Cosmic Peptides research library

Sources

Every source cited in the research library: 130 in all, each checked against the publisher's or issuing body's own record before it was cited, with the pages that cite it.

Last reviewed · Editorial policy

Peer-reviewed literature and reference books

  1. Aguilar MI. Reversed-phase high-performance liquid chromatography. In: Aguilar MI, ed. HPLC of Peptides and Proteins: Methods and Protocols. Methods in Molecular Biology, vol. 251. Humana Press; 2004:9–22. doi:10.1385/1-59259-742-4:9Cited in: HPLC purity analysis of peptides, Purity depends on the method
  2. Andrushchenko VV, Vogel HJ, Prenner EJ. Optimization of the hydrochloric acid concentration used for trifluoroacetate removal from synthetic peptides. Journal of Peptide Science 2007;13(1):37–43. doi:10.1002/psc.793Cited in: Peptide salt forms: trifluoroacetate, acetate and hydrochloride, The salt form matters
  3. Behrendt R, White P, Offer J. Advances in Fmoc solid-phase peptide synthesis. Journal of Peptide Science 2016;22(1):4–27. doi:10.1002/psc.2836Cited in: Peptide salt forms: trifluoroacetate, acetate and hydrochloride, How synthetic peptides are made
  4. Bhushan R, Brückner H. Marfey's reagent for chiral amino acid analysis: a review. Amino Acids 2004;27(3–4):231–247. doi:10.1007/s00726-004-0118-0Cited in: Chiral analysis: finding D-amino acid impurities
  5. Biemann K. Contributions of mass spectrometry to peptide and protein structure. Biomedical and Environmental Mass Spectrometry 1988;16(1–12):99–111. doi:10.1002/bms.1200160119Cited in: Sequencing peptides by tandem mass spectrometry, The right mass does not prove the right peptide
  6. Bolden J, Smith K. Application of recombinant factor C reagent for the detection of bacterial endotoxins in pharmaceutical products. PDA Journal of Pharmaceutical Science and Technology 2017;71(5):405–412. doi:10.5731/pdajpst.2017.007849Cited in: Endotoxin in peptide research materials
  7. Burkitt WI, Pritchard C, Arsene C, Henrion A, Bunk D, O'Connor G. Toward Système International d'Unité-traceable protein quantification: from amino acids to proteins. Analytical Biochemistry 2008;376(2):242–251. doi:10.1016/j.ab.2008.02.010Cited in: Net peptide content and purity: two different numbers, Amino acid analysis of peptides
  8. Carpino LA, Han GY. 9-Fluorenylmethoxycarbonyl amino-protecting group. The Journal of Organic Chemistry 1972;37(22):3404–3409. doi:10.1021/jo00795a005Cited in: How synthetic peptides are made
  9. Cohen SA, Michaud DP. Synthesis of a fluorescent derivatizing reagent, 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate, and its application for the analysis of hydrolysate amino acids via high-performance liquid chromatography. Analytical Biochemistry 1993;211(2):279–287. doi:10.1006/abio.1993.1270Cited in: Amino acid analysis of peptides
  10. Cornish J, Callon KE, Lin CQ, Xiao CL, Mulvey TB, Cooper GJ, et al. Trifluoroacetate, a contaminant in purified proteins, inhibits proliferation of osteoblasts and chondrocytes. American Journal of Physiology–Endocrinology and Metabolism 1999;277(5):E779–E783. doi:10.1152/ajpendo.1999.277.5.E779Cited in: Peptide salt forms: trifluoroacetate, acetate and hydrochloride, The salt form matters
  11. D'Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, et al. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012Cited in: HPLC purity analysis of peptides, Mass spectrometry for peptide identity, How to read a certificate of analysis, How synthetic peptides are made, Related substances on a certificate of analysis, A mass spectrum does not prove purity, One certificate covers one lot, The right mass does not prove the right peptide, A clean-looking powder is not proof of a clean peptide
