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Accuon Lab

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Overview

Accuon Labs was established in 2018 as a destination for microbiological and chemical testing needs.   We offer cMP analytical services as a highly professional and reliable contract testing lab.   Accuon Labs is audited by US FDA and has GDUFA registration to perform chemical and microbiological analyses in accordance with GMP. All employees are continuously trained in cGMP standards. Accuon Labs is a DEA certified analytical lab for class IIIII, IV, and V, and also has ISO 17025 certification.     A

Accuon Labs offers ample microbiological testing services, providing support for Pharmaceuticals, Nutraceuticals, and other allied industries.
Our Services   Microbial limits: USP <61>/<62>& Client Methods Water testing Antimicrobial preservative Effectiveness: USP <51> & Client Methods Environmental Monitoring (validations and Routine Monitoring) Sterility Validations and Testing: USP <71> Bacterial Endotoxin Testing: USP <85> Antibiotic Potency Assays: USP <81> Burkholderiacepacia complex: USP <60> Enumeration of Probiotics

Chemical Lab Testing Capabilities   The chemical lab provides comprehensive testing services including but not limited to:
 Purity of HPLC ·Residual solvents by GC ·  Nitroso and NDSRI impurities method development, validation and routine testing ·         Genotoxic and trace level impurities method development, validation and routine testing ·   Elemental impurities by ICP-MS ·         Diethylene Glycol and Ethylene Glycol as per FDA guidance ·  Leachable and Extractable studies ·  Packaging systems qualifications US <671>,<661>,<661.2> ·  Dissolution ·   Conductivity, Total Organic Carbon (TOC] ·  Disintegration Analysis by GC-MS ·         Stability Studies ·  Photo stability Studies as per ICH Q1B ·  Water content by KF · Titrimetric analysis . EG/DEG testing in excipients as per FDA requirements

Standards & Methodologies

cGMP

Qualifications, Certifications, Accreditations & Licenses

USFDA, DEA certified analytical lab for class II, III, IV & V and ISO 17025 certified

Industries Served

  • CBD Oil
  • Oral Care Products
  • Organic Chemicals
  • Packages and Packaging
  • Packaging (Sterile)
  • Packaging - Bottles
  • Packaging - Bulk
  • Packaging - Cans
  • Pharmaceutical
  • Pharmaceutical - Pediatric
  • Pharmaceutical - Active Pharmaceutical Ingredients (API)
  • Pharmaceutical - Compounding
  • Pharmaceutical - Over the Counter (OTC)
  • Pharmaceutical - Small Molecules
  • Pharmaceutical - Sterile
  • Pharmaceutical Excipients
  • Pharmaceuticals - Large Molecules

Testing Types

  • chemistry analysis
  • Gas Chromatography
  • Gas Chromatography/Flame Ionization Detection (GC/FID)
  • Gas chromatography/mass spectrometry (GC/MS)
  • GC/MS
  • GC/MS (Gas Chromatography/Mass Spectrometry)
  • Heavy Metals
  • High performance liquid chromatography (HPLC)
  • High Performance Liquid Chromatography (HPLC) Fingerprinting
  • High performance liquid chromatography/mass spectrometry (LC/MS)
  • Method Development
  • Method Transfer
  • Method Validation
  • Microbial
  • Microbial Contamination
  • Microbial Counts
  • Microbial Enumeration Test (MET)
  • Microbial Limit Testing (MLT)
  • Microbial Suitability
  • Microbial Total Viable Count
  • N-Nitroso-dimethylamine (NDMA)
  • Near-Infrared Spectroscopy
  • Total Organic Carbons (TOC)

Publications

Accuon Lab has not posted any publications.

DISCLAIMER: This Laboratory Profile was provided by the company above.