Kémiai és fizikai vizsgálatok

Intro

Tablets for chemical-physical pharmaceutical analysis

Kémiai és fizikai vizsgálatok

[Translate to Magyar:]

Testing of raw materials, ancillary and active substances

 
  • Identification and determination of APIs and ingredients
  • Quality control of raw materials
  • Tests for identity, content and purity according to current national and international monographs or customer regulations (Ph. Eur, USP, JP, RuP, ChP, etc.)

Release tests  

EU-Batch Release Service, including batch release by WESSLING-QP

Stability tests

We conduct long-term, short-term and in-use stability tests on ready-to-use pharmaceuticals, medical products containing pharmaceutical ingredients and active ingredients in accordance with current ICH and GMP specifications. The test includes the parameters relevant for stability, such as content, purity and active substance release.

Our service includes the development of test plans, overview tables for stability tests and individual stability reports.    

Storage without commissioning analytical tests is also possible.   

We can offer you the following climatic conditions:

  • 25°C/60% rel. humidity
  • 30°C/75% rel. humidity
  • 40°C/75% rel. humidity
  • Photo stabilities
  • Subtropical and tropical conditions on request

Method development, -transfer and -validation

Our pharmaceutical experts at WESSLING develop and validate methods under GMP on behalf of customers. The suitability and thus the validity of all test methods used must be proven during the approval and registration of medicinal products.
In addition, for food and dietary supplements we provide adapted validations based on pharmaceutical validation.

  • Development of new and optimisation of existing methods
  • Validiation in compliance with ICH guidelines
  • Preparation of validation plans
  • Preparation of validation protocols and non-confomrance reports
  • Preparation of final validation reports
  • Method transfer
  • Development of test regulations

Elemental impurities - ICH Q3D

The experts for pharmaceutical analysis competently support their customers in implementing the ICH Q3D Guideline, evaluating their active ingredients, reagents, starting materials and excipients and preparing risk analyses.

The elements are determined in our GMP laboratories using ICP-MS and ICP-OES devices.

These techniques have now found their way into international pharmacopoeias. In the European Pharmacopoeia they are listed in chapters 2.2.58 and 2.2.57, in the USP in chapter '233'. Both methods are characterised by the highest selectivity and lowest detection limits.

Our experts at WESSLING are also happy to conduct the product-specific validation of the methods according to the ICH Q2B Guideline.