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The first report is in, once the graphics are in I'll post them here:
we have completed the tests of the four samples and are writing the report. We
checked the identity, content (strength) and related proteins against the
standard Somatropin CRS batch 3 from EDQM.
Identity was checked by MALDI-TOF-MS peptide mass fingerprint analysis of
trypsin digests. All samples gave very similar results as the Somatropin CRS,
thus all samples really contain somatropin.
For strength and related proteins, reversed-phase HPLC was performed according
to the supplied standard testing procedure. Tthe strength has been calculated
using the peak area of the main signal, which had the same retention time as the
signal of the standard. The peak area of the related proteins
(desamido-somatropin) is given in percent of total peak area. Strength is given
in mg per vial and i.u.
KIGTROPIN 10iu (Tober_6387-2) 0.8 mg (2.4 i.u.), 8.8% related proteins
BLUE TOP HGH 10iu (Tober_6387-3) 2.54 mg (7.6 i.u.), 7.7% related proteins
HYGETROPIN 10iu (Tober_6387-4) 4.36 mg (13 i.u.), 0.9% related proteins
Elitropin Black Top10 iu (Tober_6387-5) 2.28 mg (6.8 i.u.), 1.5% related proteins.
The report will contain method descriptions, spectra and identified peptides
from the trypsin digests, and the HPLC chromatograms for quantitation.
Best regards,
we have completed the tests of the four samples and are writing the report. We
checked the identity, content (strength) and related proteins against the
standard Somatropin CRS batch 3 from EDQM.
Identity was checked by MALDI-TOF-MS peptide mass fingerprint analysis of
trypsin digests. All samples gave very similar results as the Somatropin CRS,
thus all samples really contain somatropin.
For strength and related proteins, reversed-phase HPLC was performed according
to the supplied standard testing procedure. Tthe strength has been calculated
using the peak area of the main signal, which had the same retention time as the
signal of the standard. The peak area of the related proteins
(desamido-somatropin) is given in percent of total peak area. Strength is given
in mg per vial and i.u.
KIGTROPIN 10iu (Tober_6387-2) 0.8 mg (2.4 i.u.), 8.8% related proteins
BLUE TOP HGH 10iu (Tober_6387-3) 2.54 mg (7.6 i.u.), 7.7% related proteins
HYGETROPIN 10iu (Tober_6387-4) 4.36 mg (13 i.u.), 0.9% related proteins
Elitropin Black Top10 iu (Tober_6387-5) 2.28 mg (6.8 i.u.), 1.5% related proteins.
The report will contain method descriptions, spectra and identified peptides
from the trypsin digests, and the HPLC chromatograms for quantitation.
Best regards,
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