Hydroxy Methylene Blue: A Reference Standard for Methylene Blue Quality Control

Methylene Blue is a long-established drug used to treat methemoglobinemia and, more recently, investigated and applied in a range of other clinical and diagnostic contexts. As an older, chemically reactive molecule, it is prone to forming several structurally related degradation and process impurities, making a dependable impurity reference library essential for manufacturers. Hydroxy Methylene Blue is one of the standards supporting that work.

What Is Hydroxy Methylene Blue?

Hydroxy Methylene Blue is chemically identified as 3,7-Bis(dimethylamino)-10H-phenothiazin-10-ol — a hydroxylated analog of Methylene Blue relevant to its manufacturing and degradation chemistry. As a close structural relative of the parent drug, it requires precise analytical separation during quality testing.

Key specifications:

  • CAT No: SZ-M114015
  • CAS No: NA
  • Molecular Formula: C16H19N3OS
  • Molecular Weight: 301.4
  • Availability: Synthesis on demand
  • Shipping Condition: Ambient temperature

Why This Standard Matters in Methylene Blue Manufacturing

Reference standards like Hydroxy Methylene Blue are indispensable for laboratories working on Methylene Blue formulations, whether for pharmaceutical, diagnostic, or research applications. Specifically, they support:

  • Analytical method development and validation (AMV): ensuring HPLC/LC-MS methods can reliably detect and separate this impurity from Methylene Blue itself
  • Quality control (QC) testing: confirming batch purity during commercial production
  • ANDA filing support: providing the authentic reference material regulators expect for submission dossiers
  • Forced degradation studies: helping labs understand how Methylene Blue behaves and breaks down under stress conditions, since hydroxylation is a known degradation pathway for phenothiazine-class compounds
  • Unknown impurity identification: serving as a match standard when unexpected peaks appear during routine analysis

Sourcing Hydroxy Methylene Blue

SynZeal's Hydroxy Methylene Blue reference standard is supplied with detailed characterization data compliant with regulatory guidelines, and traceability against USP or EP pharmacopeial standards can be provided based on feasibility. As with all SynZeal reference materials, it is intended strictly for laboratory, research, and analytical use, not for human consumption.

It is part of a broader Methylene Blue-related impurity series that includes the parent compound, Azure A, B, and C (USP), the Azure A Isomer, Thiosulfonic Acid Bindschedler Green (V), Benzoyl Leuco Methylene Blue, Methylene Violet, and Methylene Blue Impurities 1 through 4 — useful for labs building a complete impurity library for this widely used phenothiazine dye and drug.

Explore More

For labs working across diagnostics, hematology, and other therapeutic areas, it's worth browsing the full SynZeal product catalog, which spans thousands of pharmacopeial and non-pharmacopeial reference standards, metabolites, and stable isotope-labelled compounds across major therapeutic categories.

This article is for general informational purposes and does not constitute regulatory or medical advice. This compound is intended strictly for laboratory, research, and analytical use, not for human consumption. Product availability, CAS numbers, and specifications should always be verified directly on the manufacturer's website before ordering.

Comments

Post a Comment

Popular posts from this blog

The Crucial Role of Reference Standards in the Pharmaceutical Industry

Image
  Introduction In modern pharmaceutical research, accuracy isn’t optional—it’s essential. Every Active Pharmaceutical Ingredient (API) and every formulation depends on precise analytical testing. This is where reference standards play a critical role. These highly purified compounds serve as measurement benchmarks, ensuring that every analytical result is consistent, reliable, and compliant with global regulatory expectations. Among global providers, SynZeal Research has emerged as a trusted partner supplying high-quality impurity standards, reference standards, metabolites, and custom synthesis materials to support consistent analytical performance from R&D to regulatory submission. Why Reference Standards Matter in Pharma 1. Ensuring Accurate API Identification Pharmaceutical companies rely on reference standards to confirm the identity of APIs and impurities using techniques like HPLC, GC, LC-MS, NMR, and IR. A high-purity standard ensures that analytical teams can verify e...
Read more

Pharmaceutical Reference Standards: A Complete Guide by SynZeal

Image
  In modern pharmaceutical research and quality control, pharmaceutical reference standards are foundational tools that ensure accurate, consistent, and compliant analytical results. At SynZeal , we specialize in delivering high-purity reference materials — including APIs, impurity standards, metabolites, isotopically labelled compounds and custom reference standards — to support global drug development and regulatory testing workflows. What Are Pharmaceutical Reference Standards? A pharmaceutical reference standard is a well-characterized, highly purified material used as a benchmark for testing the identity, strength, quality, and purity of drug substances, excipients and finished products. These standards are essential in analytical method development, quality control testing, and regulatory submissions. Reference standards can be sourced from national or international pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or developed in-ho...
Read more

Impurity Reference Standards Across Therapeutic Areas: What Analytical Labs Need to Know

Image
  Impurity profiling looks different depending on which drug class you're testing. A diabetes drug, a statin, and an anticoagulant each carry their own set of process-related impurities, degradation products, and pharmacopeial (USP/EP) related compounds. Having the right, well-characterized reference standard for each is what actually makes a validated analytical method possible. Here's a practical look at three real examples spanning three major therapeutic categories — and why sourcing the correct reference standard matters more than it might seem. Quick Reference: The Three Impurities at a Glance Therapeutic Area Drug Impurity CAS No. Diabetes (SGLT2 inhibitor) Dapagliflozin Hydroxy Dapagliflozin (USP) 1204222-85-4 Cardiovascular (Statin) Pravastatin EP Impurity A (6′-Epipravastatin) 81176-41-2 Anticoagulant Dabigatran Etexilate Despyridyl Ethyl Ester 1408238-36-7 Diabetes: Dapagliflozin and Its Impurity Profile Dapagliflozin is an SGLT2 inhibitor widely used in ...
Read more