Laboratory Testing

Synergy Bioscience is committed to providing expert and timely analytical chemistry services with a level of quality and reliability you can trust. We offer a wide range of analytical services, including compendial testing according to USP/NF, EP, BP, JP, ACS, AOAC, ISO/IEC 17025, ISO 10993, and customer-specified monographs, to support raw materials, in-process analysis, and finished product release testing that will meet all of your product needs.

Our team of experts specializes in testing a variety of drug products, drug substances, and dosage forms, including tablets, capsules, semi-solids, parenteral, sterile, transdermal, and inhalation products. We have built a solid reputation in the industry for our high-quality services and timeliness since 2016.

At Synergy, our mission is to provide you with the analytical solutions you need to achieve your drug development goals quickly and easily.

Our testing services include, but are not limited to:

  • Full amino acid and therapeutic protein sequencing and profiling
  • PCR and DNA sequencing to support drug product R&D activities
  • Next Generation Sequencing (NGS)
  • Chromatographic testing using HPLC
  • Pharmaceutical product characterization using Mass Spectrometry
    HPLC-MS/MS or UPLC-MS/MS
  • Residual solvent identification and quantitation
  • Trace metals by ICP-MS / ICP-OES
  • Cleaning validation samples testing using TOC
    (Total Organic Carbon analyzer)
  • Extractables/Leachables studies using LC-MS, GC-MS, IC-MS
  • Organic volatile impurities testing using GC
    (direct injection and headspace capability (detectors: FID, TCD, and NPD))
  • UV-Vis spectrophotometer
  • Dissolution testing
  • Moisture determination
    (Karl Fischer, direct titration and coulometric titration)
  • Capillary Electrophoresis testing CE
  • Fluorescent spectrophotometer
  • Thermal analysis (TGA and DSC)
  • Container/Closure testing
  • Particle size distribution (laser diffraction)
  • Polarity Testing (Polarimetry)
  • Photostability Testing
  • Viscosity determination
  • Collagen Testing
  • Glycosaminoglycan (GAG) Content
  • Particle Characterization (morphology & Imaging)
  • Particle Size Determination
  • Density Measurement
  • Refractive Index
  • Melting Point Measurement
  • Boiling Point Measurement
  • Acrylamide using LC-MS/MS
  • Aflatoxins M1 using LC-MS/MS
  • Benzo(a)pyrene using HPLC-FLD
  • Dioxins and PCBs using HRGC/HRMS
  • Ethanol Residues using SHS-GC/MS
  • Free 3-MCPD using GC-MS/MS
  • Multi-Mycotoxins using LC-MS/MS
  • Nitrate and Nitrite Ions using Ion Chromatography
  • Patulin using LC-MS/MS
  • Western Blotting
  • SDS PAGE
  • Gene Stability / Gene Integrity
  • Synthetic Sweeteners using LC-MS/MS
  • Total fat (%) using Soxhlet Extraction
  • Veterinary Drugs using LC-MS/MS
  • Vitamin B Complex using LC-MS/MS
  • Pesticide Residues in Foods using LC-MS/MS & GC-MS/MS
  • Chemical identification and quantification test
  • Impurities profile
  • Particulate matter
  • Compendial testing methods verification

Analytical Chemistry

Synergy Bioscience is committed to providing expert and timely analytical chemistry services with a level of quality and reliability you can trust. We offer a wide range of analytical services…

Structural Chemistry

Synergy Bioscience offers an array of approaches and techniques to characterize drug structures and analyze their purity at every step of the development process. In addition, Synergy’s integrated…

Structural Chemistry

Synergy Bioscience offers an array of approaches and techniques to characterize drug structures and analyze their purity at every step of the development process. In addition, Synergy’s integrated…

Microbiology Testing

At Synergy Bioscience, we prioritize quality, safety, and compliance in all our microbiology testing services. We deliver a suite of tests that comply with all the USP General Chapters…

Extractables and Leachables

The assessment of extractables and leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment as well as primary and secondary…

Extractables and Leachables

The assessment of extractables and leachables in bio/pharmaceutical products is an important step in drug product development. Processing equipment as well as primary and secondary…

Elemental Impurities

Manufacturers of pharmaceutical drugs must follow the guidelines for testing for elemental impurities in USP 232 and 233, which have been harmonized with ICH Q3D guidelines around…

Product Stability Testing

The drug product stability studies are the most resource intensive activities in the drug development process. For this reason, the scrutiny of the FDA review of this section during an…

Product Stability Testing

The drug product stability studies are the most resource intensive activities in the drug development process. For this reason, the scrutiny of the FDA review of this section during an…

Dissolution Testing

Pharmaceutical Dissolution Testing is a vital tool that quantifies the rate at which the active ingredient of a medication is released in a controlled lab setting that simulates the conditions…

Residual Solvents Testing

Residual solvents, formerly referred to as organic volatile impurities (OVIs), are trace level chemical residues that are used in the manufacture of drug substances and excipients…

Residual Solvents Testing

Residual solvents, formerly referred to as organic volatile impurities (OVIs), are trace level chemical residues that are used in the manufacture of drug substances and excipients…

Cannabinoids Testing

Recently, there has been a significant increase in the use of cannabinoid-containing products in the USA. This is mostly due to the legalization of medicinal and recreational marijuana…

Biocompatibility Testing

Biocompatibility evaluation of a medical devices include chemical toxicity, unacceptable biological response to the medical device or changes in the device’s physicochemical characteristics…

Biocompatibility Testing

Biocompatibility evaluation of a medical devices include chemical toxicity, unacceptable biological response to the medical device or changes in the device’s physicochemical characteristics…

Clinical Research

At Synergy Bioscience, we’re at the forefront of clinical research, offering an integrated suite of services that encompass:

  • Drug metabolism studies
  • Pharmacokinetics (PK)
  • Pharmacodynamics (PD)
  • Immunogenicity studies…

Drug Metabolism

At Synergy Bioscience, we are dedicated to advancing the field of drug development with our comprehensive suite of Drug Metabolism and Pharmacokinetics (DMPK) services…

Drug Metabolism

At Synergy Bioscience, we are dedicated to advancing the field of drug development with our comprehensive suite of Drug Metabolism and Pharmacokinetics (DMPK) services…

Pharmacokinetics

At Synergy Bioscience, our pharmacokinetics (PK) services are a cornerstone of the drug development process, providing crucial insights into the safety and efficacy of therapeutics…

Pharmacodynamics

Synergy Bioscience is at the forefront of pharmacodynamics (PD) studies, playing a pivotal role in the early stages of drug development. Our cutting-edge PD assessments yield…

Pharmacodynamics

Synergy Bioscience is at the forefront of pharmacodynamics (PD) studies, playing a pivotal role in the early stages of drug development. Our cutting-edge PD assessments yield…

Biomarkers

At Synergy Bioscience, we recognize that biomarker analysis is a pivotal component in the drug development process, providing essential insights into a therapeutic’s efficacy, safety…

Immunogenicity

Synergy Bioscience stands as a bastion of safety and efficacy in the realm of therapeutic development, particularly through our unmatched expertise in immunogenicity risk…

Immunogenicity

Synergy Bioscience stands as a bastion of safety and efficacy in the realm of therapeutic development, particularly through our unmatched expertise in immunogenicity risk…

CMC Bioanalytical

In the intricate landscape of drug development, Synergy Bioscience stands as a beacon of excellence in CMC bioanalytical testing. Recognized for our meticulous approach…

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