**3.2 Contaminant proteins in rhCG preparations versus uhCG**

Recombinant hCG was significantly cleaner but a certain number of other proteins were also identified. Although the majority of these proteins seem to be

**Figure 1.**

*Total ion chromatogram (TIC) of tryptic peptides generated from a Pregnyl formulation.*


**Table 2.**

*Total number of proteins identified in addition to the main therapeutic component in each of the samples' groups.*

**15**

**4. Discussion**

**Figure 2.**

*Background Proteins in Human Chorionic Gonadotropin Pharmaceutical Formulations…*

**u-hCG u-hCG-HP r-hCG**

Protein 1

lipocalin Serum albumin Apolipoprotein D Ribonuclease pancreatic

Protein AMBP

component C7

Growth/differentiation factor Peptidoglycan recognition

Prostaglandin-H2 D-isomerase

Neutrophil gelatinase-associated

Bone marrow proteoglycan complement

Serum albumin Prelamin-A/C Keratin, type I cytoskeletal 9 Keratin, type I cytoskeletal 10 Keratin, type I cytoskeletal 14 Histone H1.2 Jupiter microtubule associated homolog 2 Nucleoside diphosphate kinase A Keratin, type II cytoskeletal 1 Trypsin-3

common contaminants such as keratins, in order to ensure that these proteins do not origin from previous injections of urinary formulations, blank sample injections (buffer used for dissolving peptides) were analyzed before and after the injection of

In European Union, the production and the quality of medical products for both

human and animal use is strongly regulated and controlled from both national

each sample, and the TIC of such a blank injection is shown in **Figure 2**.

*Blank injection following analysis of digested recombinant hCG.*

*DOI: http://dx.doi.org/10.5772/intechopen.82652*

Uromodulin

protein 7 Cystatin-M

**Table 3.**

Ribonuclease pancreatic Nonsecretory ribonuclease Apolipoprotein D Protein AMBP Prothrombin

Growth/differentiation factor 15 Insulin-like growth factor-binding

Prostaglandin-H2 D-isomerase

*Proteins identified with highest scores in analyzed samples.*

*Background Proteins in Human Chorionic Gonadotropin Pharmaceutical Formulations… DOI: http://dx.doi.org/10.5772/intechopen.82652*


#### **Table 3.** *Proteins identified with highest scores in analyzed samples.*

*Embryology - Theory and Practice*

 **3.1 Identification of contaminant proteins in hCG preparations**

ionization and database search using the common SwissProt database.

shows an exemplary total ion chromatogram (TIC) of an hCG sample.

with the highest scores identified in all samples is shown in **Table 3**.

 **3.2 Contaminant proteins in rhCG preparations versus uhCG**

All sample preparations were performed using standard procedures used in the Proteomics Core Facility of the Medical University of Vienna. No gel separations have been performed, and all results are generated upon the in-solution digest of different commercial formulations. Following chromatographic separation of tryptic peptides, the detection was performed using nanoelectrospray positive

For all analyzed samples, active substances were identified as major compounds. However, a number of other proteins were also identified in all samples. **Figure 1**

**Table 2** shows the total number of identified compounds in each of the analyzed sample in addition to the main sample component, and an overview of the proteins

Recombinant hCG was significantly cleaner but a certain number of other proteins were also identified. Although the majority of these proteins seem to be

Sample's commercial name Pregnyl Chorimon Ovitrelle Number of analyzed batches 7 1 1 Origin Urine Urine Recombinant Number of additionally identified proteins 383 21 9

*Total ion chromatogram (TIC) of tryptic peptides generated from a Pregnyl formulation.*

*Total number of proteins identified in addition to the main therapeutic component in each of the samples' groups.*

**3. Results**

**14**

**Table 2.**

**Figure 1.**

**Figure 2.** *Blank injection following analysis of digested recombinant hCG.*

common contaminants such as keratins, in order to ensure that these proteins do not origin from previous injections of urinary formulations, blank sample injections (buffer used for dissolving peptides) were analyzed before and after the injection of each sample, and the TIC of such a blank injection is shown in **Figure 2**.
