By HAPILA GmbH
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HAPILA extends analytical gas chromatography capabilities
Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has extended its advanced analysis and quality control capabilities by installing two new analytical gas chromatography (GC) systems.
The new GC systems will allow HAPILA to make its GMP quality control (QC) of active pharmaceutical ingredient (API) production even more rigorous, in securing stable analytical quantification of important data for release of APIs and intermediates.
Trace element detection
The new PerkinElmer® instrument with head space coupling (GC-HS) and the new Agilent instrument with mass spectrometry coupling (GC-MS), will also support development of new synthesis processes.
The GC-MS system allows improved and reliable identification from comparative atomic mass peaks of potential byproducts with different molar mass (molecular weight), that show wave interferences with each other to allow even trace element substances to be detected.
Meanwhile, the GC-HS system allows combined analysis of solids and solvents in one process.
The installations meet general pharma industry need for faster and more precise analysis of vaporizable APIs, intermediates, raw materials, and redistilled solvents. In general they will improve sustainability by enabling higher solvent recycling rates.
They will also improve bottom line performance with faster analysis making production processes more efficient and improved solvent recycling reducing consumption, counteracting immense recent rises in the procurement costs of solvents.
Special nitrosamine detection
In addition to use of GC technology for analysis of solvents, the new systems also anticipate new European pharmacopoeia (Pharm. Eur.) guidelines for specific detection of nitrosamines, alkyl tosyltates or mesylates, which are reported to be carcinogenic at trace levels. It is about to become mandatory for drugs to be entirely free of nitrosamines.
While HAPILA had already invested capabilities developing suitable methods for detection and quantification of nitrosamines, alkyl tosyltates or mesylates, the new GC installations will make continuous regulatory compliance easier and cheaper.
Extended analytical capabilities
The new GC installations will ensure that HAPILA has the full suite of systems needed to meet the analytical needs of API production, both with regard to precision and speed of inherent measurements and also to full documentation of results for regulatory submissions.
“These new systems will further consolidate HAPILA’s status as a reliable partner for API development by making it possible to detect single substances at the lowest levels and handle even the most challenging analytical tasks in house under our rigorous internal quality management QM system,” commented HAPILA’s Quality Control Officer.
About HAPILA GmbH
HAPILA GmbH is a Contract developer and manufacturer (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and GMP manufacture of active pharmaceutical ingredients (APIs).
HAPILA is an independent company with particular experience in GMP-related development and GMP manufacturing, offering full regulated service for API (CEP, ASMF, IMPD Drug Substance) to very high scientific and quality assurance (QA) levels.
It supports the development and manufacture of drug products with sophisticated processes and in-depth experience in the API value-creation chain from synthesis through purification to particle design.
The company’s mission is to supply exclusive products of highest quality, potency and safety in compliance with GMP, occupational safety and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.
All HAPILA chemical synthesis including chemical-physical tests for in-process controls and release testing are carried out in-house at its GMP certified plants and laboratories at Gera, Thuringia, in east-central Germany.
When combined with purification and particle design, HAPILA’s chemical synthesis services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.
Learn more at: https://www.hapila.de/en/home.html
Click on HAPILA QM-System to learn more about quality management at HAPILA GmbH.