Tranexamic Acid Powder
English name: Tranexamic Acid
Extraction source: Lysine synthetic derivatives
CAS number: 1197-18-8
Product Appearance: White Powder
Product specification: 99%
Solubility: Easily soluble in water and glacial acetic acid, almost insoluble in acetone and ethanol (96%)
Detection method: HPLC
Application scenario: Widely used in the fields of medical hemostasis and cosmetic whitening
Packaging method: Small goods: packaged in aluminum foil bags, large goods in 25KG/cardboard drums;
Storage conditions: Sealed and shaded, stored in a dry, cool and ventilated place
Validity period: 24 months
Pharmaceutical & Cosmetic Grade Tranexamic Acid (API)
Manufactured by Xi'an Tihealth Biotechnology Co., Ltd.
Xi'an Tihealth is a premier global B2B supplier of highly purified Tranexamic Acid (CAS: 1197-18-8). Manufactured in a stringent GMP-compliant facility, our product is delivered as a premium white crystalline powder, scientifically verified via HPLC to achieve an exceptional purity of ≥ 99.9%.
Engineered for dual-industry superiority, this raw material serves as a critical Active Pharmaceutical Ingredient (API) for medical formulations, effectively inhibiting plasminogen activation. Simultaneously, its ultra-low endotoxin profile and rapid cold-water solubility make it a gold-standard tyrosinase inhibitor for high-end cosmetic skin-brightening matrices. Supported by full batch traceability and dual ISO/Pharmacopeia certifications, Tihealth ensures uncompromising quality for both your clinical R&D and large-scale manufacturing requirements.
Technical Data Sheet (TDS) & Analytical Control
| Analysis Item | Target Specification | Result (Typical Batch) | Methodology |
|---|---|---|---|
| Product Identity | Tranexamic Acid (CAS: 1197-18-8) | Verified | IR Spectrum |
| Purity (Assay) | ≥ 99.0% - 101.0% | 99.93% | HPLC / USP <621> |
| Endotoxin Limit | < 0.1 EU/mg | 0.03 EU/mg | LAL / USP <85> |
| Appearance | White crystalline powder | Complies | Visual Assessment |
| Solubility (Water 25°C) | Complete dissolution ≤ 10s | 8s | DLS |
| Loss on Drying | ≤ 0.5% | 0.21% | USP <731> |
| Heavy Metals (Pb, As) | ≤ 5.0 ppm / ≤ 2.0 ppm | Not Detected | ICP-MS |
| Microbiology (Total Plate) | ≤ 1000 CFU/g | 125 CFU/g | USP <61> |
Mechanisms & Potential Indications
Plasminogen Activation Inhibition (Hemostasis)
In medical formulations, Tranexamic Acid acts as a highly effective competitive inhibitor. It binds reversibly to the lysine-binding sites on plasminogen molecules, thereby preventing plasmin formation and the subsequent degradation of fibrin clots. This makes it a critical intermediate for formulations targeting surgical hemostasis and menorrhagia.
Melanogenesis Disruption (Depigmentation)
In dermatological applications, it effectively blocks the plasminogen/plasmin pathway induced by UV radiation. By inhibiting the release of arachidonic acid and prostaglandin E2, it prevents the transfer of melanin from melanocytes to keratinocytes, offering a profound mechanism for addressing hyperpigmentation.
Vascular Endothelial Regulation
Exhibits significant anti-inflammatory properties by regulating vascular endothelial cell function. It is extensively researched as an API for reducing localized skin erythema (redness) associated with conditions like rosacea or post-laser repair therapies.
Bradykinin Suppression
By inhibiting plasmin, it subsequently blocks the excessive production of bradykinin. This pharmacological pathway is utilized in specialized pharmaceutical R&D focused on reducing the frequency of acute edematous episodes in hereditary angioedema.
Formulation Stability & Handling Guidelines
Optimal pH Range: Highly stable in aqueous solutions within a pH range of 3.0 to 8.0. Avoid formulation in extreme alkaline environments to prevent molecular degradation.
Cosmetic Synergies: Exhibits excellent dermatological synergy when formulated alongside Niacinamide, Vitamin C derivatives, and Alpha Arbutin for brightening serums.
Medical Safety Note: For pharmaceutical injectable applications, strict adherence to coagulation monitoring and thrombosis contraindications is required by the final formulating manufacturer.
Industrial Formulation Applications
Pharmaceutical Injectables & Tablets
Endotoxin-controlled API used in the manufacture of surgical hemostatic injections, oral menorrhagia therapies, and hemophilia adjunctive treatments.
Premium Whitening Cosmeceuticals
The core active ingredient in high-end brightening serums, melasma correction creams, and post-laser repair facial masks.
Oral Care & Dental Formulations
Incorporated into clinical-grade toothpaste and mouthwashes to locally inhibit plasmin activity and effectively control gingival bleeding.
Advanced Medical Dressings
Used as a highly stable coating agent in hemostatic gauze and Class II medical aesthetic repair hydrogels for trauma recovery.
Contract Manufacturing & Global Supply Chain
♦ GMP Certified Production
Our facility operates under stringent GMP protocols, ensuring that our Tranexamic Acid meets the exacting purity (≥ 99.9%) and endotoxin standards required for sensitive pharmaceutical and cosmetic applications.
♦ Complete Traceability & QC
Every batch is rigorously audited via HPLC and ICP-MS. We provide comprehensive documentation, including detailed COAs, MSDS, and structural chromatograms, expediting your QC validation process.
♦ Secure Export Fulfillment
We specialize in global B2B logistics. Offering secure packaging (from 1kg sealed foils to 25kg commercial drums) and comprehensive export compliance documentation for rapid, hurdle-free customs clearance.
Packaging, Logistics & Secure Payment
Reliable B2B Supply Chain Solutions
We provide pharmaceutical-grade aseptic packaging, efficient global logistics (Air/Sea freight with dual customs clearance), and secure multi-currency payment methods to ensure seamless, oxidation-free cross-border transit for our B2B procurement partners.
Formulator & Procurement FAQ
01. Does your Tranexamic Acid meet injectable API standards?
Yes. Our pharmaceutical-grade powder is strictly processed to ensure Endotoxin levels are < 0.1 EU/mg, with Heavy Metals completely undetectable (< 5 ppm). It fully complies with ChP, EP, and USP pharmacopeia requirements for sterile medical formulations.
02. What is the recommended dosage for cosmetic skin-brightening formulations?
For topical cosmeceuticals, international dermatological guidelines generally recommend a formulation concentration between 2.0% and 3.0%. Our micronized powder dissolves seamlessly in the water phase without causing gritty textures.
03. Can it be co-formulated with active acids (AHAs/BHA)?
While Tranexamic Acid is highly stable, formulating it alongside high concentrations of strong exfoliating acids (AHAs/BHA) requires careful buffering to maintain the optimal pH (3.0 - 8.0) and prevent potential skin barrier irritation in the final product.
04. Do you provide validation documents for customs clearance?
Absolutely. Every bulk shipment includes a comprehensive COA, MSDS, and HPLC chromatograms. For medical API imports, we provide full traceability data and compliance declarations to expedite your customs clearance process.
05. What is the Minimum Order Quantity (MOQ) and lead time?
Our standard MOQ for mass production is 25kg, packed in heavy-duty commercial drums lined with sterile bags. We also supply 1kg bespoke MOQ sizes for pilot manufacturing and stability trials. Standard global dispatch is within 7-10 days.
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