White Label minimum quantity for FDA-registered peptides with Methyl Vitamin B12 (1000mcg API)/ml is 50,000 packs for companies interested in ANDA drug application. Manufactured with approved DMF according to the Federal Food, Drug, and Cosmetic Act for commercial distribution, ANDA registration or clinical trials. The NDC number is activated upon order.

Peptide APIs are available in bulk, with a minimum quantity of 5kg of lyophilized powder in ready-to-use packs.  Documents we provide  within 30 days of order are listed below: 

·Circular Dichroism Spectrometer CD analytical report that confirms the molecular structure, intermolecular interactions, and kinetic analysis of each peptide. We evaluate the secondary structure, folding, and binding properties of the peptides.

High Resolution Mass Spectrometer (HRMS) analysis report, which is more accurate and reliable, along with the Prep-HPLC purity test report. High-resolution mass spectrometry (HRMS) is an analytical chemistry technique that can distinguish between the molecular masses of compounds and provide high-resolution and high-quality mass spectral data.

Amino Acid Analysis report. We conduct amino acid analysis on finished peptide drugs using Biochrom30+, German MembraPure A300. It is an instrument used to determine the composition or content of amino acids in proteins, peptides, and other pharmaceutical preparations.

Comprehensive Certificate of Analysis showing details of all the test results with a full spectral peptide scan, showing the absorbance levels across the range of wavelength.

Module 1 –Manufacturer`s Information