EXTRACTABLES AND LEACHABLES

Extractables and Leachables are a Group of Compounds that can be of Potent Risk and may infuse a Serious threat to Pharmaceuticals Manufacturers producing API, Generics, and Formulation End Products for both Domestic & Export Market. When Elements and Compounds leach into Products, from Packaging or Manufacturing Conditions they can render them unfit and even dangerous for use.

When Elements and Compounds leach into Products, from Packaging or Manufacturing Conditions they can render them unfit and even dangerous for use. Extractables include Leachables and are Groups of Compounds that can be of Potent Risk to Pharmaceutical Manufacturers by infusing Serious threats like leaching Compounds into  Pharmaceutical Components such as APIs & Products like Generics, and Formulation End Products Manufactured for sale in both Domestic & Export Markets.

Leachables analysis identifies Substances that migrate from Polymeric, Metallic, or Glass materials into the patient and are typically a subset of those identified in the Extractables Analysis. This type of Analysis is required when there is a risk that harmful Substances may have leached into a Liquid Product, such as Eye Drop, from its Container or Packaging.

Leachable Substances are a subset of the Extractable Set of Substances that migrate from Polymeric, Metallic, or Glass materials into the Patient. Leachables Analysis is required when there is a risk that harmful Substances may leach into a Liquid Pharmaceutical Product such as Eye Drop, from its Container or Packaging.

The Assessment of Extractables and Leachables in Bio-Pharmaceutical Products is an important step in Drug Product Development. Processing Equipment, as well as, Primary and Secondary Container Closures are Potential Vectors for Chemical Contaminants.

Extractables Analysis identifies Categorization and Quantification of Substances which could potentially migrate from Polymeric, Metallic, or Glass Material into the Consumer’s body through any of the Medicines consumed by them during the process of treatment.

[Extractables Analysis involves the identification, Categorization, and Quantification of Substances that could potentially migrate from Polymeric, Metallic, or Glass Material into the Consumer’s body through any of the Medicines consumed by them during the process of treatment.]

It includes Monomers and Polymer Additives such as Antioxidants, Plasticisers, Stabilizers, Dyes, Metal Catalysts & other Harmful Chemicals which may potentially migrate into the Product under Storage Conditions.