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Imputities in Peptide APIs - Bachem

Impurities of the Buserelin Ph. Eur. Monograph(Des-Gly ,D-His ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-His )-Buserelin)Impurity AH-8780(Des-Gly ,D-Ser ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Ser )-Buserelin)Impurity BH-8785(Des-Gly ,D-Tyr ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Tyr )-Buserelin)Impurity DH-8790(Des-Gly ,D-Pyr ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Pyr )-Buserelin)Impurity EH-8775(Des-Gly10,D-Ser(tBu)6,Pro-NHEt9) -LHRH(Buserelin)H-4224 Impurities of Exenatide(D-Asn )-Exenatide H-8192(Asp )-ExenatideH-7496(D-Asp )-ExenatideH-8184( -Asp )-ExenatideH-8186( -D-Asp )-ExenatideH-8188(D-His )-ExenatideH-7494 Met(O)

Published by Global Marketing, Bachem Group, July 2017 Custom Synthesis at Bachem Quality • GMP and non-GMP quality • Broad range of impurities and related products • State-of-the-art analytical capabilities • ISO 13485 certified manufacturing site in Vista, USA Chemistry • Fmoc-, Boc-, Z- and other synthetic strategies • Native chemical …

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Transcription of Imputities in Peptide APIs - Bachem

1 Impurities of the Buserelin Ph. Eur. Monograph(Des-Gly ,D-His ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-His )-Buserelin)Impurity AH-8780(Des-Gly ,D-Ser ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Ser )-Buserelin)Impurity BH-8785(Des-Gly ,D-Tyr ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Tyr )-Buserelin)Impurity DH-8790(Des-Gly ,D-Pyr ,D-Ser(tBu) ,Pro-NHEt )-LHRH ((D-Pyr )-Buserelin)Impurity EH-8775(Des-Gly10,D-Ser(tBu)6,Pro-NHEt9) -LHRH(Buserelin)H-4224 Impurities of Exenatide(D-Asn )-Exenatide H-8192(Asp )-ExenatideH-7496(D-Asp )-ExenatideH-8184( -Asp )-ExenatideH-8186( -D-Asp )-ExenatideH-8188(D-His )-ExenatideH-7494 Met(O)

2 -ExenatideH-7498 Acetyl-ExenatideH-7488(Des-Gly )-ExenatideH-7486 Endo-38a-Pro-ExenatideH-7492 ExenatideH-8730 Impurities of Glucagon(Asp )-Glucagon (1-29) (human, rat, porcine)H-8264(Glu )-Glucagon (1-29) (human, rat, porcine)H-8258(Glu )-Glucagon (1-29) (human, rat, porcine)H-8262(Glu 4)-Glucagon (1-29) (human, rat, porcine)H-8266(Des-Thr )-Glucagon H-6156(Des-Thr7)-Glucagon H-6158(Met(O) )-Glucagon (1-29) (human, rat, porcine)H-6148 Glucagon (1-29) (human, rat, porcine) theshop of peptidesMULTIPLE VIAL DISCOUNTCHAT WITH USIMPURITIES INIMPURITIES INPEPTIDE APIPEPTIDE APIsImpurities observed in Peptide apis can be process related impurities, which cannot be removed completely during pu-rifi cation of the crude Peptide or product related impurities that are formed as degradation products during these impurities are byproducts resulting from side reactions occurring during the syntheses, such as racemization, deamidation, oxidation or aspartimide formation.

3 Peptide apis obtained by solid-phase synthesis may additionally contain analogs resulting from deletion or double insertion of amino acids. References of such compounds are needed for analytical method development and release testing, because fulfi lling the specifi cations for byproducts is required by the relevant pharmacopeia and, most importantly, for ensuring the quality of the of GonadorelinLHRH (free acid)(Gonadorelin (free acid))H-4010(D-His )-LHRH ((D-His )-Gonadorelin)H-6782(D-Leu )-LHRH((D-Leu )-Gonadorelin)H-5958 LHRH (1-5) (free acid)(Gonadorelin (1-5))H-6212 LHRH (acetate salt)Gonadorelin (acetate salt)H-4005 Impurities of the Goserelin Ph.

