Deuterated Labelled Compound AquigenBio

Deuterated Labelled Compound

Understanding Deuterium Labelled Compounds and Deuterated Drugs

Deuterium Labelled Compounds refer to molecules where one or more hydrogen atoms have been replaced with deuterium, a stable hydrogen isotope. Deuterium is twice as heavy as hydrogen, making it useful as a tracer for studying metabolic pathways and biological processes. Deuterated drugs are an emerging area in the pharmaceutical industry where hydrogen atoms in drug molecules are exchanged for deuterium.

This substitution allows Deuterium Labelled Compounds to be visually distinguished from the non-labelled parent compound using analytical techniques like mass spectrometry. The added mass of deuterium provides a distinguishable signature. These labelled compounds serve as useful tracers in metabolic and degradation studies. They enable researchers to track the incorporation and breakdown of compounds within biological systems over time. Due to the kinetic isotope effect, compounds containing deuterium may also exhibit altered metabolic properties like an extended half-life compared to the non-labeled compound.

DID YOU KNOW?

“Deutetrabenazine (Deuterabenazin) was the first deuterated drug approved by the FDA in 2017. Deutetrabenazine is a deuterated version of tetrabenazine for chorea associated with Huntington’s disease. It has a longer half-life than the non-deuterated form due to the isotope effect.”

Our team at Aquigen Bio Sciences has 5+ years of experience synthesizing, handling, and addressing stability concerns of deuterated compounds. We have delivered over 100 deuterated impurities for APIs and intermediates globally. Aquigenbio successfully synthesized impurities for Deutetrabenazine. We also supply deuterated solvents. With capabilities in deuterated compound synthesis, Aquigenbio is a reliable source for deuterated materials. Get in touch with us today!

Sources of Impurities in Drug Substances

Organic Impurities

Organic impurities in active pharmaceutical ingredients can be either drug-related or process-related. They include identified specified impurities, unidentified specified impurities, and total unknown impurities.

Process-related impurities arise during chemical synthesis and manufacturing as residual unreacted materials or side reactions. Degradation-related impurities are generated when the active ingredient breaks down under certain storage conditions, such as oxidation or dehydration.

The active ingredient’s interaction with excipients, containers or residual impurities in solvents and reagents can also lead to degradation-related impurities. Even with washing and purification steps, residual unreacted materials from the synthesis process may remain as potential process-related impurities unless manufacturing is carefully controlled.

Metabolites

Metabolites are Intermediate end products formed when the body breaks down substances through metabolism. Drug metabolites specifically refer to byproducts resulting from the body's breakdown and processing of drugs into different forms.

Inorganic Impurities

Impurities introduced during manufacturing processes used to make bulk drugs can be Inorganic. Environmental factors like input materials and storage conditions may also contribute to Inorganic Impurities. Typically identified are remnants of reagents, ligands, and catalysts used in manufacturing. Manufacturers must remove any residues from these reagents and catalysts to avoid potential safety issues, as some chemical processes involve risks of inadvertently retaining such Inorganic manufacturing aids in the final medications.

Solvents

Residual solvents are organic volatile chemicals that are generated during the production or manufacturing process. Residual toxic solvents should be avoided in bulk drug production to ensure patient safety. Strict controls prevent hazardous solvents from remaining in final medications.

Heavy Metals

Heavy Metals contaminants can enter drug manufacturing from water used in processes and from stainless steel reactors during acidification or acid hydrolysis. Sources like tap water and unlined vessels risk introducing heavy metals into drugs. Carefully using demineralized water and glass-lined reactors prevents heavy metals contamination during synthesis.

Other Materials (Filter Aids, Charcoal, etc)

Materials like Filter Aids, Charcoal and Centrifugation sacks are commonly used in bulk drug manufacturing but require monitoring to prevent contamination. Fragments from filters or carbon particles could be introduced during processing if not tightly controlled. Careful inspection of bulk drugs is important to catch and remove any fibers or black particles to avoid contamination.

What are the different sources of Impurities in Drug Products?

Impurities in pharmaceutical drug products can come from the drug substance’s degradation or may be formed during various stages such as processing, formulation, and storage, involving factors like excipients used and processing-related degradation, etc.

Importance of Testing Impurities

The presence of impurities beyond acceptable criteria could impact the identity, quality, safety and efficacy of active pharmaceutical ingredients and drug products. Impurities may also accelerate active ingredient degradation and negatively impact stability posing serious concerns. Therefore, thorough qualitative and quantitative impurity analysis is essential. Identifying and measuring impurity levels (Impurity Profiling) represent critical quality attributes carefully reviewed by regulators. Pharmacopeias and ICH provide specified impurity limits and thresholds that products must meet prior to human use. Adherence to these impurity specification guidelines through analytical testing is mandatory to ensure appropriate product release for consumption.

Why is Aquigen Bio a top choice for Impurity Supply?

Aquigen Bio is the most reliable impurity standard supplier in India. Our exclusive Aquigen Bio catalogue showcases wide range of products, with more than 10000 impurities in inventory. We provide extended portfolio of impurity reference standards including the process related, degradation, peptide, and metabolite impurities. Choose Aquigen Bio and get a customized quote!