24-12-2012, 05:03 PM
Color Measurement in Pharmaceutical Industry
Color Measurement.pdf (Size: 1.98 MB / Downloads: 118)
Color (or lack of color) is used as:
• An indicator of quality
• To differentiate between medications
• To indicate test results on dip strips
• Part of a brand's identity
• An indicator of degradation and loss of potency over time
• Compliance with US FDA standards
• Compliance with internal quality standards
• To check degradation and loss of potency over time.
• Differentiation with spurious supply in market place.
Monograph 631-Color & Achromicity
• Defines colour and colourlessness, the visual
observing situation and how colour should be
evaluated visually.
Compliance US Pharmacopoeia regulations
Konica Minolta Sensing Americas, Inc. Instruments Comply
With US Pharmacopeia Regulations, Plus the CM Series
Comply with FDA Code of Federal Regulations Title 21,
Part 11
RAMSEY, N.J. – August 1, 2007 –Konica Minolta Sensing
Americas, Inc. (KMSA), a worldwide leader in measuring,
matching, reproducing, and communicating Color and
Light, announces widespread compliance of KMSA color
and measurement instruments, light booths and software
for the pharmaceutical industry under the guidelines of US
Pharmacopeia and the Food and Drug Administration
(FDA).
Applications
Some colorimetric studies have been made in the field of pharmaceutical
technology. Siddiqui and Nazzal (2007) conclude that there is a
correlation between the surface colour and tensile strength of tablets
and colour measurement could be in use to detect deviations in tablet
hardness.
Chan and coworkers (2001) measured colour distribution on the film
coat using tristimulus colorimeter. Surface colour of tablets has also been
studied by Bogdansky (1975) with tristimulus colorimeter.
Oram and Strine (2006) identified key process parameters of a drug
using colour measurement. Berberich and coworkers (2002) studied
the whiteness of uncoated tablets during storage.
Also the surface coverage of coarse particles which were coated with
coloured or uncoloured stearic acid has been studied (Gren and
Nyström, 1991).