Product Basic Information
| Item | Details |
|---|---|
| Product Name | Tranexamic Acid |
| CAS No. | 1197-18-8 |
| Synonyms | trans-4-(Aminomethyl)cyclohexanecarboxylic acid; AMCHA; Cyklokapron® (brand name for injectable hemostasis); Lysteda® (brand name for oral menorrhagia) |
| Molecular Formula | C₈H₁₅NO₂ |
| Molecular Weight | 157.21 |
| Appearance | White or almost white crystalline powder; Odorless |
| Specification | - Pharmaceutical Grade: Purity ≥99.0% (HPLC); pH (5% aqueous solution) 6.0-8.0; Loss on drying ≤0.5%; Residue on ignition ≤0.1%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm); Chloride (Cl⁻) ≤0.02%- Cosmetic Grade: Purity ≥98.0% (HPLC); Compliant with INCI (International Nomenclature of Cosmetic Ingredients) standards |
| Melting Point | 233-237°C (with decomposition) |
| Solubility | Freely soluble in water (≥100 g/L at 25°C); Slightly soluble in methanol; Insoluble in ethanol, acetone, and chloroform |
| Storage Conditions | Store in a cool (15-25°C), dry, light-protected container; Sealed to prevent moisture absorption; Shelf life: 36 months for pharmaceutical grade, 24 months for cosmetic grade |
Core Functions & Applications
Tranexamic Acid exerts its primary biological effect by competitively inhibiting the binding of plasminogen to fibrin-blocking plasminogen activation into plasmin (the enzyme that degrades fibrin clots). This preserves existing blood clots and reduces fibrinolysis (clot breakdown), thereby controlling bleeding. In cosmetics, it inhibits melanin synthesis by suppressing tyrosinase activity and melanocyte activation. It is exclusively used in human pharmaceutical and cosmetic products (no veterinary application) across key areas:
1. Pharmaceutical Field (Hemorrhage Control & Hemostatic Therapy)
1.1 Gynecological & Obstetric Hemorrhage
Heavy Menstrual Bleeding (Menorrhagia): The first-line oral treatment for idiopathic menorrhagia (excessive menstrual blood loss ≥80 mL/cycle) in premenopausal women. Reduces menstrual blood volume by 30-50% within 1-2 cycles by stabilizing endometrial blood clots. Standard dose: 1-1.5 g orally, 3 times daily during menstruation (for 3-5 days).
Postpartum Hemorrhage (PPH): Used as a second-line agent for PPH unresponsive to uterotonics (e.g., oxytocin). Administered as an intravenous (IV) infusion (1 g over 10 minutes, followed by 1 g over 8 hours) to reduce the risk of severe PPH and blood transfusion needs, especially in cases of uterine atony or placental abruption.
1.2 Surgical Hemorrhage
Cardiac, Orthopedic, & Dental Surgery: Prophylactically administered to reduce perioperative bleeding and transfusion requirements. For example:
Cardiac surgery: IV infusion of 10-20 mg/kg before skin incision, followed by 10 mg/kg every 6 hours for 24 hours.
Dental extraction (in patients with hemophilia): Oral dose of 1-1.5 g 2 hours before surgery, then 1 g every 6 hours for 2-3 days to prevent post-extraction bleeding.
Trauma-Associated Hemorrhage: Included in damage control resuscitation protocols for severe trauma (e.g., blunt abdominal injury, pelvic fractures) to reduce fibrinolysis-induced coagulopathy. IV dose: 1 g loading dose, followed by 1 g over 8 hours (if bleeding persists).
1.3 Other Hemorrhagic Disorders
Hemophilia A/B & Von Willebrand Disease: Adjunctive therapy to factor replacement therapy (FRT) to enhance hemostasis during bleeding episodes (e.g., joint bleeds, mucosal bleeding). Oral or IV administration reduces FRT dosage and duration.