4 Eur. Monograph(D-Ser ,D-Ser(tBu) ,Azagly )-LHRH ((D-Ser )-Goserelin)Impurity AH-5654(Ser(tBu) ,Azagly )-LHRH ((Ser(tBu) )-Goserelin)Impurity BH-6644(Des-Gly ,D-Ser(tBu) ,Pro-NHNH )-LHRH (Decarbamoylgoserelin)Impurity EH-5762(D-Tyr ,D-Ser(tBu) ,Azagly )-LHRH ((D-Tyr )-Goserelin)Impurity FH-5734(D-His ,D-Ser(tBu) ,Azagly )-LHRH ((D-His )-Goserelin)Impurity GH-5796(Ser(Ac) ,D-Ser(tBu) ,Azagly )-LHRH((Ser(Ac) )-Goserelin)Impurity KH-6646(D-Ser(tBu) ,D-Leu ,Azagly )-LHRH ((D-Leu )-Goserelin)Impurity LH-5418(Glu ,D-Ser(tBu) ,Azagly )-LHRH ((Glu1)-Goserelin)H-6652(D-Ser(tBu)6,Aza gly10)-LHRH (Goserelin)H-6395 Impurities of Histrelin(Des-Gly ,D-His ,D-His(Bzl) ,Pro-NHEt )-LHRH ((D-His )-Histrelin)H-4652(Des-Gly ,His(Bzl) ,Pro-NHEt )-LHRH((His(Bzl) )-Histrelin)H-4656(Des-Gly ,D-Ser ,D-His(Bzl) ,Pro-NHEt )-LHRH ((D-Ser )-Histrelin)H-4704(Des-Gly ,D-Tyr ,D-His(Bzl) ,Pro-NHEt )-LHRH ((D-Tyr )-Histrelin)H-4654(Des-Gly ,D-His(Bzl) ,Pro-NHEt )-LHRH (Histrelin)H-9210 Impurities of the Leuprorelin Ph.

5 Eur. Monograph(Des-Gly ,D-Ser ,D-Leu ,Pro-NHEt )-LHRH((D-Ser )-Leuprorelin)Impurity AH-6168(Des-Gly ,D-His ,D-Leu ,Pro-NHEt )-LHRH((D-His )-Leuprorelin)Impurity BH-4316(Des-Gly ,Leu ,Pro-NHEt )-LHRH((Leu )-Leuprorelin)Impurity CH-6402(Des-Gly ,Ser(Ac) ,D-Leu ,Pro-NHEt )-LHRH (Ser(Ac) )-Leuprorelin)Impurity DH-6172(Des-Gly ,D-Trp ,D-Leu ,Pro-NHEt )-LHRH((D-Trp )-Leuprorelin)Impurity EH-6636(Des-Gly ,D-His ,D-Ser ,D-Leu ,Pro-NHEt )-LHRH ((D-His ,D-Ser )-Leuprorelin)Impurity FH-6638(Des-Gly ,D-Tyr ,D-Leu ,Pro-NHEt )-LHRH ((D-Tyr )-Leuprorelin)Impurity GH-4638(Des-Gly ,D-Leu ,D-Leu ,Pro-NHEt )

6 -LHRH ((D-Leu )-Leuprorelin)Impurity HH-4636(Des-Gly ,D-Pyr ,D-Leu ,Pro-NHEt )-LHRH ((D-Pyr )-Leuprorelin)Impurity IH-6642(Des-Gly ,D-Leu ,Orn8,Pro-NHEt )-LHRH ((Orn8)-Leuprorelin)H-6716(Des-Gly10,D-L eu6,Pro-NHEt9)-LHRH(Leuprorelin, Leuprolide)H-4060 Impurities of OctreotideOctreotide (Dimer, Antiparallel) H-7376 Octreotide (Dimer, Parallel) H-7374 OctreotideH-5972 IMPURITIES INPEPTIDE APIsOur e-brochures can be downloaded at and ordered by email at peptides LHRHAGONISTS AND ANTAGONISTSI mpurities of TeriparatidepTH (2-34) (human)H-6786pTH (1-34) (human) (Teriparatide)H-4835 Impurities of Tetracosactide (Cosyntropin)(D-Lys )-ACTH (1-24) (human, bovine, rat)((D-Lys )-Tetracosactide) H-4996(D-Ser )-ACTH (1-24) (human, bovine, rat)((D-Ser )-Tetracosactide) H-4718(Des-Glu )-ACTH (1-24) (human, bovine, rat)((Des-Glu )-Tetracosactide) H-6756(Des-His )-ACTH (1-24) (human, bovine, rat)((Des-His )-Tetracosactide)H-6754(Des-Ser )-ACTH (1-24) (human, bovine, rat)((Des-Ser )-Tetracosactide)H-6742 Endo-4a-Glu-ACTH (1-24) (human, bovine, rat) (Endo-4a-Glu-Tetracosactide)H-6758 ACTH (2-24) (human, bovine, rat)(Tetracosactide (2-24))H-6738 Acetyl-ACTH (3-24)

