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17 Alpha Hydroxyprogesterone is a steroid hormone and can be produced naturally and also artificially. It is a metabolite of progesterone with a hydroxyl group at the 17th alpha position. It is an intermediate between the biosynthesis of hydrocortisone and gonadal steroid hormones. After studying the chemical properties of the compound, it has been found useful in treating recurrent abortion or termination of the fetus. After being used on many women, the drug has being passed for legal use. The drug is completely safe to be used under physician's prescription.

17 Alpha Hydroxyprogesterone is also naturally secreted in the body by the adrenal glands. During pregnancy, the quantity of this secretion increases gradually. During the trimester period of pregnancy, the secretion increases because of the formation of adrenal glands of the fetus. If this secretion is not enough, the fetus is not able to survive and this leads to sudden abortion. To avoid such serious and unwanted circumstances, the hormone is provided externally.

The effect of a dose of 17 Alpha Hydroxyprogesterone differs from person to person and also differs according to the situation. The dose is clinically tested before it can be given to the patients. There are different ways of testing it. Initially it was tested with RAI (radioimmunoassay) and IRMA (immunoradiometric assay). Today, there are much better ways that give quick and accurate results. The most commonly used method is gas chromatography and liquid chromatography. Mass spectrometry is also been widely used all around the world. The does cannot be easily available in any medical store. The legal possession of this drug is possible only if a legally certified physician recommends the drug.

The hormone is highly risky if consumed largely or at the wrong time. This is the reason why you need medical advice. The above discussed is not the only cause for abortion. There are many reasons for it and the medicines vary according to the reason.

Author writes for 17 Alpha Hydroxyprogesterone.

On-Line HPLC as a Toolkit for Process Analytical Technology (PAT) in Pharmaceutical Processes

Process analytical technology (PAT) requires continuous monitoring of quality and this in turn requires a model able to predict product qualities that can be measured in real-time from the values of real-time process measurements. Process scale chromatography plays an important role in the purification of pharmaceutical products. Adjusting the eluent collection points allows the process to compensate for the chromatography variability rather than increased variability in the product purity. In addition to reducing product variability, using on-line HPLC also increases product yield, enables the use of increased levels of automation and reduces overall cycle time.

Determining where the product elution occurs, generally involves collecting the column eluent stream in small volumes that are sampled and analyzed in the laboratory utilizing higher resolution chromatographic techniques such as reversed-phase chromatography. This process of eluent fractionation and off-line chromatographic analysis is performed in process development area in order to generate sufficient process understanding to enable when the product elutes from the process scale chromatography column.

Fractionation of the column eluent has several negative issues associated with it including:

• Degradation of product caused by the delays
• Difficulty automating processing due to manual handling of fractions
• Increased process cycle time caused by time to obtain off-line assays
• Labor intensive
• Error may occur
• Reduced production capacity due to long cycle times
• Opportunities for product contamination
• Storage required for “Work in Process” (the column fractions)

Due to the many negative issues associated with column fractionation, companies strive to eliminate this process operation as quickly as possible. Options to eliminate fractionation include:

1. Collection of product based on column eluent volume.

In this approach, the eluent volume where the product of sufficient purity is expected to elute is determined from historical data and the start collection and stop collection set points are set. An in-line flow meter is used to measure the eluent volume to control the collection of the product of interest as it elutes from the process chromatography column.

The issue with this approach is that it is totally dependent on the reproducibility of the column elution profile which is impacted by column loading, purity of the starting material, column packing, and column gradient generation.

2. Collection of product based on column eluent volume and optical density.

In this approach, an in-line UV sensor set to 280 nm is used to measure the absorbance from the product’s peptide bonds. Since this is a non product specific measurement, the OD sensor’s output is examined in combination with the in-line flow meter to gain an additional level of resolution. That is, the product is only collected when the OD at 280 nm exceeds the OD set point and falls within the volume set point window. This imparts greater selectivity than using the eluent volume approach alone, but is still dependent on the reproducibility of the column’s elution profile.

Although the variability is less with this approach, the lack of a high level of selectivity still leads to conservative collection set points that negatively impact product yields.

3. Measurement of product purity by on-line HPLC.

The critical quality attribute of the product is its purity. Meeting a specified purity value is the criterion that determines if the process chromatography step has been successful and if the in-process material is suitable for forward processing. By transferring the specificity of HPLC to an on-line analyzer, it is possible to directly measure the critical quality attribute in near real time, thus allowing the process decision (i.e., when to start and stop collection of the product eluting from the process chromatography column) to be based on the critical quality attribute rather than being based on a surrogate measurement that is impacted by the process variability.

The increased emphasis on cost reduction and improving production efficiency needs real-time process information. Product safety methodologies result in an increased need to track product quality throughout the manufacturing process. So this on-line HPLC helps to give advanced process control and real-time product release.

About the Author

S.Poongothai, Research Scholar, Bharath University, Chennai-600 073, India.

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Malvern Reveals Blush Brilliance with Morphologi G3
Malvern, UK: A new application note from Malvern Instruments outlines research and methodology for measuring the size, shape and intensity of particles in mineral-based powder make-up, using the Morphologi G3 image analysis based particle characterization system. The freely downloadable publication 'Morphologi G3: Understanding Mineral-based Make-up using Size, Shape and Intensity Measurements ...

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