Melena & Hematemesis (Gastrointestinal Bleeding): Used in patients with peptic ulcer bleeding or esophageal variceal bleeding (after endoscopic hemostasis) to prevent rebleeding. IV infusion of 1 g every 6 hours for 5 days reduces rebleeding risk by ~20%.
2. Cosmetic Field (Hyperpigmentation Management)
Melasma & Chloasma: A gold-standard ingredient in brightening serums, creams, and masks for treating hormone-induced melasma (e.g., pregnancy-related, oral contraceptive-induced). It inhibits melanin production by:
Blocking the interaction between melanocytes and keratinocytes (reducing melanin transfer).
Suppressing tyrosinase (the rate-limiting enzyme in melanin synthesis).
Typical cosmetic concentration: 2-5% (safe for long-term topical use). Visible improvement in pigmentation intensity within 8-12 weeks of daily use.
Post-Inflammatory Hyperpigmentation (PIH): Effective for reducing PIH caused by acne, burns, or laser treatments. Topical application accelerates fading of dark spots by inhibiting abnormal melanin deposition, often combined with vitamin C or niacinamide for synergistic effects.
Quality & Safety Assurance
Tranexamic Acid's use in critical hemostasis and cosmetic applications demands rigorous quality control and safety management:
Raw Material & Synthesis: Produced via catalytic hydrogenation of para-aminomethylbenzoic acid (PAMBA) followed by purification via recrystallization. Raw materials meet USP/EP standards for impurity limits (e.g., PAMBA ≤0.1%), ensuring no residual toxins or allergens.
Production Process:
Pharmaceutical-grade Tranexamic Acid is manufactured in GMP-certified workshops (Class D cleanroom for final processing) with automated pH control and filtration systems to ensure batch uniformity.
Cosmetic-grade products undergo additional purification to remove trace metals (≤5ppm) and meet skin irritation safety standards (patch test-negative).
Comprehensive Testing Protocol:
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Related Substances | HPLC (C18 column, 220 nm detection) | Pharmaceutical grade: ≥99.0%, single impurity ≤0.1%; Cosmetic grade: ≥98.0%, single impurity ≤0.5% |
| pH Value | Potentiometry (5% aqueous solution) | 6.0-8.0 |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Chloride Content | Titration (silver nitrate method) | ≤0.02% |
| Identification | IR Spectroscopy & HPLC Retention Time | Matches reference standard spectrum and retention time |
Safety Reminders:Pharmaceutical Use:
Contraindications: Hypersensitivity to Tranexamic Acid; active venous thromboembolism (VTE, e.g., deep vein thrombosis, pulmonary embolism); severe renal impairment (creatinine clearance <30 mL/min).
Rare Side Effects: Gastrointestinal discomfort (nausea, diarrhea), headache, and, in long-term use, increased VTE risk-monitor patients with a history of thrombosis.
Cosmetic Use:
Safe for most skin types, but patch testing is recommended for sensitive skin (avoid use on broken or inflamed skin).
Not photosensitizing, but concurrent use of sunscreen (SPF ≥30) is advised to prevent further pigmentation.
Cooperation & Contact
We supply Tranexamic Acid in both pharmaceutical grade (for oral tablets, IV injections, and topical hemostatic gels) and cosmetic grade (for brightening formulations). We offer flexible supply capacities:
R&D samples: 100g-1kg (for formulation development and clinical trials).
Commercial bulk: 10kg-500kg per order (monthly production capacity of 1000kg).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support client registration in the EU, US, and Asia.
Customized particle size control (micronization for cosmetic serums) and aqueous solution preparation (for ready-to-use cosmetic bases).
Technical support for formulation stability (e.g., preventing hydrolysis in liquid dosage forms).
If you are a pharmaceutical manufacturer, cosmetic formulator, or medical device company, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "pharmacopeial compliance, safety priority, and win-win cooperation" and look forward to partnering with global healthcare and beauty enterprises!
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