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Explore Our Expertise
- Custom synthesized compounds
- Research Chemicals
- Metabolites
- Isotope Labelled Compounds
- Impurity Standards
- Reference Standards
- Working Standards
Custom synthesized compounds
Impurity.com delivers high quality and cost effective custom synthesized complex organic molecules. Our chemical synthesis capabilities include:
- Impurities & Drug impurities standards
- API’s, impurities, and metabolites
- Labelled isotopes synthesis
- Pharmaceutical Reference Standards
- Amino acids and oligopeptide synthesis
- Nucleosides and heterocycles & more
Research Chemicals
Research chemicals are chemical substances used by scientists for scientific research and development purposes. Research Chemicals are produced by Custom Synthesis Methods.
- Research chemicals are generally labelled as “only for research purposes” or “not for human consumption,” when the opposite is true. Instead of being referred to as research chemicals, they may be called plant food, bath salts, or other names denoting they are for purposes other than human consumption
- The four main types of research chemicals are: Phenyl-amphetamine, Tryptamines, Cannabinoids and others
Metabolites
A metabolite is the intermediate end product of metabolism. The term metabolite is usually restricted to small molecules. A drug metabolite is a byproduct of break down, or “metabolizing,” a drug into a different substance.
- Estimation of Drug metabolites in the blood is an essential part to understand the distribution of drug in the blood. High purity, well characterized drug metabolite standards are required for Bio-Analytical BE/BA Studies.
- Identification and characterization of metabolites is a critical step in the long and expensive process of bringing a new chemical entity to market. For drug candidates, every significant metabolite must be identified, and sufficient quantities synthesized to meet MIST requirements.
- Pharmacologically active metabolites can contribute significantly to the overall therapeutic and adverse effects of drugs. Therefore, to fully understand the mechanism of action of drugs, it is important to recognize the role of active metabolites.
Isotope Labelled Compounds
Isotope Labelled Compound is a chemical substance in which part of the molecules are labeled with an isotope so that observations the isotopic composition make it possible to follow the compound or its fragments through physical, chemical, or biological processes.
- Isotopic labelling of compounds is a non-radioactive method of labelling , provides site-specific investigation of structures, makes molecules easily detectable by mass spectrometry and NMR, maintaining the physico-chemical properties of the target molecule, and is cost-effective and easy to use.
- Stable isotopes can be incorporated into a molecule, producing a molecule with a higher molecular weight than that of the unlabelled molecule.
Impurity Standards
An impurity is “any component of the product which is not the chemical entity defined as the active substance or an excipient in the product”.
- Drug Impurities are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation.
- The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is an important task pharmaceutical impurities as per the regulatory norms.
- High Pure and Well characterized impurity Standards are used for Related Substances, Organic impurities and Validation of Analytical Methods.
Reference Standards
A reference standard is a highly purified and well-characterized material suitable to test the identity, strength, quality, and purity of substances for Chemical, pharmaceutical, and medicinal products. Using reference standards, working standard can be prepared. Reference Standards can be taken from USP, EP, BP, and IP or In-house.
- Reference standards serves as basis for evaluation of both process and product performance and serves as benchmark for drug safety.
- Reference standards are one of the key factors for consistently good quality of pharmaceutical products. They are used as primary or secondary standards for the quality control of active pharmaceutical ingredients (API), excipients and finished pharmaceutical products.
Working Standards
A Working Standard is a drug Substance or chemical material of established quality and purity as shown by comparison to the reference standard material and used as Reference Working Substance for routine quality control analysis.
- A working standard is a material of highest purity grade available whose composition is known in relation to a certified reference material having established traceability to a recognized global standard body.
- As a working standard is to be used over a prolonged time period it is necessary to evaluate its composition periodically to verify that it does not vary beyond acceptable limits.
- Working standard also necessitates care in handling and preservation under prescribed storage conditions. Before its expiry date another working standard is prepared and its composition is compared to the existing standard.
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