Laboratory Tests Confirmed High Quality Of Neotropin Human Growth Hormone

In November 2010, Neotropin human growth hormone was given to the laboratory for quantitative and qualitative tests. Basing on the test results, lab specialists concluded that Neotropin is a quality and “pure” drug that corresponds all the parameters declared by the manufacturer and can be used for its intended purpose within the limits of prescribed doses.

Testing: A vial containing Neotropin recombinant human growth hormone (somatropin) was given to the laboratory for tests. This vial was properly packed and without any signs of previous opening. It was white powder without any clods and other foreign bodies. Quantitative and qualitative tests were done.

To identify somatropin and get data on the “purity” of the drug such methods as    size-exclusion chromatography, reversed-phase high-performance liquid chromatography (HPLC) and       mass spectrometry (MS)* were used.

Table 1: The Results Of Neotropin Testing

Somatropin

Quantitative test

Qualitative test

Quantity

“Purity”

mg in vial  (±10%, Р=0,95)

iu in vial  (3iu = 1mg, ±10%, Р=0,95)

Reversed phase HPLC

UV 280nm%

Exclusion chromatography

UV 214nm %

Reversed phase HPLC

DAD

210-600nm

Neotropin

4,3

13

98,6

100,0

+

 

Conclusions: the drug contains somatropin in quantity corresponding that declared by the manufacturer; the drug is “pure” and does not include any proteins - substances of chemical degradation of somatropin; Neotropin can be used for its intended purpose within the limits of prescribed doses.

 *Additional information:

Chromatography is the collective term for a set of laboratory techniques for the separation of mixtures. The purpose of chromatography is to separate the component (analyte) of a mixture for further measurements and examination of its physical/chemical properties.

Size-exclusion chromatography (SEC) is a chromatographic method in which molecules in solution are separated by their size, not by molecular weight. It is usually applied to large molecules or macromolecular complexes such as proteins and industrial polymers.

High-performance liquid chromatography is a chromatographic technique that can separate a mixture of compounds and is used in biochemistry and analytical chemistry to identify, quantify and purify the individual components of the mixture.

Mass spectrometry (MS) is an analytical technique that measures the mass-to-charge ratio of charged particles. It is used for determining masses of particles, for determining the elemental composition of a sample or molecule, and for elucidating the chemical structures of molecules, such as peptides and other chemical compounds.

20.Feb.2011

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