1. Drug impurity reference substances

We supply more than 20,000 kinds of spot impurity reference products, with sufficient supply and same-day delivery, to meet the urgent needs of customers at any time. The company has its own R&D center and laboratory, and the team members have more than ten years of experience in the research and development of drug impurity reference substances. Our website www.molcoo.com cover more than 98% of cutting-edge generic drug projects, with complete structural formulas, which greatly saves customers time in impurity structure analysis and inference. All products have strict quality control testing and provide relevant information such as: (COA), H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetry, IR INFRARED, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc., to ensure quality and reliability through these structural confirmation maps. Our products have a full range of products, fast delivery, good quality and low price, which can quickly solve various needs such as customer replenishment and consistency evaluation.

2. Customized synthesis of impurities and new molecules

(1) CDE is issued to supplement impurities, all brands are not in stock, and customized synthesis is required, we can complete it at the fastest speed and report the progress of the project to customers every week.

(2) For impurities that have formulated quality standards, some brands are expensive, untimely in supply, unstable in quality, and unable to continue to supply. After the successful development of MOLCOO customization, it can ensure a stable supply and never exceed the last purchase price.

(3) Customized synthesis of neoconstituent compounds of innovative drug R&D companies, which are basically not reported in the literature, and the custom synthesis team of MOLCOO new molecules has strong new molecule synthesis capabilities.

3. Pharmaceutical standards

CP, EP, USP, BP, JP and other official standard products, we provide one-stop purchase service to help customers purchase according to the import cost price.

4. Preparation and separation of unknown impurities

In view of the fact that the impurities of many projects cannot be obtained by synthetic means, and need to be obtained from raw materials, intermediates, crude products of the reaction or trace target compounds contained in the side reactions, Hubei MOLCOO has a professional impurity preparation and separation technical team, equipped with professional SFC preparation and separation instruments, which can efficiently and accurately separate impurities for complex projects and solve the problem of impurity preparation for customers.

5. Process development of new drug intermediates

We not only provide the supply of new drugs and new molecular impurities, but also provide process optimization services. For example, the screening of commercialization routes (small-scale research, pilot scale-up, workshop production), the development and optimization of commercialization processes through reaction design (DoE) and quality design (QbD), unit operation research and confirmation of key process parameters in each step, structural identification and analysis of impurities, impurity source analysis and quality control research, and the development of various analytical methods to help customers on the road to new drug research and development.

6. Synthesis of drug peptides

In the process of peptide synthesis, some heteropeptides with similar structures to the target peptide will be produced, such as diastereomers due to amino acid racemization, missing peptides due to partial amino acid unattached, and broken peptides due to peptide bond breakage. Therefore, it is important to consider the selection of reliable separation and purification methods to achieve the required purity of the peptides. The sources of process impurities in synthetic peptide APIs are different from those of general chemical drugs, and the possible process impurities include: missing (incomplete) peptides, broken peptides, deamide peptides, by-products formed by incomplete deprotection of amino acid side chains, oxidized peptides, products of disulfide bond exchange, diastereomeric peptides, oligomers and/or polymers, and toxic reagents and solvents used in synthesis. These possible process impurities need to be fully considered in the research of the relevant substance inspection methods for the synthesis of peptide drugs, and the verification of the detection ability of these process impurities is an important aspect of methodological validation.

MOLCOO has a professional pharmaceutical peptide synthesis team, which can customize the synthesis of pharmaceutical peptides according to the peptide sequences provided by customers, and can also provide customers with various degradation impurities and process impurities generated in the research and development of peptide drugs. We provide conventional structural confirmation spectral data such as mass spectrometry, liquid chromatography, ultraviolet spectroscopy, and can also provide amino acid composition analysis, amino acid sequence determination and other data according to customer needs. According to the customer's project requirements, the purity range is generally 90%-99%.