Tranexamic Acid
Tranexamic Acid Manufacturer | Hemostatic API & Cosmetic Whitening Headline: Premium Tranexamic Acid Manufacturer | BP/USP/JP Standard (CAS: 1197-18-8) Sub-headline: 99%+ Purity | Powerful Anti-Fibrinolytic & Skin Brightening Agent Unique Selling Proposition (USP): • Dual Application: A trusted API for trauma hemostasis and a revolutionary ingredient for treating melasma and hyperpigmentation. • Global Compliance: Manufactured to meet stringent BP, USP, and JP pharmacopeial monographs, ensuring safety for both injectable and topical use. • High Stability: Excellent thermal and pH stability, making it easy to formulate in creams, serums, and tablets.
Introduction
Tranexamic Acid (TXA), CAS No. 1197-18-8, is a synthetic derivative of the amino acid lysine. It appears as a white crystalline powder that is odorless and freely soluble in water.
In medicine, it is a WHO Essential Medicine used to prevent excessive bleeding by inhibiting the breakdown of fibrin clots. In the cosmetics industry, it has emerged as a top-tier whitening agent. Unlike exfoliating acids, it works by inhibiting the plasminogen/plasmin pathway, effectively blocking the interaction between melanocytes and keratinocytes to reduce dark spots and redness.
Category：
Keywords：
acid
whitening
tranexamic
Functions
1. Anti-Fibrinolytic (Hemostasis)
• Mechanism: Reversibly binds to lysine receptor sites on plasminogen.
• Action: Prevents plasminogen from being activated into plasmin (the enzyme that dissolves clots). This stabilizes the fibrin clot and reduces bleeding during surgery or trauma.
2. Skin Whitening (Melasma Treatment)
• Mechanism: Inhibits the release of arachidonic acid and prostaglandins (inflammatory mediators) stimulated by UV light.
• Action: Reduces melanocyte tyrosinase activity indirectly. It is particularly effective for melasma and post-inflammatory hyperpigmentation (PIH) where inflammation is a root cause.
3. Anti-Inflammatory
• Mechanism: Suppresses angiogenesis and mast cell activity.
• Action: Reduces skin redness (erythema) and strengthens the skin barrier, making it suitable for sensitive skin formulations.
Applications
1. Pharmaceutical Formulations
• Application: Tablets (Lysteda), Injections (Cyklokapron), and Topical Hemostats.
• Why it works: Gold standard for treating menorrhagia (heavy periods) and preventing blood loss in orthopedic/cardiac surgeries.
2. Dermo-Cosmetics (Whitening)
• Application: Serums, Creams, and Masks (typically 2-5% concentration).
• Why it works: Safe for long-term use and pairs well with other brighteners like Niacinamide and Vitamin C.
3. Oral Care
• Application: Toothpaste and Mouthwash.
• Why it works: Used to control gum bleeding (gingivitis) and reduce inflammation in the oral cavity.
Flow Chart
1.Starting Material: 1,4-Cyclohexanedimethanol or related intermediates.
2.Oxidation/Esterification: Conversion to intermediate esters.
3.Amination: Introduction of the amino group.
4.Isomerization: Critical step to ensure the trans-isomer (the active form) is dominant over the cis-isomer.
5.Hydrolysis: Formation of the carboxylic acid.
6.Purification: Crystallization to remove the cis-isomer (<0.5%) and other impurities.
7.Drying: Fluid bed drying.
8.Milling: Size reduction.
9.Packaging: 25kg Drums.
Quality Standard of Lactoferrin
Product: Tranexamic Acid (BP / USP / JP) CAS: 1197-18-8
| Item | Specification | Result |
| Appearance | White crystalline powder | Conforms |
| Assay (Titration) | 99.0% - 101.0% | 99.8% |
| pH (5% solution) | 7.0 - 8.0 | 7.4 |
| Loss on Drying | ≤ 0.5% | 0.2% |
| Residue on Ignition | ≤ 0.1% | 0.04% |
| Related Substances (Cis-isomer) | ≤ 0.5% | 0.1% |
| Heavy Metals | ≤ 10 ppm | < 5 ppm |
| Chlorides | ≤ 0.014% | Conforms |
Method of Analysis of Lactoferrin
Test Method: HPLC (High-Performance Liquid Chromatography)
• Column: C18 with specific packing (e.g., Sodium Dodecyl Sulfate mobile phase for ion-pairing).
• Detection: UV at 220 nm.
• Critical Check: Separation of the Cis-isomer (inactive impurity) from the Trans-isomer (active API). The BP/USP monographs have strict limits on the cis-isomer content.
Reference Chromatogram of Lactoferrin Reference Substance
(Description) The chromatogram displays a major peak for Trans-Tranexamic Acid. A small, well-separated peak may appear for the Cis-isomer, which must be integrated to ensure it stays below the 0.5% limit.
Stability and Safety
Stability Studies
• Thermal Stability: Very stable. Does not easily degrade under heat, making it suitable for various cosmetic processing temperatures.
• Light/pH: Stable to light and over a wide pH range (pH 3-9).
• Shelf Life: 36 Months (3 Years) when stored properly.
Safety & Handling (MSDS Summary)
• Classification: Non-hazardous active ingredient.
• Handling: Avoid inhalation of dust.
• Storage: Store in a cool, dry place. Keep container closed.
Customer Comments
R&D Director, Clinical Skincare (Korea)
2026.02.05
★★★★☆
QA Manager, PharmaInject (India)
2026.02.05
★★★★☆
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FAQ
Is it safe for topical use during pregnancy?
While Tranexamic Acid is generally considered safe, pregnant women should always consult a doctor. However, it is not a retinoid and does not have the same teratogenic risks.
What is the optimal pH for cosmetic formulation?
Tranexamic Acid is stable across a broad pH range, but it works best in formulations with a pH of 5.0 - 7.0, which is compatible with most skin care products.
Does it thin the blood?
No, quite the opposite. Systemically (oral/injection), it is a coagulant (helps blood clot). Topically, it does not enter the bloodstream in significant amounts to affect systemic clotting.
References
1.Dunn, C.J., et al. (1999). "Tranexamic acid: a review of its use in surgery and other indications." Drugs.
2.Tse, T.W., et al. (2013). "Tranexamic acid: an important adjuvant in the treatment of melasma." Journal of Cosmetic Dermatology.
3.Ebrahimi, B., et al. (2014). "Topical tranexamic acid as a promising treatment for melasma." Journal of Research in Medical Sciences.
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