Product Name: Tranexamic Acid 98% by HPLC
CAS No.: 1197-18-8
Molecular Formula: C₈H₁₅NO₂
Molecular Weight: 157.21 g/mol
Purity: ≥98% (HPLC)
Appearance: White crystalline powder
Storage: +4°C (short-term), -20°C (long-term)
Application: Pharmaceutical, Cosmetics, Research
1. Product Overview
Tranexamic Acid (TXA), a synthetic lysine analog, is widely used as an antifibrinolytic agent to reduce bleeding in surgical and trauma settings. This product is manufactured under strict quality control, ensuring a purity of ≥98% as verified by High-Performance Liquid Chromatography (HPLC). Its chemical structure (trans-4-(aminomethyl)cyclohexanecarboxylic acid) and high stability make it suitable for diverse applications, including:
- Medical Use: Hemorrhage control, traumatic brain injury (TBI) treatment.
- Cosmetics: Skin whitening creams targeting hyperpigmentation.
- Research: Analytical method development and pharmacokinetic studies.
2. Chemical and Physical Properties
- IUPAC Name: 4-(Aminomethyl)cyclohexane-1-carboxylic acid
- SMILES: NC[C@@H]1CCC@HC(=O)O
- InChI Key: InChI=1S/C8H15NO2/c9-5-6-1-3-7(4-2-6)8(10)11/h6-7H,1-5,9H2,(H,10,11)/t6-,7
- Melting Point: 386°C (dec.)
- Solubility: Soluble in water (1N HCl, pH-adjusted buffers), methanol, and acetonitrile.
3. Quality Assurance
3.1 HPLC Analysis
Our HPLC method ensures precise quantification and impurity profiling:
- Column: XBridge C18 (4.6 mm × 250 mm, 5 μm) or equivalent.
- Mobile Phase: Methanol:acetate buffer (20 mM, pH 4) (75:25 v/v).
- Flow Rate: 0.8–0.9 mL/min.
- Detection: UV at 220 nm or 570 nm (post-derivatization with 1% ninhydrin).
- System Suitability:
- Precision: ≤2% CV for peak area (6 replicates).
- Recovery: 98–102% (80%, 100%, 120% spiked levels).
3.2 Impurity Profile
- Impurity A: ≤0.1%.
- Impurity B: ≤0.2%.
- Total Impurities: ≤0.2%.
- Halides (as Cl⁻): ≤140 ppm.
3.3 Stability
- pH Stability: Compatible with buffers (pH 2–7.4) and common IV solutions (e.g., fructose, sodium chloride).
- Thermal Stability: Stable at 37°C for 24 hours in biological matrices.
4. Applications
4.1 Medical Use
- Trauma Care: Reduces mortality in TBI patients by 20% (CRASH-3 trial).
- Surgery: Minimizes perioperative blood loss (orthopedic, cardiac surgeries).
4.2 Cosmetics
- Mechanism: Inhibits plasmin-induced melanogenesis by blocking lysine-binding sites.
- Formulations: 3% TXA creams for melasma and hyperpigmentation.
- Safety: Topical use avoids systemic risks (e.g., thrombosis).
4.3 Research & Development
- Analytical Methods:Synthesis: Prodrug interconversion studies under acidic conditions.
- UPLC-MS/MS: For plasma analysis (LOD: 0.1 ppm).
- Fluorimetry: Derivatization with NDA/CN (5-minute reaction).
5. Packaging & Storage
- Primary Packaging: Sealed aluminum bags with desiccant.
- Shelf Life: 24 months at -20°C.
- Shipping: Ambient temperature (validated for 72 hours).
6. Safety and Compliance
- Handling: Use PPE (gloves, goggles) to avoid inhalation/contact.
- Regulatory Status: Complies with USP, EP, and JP pharmacopeias.
- Toxicity: LD₅₀ (oral, rat) >5,000 mg/kg; non-carcinogenic.
7. References
- System suitability validation for HPLC.
- Calibration curve and derivatization protocols.
- UPLC-MS/MS method comparison.
- Cost-effectiveness in trauma care.
- Cosmetic formulation stability.
Keywords: Tranexamic Acid 98% HPLC, Antifibrinolytic Agent, Skin Whitening, Trauma Care, UPLC-MS/MS, CRASH-3 Trial, Melasma Treatment
Meta Description: High-purity Tranexamic Acid (≥98% by HPLC) for medical, cosmetic, and research use. Validated HPLC methods, cost-effective trauma care, and safe topical formulations. CAS 1197-18-8.
