as they are part of the narcotic substances. The laboratory will be able to verify if your specific active ingredient is free to manipulate or subject to restrictions and in this case request authorization from the Italian Ministry of Health. Neotron is currently collaborating with customers for analysis of cannabinoid-based drugs with ministerial authorization.