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
Navigating US Inflation Reduction Act Incentives for Domestic API Manufacturing Supplies
The Inflation Reduction Act (IRA) offers US API manufacturers a domestic‑content tax credit of up to 30% of qualified investment, subject to a $7,500 per employee cap and a minimum 40% domestic‑content threshold. Eligibility hinges on detailed documentation, timing of asset placement, and compliance with IRS and Treasury guidance.
Aug 26, 2026 · 6 min read -
Regulatory
Emerging REACH SVHC Additions in 2026: Impact on Organophosphorus Reagents
From 1 June 2026 the EU REACH candidate list will include three new surface‑treatment agents and five additional substances, several of which are organophosphorus intermediates. These additions trigger registration, communication and possible restriction obligations for manufacturers and users of organophosphorus reagents.
Aug 25, 2026 · 5 min read -
Regulatory
US TSCA/EPA Chemical Review Backlog: What Importers Should Watch in 2026
The US EPA’s TSCA review backlog exceeds 1,500 chemicals, meaning importers will face extended evaluation times, tighter PMN scrutiny and possible SNURs in 2026. Monitoring EPA updates, preparing robust dossiers and aligning with REACH‑equivalent documentation are essential to avoid delays.
Aug 19, 2026 · 4 min read -
Regulatory
Green solvents replacing DMF, NMP and DCM under tightening REACH SVHC rules
The REACH SVHC list now includes DMF, NMP and DCM, prompting chemists to adopt greener alternatives such as Cyrene, γ‑valerolactone and 2‑MeTHF. These solvents meet performance criteria while reducing toxicity and regulatory burden, facilitating compliance across pharma and fine‑chemical processes.
Aug 17, 2026 · 6 min read -
Regulatory
Nitrosamine impurity controls in pharma APIs: current regulatory expectations
Regulators now require systematic risk assessment, strict limits (typically 0.5 ppm or lower) and validated analytical methods for nitrosamines in pharmaceutical APIs. Compliance hinges on ICH M7 guidance, FDA and EMA specific limits, and robust control strategies throughout synthesis and storage.
Aug 5, 2026 · 4 min read -
Regulatory
PFAS Universal Restriction under REACH: Status in 2026 and Implications for Fluorochemical Buyers
The REACH PFAS universal restriction entered into force in 2024, banning non‑essential per‑ and poly‑fluoroalkyl substances above 0.1 % w/w in articles and covering roughly 12 000 compounds. By 2026 the rule is fully applicable, reshaping supply chains, raising compliance costs and prompting buyers to seek alternatives.
Aug 3, 2026 · 4 min read -
Regulatory
EU Critical Medicines Act 2026: Implications for API Sourcing
The EU Critical Medicines Act 2026 introduces mandatory stock‑piling, supply‑chain transparency and stricter REACH compliance for active pharmaceutical ingredients (APIs). Companies must assess criticality, maintain a 12‑month reserve, and report provenance, reshaping sourcing strategies across Europe.
Aug 2, 2026 · 6 min read -
Regulatory
Why Batch-Level Certificates of Analysis Matter for Regulated Buyers
Batch-level Certificates of Analysis (CoAs) are essential for compliance in regulated industries. They provide verified, traceable data on purity, identity, and impurities for each production batch, ensuring adherence to USP, EP, BP, ISO, and REACH standards. Without batch-specific CoAs, regulatory submissions may be rejected.
Jun 27, 2026 · 4 min read -
Regulatory
IATA/ADR Transport Classifications for Laboratory Chemicals
Laboratory chemicals are subject to IATA (air) and ADR (road) regulations based on hazard classification. Key categories include flammable liquids (Class 3), corrosives (Class 8), and toxic substances (Class 6.1). Proper classification requires evaluation of flash point, toxicity (LD50), and reactivity. Labels, packaging, and documentation must comply with UN recommendations and regulatory standards.
May 31, 2026 · 5 min read -
Regulatory
Cold-chain shipping regulations for biological reagents
Biological reagents must be shipped under controlled temperature conditions to maintain stability and integrity. Regulations vary by region, with EU and US frameworks requiring compliance with ISO 11607, REACH, and TSCA. Temperature monitoring via validated data loggers and adherence to GHS labelling are mandatory. Shipping durations and storage conditions depend on the reagent type and stability data.
May 30, 2026 · 5 min read -
Regulatory
GHS Pictograms and Hazard Statements: A Buyer's Guide for Chemists and Biotech Teams
GHS pictograms and hazard statements are standardised across global chemical regulations to communicate hazards clearly. This guide explains their structure, interpretation, and compliance requirements under REACH, TSCA, and GHS, with reference to specific hazard classes and signal words.
May 27, 2026 · 5 min read -
Regulatory
TSCA Inventory: What U.S. Importers Should Know
The U.S. Toxic Substances Control Act (TSCA) inventory lists chemicals manufactured or imported into the United States. Importers must verify a chemical’s presence on the TSCA Inventory before importing. As of 2023, the inventory includes over 86,000 chemicals. Non-inventory chemicals require pre-manufacture notification (PMN) under TSCA §5. Compliance is enforced by the U.S. Environmental Protection Agency (EPA).
May 26, 2026 · 4 min read