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
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 -
Supplier-news
Cold‑chain and biologics logistics pressures shaping reagent and excipient sourcing in 2026
Cold‑chain constraints and the increasing complexity of biologics logistics are driving changes in how reagents and excipients are sourced in 2026. Suppliers must prioritise temperature‑stable grades, regulatory compliance, and supply‑chain resilience to meet tighter stability windows and global distribution demands.
Aug 18, 2026 · 5 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 -
Applications
Continuous Manufacturing Adoption in Pharma and the Reagents It Shifts Demand For
Continuous manufacturing is increasingly adopted in pharma to improve efficiency, reduce waste and shorten time‑to‑market. It drives higher demand for high‑purity solvents, specialised catalysts, real‑time analytical reagents and robust excipients that meet tighter quality and regulatory specifications.
Aug 8, 2026 · 6 min read -
Supplier-news
GLP‑1 demand and the specialty‑chemical squeeze for peptide synthesis reagents
GLP‑1 analogue sales surpassed $10 bn in 2023, driving a sharp rise in peptide manufacturing. This surge strains the supply of high‑purity reagents such as Fmoc‑protected amino acids and coupling agents, leading to longer lead times and price increases across the specialty‑chemical market.
Aug 7, 2026 · 4 min read -
Supplier-news
China and India API Manufacturing Shifts in 2026 and Their Implications for Western Procurement
By 2026, China is expected to reduce its share of global API output to around 30% from 45% in 2022, while India aims to increase capacity by 20‑25% to meet rising demand. These shifts will pressure Western buyers to diversify supply chains, reassess risk matrices, and adopt stricter quality‑by‑design controls.
Aug 6, 2026 · 5 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 -
Supplier-news
Building a Long-Term Supply Partnership for Biotech R&D
Establishing a reliable, scalable supply partnership is critical for biotech R&D. Key factors include consistent quality (verified via CoA, HPLC, NMR), regulatory compliance (ISO, REACH, TSCA), and transparent communication. Long-term agreements with traceable documentation and flexible scaling support innovation without supply chain disruption.
Jun 29, 2026 · 4 min read -
Supplier-news
Evaluating Supplier Reliability in Fine Chemicals: Lead Time, Documentation, and Traceability
When sourcing fine chemicals and biochemicals, reliability hinges on consistent lead times, comprehensive documentation (including CoA, SDS, and batch-specific data), and full traceability from raw material to final product. Suppliers must meet ISO, REACH, and GHS standards, with batch records and analytical data (e.g., HPLC, NMR) available upon request. Molekula ensures traceability via digital batch records and compliance with USP, EP, and BP specifications.
Jun 28, 2026 · 4 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