  12. Dawson PE, Muir TW, Clark-Lewis I, Kent SB. Synthesis of proteins by native chemical ligation. Science 1994;266(5186):776–779. doi:10.1126/science.7973629Cited in: How synthetic peptides are made
  13. Ding JL, Ho B. A new era in pyrogen testing. Trends in Biotechnology 2001;19(8):277–281. doi:10.1016/S0167-7799(01)01694-8Cited in: Endotoxin in peptide research materials
  14. El-Faham A, Albericio F. Peptide coupling reagents, more than a letter soup. Chemical Reviews 2011;111(11):6557–6602. doi:10.1021/cr100048wCited in: How synthetic peptides are made
  15. Fenn JB, Mann M, Meng CK, Wong SF, Whitehouse CM. Electrospray ionization for mass spectrometry of large biomolecules. Science 1989;246(4926):64–71. doi:10.1126/science.2675315Cited in: Mass spectrometry for peptide identity, How to read a certificate of analysis, A mass spectrum does not prove purity
  16. Fischer K. Neues Verfahren zur maßanalytischen Bestimmung des Wassergehaltes von Flüssigkeiten und festen Körpern. Angewandte Chemie 1935;48(26):394–396. doi:10.1002/ange.19350482605Cited in: Net peptide content and purity: two different numbers, Water content of peptides: Karl Fischer titration
  17. Fountoulakis M, Lahm HW. Hydrolysis and amino acid composition analysis of proteins. Journal of Chromatography A 1998;826(2):109–134. doi:10.1016/S0021-9673(98)00721-3Cited in: Amino acid analysis of peptides
  18. Frank H, Nicholson GJ, Bayer E. Rapid gas chromatographic separation of amino acid enantiomers with a novel chiral stationary phase. Journal of Chromatographic Science 1977;15(5):174–176. doi:10.1093/chromsci/15.5.174Cited in: Chiral analysis: finding D-amino acid impurities
  19. Geiger T, Clarke S. Deamidation, isomerization, and racemization at asparaginyl and aspartyl residues in peptides. Succinimide-linked reactions that contribute to protein degradation. Journal of Biological Chemistry 1987;262(2):785–794. doi:10.1016/S0021-9258(19)75855-4Cited in: Peptide stability and storage, The right mass does not prove the right peptide, Freeze-dried does not mean stable forever
  20. Goebel-Stengel M, Stengel A, Taché Y, Reeve JR. The importance of using the optimal plasticware and glassware in studies involving peptides. Analytical Biochemistry 2011;414(1):38–46. doi:10.1016/j.ab.2011.02.009Cited in: Peptide stability and storage
  21. Gorbet MB, Sefton MV. Endotoxin: the uninvited guest. Biomaterials 2005;26(34):6811–6817. doi:10.1016/j.biomaterials.2005.04.063Cited in: Endotoxin in peptide research materials, Endotoxin matters in the laboratory too
  22. Holzgrabe U. Quantitative NMR spectroscopy in pharmaceutical applications. Progress in Nuclear Magnetic Resonance Spectroscopy 2010;57(2):229–240. doi:10.1016/j.pnmrs.2010.05.001Cited in: Net peptide content and purity: two different numbers
  23. Isidro-Llobet A, Álvarez M, Albericio F. Amino acid-protecting groups. Chemical Reviews 2009;109(6):2455–2504. doi:10.1021/cr800323sCited in: How synthetic peptides are made
  24. Iwanaga S. Biochemical principle of Limulus test for detecting bacterial endotoxins. Proceedings of the Japan Academy, Series B 2007;83(4):110–119. doi:10.2183/pjab.83.110Cited in: Endotoxin in peptide research materials
  25. Kaiser E. Determination of residual trifluoroacetate in protein purification buffers and peptide preparations by ion chromatography. Journal of Chromatography A 2004;1039(1–2):113–117. doi:10.1016/S0021-9673(04)00495-9Cited in: Net peptide content and purity: two different numbers, Peptide salt forms: trifluoroacetate, acetate and hydrochloride
  26. Karas M, Hillenkamp F. Laser desorption ionization of proteins with molecular masses exceeding 10,000 daltons. Analytical Chemistry 1988;60(20):2299–2301. doi:10.1021/ac00171a028Cited in: Mass spectrometry for peptide identity
