Knowledge hub
Articles from the Molekula editorial team
Coverage of chemistry, regulatory updates, methods, supply-chain insight, and product spotlights. New articles published daily.
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Regulatory
EU CLP Revision 2026: New Hazard Classes for Endocrine Disruptors and PBT Substances
The 2026 revision of the EU Classification, Labelling and Packaging (CLP) Regulation introduces dedicated hazard classes for endocrine‑disrupting chemicals (EDCs) and for substances that are persistent, bioaccumulative and toxic (PBT). The changes tighten labelling thresholds, require new test data, and align CLP with the latest scientific consensus and REACH amendments.
Oct 17, 2026 · 5 min read -
Regulatory
Elemental Impurities under ICH Q3D: Qualifying Palladium Catalyst Residues in APIs
ICH Q3D provides a risk‑based framework for controlling elemental impurities, including palladium residues from catalytic steps. Acceptable limits are defined by the Permitted Daily Exposure (PDE), and qualification involves toxicological assessment, manufacturing controls, and validated analytical methods such as ICP‑MS.
Oct 16, 2026 · 4 min read -
Regulatory
ICH Q3E Extractables and Leachables Guidance: Implications for Single‑Use Component Buyers
ICH Q3E defines the scientific and regulatory framework for assessing extractables and leachables from single‑use (SU) components. It requires systematic testing, risk‑based limits, and clear documentation, meaning buyers must demand robust data, verify supplier compliance, and integrate the guidance into their qualification processes.
Oct 15, 2026 · 6 min read -
Regulatory
Impact of Chinese Export Licensing Reforms on Supply of High‑Purity Phosphine Ligands
Recent Chinese export licensing reforms have tightened controls on high‑purity phosphine ligands, leading to longer lead times, reduced batch availability and modest price increases in Europe. The changes affect both bulk and custom‑synthesised grades, prompting procurement teams to reassess inventory strategies and supplier diversification.
Oct 14, 2026 · 5 min read -
Regulatory
Guidelines for Selecting GMP‑Grade Ionic Liquids for Electrochemical Bioprocessing
GMP‑grade ionic liquids for electrochemical bioprocessing must meet cGMP purity (>99.5%), low water content (<0.1%), documented traceability, and compliance with REACH, TSCA and GHS. Selection should be based on physicochemical suitability, validated analytical data, supplier audit records and the regulatory expectations set out by the FDA and GMP standards.
Oct 13, 2026 · 5 min read -
Regulatory
Assessing the environmental footprint of titanium dioxide nanoparticle production
Titanium dioxide (TiO₂) nanoparticle production involves energy‑intensive processes, chemical reagents, and waste streams. Quantifying its environmental footprint requires life‑cycle assessment (LCA) of raw material extraction, synthesis routes (e.g., sol‑gel, hydrothermal, flame spray), emissions, water use and end‑of‑life handling, with results typically expressed in CO₂‑equivalents per kilogram of product.
Oct 12, 2026 · 6 min read -
Method
Choosing the optimal cryoprotectant cocktail for high‑throughput cell‑sorting applications
Selecting a cryoprotectant cocktail for high‑throughput cell sorting requires balancing cell viability, post‑thaw functionality, and compatibility with sorting buffers. Key considerations include permeating versus non‑permeating agents, concentration, cooling rate, and downstream assay requirements. Molekula supplies GMP‑grade reagents that meet these criteria.
Oct 11, 2026 · 5 min read -
Regulatory
Navigating UK REACH equivalents post‑Brexit for imported specialty chemicals
UK REACH, administered by the HSE, replaces EU REACH for chemicals imported into Great Britain after Brexit. Registration is mandatory for most specialty chemicals above 1 t yr⁻¹, with fees ranging from £1,500 to £3,000 per tonne, and compliance requires a UK‑specific SDS, CoA and notification to the HSE.
Oct 10, 2026 · 5 min read -
Method
Circular economy approaches to recycle spent chromatography solvents in pharmaceutical laboratories
Recycling spent chromatography solvents in pharma labs reduces waste, cuts costs and supports sustainability. Techniques such as distillation, membrane filtration and solvent‑exchange can recover 80–95 % of solvents like acetonitrile, methanol and water, provided they meet USP/EP purity specifications and are managed under REACH and ISO guidelines.
Oct 9, 2026 · 5 min read -
Method
Best practices for handling and storing moisture‑sensitive organolithium reagents
Organolithium reagents must be stored under inert gas at low temperature, handled in a dry, oxygen‑free environment, and transferred using air‑free techniques. Use compatible solvents, sealed ampoules or Schlenk tubes, and monitor for moisture ingress to maintain reactivity and safety.
Oct 8, 2026 · 4 min read -
Regulatory
Regulatory considerations for 3‑D‑printed pharmaceutical excipients under the EU MDR
3‑D‑printed pharmaceutical excipients are subject to the EU Medical Devices Regulation (MDR) when used in authorised drug‑device combinations. They must meet classification, conformity assessment, and post‑market surveillance requirements, with specific attention to material safety, manufacturing controls and the role of notified bodies.
Oct 7, 2026 · 6 min read -
Method
Implementing AI‑driven demand forecasting for specialty amino‑acid inventories
AI‑driven demand forecasting uses machine‑learning models to predict future consumption of specialty amino acids, reducing stock‑outs and excess inventory. By integrating historical sales, production schedules, and market indicators, companies can achieve more accurate safety‑stock calculations and improve cash flow while complying with REACH and GMP requirements.
Oct 6, 2026 · 5 min read