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Particle Analysis
and Method
Development Services
Services for sizing,
distribution, identification,
and surface area analysis of
particles

We offer cGMP and non-GMP Particle

Size Analysis, Particle Distribution,
Counting, Property Assessment, and
Identification and Contamination
services as well as Method Development
and release testing.
Particle size and particle distribution significantly impacts drug product
efficacy as well as other organic, inorganic, and metallic materials. Triclinic
Labs has significant experience in both wet and dry particle size and
distribution analysis, method development, contaminant identification,
property determination and support of the following monographs:.

USP <429> Laser Diffraction Measurement of Particle Size

USP <616> Bulk Density (Method I) and Tapped Density (Method II) of
Powders
USP <695> Crystallinity
USP <846> Specific Surface Area
USP <776> Optical Microscopy (Particle Size, Particle Shape Analysis,
Static Image Analysis and Crystallinity Characterization)
USP <1174> Powder Flow
USP <1241> Water-Solid Interactions in Pharmaceutical Systems -
Determination of Sorption Desorption Isotherms

see below for more detail about the services

and techniques we offer.
 Please contact us about cGMP Particle Size
Method Development, Validation, and Release
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testing.
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Particle Size Analysis and

Particle Size Distribution -

Determine size and distribution of particles

using Laser-Diffraction

Application AND Technique Description

In a laser diffraction particle size measurement, a laser beam passes

through a dispersed particulate sample and the angular variation in
intensity of the scattered light is measured. Large particles scatter
light at small angles relative to the laser beam and small particles
scatter light at large angles. The angular scattering intensity data is
then analyzed to calculate the size of the particles that created the
scattering pattern using the Mie theory of light scattering. The particle
size is reported as a volume equivalent sphere diameter. The particle-
size distribution (PSD) of a powder, or granular material, or particles
dispersed in fluid, is a list of values or a mathematical function that
defines the relative amount, typically by mass, of particles present
according to size (see figure below)
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Instrument Model Notes

Mastersizer cGMP and non-GMP testing available.

3000 v.3.70
Malvern We offer cGMP method development,
Access validation, and release testing as well
Configurator as method verification and transfer
v.2.20 capabilities.
Contact us for details.
Particle
Analysis
Malvern
Ranges:

Dry Range:
0.1 -
3500um

Wet Range:
cGMP Analysis and Method
0.01 -
Development Available
1400um

RAMAN Spectroscopy -

Identify molecules, determining particle

morphology and composition of a component in
a mixture, study chemical bonding, spatially
locate chemicals
 Application AND Technique Description

Home Raman is a spectroscopic technique used to observe vibrational,

About rotational,
Us and other low-frequency modes in a system. Raman
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spectroscopy is commonly used in chemistry to provide a structural
Materials Characterization
fingerprint by which molecules can be identified. A sample is
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illuminated with a laser beam. Electromagnetic radiation from the
Submitilluminated
Samples spot is collected with a lens and sent through
Contacta Usmonochromator. Elastic scattered radiation at the wavelength
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corresponding to the laser line (Rayleigh scattering) is filtered out by
Portal either a notch filter, edge pass filter, or a band pass filter, while the rest
of the collected light is dispersed onto a detector.

We specialize in hyper-spectral imaging or chemical imaging, in which

thousands of Raman spectra are acquired from all over the field of
view. The data can then be used to generate images showing the
location and amount of different components. Raman spectroscopy is
suitable for the microscopic examination of minerals, polymers and
ceramics, forensic trace evidence, organic and inorganic materials,
and to differentiate polymorphic forms of active pharmaceuticals.
With Raman microscopy you can:

Spacially locate components in a sample (e.g. excipients,

coatings, API)
Identify mixture composition
Identify contaminants and failures
Identify unknowns
Determining particle morphology and composition

Triclinic Labs has a NXT FT-Raman module that is interfaced to a

Nicolet 6700 FT-IR spectrometer. The FT-Raman module has an
Indium Gallium Arsenide (InGaAs) detector and is equipped with a
1064 Nd:YAG laser. We generally do not use the FT-Raman for
characterization of carbon nanotubes because the sample spectrum
is usually quite poor. Rather, we use our Renishaw inVia Raman
microscope for such analyses. The inVia instrument combines a
DMLM Leica microscope with a dispersive Raman spectrometer. The
instrument is equipped with a 785 nm laser and a charge-coupled
detector (CCD). The 785 nm laser allows us to obtain very good data.

Instrument Model Notes:

Renishaw Dispersive Raman: inVia Chemical cGMP and

imaging, microsampling, Confocal, non-GMP
785 nm laser. Morphologically testing
Directed Raman Spectroscopy (MDRS) available.

Thermo Wiki
Reference for
FT Raman: Thermo FT Micro and Raman
macro sampling, 1064 nm laser, spectroscopy
Omnic v.9.7.46 software with spectral
Ondax libraries.

Low frequency: Ondax THz-Raman®

 With Probe Stokes and anti-Stokes
signals from ±5 cm-1 to 200 cm-1, (or
Home 150 GHz to 6 THz) cGMP
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Hall Flow Rate Testing -

Powder flow rate and density

Application AND Technique Description

This technique determines both flow rate and apparent density. It is

applicable to both free-flowing metallic powders and other fine
powders testing. The testing is performed with a calibrated hall
flowmeter funnel according to International Standards.

Used in: Powder metallurgy, metallic powders, food powders, cement

powders, plastic powders, rubber powders, ceramic powders,
pharmaceutical powders,foundry,casting,metalworking.

Instrument Brand Model References

Hall FlowMeter AS-300

Particle Charge Analysis -

Identify handling issues due to charge

Application AND Technique Description

Powders and other materials can acquire an electrical charge on the

surface of their particles due to contact and movement against
processing and handling equipment and containers. Contact, friction,
and movement of particles within the material itself can also cause
charge acquisition.

It is important to measure particle charge since this can lead to

 problems and unstable flow and powder behaviors. Charged materials
stick to processing equipment and storage systems, can become
Home airborne more easily, and can flow in different ways than materials
About with
Us no charge.
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Instrument Brand Model References
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Density Testing -
Density is the mass of a substance with regard to the space in which it
occupies. It is important to determine the density when there are changes in
vendor materials or in processing.

We offer the following density testing: (True, Apparent, Bulk, Tapped, Carr
index)

Tapped and Bulk Density -

Explore powder flowability and settlement

Application AND Technique Description

The bulk density of a material is the ratio of the mass to the volume
(including the inter-particulate void volume) of an untapped powder
sample. The tapped density is an increased bulk density attained after
mechanically tapping a container containing the powder sample. The
tapped density is obtained by mechanically tapping a graduated
measuring cylinder or vessel containing the powder sample. This
technique is particularly useful in powder flowability studies and also
in determining the amount of settlement.

The compressibility index and Hausner ratio are measures of the

products ability to settle, and permit an assessment of the relative
importance of inter-particulate interactions. In a free-flowing powder
these interactions are less significant and the bulk and tapped
densities will be closer in value. For poorly flowing materials, there are
greater inter-particulate interactions and a greater difference between
the bulk and tapped densities will be observed. The differences are
reflected in the compressibility index and Hausner ratio.

Instrument
Model References
Brand

Caleva TDT WHO Reference for Bulk and Tapped

12 Density
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Charge
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Porosity
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Sieve Analysis
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Contact us for further details or pricing.

Particle Analysis Service Levels

Available:
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Triclinic Labs, Inc.

2660 Schuyler Ave. Ste. A.
Lafayette, IN 47905 USA
PH: +1.765.588.6200
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