  27. Kent SB. Chemical synthesis of peptides and proteins. Annual Review of Biochemistry 1988;57:957–989. doi:10.1146/annurev.bi.57.070188.004521Cited in: How synthetic peptides are made
  28. Lai MC, Topp EM. Solid-state chemical stability of proteins and peptides. Journal of Pharmaceutical Sciences 1999;88(5):489–500. doi:10.1021/js980374eCited in: Peptide stability and storage, Freeze-dried does not mean stable forever, A clean-looking powder is not proof of a clean peptide
  29. Li S, Schöneich C, Borchardt RT. Chemical instability of protein pharmaceuticals: mechanisms of oxidation and strategies for stabilization. Biotechnology and Bioengineering 1995;48(5):490–500. doi:10.1002/bit.260480511Cited in: Peptide stability and storage
  30. Liardon R, Ledermann S, Ott U. Determination of D-amino acids by deuterium labeling and selected ion monitoring. Journal of Chromatography A 1981;203:385–395. doi:10.1016/S0021-9673(00)80309-XCited in: Chiral analysis: finding D-amino acid impurities
  31. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6Cited in: Peptide stability and storage, Freeze-dried does not mean stable forever, A clean-looking powder is not proof of a clean peptide
  32. Mant CT, Chen Y, Yan Z, Popa TV, Kovacs JM, Mills JB, et al. HPLC analysis and purification of peptides. In: Fields GB, ed. Peptide Characterization and Application Protocols. Methods in Molecular Biology, vol. 386. Humana Press; 2007:3–55. doi:10.1007/978-1-59745-430-8_1Cited in: HPLC purity analysis of peptides, How to read a certificate of analysis, Related substances on a certificate of analysis, A mass spectrum does not prove purity
  33. Marfey P. Determination of D-amino acids. II. Use of a bifunctional reagent, 1,5-difluoro-2,4-dinitrobenzene. Carlsberg Research Communications 1984;49(6):591–596. doi:10.1007/BF02908688Cited in: Chiral analysis: finding D-amino acid impurities
  34. Mergler M, Dick F, Sax B, Weiler P, Vorherr T. The aspartimide problem in Fmoc-based SPPS. Part I. Journal of Peptide Science 2003;9(1):36–46. doi:10.1002/psc.430Cited in: How synthetic peptides are made
  35. Merrifield RB. Solid phase peptide synthesis. I. The synthesis of a tetrapeptide. Journal of the American Chemical Society 1963;85(14):2149–2154. doi:10.1021/ja00897a025Cited in: How synthetic peptides are made
  36. Paizs B, Suhai S. Fragmentation pathways of protonated peptides. Mass Spectrometry Reviews 2005;24(4):508–548. doi:10.1002/mas.20024Cited in: Sequencing peptides by tandem mass spectrometry
  37. Palasek SA, Cox ZJ, Collins JM. Limiting racemization and aspartimide formation in microwave-enhanced Fmoc solid phase peptide synthesis. Journal of Peptide Science 2007;13(3):143–148. doi:10.1002/psc.804Cited in: How synthetic peptides are made, Chiral analysis: finding D-amino acid impurities, The right mass does not prove the right peptide
  38. Paradís-Bas M, Tulla-Puche J, Albericio F. The road to the synthesis of "difficult peptides". Chemical Society Reviews 2016;45(3):631–654. doi:10.1039/c5cs00680eCited in: How synthetic peptides are made
  39. Raetz CR, Whitfield C. Lipopolysaccharide endotoxins. Annual Review of Biochemistry 2002;71:635–700. doi:10.1146/annurev.biochem.71.110601.135414Cited in: Endotoxin in peptide research materials, Endotoxin matters in the laboratory too
  40. Reich J, Weyer F, Tamura H, Nagaoka I, Motschmann H. Low endotoxin recovery—masking of naturally occurring endotoxin. International Journal of Molecular Sciences 2019;20(4):838. doi:10.3390/ijms20040838Cited in: Endotoxin in peptide research materials
