Superior purity and safety: Phenol red suitable for biopharmaceutical production
EMD’s new Phenol red suitable for biopharmaceutical production features an unprecedented purity of over 98 percent – for higher quality and safety of vaccines and other biopharmaceuticals.
| Your benefits | |
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| Superior purity: Includes HPLC test for minimum purity of > 98%. |
Superior safety: You know what’s inside your biopharmaceutical. |
Phenol red – The purity is important
Phenol red, also known as phenolsulfonphthalein or PSP, is most commonly used as pH indicator, for example in acidimetric titrations. Another important application is found in biopharmaceutical manufacturing where it serves as pH indicator in cell culture and fermentation processes. When used in biopharmaceutical production, maximum purity is very important: Many vaccines include traces of phenol red due to the fact that this compound can hardly be completely removed in the purification process.
Conventional quality grades of phenol red, like the ACS grade, are specified to purpose, ensuring that the compound meets the pH transition points at pH 1.2-3.0 and pH 6.5-8.0. However, these specifications do not include any analysis regarding purity. Therefore, the monograph of phenol red in the European Pharmacopoeia relevant for applications in biopharmaceutical manufacturing includes two analyses related to purity: the determination of the assay and a purity test by thin-layer chromatography (TLC).
| Phenol red | |
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| Phenol red suitable for the biopharmaceutical production | Conventional grades of phenol red |
Phenol red suitable for biopharmaceutical production - Good to know what’s inside
Merck decided to develop a new quantitative test for exactly determining the purity of phenol red. The method of choice was High Pressure Liquid Chromatography (HPLC) which does not exhibit the same shortcomings as the bromatometric titration used according to Ph. Eur.
Bromitometric titration not only determines the compound phenol red itself but related substances as well. Therefore, the method tends to give a higher assay than the substance really has. The purity test by TLC, on the other hand, shows slightly coloured spots which simulate a lower concentration than effectively present.
Using the new developed method HPLC, we have been able to show that conventional grades of phenol red have a purity of only 60 up to 90% – not sufficient for biopharmaceutical production.
Phenol red suitable for biopharmaceutical production - Unprecedented purity
In order to remove these impurities, our chemists developed a novel purification strategy yielding a phenol red in never-before-seen purity of > 98%. As a consequence, our new item “1.37038 Phenol red suitable for biopharmaceutical production” is not only specified to match the monograph of the Ph. Eur. but includes the HPLC test for minimum 98% purity. Using this new offer from Merck, you can effectively rule out contamination of your products with phenol red impurities – for higher quality and safety.
