Service Capabilities

Outcome-driven testing for regulated programs.

From raw material verification to complete stability lifecycle management, we provide the defensible analytical data required to confidently bring your products to market.

High Performance Liquid Chromatography (HPLC) instrumentation at BioChroma Labs

Analytical Precision

Traceable, compendial methodologies.

Analytical Chemistry

Verification of product specifications, identity, and purity for raw materials and finished goods.

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Microbiology Programs

Testing protocols designed to ensure product safety, microbiological stability, and facility hygiene.

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Stability Testing

Data-driven shelf life studies to ensure product integrity remains intact from warehouse to consumer.

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Method Development

Custom analytical protocols built for your specific matrix and regulatory pathway.

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Testing Methodologies

Detailed Analytical Specifications

Analytical Chemistry

Quantitative and qualitative analysis utilizing compendial methods to ensure raw materials and final products meet strict regulatory specifications.

Active Ingredient Assay

Method: HPLC / UPLC / UV-Vis
App: Label claim verification and potency tracking.

Residual Solvents

Method: GC-MS / USP <467>
App: Screening for Class 1, 2, and 3 manufacturing solvents.

Heavy Metals & Elementals

Method: ICP-MS / USP <232>/<233>
App: Trace level detection of Pb, As, Cd, Hg, and others.

Material Identification

Method: FTIR / Wet Chemistry
App: Authenticity testing for incoming raw material release.

Compositional Profiling

Method: Protein Analyzer / Titration
App: Nutritional labeling and macro-component consistency.

Microbiology Programs

Risk-based microbiology testing designed to protect consumer health and validate the hygiene of your manufacturing environment.

Microbial Enumeration

Method: USP <61> / BAM
App: Total Aerobic Microbial Count (TAMC) and TYMC.

Specified Pathogens

Method: USP <62>
App: Absence testing for S. aureus, Salmonella, E. coli, P. aeruginosa.

Antimicrobial Effectiveness

Method: USP <51> (AET)
App: Preservative challenge testing for multi-dose formulations.

Environmental Monitoring

Method: Air / Surface Plates
App: Facility hygiene and cleanroom compliance testing.

Water Suitability

Method: Membrane Filtration
App: Verification of process water systems and TOC limits.

Stability Testing

Comprehensive lifecycle management to establish and defend product expiration dates under various climatic conditions.

Accelerated Aging

Method: 40°C / 75% RH
App: Rapid degradation assessment for early shelf-life estimates.

Real-Time Storage

Method: 25°C / 60% RH
App: Long-term baseline stability required for final regulatory filing.

Photostability

Method: ICH Q1B Options 1 & 2
App: Stress testing against UV and visible light exposure.

Forced Degradation

Method: Acid / Base / Heat / Oxidative
App: Identifying degradation pathways and stability-indicating markers.

Method Development & Transfer

Translating complex analytical challenges into robust, validated, and transfer-ready standard operating procedures.

Matrix Optimization

Method: Extraction & Recovery
App: Modifying compendial methods for complex or novel formulations.

Formal Validation

Method: USP <1225> / ICH Q2
App: Validating accuracy, precision, specificity, and linearity.

Technology Transfer

Method: Comparative Testing
App: Seamlessly moving methods from R&D to QA manufacturing labs.

Failure Investigation

Method: Root Cause Analysis
App: OOS (Out of Specification) investigations and troubleshooting.

Infrastructure

Full Analytical Instrumentation Registry

Chromatography

  • UPLC / HPLC (PDA, RI, ELSD)
  • Ion Chromatography (IC)
  • Gas Chromatography (GC / FID)

Mass Spectrometry

  • LC-MS (Liquid / Mass Spec)
  • GC-MS (Gas / Mass Spec)
  • ICP-MS (Inductively Coupled Plasma)

Spectroscopy

  • FTIR (Fourier Transform Infrared)
  • UV-Vis Spectrophotometry

Specialized Analysis

  • Protein Analyzer (Kjeldahl/Dumas)
  • Stability Chambers (Zone I-IV)
  • Class II Biosafety Enclosures