| The Single-Component and
Multiple-Component Dissolution systems offer optimal flexibility in
defining an application setup based on USP or British Pharmacopoeia
(BP) guidelines. Acceptance tables, based on user-defined limits,
may be viewed or printed out in a formal report. In compliance with
USP and BP guidelines, hard copy output documents the resulting
"pass" or "fail" of up to 24 samples per file by comparison to set
limits.
The percent (%) dissolved is determined automatically for
either single or multiple ingredients. For a single active
ingredient, calculations can be made by either referencing a
dissolved standard, using a Pharmacopoeia defined absorptivity
coefficient, or using coefficients from a linear or quadratic
standard calibration curve. For multiple ingredients, calculations
are based on a calibration using standard mixtures.
The system interfaces easily with popular dissolution baths and
sampling devices, with the ability to sample either manually or
automatically from up to two baths.
Features
- Applications setup enables an automatic comparison of results
to acceptance tables based on USP or British Pharmacopoeia
guidelines.
- For single-component measurements: Pharmacopoeia protocols for
quality (Q) limits, stage 1, 2, and 3 (S1,S2, S3) testing,
dissolution limits (D) with levels 1, 2,and 3 (L1, L2, L3)
testing.
- For multiple-component measurements: Pharmacopoeia protocols
for quality (Q) limits, and stage 1 (S1) testing.
- Up to 24 samples per file may be compared in meeting S1 to S3
or L1 to L3 testing.
- Final results may be presented as percent dissolved or other
concentration units.
- Weight correction for actual sample weights.
- Out-of-range results are automatically flagged.
- Total time can be composed of up to five different time
intervals.
- Cell match function provides automated zero correction of
multiple cells.
- May be used with Single-Component and/or Multiple- Component
Quantitative Analysis packages, described previously within this
guide.
Note: When selecting two baths, S3 or L3 testing cannot be
performed.
Accessories
Hardware
The system can utilize up to eight kettles per bath with a choice of
either an automatic or manual sampling mode. For automatic sampling,
the DU® Series software provides full control of devices
which are interfaced to either a multiple- or single-flow cell
sampling system. Device control is selected with a simple click of
the mouse.
Up to eight multiple flow cells can be interfaced to either an
eight-channel peristaltic pump or to a Hanson Dissoscan. The Auto 8
and Auto 7 Cell Holders are transport-mounted accessories that
accommodate up to 10 mm path length flow cells for up to six
samples, and either a static or flowing reference and/or blank.
For more economical or batch sampling, a single-flow cell
connected to a sipper can be interfaced to either an Isco or Gilson
batch sampler or a Valco* 16-port switching valve.
The Dissolution Valve Kit enables automation and use of a Valco
16-Port Switching Valve* with sample flow, blank, and/or reference
measurement via a single flow cell. The Sipper Accessory provides
automated delivery of each dissolved sample to the flow cell.
Batch samplers that hold up to 114 samples in 13 mm x 100 mm test
tubes in serial mode or up to 80 samples in a serial or random
access mode (Gilson batch sampler) may be used. Other racks are also
available for Gilson samplers to provide for a larger number of
tubes or other tube sizes.
* Valco 16-port switching valve is not available from Beckman
Coulter.
Software
The Single-Component Dissolution Analysis system can be provided
with Content Uniformity and %Label Claim software to meet
formulation and quality testing requirements, as described in a
further section of this guide.
Multiple-Component Analysis expands the utility of the
dissolution system by enabling the analysis of even the most complex
of mixtures, utilizing a powerful quantitative technique called
Full-Spectrum Quantitation (FSQ™).
Rather than being confined to the selection of discreet
wavelengths across a spectrum, FSQ performs principle component
regression analysis over the entire spectrum, utilizing the power of
Fourier transform action. Standards no longer need be limited to a
single component, but can be comprised of mixtures to take into
account possible component interactions. And, with FSQ, analyses are
performed in a matter of seconds, saving time-consuming separation
steps.
Note: For multiple bath control, DU Series 600 and 7000
Spectrophotometers can be interfaced to the Hanson Dissoscan (not
available from Beckman Coulter). For more details, please contact
your local Beckman Coulter office. |
Click on the thumbnail to
view the full-size image in a
separate window.
Real-Time Data
Plotting Window.
Data Tabulation Window.
Test Type Level Window.
Weight Correction Window.
Switching Valve Flow
Schematic; The System may
be used with One or Two
Baths - Each with Up to Six
Flowing Samples and Either
Static or Flowing Upscale
Reference and/or Blank.
Multicomponent Dissolution
Plotting Window.
Multicomponent Dissolution
Tabulation Window.
Typical Test Report.
Sampling Setup Window.
Report Information Window
for Quick Report
Format Setting.
Concentration
Parameters Window.
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