Spectroscopy Platform

Spectroscopy Platform

Spectroscopy is a core foundational technology for qualitative and quantitative analysis in the pharmaceutical industry, enabling rapid, non-destructive, high-precision characterization of molecular structure, identity, purity, potency and stability. Our platform integrates UV-Vis, FTIR, AAS, AFS and supporting hyphenated systems, widely used for raw material verification, formulation analysis, impurity testing, polymorphism identification and regulatory compliance throughout the drug lifecycle. The core advantages of key techniques are compared below:

Technology Type Core Advantages Applicable Scenarios
UV-Vis High sensitivity, good linearity, easy operation, compliant with pharmacopoeias; ideal for routine assay and quantitative analysis
  • API assay
  • Content uniformity
  • Dissolution testing
  • Impurity quantification
  • Identification testing
FTIR Unique fingerprint spectrum, non‑destructive, fast scanning; excellent for structural identification and polymorphism
  • Material identification
  • API/excipient confirmation
  • Polymorphism
  • Counterfeit detection
AAS High accuracy, low detection limit; dedicated for elemental and heavy metal analysis
  • Heavy metal testing
  • Catalyst residues
  • Trace elemental impurities in APIs and excipients
AFS Ultra-high sensitivity for hydride-forming elements; strong anti-interference
  • Determination of As, Hg, Pb, Se, Sb and other toxic elements

Spectroscopy Platform

PharmaAnalytica has built a fully automated, high-precision integrated spectroscopy platform for pharmaceutical qualitative and quantitative analysis and quality control, equipped with high-performance analytical instruments to guarantee standardized, efficient and stable experimental operations.

UV-2601 Double Beam UV-Vis Spectrophotometer

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UV-2601 adopts a dual-beam optical system with a wavelength range of 190–1100 nm and five adjustable spectral bandwidths (0.5 nm, 1 nm, 2 nm, 4 nm, 5 nm) to fully meet pharmacopeial requirements. It is equipped with imported deuterium/tungsten lamps and silicon photodiode detectors, ensuring high accuracy, low stray light and excellent long‑term stability. The instrument supports wavelength scanning, quantitative analysis, time scanning, multi‑wavelength determination and DNA/protein testing, with automatic light source switching, wavelength calibration and zero adjustment. It is widely used for API assay, content uniformity, dissolution testing, impurity quantification, identification verification and routine quality control, providing reliable and compliant data for pharmaceutical analysis.

TAS-990AFG Atomic Absorption Spectrophotometer

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TAS-990AFG is an automatic integrated flame–graphite furnace atomic absorption spectrometer with automatic switching between flame and graphite furnace modes. It features a wavelength range of 190–900 nm, 5-step automatically adjustable spectral bandwidth, and an 8-lamp automatic turret for multi-element sequential analysis. Equipped with transverse-heated graphite furnace and dual background correction (deuterium lamp + self-absorption), it delivers ultra-low detection limits and high stability. The system provides full automation including ignition, gas control, parameter optimization, and comprehensive safety interlocks. It is widely used for accurate quantification of heavy metals, catalyst residues, and trace elemental impurities in APIs, excipients, and drug products, fully complying with ICH Q3D and global pharmaceutical regulatory requirements.

FTIR-850 Fourier Transform Infrared Spectrometer

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FTIR‑850 features a wavenumber range of 7800–350 cm⁻¹ and high resolution up to 0.5 cm⁻¹, with dynamic alignment control up to 130,000 adjustments per second to ensure outstanding spectral stability and peak shape. It adopts a fully sealed optical system and an extra‑large desiccant cartridge for excellent moisture protection, reducing maintenance frequency. The large sample chamber supports multiple sampling modes including transmission, ATR, diffuse reflection and liquid/gas cells, with strong scalability. The software provides three‑level user authority and audit trail functions, supporting 3Q qualification to meet pharmaceutical regulatory requirements. It delivers unique molecular fingerprint spectra for raw material identification, structural confirmation, polymorphism discrimination, drug-excipient compatibility evaluation and counterfeit detection, serving as a core tool for solid‑state characterization and identity testing.

LabAF 1000 Atomic Fluorescence Spectrometer

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This instrument features a three-channel simultaneous detection design, dual-mode hydride generation, high-performance hollow cathode lamps, and a solar-blind photomultiplier detector for ultra-high sensitivity and low noise. It adopts a shielded short‑path optical system and double-layer quartz atomizer to reduce interference and memory effects. It achieves ppb-level determination of As, Hg, Pb, Se, Sb, and other toxic elements, supporting elemental analysis and speciation analysis for pharmaceutical safety evaluation. The software complies with 21 CFR Part 11, with audit trail and rights management to ensure data integrity and regulatory compliance.

Covered Drug Categories for Bioanalysis

Supported by our mature and stable integrated spectroscopy platform, PharmaAnalytica provides customized, full-process analytical services covering a full spectrum of small-molecule drugs, innovative drugs, generic drugs, natural products and pharmaceutical preparations.

  • Small-molecule APIs and finished pharmaceutical products
  • Innovative small-molecule drugs and generic drugs
  • Oral solid preparations, injections and topical formulations
  • Natural products
  • Pharmaceutical excipients and raw materials
  • Solid dispersions, liposomes, sustained‑release and controlled-release formulations

Core Spectroscopy Analysis Services

Raw Material & API Testing

  • Identity verification by infrared, Raman, or UV spectral comparison
  • Assay determination and purity evaluation using validated spectrophotometric methods
  • Organic impurity quantification and related substances screening
  • Heavy metal and elemental impurity screening (Pb, As, Hg, Cd, Cu, Ni, etc.)
  • Catalyst residue detection and elemental safety assessment
  • Characteristic spectral fingerprint establishment and database comparison
  • Batch‑to‑batch consistency evaluation of raw materials and APIs

Formulation Analysis & Process Control

  • Content uniformity testing for tablets, capsules, granules, and injections
  • Dissolution profile determination and similarity factor evaluation
  • Drug-excipient compatibility evaluation via spectral changes
  • Polymorph consistency monitoring during formulation and processing
  • Blend uniformity and homogeneity analysis for granulation and mixing stages
  • Moisture, volatile content, and active component rapid screening
  • In-process real-time monitoring for production line quality control
  • Packaging material safety evaluation and extractable/leachable screening

Stability & Impurity Evaluation

  • Stress testing under heat, humidity, light, oxidation, and acid/alkali conditions
  • Accelerated and long‑term stability sample analysis
  • Degradation product detection and structural change monitoring
  • Polymorphic transformation and crystallinity variation assessment
  • Peak purity verification and impurity profile comparison
  • Shelf-life prediction and storage condition recommendation
  • Degradation pathway analysis and stability risk assessment

PharmaAnalytica's Spectroscopy Platform provides rapid, non-destructive, and compliance-ready analytical solutions covering raw material inspection, formulation development, process control, stability study, and commercial release. Supported by high-performance instruments and standardized workflows, the platform ensures reliable, efficient, and regulatory-compliant analysis throughout the drug lifecycle. With professionalism, precision, and compliance, we accelerate pharmaceutical R&D and ensure consistent, safe, and high-quality drug products.

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