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Degradation Products
Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In s …
CONTROL OF IMPURITIES
Regulatory bodies, such as the EMA and FDA, provide increasingly stringent guidelines around impurity limits, control of those impurities becomes exponentially critical in a Pharma QA/QC laboratory.
Regulatory bodies, such as the EMA and FDA, provide increasingly stringent guidelines around impurity limits, control of those impurities becomes exponentially critical in a Pharma QA/QC laboratory. Implementing testing to control impurities is crucial on your path to compliance.
PerkinElmer provides the tools and processes you need to take control of impurities testing for both drug substances and drug products – providing the best technology for the identification and quantification of elemental impurities and the accurate measurement of residual solvents in accordance with strict regulatory guidelines.
The suitability of either a drug substance or drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.
Contact usANALYTICAL SOLUTIONS FOR IMPURITIES CONTROL
Elemental Impurities Testing
Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in …
Extractables & Leachables
Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to …
Foreign Particle Material Identification
Foreign Particle Material Identification is a key step in the quality control of medicines and is used to identify contaminants in drug products which might aff …
Organic Impurities
Pharmaceutical laboratories summarise actual and potential impurities that are most likely to arise during the synthesis, purification, and storage of the drug …
Residual Solvents
The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various sol …
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