Method Development, Verification, Validation, Modification, and Transfer are all interrelated and may occur during various phases of product development.
Method Development creates an reproducible process for preparing and analyzing a sample for a desired analytical result. Typically, method development requires a series of experiments to identify an accurate, reproducible, and efficient process the preparation and subsequent analysis of a sample.
Scientech has the knowledge and experience to develop methods for new chemical enitites (NCEs) or other ingredients where existing published or compendial methods do not exist. Specifically, methods establish the physical characteristics of a product or ingredient(s), including its purity and potency.
API impurities may detract from the efficacy of the drug product, or worse, cause significant unintended side effects or pose safety issues.
Method Development, Verification, Validation, Modification, and Transfer are all interrelated and may occur during various phases of product development.
Method Development creates an reproducible process for preparing and analyzing a sample for a desired analytical result. Typically, method development requires a series of experiments to identify an accurate, reproducible, and efficient process the preparation and subsequent analysis of a sample.
Scientech has the knowledge and experience to develop methods for new chemical enitites (NCEs) or other ingredients where existing published or compendial methods do not exist. Specifically, methods establish the physical characteristics of a product or ingredient(s), including its purity and potency.
Forced degradation studies are used to identify likely degradation products of the API itself or in the finished drug product. APIs are subjected to stress conditions of heat, acid, base, and/or light to deliberately break down the chemical structure so the resulting degradants can be identified and measured in future studies. US FDA guidance recommends the reporting of all degradation products present at 0.1% or more.
Method Development, Verification, Validation, Modification, and Transfer are all interrelated and may occur during various phases of product development.
Method Development creates an reproducible process for preparing and analyzing a sample for a desired analytical result. Typically, method development requires a series of experiments to identify an accurate, reproducible, and efficient process the preparation and subsequent analysis of a sample.
Scientech has the knowledge and experience to develop methods for new chemical enitites (NCEs) or other ingredients where existing published or compendial methods do not exist. Specifically, methods establish the physical characteristics of a product or ingredient(s), including its purity and potency.
cGMP compliant
FDA registered
DEA licensed
Documentation
cGMP compliant
FDA registered
DEA licensed
Documentation
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