7 (human, bovine, rat)H-6744 Acetyl-ACTH (7-24) (human, bovine, rat)H-6752 ACTH (1-24) (human, bovine, rat)(Tetracosactide, Cosyntropin)H-1150 Impurities of Triptorelin(D-Trp )-LHRH (free acid)(Triptorelin (free acid))H-3078(D-Trp ,D-Leu )-LHRH((D-Leu )-Triptorelin)H-4648(D-Ser ,D-Trp )-LHRH((D-Ser )-Triptorelin)H-4644(D-Tyr ,D-Trp )-LHRH((D-Tyr )-Triptorelin)H-4646(D-Trp )-LHRH (acetate salt)(Triptorelin (acetate salt))H-4075(D-Trp )-LHRH (pamoate salt)(Triptorelin (pamoate salt))H-6150 Impurities of AntazolineN-(2-Aminoethyl)-2-(benzylphen ylamino)acetamide maleate Impurity A of Antazoline Hydrochloride Ph.

8 (N-Phenyl-N-benzyl-aminomethyl)-imidazol e Q-2755 Antazoline HClQ-2185 Antazoline H PO Q-2695 Antazoline H SO Q-2115 Impurities of L-Alanyl-L-Glutamine for Parenteral NutritionH-Ala-D-Gln-OHG-3685H-D-Ala-Gln -OHG-3690H-Ala-Glu-OHG-1200H-Ala-Ala-Gln -OHH-2552 Cyclo(-Ala-Gln)G-4770 Cyclo(-Ala-Glu)G-4775H-Ala-Gln-OHG-1210 Impurities of the Aspartame Ph. Eur. MonographCyclo(-Asp-Phe)Impurity AG-1695H-Asp-Phe-OHImpurity BG-1620H-Phe-OHImpurity CE-2230 AspartameG-1545 CUSTOM Peptide SYNTHESIS @BACHEMIn addition to our thousands of catalog peptides , we offer comprehensive custom synthesis the Peptide you require is not included in this list, please ask for a by global Marketing, Bachem Group, July 2017 Custom Synthesis at Bachem Quality GMP and non-GMP quality Broad range of impurities and related products State-of-the-art analytical capabilities ISO 13485 certified manufacturing site in Vista, USA Chemistry Fmoc-, Boc.

9 Z- and other synthetic strategies Native chemical ligation Synthesis of complex peptides Capacity Production sites in the USA and Europe Largest production facilities in the market Up-to-date technology Modifi cations Acylation, acetylation, amidation, PEGylation, glycosylation etc. Cyclizations Stabilizing modifications Support Highly qualified technical support team Documentation Confidentiality Partnering to achieve client objectivesPublished by global Marketing, Bachem Group, February 2015 All information is compiled to the best of our knowledge. We cannot be made liable for any possible errors or misprints.

10 Some products may be restricted in certain com & Sales Contact Europe, Africa, Middle East and Asia Pacifi cBachem AGTel. +41 58 595 Americas, +1 888 422 2436 (toll-free in USA & Canada) +1 310 539 our website or shop online published by global Marketing, Bachem Group, October 2017 All information is compiled to the best of our knowledge. We cannot be made liable for any possible errors or misprints. Some products may be restricted in certain


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