Chemistry
5 focused groups spanning potency, impurities, elemental, volatile, and physical testing workflows.
Chemistry, Microbiology, Molecular Biology & Stability
Testing capabilities organized for release, shelf-life, and regulatory review.
BioChroma supports product release, investigations, stability programs, and method-driven quality decisions through five chemistry groups, microbiology, molecular biology workflows, and ICH-aligned stability studies.
ISO 17025 accredited operations
Independent QC review
Compendial and guideline alignment
Capability matrix
Service lines mapped by lab discipline
Microbiology
Microbiology workflows support product safety, contamination investigation, sterility, preservative systems, and environmental monitoring across regulated and consumer products.
Molecular Biology & PCR
Molecular biology workflows support projects that require species identification, adulteration detection, or deeper biological characterization beyond conventional wet chemistry or microbiology alone.
Stability Programs
Stability workflows support shelf-life and storage decisions through protocol planning, chamber control, scheduled pulls, forced degradation, and trend reporting for quality or regulatory review.
BioChroma’s testing capabilities span five chemistry groups, a dedicated microbiology department, molecular biology workflows, and ICH-aligned stability programs. Projects can move from raw material identification through finished product release, investigation support, and long-term shelf-life review within one coordinated laboratory structure.
ISO 17025 accredited operations
Testing is executed under accredited laboratory controls with methods selected to fit the product and decision in front of you.
Independent QC review
Analytical datasets are reviewed through BioChroma's quality process before release to support defensible reporting.
Compendial and guideline alignment
USP, EP, AOAC, FDA BAM, USDA, and ICH references are used where applicable to the service line and study type.
Testing disciplines
Chemistry organized as five dedicated groups
Under chemistry leadership, BioChroma routes work through five analytical groups so raw material identification, potency, impurities, elemental analysis, residual solvents, and physical testing can stay inside one coordinated structure.
Chemistry leadership Joe Galbraith Director of Chemistry
Oversees five analytical groups and the full spectrum of chemical analysis from raw material identification through finished product release.
Potency, label claim, impurities, and degradation profiling
HPLC Analysis
HPLC workflows support raw material and finished product programs where identity, potency, preservatives, impurities, and degradation behavior need to be measured under compendial or validated methods.
Services
- Potency and active ingredient assay
- Label claim verification
- Preservative analysis
- Impurity profiling and degradation studies
- Nutritional analysis for vitamins and supplements
- Method development and validation
Methods
- USP, AOAC, and EP-aligned methods
- Method development and validation to compendial standards
Key instruments
Trace-level quantitation for complex matrices
LC-MS/MS
LC-MS/MS workflows support projects that require lower detection limits, matrix-specific cleanup, and targeted quantitation for contaminants or difficult analytes.
Services
- LC-MS/MS trace-level quantitation
- Allergen analysis
- Toxin screening
- Pesticide analysis
- Advanced method development for complex matrices
Methods
- USP, AOAC, FDA BAM, and customer-specific validated workflows as appropriate to matrix and analyte
Key instruments
Volatiles, solvents, and headspace analysis
GC & GC-MS
GC and GC-MS workflows support residual solvent, volatile, and aroma-profile questions where headspace or gas-phase separation is the best technical fit.
Services
- Residual solvents
- Volatile organic compound screening
- Headspace GC-MS
- Flavor and fragrance profiling
Methods
- USP <467> residual solvents
- Headspace and volatile analysis workflows matched to sample type
Key instruments
Heavy metals, minerals, and elemental impurities
IC & ICP-MS
Inorganic workflows support metals and mineral analysis where trace detection, matrix digestion, and regulatory alignment are central to the project scope.
Services
- Heavy metals and elemental impurities
- California Prop 65 compliance support
- Mineral profiling
- Parts-per-billion detection for complex matrices
- Matrix digestion for powders, creams, and liquids
Methods
- USP <232>/<233> elemental impurity workflows
- Inorganic analysis aligned to matrix and reporting requirement
Key instruments
Bench chemistry, raw material ID, and physical characterization
Wet Chemistry & Physical Testing
Wet chemistry workflows address core release and investigation measurements that rely on titrations, physical properties, and orthogonal bench techniques.
