NABL Accredited · Physical Characterisation Laboratory

Particle Size Analysis Laboratory India | Laser Diffraction | NABL

Particle size analysis for pharmaceutical APIs, excipients, and formulations from an NABL-accredited laboratory in India.

Particle size is a critical quality attribute in pharmaceutical manufacturing, directly influencing dissolution rate, bioavailability, content uniformity, flowability, and aerodynamic behaviour of drug products. Auriga Research operates an NABL-accredited particle size analysis laboratory equipped with laser diffraction analysers, dynamic light scattering (DLS) instruments, and sieve analysis capabilities to characterise particles across the full pharmaceutical size range — from nanometres to millimetres.

Our laser diffraction systems provide rapid, reproducible particle size distribution measurements for APIs, excipients, and formulated products in both wet (suspension) and dry (powder) dispersion modes. For nanoparticulate systems including liposomes, nanosuspensions, and polymeric nanoparticles, DLS provides hydrodynamic diameter and polydispersity index measurements. We also perform sieve analysis per pharmacopoeial methods for coarse powder characterisation.

All measurements follow validated methods with system suitability verification using certified reference standards. Results are reported as D10, D50, D90 with span values, full distribution curves, and compliance assessment against product specifications. Our particle size data supports formulation development, process validation, batch release, and regulatory submissions.

Particle Size Analysis Capabilities

  • Laser diffraction — wet and dry dispersion, 0.1 to 3000 microns
  • Dynamic light scattering (DLS) — 1 nm to 6 microns for nanoparticles and colloids
  • Sieve analysis per pharmacopoeial methods for coarse powder characterisation
  • Zeta potential measurement for colloidal stability assessment
  • Particle shape and morphology by optical and scanning electron microscopy
  • Aerodynamic particle size distribution by cascade impactor (inhalation products)
  • Method development and validation for particle size specifications
  • Stability-linked particle size monitoring for suspension and emulsion products

Turnaround Time

Laser Diffraction: 3-5 business days
DLS (Nanoparticles): 3-5 business days
Rush Analysis: 1-2 business days
Cascade Impactor Testing: 5-7 business days

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Frequently Asked Questions — Particle Size Analysis

What methods are used for pharmaceutical particle size analysis?
Common methods include laser diffraction (for particles from 0.1 to 3000 microns), dynamic light scattering (DLS) for nanoparticles and colloids (1 nm to 6 microns), sieve analysis for coarse powders, and microscopy (optical and SEM) for particle shape and morphology. Laser diffraction is the most widely used technique in pharmaceutical applications due to its speed, reproducibility, and broad measurement range. Method selection depends on the particle size range, sample type, and regulatory requirements.
Why is particle size important in pharmaceutical manufacturing?
Particle size directly affects drug product performance. For APIs, particle size influences dissolution rate, bioavailability, content uniformity, and stability. For excipients, it affects flowability, compressibility, and blend uniformity. For inhalation products, aerodynamic particle size determines lung deposition efficiency. Regulatory agencies require particle size specifications as a critical quality attribute (CQA) for most solid dosage forms and all inhalation products.
What particle size parameters are typically reported?
Standard reporting parameters include D10, D50 (median), and D90 values representing the particle diameters below which 10%, 50%, and 90% of the distribution falls. Additional parameters include span (distribution width), specific surface area, and volume or number-weighted distribution profiles. For inhalation products, mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) are reported from cascade impactor testing.
What is the turnaround time for particle size analysis?
Standard particle size analysis by laser diffraction at Auriga Research is completed within 3-5 business days from sample receipt. DLS analysis for nanoparticles requires 3-5 business days. Cascade impactor testing for inhalation products requires 5-7 business days. Rush services are available within 1-2 business days for laser diffraction.

Need Particle Size Analysis for Your Pharmaceutical Materials?

NABL-accredited laser diffraction and DLS analysis with 3-5 day turnaround. Full distribution reports for regulatory submissions.

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