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
Heparin and Animal‑Derived Excipient Sourcing: Traceability and Adulteration Risks in 2026
Heparin and other animal‑derived excipients remain essential in biopharmaceutical formulations, but their supply chains face heightened traceability demands and adulteration threats. In 2026, robust ISO‑9001‑based documentation, REACH compliance, and advanced analytical screening are the primary safeguards against contamination and fraud.
Oct 19, 2026 · 5 min read -
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 -
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 -
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 -
Regulatory
Supply‑chain risk assessment of manganese‑based catalysts after recent export controls
Recent export controls on manganese compounds have introduced significant uncertainty for manufacturers relying on manganese‑based catalysts. Key risks include reduced availability, price volatility, longer lead times and the need for alternative sourcing strategies, all of which require proactive assessment and mitigation.
Oct 5, 2026 · 5 min read -
Regulatory
Impact of US EPA PFAS Phase‑out on Fluorinated Polymer Sourcing for Biotech
The US EPA’s PFAS phase‑out, announced in 2024, restricts production and use of long‑chain per‑ and poly‑fluoroalkyl substances, directly influencing the availability, cost and compliance requirements of fluorinated polymers used in biotech. Suppliers must adapt sourcing strategies, validate alternatives and manage regulatory documentation.
Oct 1, 2026 · 4 min read -
Regulatory
Adapting GHS Labelling for Nanomaterial Reagents under the 2026 Regulatory Updates
The 2026 GHS revision introduces specific provisions for nanomaterials, requiring updated hazard classifications, new pictograms, and expanded SDS sections. Laboratories must revise labelling, incorporate nano‑specific exposure limits, and ensure compliance with UNECE Rev. 11, while maintaining alignment with OSHA and PubChem guidance.
Sep 30, 2026 · 5 min read