Services
- Titrations, pH, moisture, and water activity
- Protein and nitrogen by Kjeldahl
- TOC
- FTIR raw material identification and authentication
- Viscosity, specific gravity, and density
- UV-Vis spectroscopy
Methods
- USP, AOAC, and EP-aligned wet chemistry and physical testing methods
Key instruments
Microbiology
Microbiology
Microbiology workflows support product safety, contamination investigation, sterility, preservative systems, and environmental monitoring across regulated and consumer products.
Department leadership with Jenna Rutledge as Microbiology Group Lead Stacey Choate-Ciletti Director of Microbiology
Service scope
- USP <61>/<62> microbial limits and enumeration
- USP <51> preservative efficacy (AET)
- USP <85> bacterial endotoxin (BET)
- USP <71> sterility testing
- Pathogenic bacteria screening including Salmonella, E. coli, Staph aureus, and Pseudomonas
- Microbial identification and species ID
- Environmental monitoring with sampling supplies provided
- Water suitability testing
- Shelf life studies, microbial kill studies, spoilage analysis, and microscopic examination
Methods and references
- USP <61>/<62>, USP <51>, USP <71>, and USP <85>
- Compendial microbiology aligned to USP, AOAC, FDA BAM, and USDA references as applicable
Key systems
Differentiated workflow
Molecular Biology & PCR
Molecular biology workflows support projects that require species identification, adulteration detection, or deeper biological characterization beyond conventional wet chemistry or microbiology alone.
R&D and molecular biology leadership: James Fowler, R&D Biochemist
Capabilities
- PCR and RT-PCR
- Species identification, authentication, and adulteration detection
- Next-Generation Sequencing with library preparation and target enrichment
- Microarray analysis
- DNA amplification, purification, quantitation, and characterization
- Bioinformatics filtering and alignment
- New method development to customer specifications
Platforms
Workflow note
- Customer-specific molecular biology workflows selected for the target organism, sequence, or authenticity question
Stability
Stability Programs
Stability workflows support shelf-life and storage decisions through protocol planning, chamber control, scheduled pulls, forced degradation, and trend reporting for quality or regulatory review.
ICH condition set
Program structure and storage conditions
01
ICH Q1A accelerated studies (40°C/75% RH)
02
Long-term and real-time studies (25°C/60% RH and 30°C/65% RH)
03
Intermediate studies
04
ICH climatic zones I-IV
05
ICH Q1B photostability
06
Forced degradation and stress testing
07
Protocol planning and pull schedule design
08
Trend reporting for regulatory and quality review
Technical infrastructure
Verified instrument platforms and laboratory systems
Instruments and systems are grouped by technique so teams can quickly match BioChroma's infrastructure to the work under review.
Liquid Chromatography
- Waters UPLC-PDA-FLR
- Agilent 1260 HPLC (PDA/RI)
Mass Spectrometry & Trace Analysis
- LC-MS/MS Triple Quad
- ICP-MS (Agilent 7850)
Gas Analysis & Volatiles
- GC-FID/GC-TCD
- GC-MS
- Headspace GC-MS
Inorganic & Wet Chemistry
- Ion Chromatography
- FTIR
- UV-Vis
- TOC Analyzer
- Protein Analyzer (Kjeldahl)
- pH meters, titration systems, and physical testing equipment
Molecular Biology
- Thermocyclers (PCR)
- Sequencers (NGS)
Microbiology & Stability
- Validated incubation and enumeration systems
- ICH-compliant stability chambers (Zones I-IV)
- Photostability chambers
Audience fit
Support for QA, operations, and development teams
QA and regulatory teams
Programs that need accredited testing, compendial method references, data integrity controls, and documentation that can stand up to review.
Manufacturing and operations teams
Projects tied to release timing, investigations, sample logistics, environmental programs, and continuity across multiple testing groups.
Product development and technical teams
Method selection, problem-solving, molecular characterization, and early testing strategy before work moves into routine release support.
Next step
Need testing support?
Tell us what needs to be tested, your timeline, and whether the work supports release, investigation, or shelf-life decisions. We will connect you to the right team.