Accuon Labs
Accuon Labs Inc. is a professional and reliable contract testing laboratory specializing in GMP analytical services, microbiological and chemical testing, and regulatory compliance to meet US FDA and other regulatory standards. The company is equipped with a highly experienced team of microbiology and chemistry experts, offering a wide range of testing services including microbiology, chemical testing, genotoxic impurities, antibiotic assays, and more. They are committed to quality assurance, regulatory compliance, and customer satisfaction, with a focus on supporting pharmaceutical, nutraceutical, and medical device industries.
Industries
Nr. of Employees
small (1-50)
Products
Sample submission forms (PDF)
Standardized sample submission and controlled-substance submission forms for initiating microbiological or chemical testing.
GMP Analytical Services
Professional and reliable contract testing laboratory services focusing on quality assurance and regulatory compliance to meet US FDA and other related regulatory requirements.
Sterility Testing
USP <71> sterility testing of sterile pharmaceutical products, medical devices, and water using membrane filtration and direct inoculation methods.
Microbial Limits Testing (MLT)
Microbial limits testing service to determine the microbial load of pharmaceutical ingredients, medical devices, and non-sterile packaging according to USP <61>, USP <60>, USP <62>, USP <2021>, and USP <2022> guidelines.
Antimicrobial Effectiveness Testing (AET)
Testing service utilized to determine the effectiveness of preservatives added to nonsterile and sterile aqueous pharmaceutical products following USP <51> guidelines.
Bacterial Endotoxin Testing
Chromogenic LAL testing service using the Sievers Eclipse instrument to detect and quantify gram-negative bacterial endotoxins in compliance with USP <85>, EP 2.6.14, and JP 4.01.
Sample submission forms (PDF)
Standardized sample submission and controlled-substance submission forms for initiating microbiological or chemical testing.
GMP Analytical Services
Professional and reliable contract testing laboratory services focusing on quality assurance and regulatory compliance to meet US FDA and other related regulatory requirements.
Sterility Testing
USP <71> sterility testing of sterile pharmaceutical products, medical devices, and water using membrane filtration and direct inoculation methods.
Microbial Limits Testing (MLT)
Microbial limits testing service to determine the microbial load of pharmaceutical ingredients, medical devices, and non-sterile packaging according to USP <61>, USP <60>, USP <62>, USP <2021>, and USP <2022> guidelines.
Antimicrobial Effectiveness Testing (AET)
Testing service utilized to determine the effectiveness of preservatives added to nonsterile and sterile aqueous pharmaceutical products following USP <51> guidelines.
Bacterial Endotoxin Testing
Chromogenic LAL testing service using the Sievers Eclipse instrument to detect and quantify gram-negative bacterial endotoxins in compliance with USP <85>, EP 2.6.14, and JP 4.01.
Services
Laboratory-based microbiological analyses including microbial limits testing, sterility testing, endotoxin testing, antimicrobial effectiveness testing, environmental monitoring and probiotic enumeration.
Chemical testing and analytical support including method development/validation, genotoxic/nitrosamine/elemental/residual solvent analysis, spectroscopy, dissolution, stability studies and packaging qualification.
Analytical and regulatory technical support for responding to regulatory deficiencies and preparing documentation for global registrations.
Laboratory-based microbiological analyses including microbial limits testing, sterility testing, endotoxin testing, antimicrobial effectiveness testing, environmental monitoring and probiotic enumeration.
Chemical testing and analytical support including method development/validation, genotoxic/nitrosamine/elemental/residual solvent analysis, spectroscopy, dissolution, stability studies and packaging qualification.
Analytical and regulatory technical support for responding to regulatory deficiencies and preparing documentation for global registrations.
Expertise Areas
- GMP analytical testing
- Analytical method development and validation
- Genotoxic and nitrosamine impurity analysis
- Elemental impurity and trace metal analysis
Key Technologies
- High-performance liquid chromatography (HPLC)
- Liquid chromatography–mass spectrometry (LC-MS / LC-MS/MS)
- Gas chromatography (GC, GC-FID, GC-MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
News & Updates
Accuon Labs has received ISO and A2LA certifications in 2024, demonstrating compliance with international quality standards.
The company has obtained DEA certification in 2025, allowing for controlled substance analysis.
Accuon Labs has received ISO and A2LA certifications in 2024, demonstrating compliance with international quality standards.
The company has obtained DEA certification in 2025, allowing for controlled substance analysis.