Allantoin Powder

Premium Allantoin Powder 98% - High-Purity Cosmetic & Pharmaceutical Grade with Certified Quality Standards

Founded in 2001, Shaanxi Hongda Phytochemistry Co., Ltd. is a leading manufacturer and supplier of high quality Allantoin Powder with purity requirements above 98.5%. With our contemporary 20000 square metre factory, 100000 level purification workshops and over 10 advanced production lines , the annual production reaches 3000 tons with tight quality control . We are a qualified cGMP, HALAL, KOSHER, FSSC22000 and ISO-compliant producer, providing pharmaceutical and cosmetic grade product to tackle crucial formulation difficulties such as irritation reduction, rapid tissue regeneration and moisture barrier stabilisation. Our GMP laboratory and 20+ professor-level researchers ensure every batch is up to international pharmacopeial standards (USP, EP, BP, JPC) with rigorous testing for purity, heavy metals and microbial content, giving you reliable supply chains and consistent product quality.

Product Introduction

Molecular formula C4H6N4O3 CAS No. 97-59-6 Our product 5-Ureidohydantoin is a white, odourless substance, which is a crystalline compound. It is well known as a powerful keratolytic and cell-proliferating agent used in the pharmaceutical and cosmetic industries . This bio-identical skin conditioner assists in the accelerated shedding of dead skin cells and encourages healthy tissue regeneration, helping to resolve the irritation-efficacy contradiction sometimes seen in high active formulations. It is the only agent that combines desquamation and hygroscopic moisture retention, making it an essential agent for delicate skin applications, where conventional keratolytic agents damage moisture barriers.

Third-Party Test Report 

Purity Analysis: Independent third-party testing by SGS and Eurofins confirms our Allantoin Powder consistently achieves assay purity >98.5% through HPLC verification, meeting pharmacopeial monograph requirements.

Safety Profile: Heavy metal concentration is under the detection limits of 10ppm and full pesticide residue screening is zero detectable residues. It is compliant with FDA Type 1 Skin Protectant.

Microbial Quality: Total plate count <1000 CFU/g, yeast and mould <100 CFU/g. Salmonella and E. coli were negative according to authorised laboratory protocols.

Physical Verification : Melting point confirmation at 228-232°C with decomposition, particle size distribution analysis to maintain free-flowing crystalline form and moisture content kept below 0.5% for optimum stability.

Specifications

Allantoin Powder Application

Skincare Formulations: Used in anti-aging serums, moisturisers and sensitive skin creams at 0.1-2.0% to provide cell renewal effects, while easing irritation and boosting product penetration with controlled keratolysis.

Pharmaceutical Preparations: Used as an active ingredient in healing ointments for wounds, burns and ulcers at therapeutic doses, with the benefit of its Type 1 Skin Protectant status in the monograph, allowing for rapid tissue restoration.

Hair Care Products: Used in shampoos, conditioners and scalp treatments to aid with dandruff, scalp irritation and hair follicle health, due to its gentle exfoliating and moisture-retaining characteristics.

Oral Care Solutions – Used in toothpastes and mouth rinses to help improve gum health and preserve mucous membranes due to its non-toxic nature and regenerative properties.

Production Process

Step 1 - Raw Material Synthesis: High-purity uric acid is reacted under controlled oxidation conditions under strict temperature control at 60-80°C to produce crude allantoin intermediate with a conversion efficiency greater than 95%, laying the groundwork for pharmaceutical-grade quality.

Step 2 - Crystallisation Purification (CP) – The crude product is redissolved in hot water (75°C) and cooled to 25°C in a controlled manner with agitation to create homogeneous crystalline structures at >98.5% purity while avoiding glass-shard formation via optimised nucleation control.

Step 3 - Filtration and Washing - Multi-stage vacuum filtration removes contaminants, followed by a series of cold water washing cycles to achieve heavy metal reduction below 5ppm and eliminate residual reactants to ensure pharmaceutical-grade purity standards.

Step 4 - Drying and Milling: The material is vacuum dried at a low temperature of 50°C to reduce the moisture content to <0.5%, followed by precision milling to a free-flowing powder with regulated particle size distribution for consistent formulation performance and longer shelf stability.

Step 5 - Quality Testing and Packaging: Extensive HPLC, ICP-MS and microbial testing ensures that every batch meets international standards before it is packaged in double-layer PE bags in 25kg fibre drums, providing contamination free shipping and full traceability documentation.

