Insight

Tranexamic Acid CAS 701-54-2 | GMP Specification & COA

Procurement teams and R&D chemists frequently encounter supply chain volatility when sourcing critical actives, where inconsistent purity and delayed Certificate of Analysis (COA) verification disrupt production timelines.

Detailed Chemical Synthesis Route and Reaction Mechanism

The industrial production of Tranexamic acid typically involves the hydrogenation of p-cyanobenzoic acid followed by isomerization to achieve the trans configuration. This process yields trans-4-(Aminomethyl)cyclohexanecarboxylic acid, ensuring the molecular conformation required for efficacy as an antifibrinolytic agent. Our synthesis protocol minimizes cis-isomer contamination, providing a reliable drop-in replacement for formulation scientists requiring high stereochemical purity.

Technical Specifications and Analytical Methods

Quality control relies on rigorous analytical methods including HPLC and FTIR to confirm identity and assay. The following table outlines the critical physical and chemical properties expected from a GMP standard manufacturer.

ParameterSpecification
CAS Registry Number701-54-2
Molecular FormulaC8H15NO2
Molecular Weight157.21 g/mol
Melting Point233 °C
Purity>99.0% (HPLC)
AppearanceWhite Crystalline Powder

Strict Quality Assurance (QA) Workflow and COA Verification Process

At NINGBO INNO PHARMCHEM CO.,LTD., every batch undergoes multi-stage testing to ensure a stable supply of pharmaceutical and cosmetic grade material. We understand that procurement officers need transparency regarding bulk price and compliance. For detailed application data, refer to our Tranexamic Acid Formulation Guide Cosmetic Whitening Agent. Our QA workflow includes raw material inspection, in-process control, and final release testing against strict pharmacopoeia standards. Clients seeking competitive advantages should review our Tranexamic Acid Bulk Price Manufacturer Gmp Standard documentation to align sourcing strategies with budgetary constraints.

Partnering with NINGBO INNO PHARMCHEM CO.,LTD. ensures access to verified documentation and consistent lot-to-lot performance.

For custom synthesis requirements or to validate our drop-in replacement data, consult with our process engineers directly.