QUALITY CONTROL OF MEDICINAL PRODUCTS

APR has more than twenty years' experience in quality control of medicinal products . The company's profound knowledge of manufacturing processes enables it to offer a wide range of assays according to pharmacopoeias (EP, BP, USP, etc.) and/or customer specifications.

The company's chemistry laboratories have highly qualified personnel and state of the art instruments and equipments. All tests are performed within the norms of an excellent quality system. All methods are subjected to validation and analysis prior to releasing New or revised protocols.

The range of controls include:

> Identification assays
> Chemical titrations
> Determination of related substances
> Analysis of chemical-physical parameters
> Determination of degradation products
> Dissolution assays
> Primary packaging checks.

DEVELOPMENT AND VALIDATION OF ANALYTIC METHODS

A profound knowledge of the medicinal products and of the norms regulating their use, combined with our highly professional team of researcher and technicians and state of the art equipments enable APR to develop and validate tailor-made Analytical Methods for our customers.
APR can also provide detailed reports on the validation of the method developed in accordance with the specific requirements established by regulations. Services for development and validation of analytical methods include:

Development of analytical methods for the identity, purity and concentration of

> Active substances
> Degradation products
> Related substances

Validation using of the following parameters:

> Specificity
> Limit of Quantitation
> Limit of Detection
> Range
> Linearity
> Precision-System Repeatability
> Precision-Method Repeatability
> Accuracy
> Robustness
> System Suitability Test

STABILITY STUDIES

APR offers customers a sample storage service in climatic chambers simulating different environmental situations, as well as verification of the product's critical post-storage parameters.

The analytical laboratory has four climatic chambers with different temperature and humidity conditions regulated by thermostats and refrigerators which make it possible to perform stability studies following the marketing regulations of each type of product (ICH, ISO, etc.) Storage conditions include continuous recording of temperature and humidity using software to manage data obtained from the measuring probes.
The climatic chambers are subject to external inspection at least once a year.

Our storage conditions:

ICH Conditions:

25°C + 2°C/60% + 5%R.H
30°C + 2°C/65% + 5%R.H.
40°C + 2°C/75% + 5%R.H.
30°C + 2°C/75% + 5%R.H.

Other conditions can be established depending on the availability of the climatic chambers.
APR offers their customers:

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

> Development and validation of methods for products' critical parameters

> Analytical research for the identification of unknown degradation products

> Preparation of preliminary reports for each period of stability

> Preparation of a final report on the stability study plus critical evaluation of the results obtained.

CHEMICAL STUDIES

APR's profound knowledge of the products and problems associated with them, in addition to their experienced researchers and technical staff, make it possible to offer qualified analytical support and solutions for regarding chemical analyses.

Chemical studies include:

> Comparative studies to establish chemical and chemical-physical behaviour

> Analytical research for identification of unknown components

> Dissolution test at various conditions.

> Studies for the establishment of in vitro bioavailability of the active substance in the most suitable media

CHEMICAL-PHYSICAL STUDIES

In order for any new substance to be registered, information must be provided on its identity, composition, spectrum data and chemical-physical characteristics.

APR SA offer a complete range of services for the identification of active substances:

> I.R. spectrum

> NMR spectrum (proton and C13)

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

> Melting point

> Relative density

> Water solubility

> Viscosity

> Friability test

> Hardness, thickness and diameter

> Dissolution test

> Other types of general analyses available on request