Analytical Services

GMP Analytical laboratories

GMP pharmaceutical laboratories provide laboratory services in accordance with Good Manufacturing Practice (GMP). APR is certified by the Swiss agency for the authorization and supervision of therapeutic products (SwissMedic). Compliance with GMP standards is confirmed by the appropriate regulatory authorities and our clients.

APR provides a wide range of services for the pharmaceutical sector:

Quality control of medicinal products - APR has over 20 years experience in quality control of medicinal products, according to worldwide pharmacopoeias like the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and also to our customers' specifications.

Our analytical laboratories are staffed by highly-qualified personnel who use state-of-art equipment. All analysis are validated and conform to international and European standards including:

Identification assays

Chemical titrations

Determination of related substances

Analysis of chemical/phisical characteristics

Determination of degradation products

Dissolution assays

Development and validation of analytical methods APR develop and validate, tailormade analytical methods to meet our clients' needs by harnessing our in-depth knowledge of pharmaceutical products as well as our understanding of the standards regulating their use. This combined with our professional team of scientists and technicians and our state-of-art laboratories, means that we can provide a unique and reliable service for our clients.
APR provides detailed validation reports of the methods developed in accordance to regulatory authorities specifications. We have developed reliable analytical methods to identify and determine the purity and concentration of active substances, degradation products and related substances using the following parameters:

Specificity

Limit of quantification and detection

Range

Linearity

Precision-system repeatibility

Precision-method repeability

Intermediate Precision

Accuracy

Robustness

System suitability test

Stability studies provide evidence on how the quality of an active pharmaceutical ingredient or medicinal product varies with time, under the influence of environmental/climatic factors. APR provides a storage service in climatic chambers (with continuous monitoring/recording of temperature and humidity), to simulate differing environmental conditions and to determine a given product post-storage parameters.
At APR we have four climatic chambers that are inspected annually, in which stability studies according to the regulatory requirements for each type of product (ICH, ISO etc.) are performed.

Our ICH storage conditions are shown below but we will make every effort to provide other climatic conditions depending our clients' requirements:

25°C + 2°C/60% + 5% RH
30°C + 2°C/65% + 5% RH

40°C + 2°C/75% + 5% RH
30°C + 2°C/75% + 5% RH

APR offers an extensive range of services to its clients:

Consultancy on the design of studies under accelerated and shelf-life conditions

Development and validation of methods for a given product's critical parameters

Analytical studies to identify unknown degradation products

Preparation of preliminary reports for each stability period

Preparation of the final report from the stability study together with a critical evaluation of results

Chemical studies one of our core competencies is providing unrivaled analytical support in the chemical composition of pharmaceutical/medicinal products. We provide:

Comparative studies to establish chemical and physiochemical properties and behavior

Analytical research to identify unknown components

Dissolution tests under various conditions

Studies to establish in vitro bioavailability of active ingredients in different substance media

Physiochemical studies to obtain regulatory approval, a complete data set needs to be supplied including information on the nature of active ingredients, composition, physiochemical characteristics etc.
APR provides a comprehensive range of services (in house or through a third party GLP Analytical Laboratory):

Infrared spectroscopy

NMR spectrum (proton and c13)

UV-VIS spectrum (with calculation of specific absorption at maximum)

Melting point

Relative density

Water solubility

Viscosity

Friability test

Hardness, thickness and diameter

Dissolutions tests

DSC

X-Ray

Other analysis available on request