  41. Roepstorff P, Fohlman J. Letter to the editors: proposal for a common nomenclature for sequence ions in mass spectra of peptides. Biomedical Mass Spectrometry 1984;11(11):601. doi:10.1002/bms.1200111109Cited in: Sequencing peptides by tandem mass spectrometry
  42. Roepstorff P, Fohlman J. Proposal for a common nomenclature for sequence ions in mass spectra of peptides [letter]. Biomedical Mass Spectrometry 1984;11(11):601. doi:10.1002/bms.1200111109Cited in: Mass spectrometry for peptide identity
  43. Roux S, Zékri E, Rousseau B, Paternostre M, Cintrat JC, Fay N. Elimination and exchange of trifluoroacetate counter-ion from cationic peptides: a critical evaluation of different approaches. Journal of Peptide Science 2008;14(3):354–359. doi:10.1002/psc.951Cited in: Peptide salt forms: trifluoroacetate, acetate and hydrochloride
  44. Rutherfurd SM, Gilani GS. Amino acid analysis. Current Protocols in Protein Science 2009;58(1):Unit 11.9. doi:10.1002/0471140864.ps1109s58Cited in: Net peptide content and purity: two different numbers, Amino acid analysis of peptides, “99% pure” is not 99% peptide
  45. Scholz E. Karl Fischer Titration. Chemical Laboratory Practice. Springer; 1984. doi:10.1007/978-3-642-69989-4Cited in: Water content of peptides: Karl Fischer titration
  46. Schwarz H, Schmittner M, Duschl A, Horejs-Hoeck J. Residual endotoxin contaminations in recombinant proteins are sufficient to activate human CD1c+ dendritic cells. PLoS ONE 2014;9(12):e113840. doi:10.1371/journal.pone.0113840Cited in: Endotoxin in peptide research materials, Endotoxin matters in the laboratory too
  47. Sikora K, Jaśkiewicz M, Neubauer D, Migoń D, Kamysz W. The role of counter-ions in peptides—an overview. Pharmaceuticals 2020;13(12):442. doi:10.3390/ph13120442Cited in: Net peptide content and purity: two different numbers, Peptide salt forms: trifluoroacetate, acetate and hydrochloride, “99% pure” is not 99% peptide, The salt form matters
  48. Snyder LR, Kirkland JJ, Dolan JW. Introduction to Modern Liquid Chromatography. 3rd ed. Wiley; 2010. doi:10.1002/9780470508183Cited in: HPLC purity analysis of peptides, Purity depends on the method
  49. Spackman DH, Stein WH, Moore S. Automatic recording apparatus for use in chromatography of amino acids. Analytical Chemistry 1958;30(7):1190–1206. doi:10.1021/ac60139a006Cited in: Amino acid analysis of peptides
  50. Steen H, Mann M. The abc's (and xyz's) of peptide sequencing. Nature Reviews Molecular Cell Biology 2004;5(9):699–711. doi:10.1038/nrm1468Cited in: Mass spectrometry for peptide identity, Sequencing peptides by tandem mass spectrometry
  51. Stoppacher N, Josephs RD, Daireaux A, Choteau T, Westwood SW, Wielgosz RI. Impurity identification and determination for the peptide hormone angiotensin I by liquid chromatography–high-resolution tandem mass spectrometry and the metrological impact on value assignments by amino acid analysis. Analytical and Bioanalytical Chemistry 2013;405(25):8039–8051. doi:10.1007/s00216-013-6953-7Cited in: Net peptide content and purity: two different numbers, Amino acid analysis of peptides, Related substances on a certificate of analysis
  52. Syka JE, Coon JJ, Schroeder MJ, Shabanowitz J, Hunt DF. Peptide and protein sequence analysis by electron transfer dissociation mass spectrometry. Proceedings of the National Academy of Sciences of the United States of America 2004;101(26):9528–9533. doi:10.1073/pnas.0402700101Cited in: Sequencing peptides by tandem mass spectrometry
  53. Westwood S, Choteau T, Daireaux A, Josephs RD, Wielgosz RI. Mass balance method for the SI value assignment of the purity of organic compounds. Analytical Chemistry 2013;85(6):3118–3126. doi:10.1021/ac303329kCited in: Net peptide content and purity: two different numbers, “99% pure” is not 99% peptide