Custom Formulation Development: Our 20+ experienced R&D professionals work with your team to design custom blends including product at optimal concentrations targeted to your specific market positioning and efficacy aims while ensuring regulatory compliance.

Flexible Packaging Solutions: We provide bulk 25kg drums but also tailor-made retail-ready packaging including sachets, jars and bottles. Our design professionals will assist you to develop your branding and we have a flexible MOQ that accelerates your time to market.

Private Label Manufacturing. Our cGMP-certified facility provides full turnkey solutions for capsules, tablets, premixed powders, and topical formulations. We deliver market-ready goods with full stability testing and regulatory paperwork.

Technical Documentation Support: Provision of full COAs, safety data sheets, regulatory dossiers and efficacy studies to support your product registration procedures in European, North American and Asian markets with expert help from our compliance specialists.

Why Choose Us?

Manufacturing Excellence Certified We are cGMP, FSSC22000, ISO9001, ISO22000, HALAL and KOSHER Certified providing systematic quality control to remove supply chain risks and batch to batch consistency for your production schedules.

Advantages of Vertical Integration: Total control of the supply chain from planting the raw material to finished product packaging. Lower expenses of 15-20%. Traceability and quality of the product at each stage of the process to protect your brand.

Rapid Response Capability: With our 3,000 square metres of diversified warehouse space and large inventory levels to deal with, we are able to supply within 3-7 working days to assist your just-in-time manufacturing requirements and avoid costly production delays.

Scientific Innovation Partnership: Our SGS-standardized laboratory with HPLC, GC, UV spectrophotometers and atomic absorption technology provides ongoing technical assistance, specific testing services and formulation optimisation that increases your competitive positioning.

International Market Knowledge: With 24 years of export expertise to Europe, North America and Asia, you can be certain of hassle free customs clearance and regulatory compliance for your global business. We have thorough knowledge of local regulatory needs.

Allantoin Powder Advantages

Superior Keratolytic Action: Our solution has superior efficacy in keratin structure softening and natural desquamation without disturbing the moisture barrier of your formulation, answering the key difficulty of achieving efficacy while preserving gentleness.

Increased Water Absorption Ability: Clinical information points to an increase in hydration of the extracellular matrix of up to 40%, giving long-term moistening that converts dry, damaged skin into soft, supple tissue through hygroscopic moisture retention activities.

Anti-Irritation Properties: Neutralises the inflammation indicators of anionic surfactants (SLS/SLES) and acidic actives, so you can manufacture high-performance solutions without compromising the dermatological compatibility of consumers with sensitive skin.

Thermal and pH Stability: Amphoteric nature ensures formulation stability in pH 4.0-9.0 ranges with excellent thermal resistance of up to 228°C, allowing you processing flexibility and avoiding degradation during the manufacturing cycles.

Cell Proliferation Stimulation: Scientifically proved to increase fibroblast proliferation and epithelialization processes, reducing wound healing periods and enhancing tissue regeneration outcomes in pharmaceutical applications.

FAQ

Q: What is the minimum order quantity of product?

A: Normally our MOQ is 25kg (one drum) but we can accept modest sample orders of 100-500g for testing formulation, with flexible payment terms.

Q: How can I keep merchandise in stable condition?

A: Keep in a cool, dry place away from direct sunlight, in firmly closed containers, below 25°C. Product is stable at >98% purity for 36 months from date of manufacture when stored properly.

Q: Does your product qualify for organic certification?

A: Our ingredients are chemically synthesised rather than derived from plants, although our manufacturing technique and purity levels comply with the requirements of several certification agencies for natural cosmetic formulations. For certification assistance details Contact Us.

Q: What is a solution for increasing solubility?

A: Yes, we provide formulation guidance from our technical team including solubilization processes employing hot water dissolving, pH modification, or compatible solubilizer systems based for your particular application needs.

Q: What documentation do you provide for regulatory compliance?

A: Full package with COA, MSDS, allergen statements, BSE/TSE certificates, non-gmo declarations, country specific regulatory dossiers supporting FDA, EU Cosmetics Regulation and CFDA registrations.

Contact Us

Ready to elevate your formulations with premium-grade Allantoin Powder backed by certified quality and reliable supply?

Email: duke@hongdaherb.com.