Active Pharmaceutical Ingredients (APIs) Identification Service

Active Pharmaceutical Ingredients (APIs) are substances or mixtures employed in the production of drugs. They have pharmacological effects or directly contribute to diagnosing, treating, mitigating symptoms, controlling, or preventing diseases, in addition to influencing the structure or function of the body. The identification of APIs is critical in drug development. Elucidating the structures and properties of APIs is pivotal for guiding subsequent studies of their physicochemical properties, structural modifications and screenings for their pharmacological efficacy, which potentiate their development of novel drugs.

 

The primary sources of APIs include:

1. Extraction from natural medicines.

2. Derivation. It can be obtained through structural modification or found in metabolites from existing medications.

3. Discovery via pharmacological model screenings. Employing extensive libraries of compounds in conjunction with high-throughput screening techniques can find components with medicinal potential and ascertain their structures.

4. Chemical sysnthesis based on physiological and pathological aspects. For example, fluorouracil, a potent antimetabolite and anti-cancer agent. It is synthesized by substituting the 5th hydrogen atom with fluorine atom in the structure of uracil according to physiological property of uracil.

 

MtoZ Biolabs provides an extensive preclinical drug R&D platform for the screening and identification of APIs. Our team is equipped to screen and identify APIs from various sources, employing LC-MS/MS technology to analyze the compound spectra of bulk drugs among others. These spectra are then compared and analyzed against a standard product database, enabling the preliminary identification of known compounds in bulk pharmaceuticals and biological samples.

• • Small Molecule Actives Identification and Quantification

  Small molecule drugs, predominantly chemically synthesized drugs with molecular weight lower than 1000 Da. These drugs are characterized by their widespread use and mature theoretical foundations. Statistically, small molecule drugs comprise about 98% of commonly used medications.

• • Protein Active Component Identification and Quantification

  Protein-based macromolecular drugs, typically organic compounds with molecular weights exceeding 1000, depend on cellular biosynthesis and are also known as biologics. Compared to traditional small molecule drugs, protein drugs are characterized by their high potency, strong specificity, low toxicity, clear biological function, and conducive to clinical application. Protein drugs are the fastest-growing class of drug molecules with more than 250 protein drugs clinically used in a variety of indications.

• • Bioactive Peptide Component Identification and Quantification

  Bioactive peptides are short protein fragments of 2-50 amino acids in length that are linked by covalent bonds (called amide bonds or peptide bonds). Bioactive peptides have the advantages of simple structure, high biological activity, high specificity and low toxicity, and have broad prospects in the design and development of new peptide drugs.