DEVELOPMENT
AND VALIDATION
AND VALIDATION
Of analytical methods for active pharmaceutical
ingredients (APIs) and drug products (special expertise in the
research of genotoxic impurities) to control the quality and
stability of products and prepare registration dossiers.
STABILITY
STUDIES
STUDIES
Stress testing and definition of
degradation profiles, studies at 5°C, 25°C/60% RH,
30°C/65% RH, 30°C/75% RH and 40°C/75% RH on active
pharmaceutical ingredients (APIs) and drug products
to control the quality and stability of products in
registration phase and already on the market.
PRODUCT
CHARACTERIZATION
AND BATCH RELEASE
TESTING
CHARACTERIZATION
AND BATCH RELEASE
TESTING
According to pharmacopeial monographs or
in-house methods via analytical transfer for small molecules,
macromolecules and biotech products (APIs,
excipients and drug products).
ISOLATION AND
IDENTIFICATION
IDENTIFICATION
Of unknown impurities by MS, NMR and the
use of enriching techniques and preparative chromatography
as well as laboratory-scale synthesis to prepare standards
for the control of pharmaceutical products.
STUDIES ON
EXTRACTABLE
AND LEACHABLE
COMPOUNDS
EXTRACTABLE
AND LEACHABLE
COMPOUNDS
To ensure product quality and patient safety.
Includes analysis based on PQRI indications and USP requirements
and toxicological evaluations (OINDPs, PODPs Topical DPs,
biodisposables and Single Use Systems). Pharmacopeial testing
on containers and closures.
NITROSAMINES
AND PGI
AND PGI
Development and validation of methods for identification and quantification of NITROSAMINES and PGI in Drug Substances, Drug Product, Excipient and Packaging.
