Overview
Tranexamic Acid is a water-soluble white crystalline powder now widely used to even out skin tone. It works by blocking the signal between skin cells that triggers melanocytes to produce excess pigment, helping reduce dark spots, post-acne marks, and uneven skin tone.
Product Parameters
|
Item |
Specification |
|
CAS Number |
1197-18-8 |
|
Molecular Formula |
C8H15NO2 |
|
Molecular Weight |
157.21 g/mol |
|
Assay (HPLC) |
99.0% – 101.0% (batch-by-batch tested) |
|
Appearance |
White to off-white crystalline powder |
|
Particle Size |
Standard: D90 ≤ 80 μm / Micronized: D90 ≤ 25 μm |
|
Loss on Drying |
≤ 0.5% |
|
Heavy Metals |
≤ 10 ppm |
|
Residual Solvents |
Complies with ICH Q3C guidelines |
|
Solubility |
Freely soluble in water |
|
PH (1% aqueous solution) |
6.0 – 8.0 |
|
Melting Point |
300–302°C (decomposition) |
Key Benefits
Dissolution Rate Optimization: Dissolves completely clear in aqueous phases within 60 seconds at a 2.0% concentration at 25°C. Eliminates the need for pre-milling or high-shear mixing, directly shortening batch tank cycle times and reducing blending energy consumption.
Extended pH & Thermal Stability: Remains chemically stable across a pH range of 4.5–7.5. Minimizes the risk of batch discoloration during high-temperature thermal cooling phases, reducing the rejection rate of finished lots.
Non-Photosensitizing Mechanism: Demonstrates zero UV-absorption or cellular photosensitivity, allowing day-use brightening claims without requiring secondary sun-sensitivity warning labels on consumer packaging.
Synergistic Multi-Active Compatibility: Formulates alongside L-Ascorbic Acid, Niacinamide, and Alpha-Arbutin without molecular complexation or crystalline precipitation, reducing formula separation risks during R&D stability trials.
Manufacturing Standards
Manufactured in compliance with ISO 22716 and EFfCI GMP guidelines for cosmetic ingredients, verified through annual independent third-party audits.
Absolute assay purity and residual solvent profiles are determined via validated HPLC, GC, and ICP-MS methods in strict alignment with international pharmacopeia limits.
Physical retention samples from every commercial lot are archived under controlled environments (20°C ± 2°C, 50% RH) for 24 months to guarantee upstream-to-downstream traceability.
Full Batch Manufacturing Records (BMR), Elemental Impurity Profiles (ICH Q3D), Non-Animal Testing Declarations, and TSE/BSE Statements are available on demand to support global regulatory filings.
Packaging & Logistics
Industrial Packaging: Supplied in 25 kg net weight heavy-duty fiber drums engineered with heat-sealed double Polyethylene (PE) liners and integrated moisture-barrier desiccant seals.
Bulk Automated Charging Formats: Anti-static 500 kg or 1,000 kg (1 MT) jumbo bags are available for automated plant charging systems on contract volumes exceeding 5 MT.
Standardized Lead Times: Dispatched within 7–10 business days for standard ex-stock inventory; 20–25 calendar days for custom-scheduled production campaigns exceeding 5 MT.
Technical Samples: Complimentary 100g to 500g validation samples dispatched within 3 business days, accompanied by lot-specific COAs, exclusive to verified corporate R&D entities.
Global Logistics: Standard execution via FOB Shanghai or FOB Ningbo ports; comprehensive CIF, CFR, and DDP options apply for major North American and European entry ports.
After-Sales Service
If any parameter deviation against the signed COA occurs, a traceable root-cause investigation report (8D/CAPA) is issued within 48 hours, backed by a credit refund or replacement delivery within 7 working days.
Direct laboratory support for Tranexamic Acid dissolution tracking and pH-drift buffering to resolve emulsion separation and viscosity drops in high-electrolyte systems, preventing batch rejection.
Establishment of a 60-day rolling-forecast buffer stock matching signed annual volume commitments to secure uninterrupted delivery and mitigate factory supply chain risks.
FAQ
Q: What is the MOQ for trial and bulk orders?
A: Standard MOQ is 25 kg per order for commercial supply. For R&D evaluation, smaller sample quantities (100 g–1 kg) can be provided depending on availability and batch scheduling. Pilot production orders (typically 25 kg–100 kg) are accepted as transitional validation batches before full-scale procurement.
Q: Do you support OEM or private label customization?
A: Yes, customization is available but is linked to technical feasibility and minimum volume requirements. Options include particle size adjustment (standard vs micronized grade), packaging configuration (25 kg drum or bulk bag), and private labeling for industrial handling.
Q: What is your sample policy for R&D evaluation?
A: Samples are provided in quantities typically ranging from 100 g to 500 g for formulation testing. Sample availability depends on current production batches and may require coordination for micronized vs standard grades.
Q: Is re-testing required for long-term stored inventory?
A: A re-test is generally recommended after 24 months from the manufacturing date if the material remains in sealed original packaging. Updated COA issuance is available upon request following sample re-evaluation or stability confirmation under controlled storage conditions.
Q: Which regulatory markets are supported?
A: The product is supplied with documentation aligned to major cosmetic regulatory frameworks, including EU Cosmetics Regulation (EC No 1223/2009) and US cosmetic ingredient standards (INCI nomenclature). Additional documentation support can be provided for ASEAN, LATAM, Canada, Korea, Japan, and Australia, depending on the specific regulatory filing requirements of the buyer.
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