Happy Holidays!
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021. One might argue that chemical contaminants have always been present in
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant Types of Contaminants that are Found in Drug Products Classification of Drug Product Chemical Contaminants and their Sources API Impurities Extractables And Leachables Supply Chain
The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a defined environment, with the eventual goal of controlling the quality of that environment. Environmental conditions that are often monitored include but are not limited to
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch of the science that investigates those effects using laboratory animals upon which testing is conducted. In contrast, in vitro toxicology is the branch of the
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.” With only a few exceptions, OTC Drugs may be launched in
Testing for product safety and claim support is crucial in the highly competitive, possibly soon-to-be-regulated personal care market. If you are just getting started, or need a refresher course, seek guidance from experts. These days, finding information is simple. Search Google for “cosmetic claim support” and find 2 million entries
The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant with the FDA means that products are safe to use and properly labeled. FDA compliance isn’t something that should be overlooked or taken lightly. Otherwise,
Bisphenol A Testing What is Bisphenol A and what is it used for? Bisphenol A (commonly abbreviated as BPA) is an organic compound that has been used in food contact materials since it was first approved by US FDA in the 1960’s. It has been primarily used to harden certain
Even when you entrust the details of your clinical trials to an established professional testing facility, you still remain responsible for your study as a study sponsor. All clinical trials must be monitored, and monitoring is the responsibility of the study sponsor. Study monitoring by sponsors is required by the
Parabens are a class of preservative agents that are commonly added to cosmetic, food and drug products to prevent microbial growth and extend product shelf life. While parabens are still regarded as safe when employed in small amounts, some studies have shown parabens to mimic the hormone estrogen, which spurs
For Businesses
For Panelists
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant
The term Environmental Monitoring generally refers to the processes and activities that are conducted for the purpose of characterizing and monitoring the quality of a
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and
Testing for product safety and claim support is crucial in the highly competitive, possibly soon-to-be-regulated personal care market. If you are just getting started, or
The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant
Bisphenol A Testing What is Bisphenol A and what is it used for? Bisphenol A (commonly abbreviated as BPA) is an organic compound that has
Even when you entrust the details of your clinical trials to an established professional testing facility, you still remain responsible for your study as a
Parabens are a class of preservative agents that are commonly added to cosmetic, food and drug products to prevent microbial growth and extend product shelf
Corporate Headquarters and Labs
70 New Dutch Ln
Fairfield, NJ 07004
973-576-5957
Satellite Clinical Lab Location
304 Wootton St.
Boonton, NJ 07005
FDA
Registration# 1000151293
CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)
US EPA/NJ DEP
Registration# NJD982726648