Pharmaceutical QA/QC Newsletter for Q1 2021
Chromatography Simplified
New HPLC and UHPLC Technology
Whether you’re looking for a high-end HPLC or powerful UHPLC platform, our LC 300 systems help your lab achieve fast, accurate results. The LC 300 system was designed for very low dispersion, increasing separation efficiency, and lowering detection limits. It’s available with your choice of five high-sensitivity detectors (photodiode array, UV/Vis, multi-wavelength UV/Vis, fluorescence, and refractive index) to meet your diverse application needs.
Learn MoreLC 300 Product Note
Each of the components of the LC 300 system come together seamlessly to deliver the dependability, power, and efficiency you need to achieve your goals. Whether analyzing active ingredients in pharmaceuticals or consumer goods for potential impurities, the LC 300 system, paired with SimplicityChrom CDS software, not only meets your needs, but grows with you.
Never Miss a Peak in Your QC Lab
Whatever your separation challenge, your choice of liquid chromatography (LC) column can make all the difference. Our Quasar portfolio of LC columns allows you to achieve rugged and reproducible results – batch to batch and column to column – with an all-encompassing, flexible solution that meets the diverse, changing needs of analysis.
Read more by clicking on API name below:
Levothyroxine Sodium
Levothyroxine sodium is the sodium salt of levothyroxine, a synthetic form of thyroxine (a major endogenous hormone). It is primarily used in the treatment of hypothyroidism (commonly known as an underactive thyroid), where the thyroid gland produces insufficient quantities of hormones T3 and T4.
Meloxicam
Meloxicam is a common pharmaceutical drug used to treat pain resulting from various musculoskeletal conditions such as osteoarthritis. It belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs) which are effective in relieving pain and reducing inflammation, although they are known to exhibit problematic side effects such as stomach ulcers, headaches and drowsiness.
Tadalafil
Tadalafil is a drug used in the treatment of pulmonary hypertension (high blood pressure in blood vessels that supply the lungs) and is also used to treat erectile disfunction (ED) and symptoms of an enlarged prostate.
Olopatadine Hydrochloride
Olopatadine hydrochloride is an antihistamine used to treat itching and redness in the eyes due to allergies. It is commonly available over the counter in several forms such as eye drops and as a nasal spray.
Venlafaxine Hydrochloride
Venlafaxine is an antidepressant which belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety.
On-Demand Webinar
The Evolution of ICP-MS Technology in Low-Level Elemental Impurity Analysis
At the virtual conference The Ever-Changing World of Extractables & Leachables Part 2, PerkinElmer shared the latest advancements for ultra-trace-level detection and their relevance to these applications. If you want to view the presentation, the on-demand version is available here.
Regulatory & Compliance
Data Integrity and CSV Compliance
In today’s highly digitized world, data integrity and computer system validation (CSV) compliance is of paramount importance within the pharmaceutical manufacturing industry. It is necessary to ensure the safety, efficacy, and quality of drugs, and to protect public health.
Learn MoreThe Role of USP Chapters
With so many guiding principles, it’s not always easy to know what to follow and when. To help, we’ve developed a simple breakdown of USP Chapters and what they contain, so you can feel confident in compliance.
Learn MoreTrends and Industry News
European Pharmacopoeia: Rapid implementation of the revised sartan monographs on 1 April 2021
European Pharmacopoeia: Updates of Ph. Eur. dosage form monographs and general chapters
European Pharmacopoeia: New policy for dissolution and disintegration testing in Ph. Eur. Monographs
MHRA: Pharmacovigilance inspection metrics April 2019 to March 2020
EMA: Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
FDA: Updated Guidance Control of Nitrosamine Impurities in Human Drugs