Malvern Mastersizer 3000+ Ultra

Particle Size Distribution by Laser Diffraction (Malvern 3000+)

Particle size directly governs API dissolution velocity, bioavailability, powder flowability, content uniformity, and compactability during tablet manufacturing. Satvam Research validates refractive index parameters, obscuration levels, and dispersion pressures to generate reproducible particle size curves.

Standard Turnaround
2 - 4 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Particle Size Analysis (PSD)

Satvam Research provides particle size distribution (PSD) metrics utilizing the world-standard Malvern Mastersizer 3000+ Ultra laser diffraction analyzer. Supporting both automated wet liquid dispersion and dry powder dispersion units, we measure particle dimensions from 10 nm to 3.5 mm, delivering precision D10, D50, D90, and span calculations for APIs, excipients, and industrial suspensions.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Dry powder dispersion analysis for free-flowing solids and granulations
Wet liquid dispersion analysis in aqueous and non-aqueous dispersants with sonication
Automated determination of D10, D50, D90, Span, and Sauter Mean Diameter (D[3,2])
Method development: dispersant screening, sonication time, obscuration optimization
Reproducibility verification with %RSD compliant with USP <429>
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Particle Size Analyzer - Mastersizer 3000+ Ultra
Malvern Panalytical
Model: Mastersizer 3000+ Ultra

Particle Size Analyzer

Sub-micron to millimeter laser diffraction with dual-wavelength red and blue laser optics.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

USP <429> Light Diffraction Measurement of Particle Size
ISO 13320 Particle Size Analysis – Laser Diffraction Methods
Ph. Eur. 2.9.31 Particle Size Analysis by Laser Light Diffraction
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
5 - 10 g of dry homogenous powder or 25 mL of suspension.
Container Type
Airtight plastic or glass vial with secure cap.
Storage Condition
Ambient dry conditions protected from moisture agglomeration.
Standard TAT
2 - 4 business days
Special Instruction: Indicate solubility in water, alcohol, or other organic solvents.
Frequently Asked Questions

Technical & Regulatory Inquiries

What is the measurement range of the Mastersizer 3000+ Ultra?

The Mastersizer 3000+ Ultra measures particles from 0.01 µm (10 nm) up to 3500 µm (3.5 mm) with extreme precision using high-speed optical signal processing.

Initiate Your Particle Size Analysis (PSD) Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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