CA Analytical Testing Services LLC
Contract analytical laboratory providing R&D and quality-control testing for pharmaceutical, medical device, consumer, and specialty-chemical clients. Services include analytical method development and validation, stability and cGMP testing, extractables & leachables, elemental and trace metals analysis, microbiology and endotoxin testing, formulation support and material characterization. The laboratory operates with documented quality systems to support regulatory submissions and product lifecycle activities.
Industries
Nr. of Employees
small (1-50)
CA Analytical Testing Services LLC
Vernon Hills, Illinois, United States
Services
Release testing of raw materials, intermediates, and finished products with compendial methods and instrumental analyses to support manufacturing quality.
Analytical support across product lifecycle including method development, validation, impurity characterization, elemental impurity assessment, and E&L support.
Microbiological testing including USP <61>/<62>, sterility, bioburden, and endotoxin testing using kinetic turbidimetric, chromogenic, and recombinant assays.
Pre‑formulation, formulation development, lab and pilot scale batches, stability assessment, microsphere/encapsulation, and scale‑up support for multiple dosage forms.
Comprehensive E&L screening and targeted analysis of packaging and device materials to identify potential leachable compounds and inform regulatory risk assessments.
Development, optimization, verification, and validation of analytical methods with full documentation packages aligned to ICH Q2/Q14 and compendial requirements.
Release testing of raw materials, intermediates, and finished products with compendial methods and instrumental analyses to support manufacturing quality.
Analytical support across product lifecycle including method development, validation, impurity characterization, elemental impurity assessment, and E&L support.
Microbiological testing including USP <61>/<62>, sterility, bioburden, and endotoxin testing using kinetic turbidimetric, chromogenic, and recombinant assays.
Pre‑formulation, formulation development, lab and pilot scale batches, stability assessment, microsphere/encapsulation, and scale‑up support for multiple dosage forms.
Comprehensive E&L screening and targeted analysis of packaging and device materials to identify potential leachable compounds and inform regulatory risk assessments.
Development, optimization, verification, and validation of analytical methods with full documentation packages aligned to ICH Q2/Q14 and compendial requirements.
Expertise Areas
- R&D analytical support and method lifecycle management
- Analytical method development and validation (ICH Q2/Q14)
- Quality control and compendial release testing (USP/Ph. Eur./JP/BP)
- Extractables and leachables (E&L) testing
Key Technologies
- LC‑MS/MS (triple quadrupole)
- High‑resolution mass spectrometry (HRMS / QTOF)
- GC‑MS and GC‑FID
- Headspace GC
News & Updates
Article on E&L testing for pharmaceutical, medical device, and combination products and regulatory risk mitigation.
Discussion on microplastics analysis and the importance of measurement quality for defensible results.
Notice of company attendance at the BioMaP consortium general member meeting.
Article describing use of HPLC and UHPLC instrumentation and method conversion to meet regulatory requirements.
Comparison of compendial requirements for pharmaceutical water across major pharmacopeias.
Post describing capabilities and context for small molecule synthesis.
Article on E&L testing for pharmaceutical, medical device, and combination products and regulatory risk mitigation.
Discussion on microplastics analysis and the importance of measurement quality for defensible results.
Notice of company attendance at the BioMaP consortium general member meeting.
Article describing use of HPLC and UHPLC instrumentation and method conversion to meet regulatory requirements.
Comparison of compendial requirements for pharmaceutical water across major pharmacopeias.
Post describing capabilities and context for small molecule synthesis.