USP 232/233

PDE, MDD and USP <232><233>

As we work with numerous pharma companies in performing screenings of drug products and their excipients/APIs, validations of methods, and/or conducting release/routine testing, a common point of discussion is the Maximum Daily Dose (MDD) or daily Serving Size. MDD is directly correlated with the Permitted Daily Exposure (PDE).  As many are aware, USP <232> defines… Read More >

USP 232/233

Your Guide to USP 232/233 – Changes to Testing for Elemental Impurities in Drug Products

We’re less than a month away from the deadline to comply with the USP General Chapters <232>/<233>, pertaining to Elemental Impurities in all drug products. Many of our customers are racing to implement the steps for compliance, including performing Risk Assessments, Validations and/or Verifications of methods for testing individual products, and Release Testing. Chemical Solutions… Read More >

USP Monographs

USP Monographs: A Resource for Compliance with Federal Standards

As many of our clients know, dietary supplements must be manufactured according to the dietary supplement Good Manufacturing Practices (cGMP) requirements.  We’ve found an article that explains the connection between the United States Pharmacopeia (USP) standards and meeting the GMP requirements, and more specifically, how the USP monographs can serve as resources for compliance with… Read More >

CSL

Five Things You May Not Know About CSL

When you hear ‘Chemical Solutions,’ what comes to mind?  Is it our company or is it something you learned in high school?  Well, for the companies that utilize our laboratory for the testing of their samples, our name is well-known and it’s synonymous with quality and efficiency.  For those of you who may be unfamiliar… Read More >

USP 232/233

USP 232/233 – Contending with the looming January 1st deadline

Many of our Pharma clients are facing a common issue – how to complete risk assessments and validate methods for their raw materials and finished products – prior to the January 1, 2018 deadline. Over the past few years, CSL has been conducting matrix and element-specific validations and verifications for the pharmaceutical industry.  If you’ve… Read More >

CSL Tackles DMSO

In the trace elemental analysis industry, it is not uncommon for us to come across substances that we know will be complicated to analyze. At Chemical Solutions Ltd., we don’t toss around the word “impossible” in our lab. We welcome challenges by having a “Bring It On” type of attitude. So, when we received DMSO… Read More >

Prop 65

Prop 65: Important Changes Coming August 2018

California Proposition 65 (Prop 65) is a very significant piece of legislation that is getting some renewed attention. Known as the “Safe Drinking Water Toxic Enforcement Act of 1986,” Prop 65 states that no one shall introduce into the drinking water of the state of California any substance that may cause reproductive or carcinogenic toxicity…. Read More >

Detection limits

Detection Limits and PQL

We are often asked about our detection limits (e.g. “How low can you test for lead?”).  Since this is a common question, we thought we would include a brief description of detection limits, what distinguishes various detection limits from one another, and how these relate to the question of ‘how low can you go?’ What… Read More >

contract laboratory

Choosing a Contract Laboratory – Practical Guidance

First a disclaimer… We are a Contract Laboratory, specializing in metals and minerals/heavy metals testing, and are admittedly a bit biased when it comes to providing guidance for choosing a laboratory!  However, we feel that much of the criteria for choosing a laboratory for heavy metals testing applies to many types of testing with a… Read More >

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