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Services
Our Services
The company is proposed to provide following services to meet the requirements of pharmaceutical industries, Foods and Drugs, Argo, Polymer sectors.
Nitrosamine impurities testing
Nitrosamine are a family of Carcinogens impurities which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with Nitrite or other agents with the nitrogen in the +3 states. Nitrosamine are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens,” based on both rodent carcinogenicity and mutagenicity data. They are categorized by international Agency for Cancer Research (IARC) as 2A – Probable Carcinogens based on data on several species’ studies. Nitrosamine are published in USP<1469> and European Pharmacopeia General Chapter 2.5.42.
Nitrosamine impurities testing?
Mutagenicity referes to induction of permanent transmissible changes in the amount of structure of the genetic material of cells or organs.
These changes may involve a single gene or gene segment a block of genes pr chromosomes. The genetic changes is refered to as mutation and the agenet causing the changes as a mutagen.
Genotoxity: potentional to interact with genetic material measurable DNA alteration or dmages.
Mutagenicity: Potential to change genetic properties, causing heritable, genetic mutations.
Mutagencity and Genotoxicity are used interchangeably.
Genotoxicity and mutagenicity can cause cancer.
Leachable and Extractable studies
Drug products can interact with their associated packaging systems and/or the systems of plastic/polymeric materials and its components while the product is being manufactured, shipped, stored and administered. The magnitude of these interactions must not be such that the interactions adversely affect the suitability for use of the drug product. Extractables are organic and inorganic chemical entities that are migrated from the contact surface of a pharmaceutical packaging/delivery system or manufacturing equipment/components under more aggressive conditions such as elevated temperature, extended contact time or aggressive solvent system into an extraction solvent under laboratory conditions.
Leachables are typically a subset of Extractables or are derived from extractables. Depending on specific purpose of the extraction study, these laboratory conditions (e.g., solvent, temperature, stoichiometry, time, etc.) may usually more aggressive than normal operating conditions and may exaggerate the normal conditions of storage and use.
The product quality research institute (PQRI) has developed regulatory guidance in extractables and leachable. Guidance is also provided in
USP<87>, USP<88>, USP<661>, Ph. Eur.3.1, Ph.Eur. 3.2, ISO10993, ICH Q6A and ICH Q3D for the evaluation of materials for drug packaging.
USP <1663> and USP<1664>provide framework and assessments of extractables and leachables.
Elemntal Impurities Testing
Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits. There are three parts of this guideline: the evaluation of the toxicity data for potential elemental impurities; the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern; and application of a risk-based approach to control elemental impurities in drug products.
An applicant is not expected to tighten the limits based on process capability, provided that the elemental impurities in drug products do not exceed the PDEs. The PDEs established are considered to be protective of public health for all patient populations. In some cases, lower levels of elemental impurities may be warranted when levels below toxicity thresholds have been shown to have an impact on other quality attributes of the drug product (e.g., element catalyzed degradation of drug (substances). In addition, for elements with high PDEs, other limits may have to be considered from a pharmaceutical quality perspective and other guidelines should be consulted (e.g., ICH Q3A).
Impurity Characterization
The identification of pharmaceutical-related substance or impurity is an essential analytical activity in the drug development process. Pharmaceutical impurities can arise from different sources and significantly damage the purity, stability and safety of drug substances or finished drug products. These impurities/ related substances are generally present at very low levels. Consequently, sensitive and specific assay methods are required to quantify them and collate relevant information and facilitate efficient drug manufacturing processes.
Impurity
Food and drug administration (FDA) describe an impurity as, “Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or an excipient including buffer component. It may be either process-or-product related”. The expert working group of the international conference on Harmonization (ICH) has defined impurity is “Any compound of the medicinal product which is not the chemical entity defined as the active substance or as an excipient in the product”.
Characterization
Characterization is the process of establishing structure elucidation of a chemical compound by using different analytical techniques to demonstrate its suitability or use. Impurities are generally assumed to be inferior to API because they might not have the same level of pharmacological activity. Presence of impurity in the drug substance compromises the purity of the drug even if impurity present in it contains superior pharmacological or toxicological properties.
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