Court decisions

  1. Amarin Pharma, Inc. v. Food and Drug Administration, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).Cited in: Who decides what a product is for?
  2. Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001); POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014); Lexmark International, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014); California v. Zook, 336 U.S. 725 (1949).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  3. Holistic Candlers and Consumers Association v. Food and Drug Administration, 664 F.3d 940 (D.C. Cir. 2012).Cited in: Who decides what a product is for?
  4. Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).Cited in: Who decides what a product is for?
  5. Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  6. United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).Cited in: Who decides what a product is for?
  7. United States v. Dotterweich, 320 U.S. 277 (1943).Cited in: What "research use only" means in law
  8. United States v. Park, 421 U.S. 658 (1975).Cited in: What "research use only" means in law, Common mistakes in research-use-only supply, What strict compliance costs
  9. Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004).Cited in: Who decides what a product is for?

FDA warning letters

  1. Food and Drug Administration, CDER. Warning letters to online peptide sellers dated March 31, 2026 and August 24, 2026, as listed in the second article of this series.Cited in: What strict compliance costs, Where research-use-only regulation is heading
  2. Food and Drug Administration, CDER. Warning letters to online peptide sellers dated March 31, 2026 and August 24, 2026, including reference 734884.Cited in: Who decides what a product is for?
  3. Food and Drug Administration, CDER. Warning letters to online sellers of research-labeled peptides, 2024 to 2026, as listed in the FDA enforcement tracker.Cited in: Questions we don't answer, and why
  4. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 668918. February 7, 2024.Cited in: FDA enforcement tracker
  5. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 694608. December 10, 2024.Cited in: FDA enforcement tracker
  6. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 695156. December 10, 2024.Cited in: FDA enforcement tracker
  7. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 695607. December 10, 2024.Cited in: FDA enforcement tracker
  8. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 695663. December 10, 2024.Cited in: FDA enforcement tracker
  9. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 696885. February 26, 2025.Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  10. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 721088. March 31, 2026.Cited in: How the FDA decides what a product is for, FDA enforcement tracker
  11. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 721600. March 31, 2026.Cited in: FDA enforcement tracker
  12. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 721709. March 31, 2026.Cited in: How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  13. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 721805. March 31, 2026.Cited in: How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  14. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 721806. March 31, 2026.Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  15. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 729447. June 17, 2026.Cited in: How the FDA decides what a product is for, FDA enforcement tracker
  16. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 733652. August 24, 2026.Cited in: How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  17. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 734884. August 24, 2026.Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  18. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 735063. August 24, 2026.Cited in: How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  19. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 735067. August 24, 2026.Cited in: How the FDA decides what a product is for, FDA enforcement tracker
  20. Food and Drug Administration, Center for Drug Evaluation and Research. Warning letter, reference 735127. August 24, 2026.Cited in: How the FDA decides what a product is for, Common mistakes in research-use-only supply, FDA enforcement tracker
