INSIGHTS ON QUALITY CONTROL

• The Impact Of Water Activity On The Chemical and Physical Stability Of Oral Solid Dosage Products

  Generally, a variety of specific tests are necessary to evaluate the chemical and physical characteristics of an oral solid dosage (OSD) throughout the product life cycle. This article will present three case studies to show that direct water activity measurements can determine the impact of moisture on potency and dissolution.

• Oxidation Stability With RapidOxy

  RapidOxy is an automated Rapid Small Scale Oxidation Tester that provides oxidation stability analysis under artificial aging conditions for various products, including solid, semi-solid and liquid samples.

• High Potency Fill Line

  Whether it's a liquid or lyophilized product, we provide capacity, quality, and expertise to ensure a stable supply of your promising therapeutics.

• Advantages In The Continuous Manufacturing Of APIs And Intermediates Under cGMP Conditions

  Several drug products utilizing continuous manufacturing processes have been approved by the FDA, with many others in clinical development. Review the challenges and opportunities for the use of continuous manufacturing for APIs and intermediates.

• How To Understand ASTM E2500

  12/21/2020

  ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.

• Water Activity Measurements And Microbial Contamination In Pharmaceutical Products

  6/19/2020

  Non-sterile pharmaceutical products are subject to microbiological examination prior to release and during stability testing. While the tests described in these chapters cannot be eliminated from protocol completely, USP <1112>, Application of Water Activity Determination to Nonsterile Pharmaceutical Products, suggests that water activity determination can be used to reduce the need for frequent microbial limit testing and screening.

• Introduction To USP <922>: General Chapter For Water Activity Measurement

  6/19/2020

  The newly drafted USP <922> General Chapter describes the specific methods that pharmaceutical companies will use to calibrate, qualify, and use water activity instruments in their testing protocols. USP <922> includes a description of Tunable Diode Laser Absorption Spectroscopy (TDLAS) measurements and states that it is the only method to reliably and accurately measure water activity when the sample contains other volatile compounds. The Lighthouse FMS-Water Activity Analyzer uses TDLAS to non-destructively and directly measure the water activity non-invasively of samples in a sealed glass vial.

• Raw Material Identification With Raman

  4/17/2020

  Anton Paar offers premier raman spectroscopy solutions for many pharmaceutical applications.

• Headspace Gas Ingress Testing For CCI

  3/17/2020

  Imagine a blue dye test, but replace the dye with a tracer gas. Headspace Gas Ingress Testing is a robust detection method of critical leaks. It is a rapid, non-destructive, analytical measurement and can be scientifically validated. Are you considering to upgrade your blue dye test, and do you want to learn more about this approach? Watch this webinar.