  21. Food and Drug Administration. Regulatory Procedures Manual, Chapter 4: Advisory Actions (Warning Letters and Untitled Letters).Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, What strict compliance costs, Where research-use-only regulation is heading, Who decides what a product is for?, Questions we don't answer, and why, FDA enforcement tracker

Statutes, regulations and FDA documents

  1. 21 CFR 10.115, Good guidance practices.Cited in: Who decides what a product is for?
  2. 21 CFR 10.30, Citizen petition.Cited in: Who decides what a product is for?
  3. 21 CFR 201.128, Meaning of "intended uses".Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, What strict compliance costs, Where research-use-only regulation is heading, Who decides what a product is for?, Questions we don't answer, and why, FDA enforcement tracker
  4. 21 CFR 201.5, Drugs; adequate directions for use.Cited in: What "research use only" means in law
  5. 21 CFR 809.10(c), Labeling for in vitro diagnostic products.Cited in: What "research use only" means in law
  6. 21 CFR part 312, Investigational new drug application.Cited in: What "research use only" means in law
  7. 35 U.S.C. § 271(e)(1); 21 U.S.C. § 337(a).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  8. Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act, Pub. L. 113-54 (2013).Cited in: Where research-use-only regulation is heading
  9. Eli Lilly & Co. v. Kennedy, No. 1:24-cv-01503 (S.D. Ind. Sept. 30, 2025); appeal No. 26-1301 (7th Cir., argued Sept. 24, 2026). Definition of the term "biological product", 85 FR 10057 (Feb. 21, 2020); 21 CFR 600.3(h)(6).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  10. Federal Food, Drug, and Cosmetic Act § 201(g)(1); 21 U.S.C. § 321(g)(1).Cited in: Where research-use-only regulation is heading, Who decides what a product is for?, Questions we don't answer, and why
  11. Federal Food, Drug, and Cosmetic Act §§ 201(g)(1), 201(p), 301, 303, 502(f), 505(a), 505(i); 21 U.S.C. §§ 321(g)(1), 321(p), 331, 333, 352(f), 355(a), 355(i).Cited in: What "research use only" means in law
  12. Federal Food, Drug, and Cosmetic Act §§ 201(g)(1), 201(p), 301, 303, 505(a); 21 U.S.C. §§ 321, 331, 333, 355.Cited in: Common mistakes in research-use-only supply
  13. Federal Food, Drug, and Cosmetic Act §§ 201(g)(1), 201(p), 301(d), 505(a); 21 U.S.C. §§ 321(g)(1), 321(p), 331(d), 355(a).Cited in: How the FDA decides what a product is for
  14. Federal Food, Drug, and Cosmetic Act §§ 301, 303; 21 U.S.C. §§ 331, 333.Cited in: What strict compliance costs
  15. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance. Annual Report 2025. April 2026.Cited in: How the FDA decides what a product is for, What strict compliance costs, Where research-use-only regulation is heading
  16. Food and Drug Administration. Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. Guidance for industry and FDA staff. November 2013.Cited in: What "research use only" means in law
  17. Food and Drug Administration. FDA expands artificial intelligence capabilities with agentic AI deployment. Press announcement, December 1, 2025.Cited in: Common mistakes in research-use-only supply, Where research-use-only regulation is heading
  18. Food and Drug Administration. FDA launches agency-wide AI tool to optimize performance for the American people. Press announcement, June 2, 2025.Cited in: How the FDA decides what a product is for, Where research-use-only regulation is heading
  19. Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. Drug alerts and statements; content current as of October 1, 2026.Cited in: Where research-use-only regulation is heading
  20. Food and Drug Administration. Import Alert 66-41: Detention without physical examination of unapproved new drugs promoted in the U.S.Cited in: How the FDA decides what a product is for, Where research-use-only regulation is heading
  21. Food and Drug Administration. Import Alert 66-80: GLP-1 receptor agonist active pharmaceutical ingredients (green list).Cited in: How the FDA decides what a product is for, Where research-use-only regulation is heading
  22. Food and Drug Administration. Regulations regarding "intended uses". Final rule. Federal Register 2021;86:41383. August 2, 2021.Cited in: What "research use only" means in law, Who decides what a product is for?
  23. U.S. Food and Drug Administration. FDA's concerns with unapproved GLP-1 drugs used for weight loss. June 15, 2026.Cited in: Lilly's retatrutide lawsuits: what the dockets say

Standards, guidelines and other sources

  1. Amended Complaint, Dkt. 6 (Aug. 31, 2026); Notice of Voluntary Dismissal, Dkt. 7 (Sept. 2, 2026); Motion to Allow Pre-Service Discovery to Determine Defendant's Identity, Dkt. 8 (Sept. 30, 2026), No. 5:26-cv-05147 (W.D. Tex.).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  2. CBS News. Report on two deaths submitted to FDA's adverse-event system after use of products represented as retatrutide. October 13, 2026.Cited in: Lilly's retatrutide lawsuits: what the dockets say
  3. Complaint and Motion to Dismiss under Rules 12(b)(1) and 12(b)(6), No. 1:26-cv-00347 (E.D. Tex.), Dkts. 1 (Aug. 12, 2026) and 12 (Oct. 2, 2026); Order setting Rule 16 conference, Dkt. 19 (Oct. 19, 2026).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  4. Complaint and Order approving settlement, Eli Lilly & Co. v. [research-grade seller], No. 2:24-cv-01719 (W.D. Wash. filed Oct. 21, 2024; order May 20, 2025).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  5. Complaint, Eli Lilly & Co. v. [compounding pharmacy], No. 4:26-cv-06563 (S.D. Tex. filed Aug. 12, 2026), Dkt. 1; Revised Joint Discovery/Case Management Plan, Dkt. 27 (Oct. 5, 2026); Order following scheduling conference, Dkt. 28 (Oct. 5, 2026); Order extending time to respond, Dkt. 30 (Oct. 20, 2026).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  6. Complaints filed Oct. 8, 2026: No. 5:26-cv-04146 (W.D. La.); No. 4:26-cv-08806 (S.D. Tex.); No. 3:26-cv-03514 (N.D. Tex.); No. 2:26-cv-07361 (D. Ariz.); No. 4:26-cv-01294 (N.D. Tex.).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  7. Eli Lilly and Company. Lilly calls on online platforms, payment companies and regulators to shut down the illegal retatrutide black market. News release, August 12, 2026.Cited in: Lilly's retatrutide lawsuits: what the dockets say
  8. European Pharmacopoeia. 2.5.12 Water: semi-micro determination; 2.5.32 Water: micro determination.Cited in: Water content of peptides: Karl Fischer titration
  9. European Pharmacopoeia. General monograph 2034, Substances for pharmaceutical use.Cited in: Related substances on a certificate of analysis
  10. Holland & Knight. Peptides at a crossroads: what wellness providers need to know about HHS and FDA actions. October 16, 2026.Cited in: Lilly's retatrutide lawsuits: what the dockets say
  11. International Council for Harmonisation. ICH Q2(R2): Validation of Analytical Procedures. Adopted 2023.Cited in: HPLC purity analysis of peptides, How to read a certificate of analysis, Purity depends on the method
  12. International Council for Harmonisation. ICH Q3A(R2): Impurities in New Drug Substances. 2006.Cited in: Related substances on a certificate of analysis
  13. International Organization for Standardization and International Electrotechnical Commission. ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories. 2017.Cited in: How to read a certificate of analysis, One certificate covers one lot
  14. Mealey's Litigation Report. Judge won't approve consent judgment reached by Lilly, others in tirzepatide suit (July 2026); Lilly, medical centers file stipulation of dismissal in compounded drug row (June 2026).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  15. Memorandum and Order, No. 4:25-cv-03464 (S.D. Tex. Apr. 29, 2026) (dismissing Lanham Act and Texas common-law counts; state consumer-protection counts proceed).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  16. Notice of Voluntary Dismissal with Prejudice, Dkt. 11 (Oct. 15, 2026), No. 5:26-cv-05146 (W.D. Tex.).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  17. Notice of Voluntary Dismissal with Prejudice, Dkt. 6 (Sept. 11, 2026), No. 2:26-cv-02764 (E.D. Cal.).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  18. Order on motion to dismiss, No. 2:25-cv-03570 (C.D. Cal. Feb. 3, 2026) (dismissing with prejudice for lack of Lanham Act standing).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  19. Orders on motions to dismiss, No. 3:25-cv-03534 (N.D. Cal. Oct. 24, 2025; Apr. 20, 2026; Sept. 8, 2026).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  20. Orders, Novo Nordisk Inc. v. [compounding pharmacy], No. 8:23-cv-1503 (M.D. Fla. Nov. 8, 2023, and later); No. 3:23-cv-808 (M.D. Fla. Jan. 30, 2025); Novo Nordisk Inc. v. [clinic], No. 8:24-cv-2292 (M.D. Fla. Apr. 17, 2025).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  21. Plaintiff's Motion to Strike or Excuse Compliance with Discovery Planning Deadline, Dkt. 9 (Sept. 11, 2026), and Notice of Voluntary Dismissal with Prejudice, Dkt. 10 (Oct. 16, 2026), No. 4:26-cv-06562 (S.D. Tex.).Cited in: Lilly's retatrutide lawsuits: what the dockets say
  22. United States Attorney's Office, Northern District of Indiana. Sentencing of the operators of an online peptide business, July 30, 2026.Cited in: What "research use only" means in law, How the FDA decides what a product is for, Common mistakes in research-use-only supply, What strict compliance costs, Where research-use-only regulation is heading
  23. United States Pharmacopeia. General Chapter <921> Water Determination.Cited in: Water content of peptides: Karl Fischer titration
  24. Zyla Life Sciences, L.L.C. v. Wells Pharma of Houston, L.L.C., No. 23-20533 (5th Cir. Apr. 10, 2025); petition for certiorari No. 25-257, Brief for the United States as Amicus Curiae (May 21, 2026); certiorari denied June 29, 2026.Cited in: Lilly's retatrutide lawsuits: what the dockets say

See also

Cite this page

Text

Cosmic Peptides. (2026, October 26). Sources. Cosmic Peptides Research Library. Retrieved October 26, 2026, from https://cosmicpeptides.com/research/sources

BibTeX

@misc{cosmicpeptides_research_sources,
  author       = {{Cosmic Peptides}},
  title        = {Sources},
  howpublished = {Cosmic Peptides Research Library},
  year         = {2026},
  month        = oct,
  url          = {https://cosmicpeptides.com/research/sources},
  urldate      = {2026-10-26},
  note         = {Last reviewed 2026-10-26}
}

RIS

TY  - ELEC
AU  - Cosmic Peptides
TI  - Sources
T2  - Cosmic Peptides Research Library
PB  - Cosmic Peptides
PY  - 2026
DA  - 2026/10/26
UR  - https://cosmicpeptides.com/research/sources
Y2  - 2026/10/26
LA  - en
ER  -

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For in vitro laboratory research only. Not for human or veterinary use. This library describes chemistry, analytical methods and published laboratory research; it gives no guidance on use in people or animals.