Salicylic Acid

Salicylic Acid is a white, crystalline organic compound (C7H6O3, CAS No. 69-72-7) synthesized via the Kolbe-Schmitt carboxylation process using sodium phenolate and carbon dioxide under controlled thermal-pressure parameters. The resulting crystalline structure provides high purity and uniform morphology, functioning as an active keratolytic agent in topical dermatological preparations and a primary chemical intermediate in pharmaceutical and industrial synthesis.

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Product Introduction

USP/EP Grade Salicylic Acid:

USP/EP Grade Salicylic Acid Specifications:
Compliant with USP, EP, and BP pharmacopeial monographs.

Test Parameter	Specification Limit	Test Method
Assay (Dried Substance)	99.0% - 100.5%	Titrimetry (Pharmacopeial Procedure)
Melting Range	158.0°C - 161.0°C	Capillary Melting Point Apparatus
Loss on Drying	<= 0.5% (105°C, 3h)	Gravimetric Analysis
Residue on Ignition	<= 0.1%	Sulfated Ash
Chloride	<= 200 ppm	Turbidimetric Limit Test
Sulfate	<= 200 ppm	Turbidimetric Limit Test
Heavy Metals (as Pb)	<= 10 ppm	Colorimetric / Atomic Absorption Spectroscopy (AAS)
Phenol Content	<= 0.05%	High-Performance Liquid Chromatography (HPLC)

Chemical & Physical Properties:

CAS Number	69-72-7
Chemical Formula	C7H6O3
Molecular Weight	138.12 g/mol
Appearance	White, needle-like crystals or light crystalline powder
Odour	Practically odorless or faint characteristic phenolic trace
Bulk Density	0.35 - 0.45 g/cm3 (uncompacted)
Solubility	Slightly soluble in water (2.2 g/L at 25°C); freely soluble in ethanol (96%) and ether; sparingly soluble in chloroform.
PH (Saturated Aqueous Solution)	Approx 2.4

Applications:

Pharmaceutical Synthesis: Functions as the core precursor for manufacturing Acetylsalicylic Acid (Aspirin), methyl salicylate, and systemic anti-inflammatory agents.

Dermatological APIs: Utilized in topical formulations at concentrations from 0.5% to 40% for treating acne vulgaris, hyperkeratosis, psoriasis, warts, and seborrheic dermatitis due to its keratolytic action on the stratum corneum.

Cosmetic Formulations: Incorporated into leave-on and rinse-off products for sebum regulation and follicular exfoliation.

Industrial Chemical Manufacturing: Serves as an intermediate for dyestuffs, rubber anti-scorching additives, and ultraviolet (UV) stabilizing filters.

Pharmaceutical Manufacturing Relevance:

Engineered for direct integration into GMP-certified manufacturing processes within an ISO 9001:2015 and FDA-registered facility framework. The low impurity profile-specifically controlled phenol levels (<= 0.05%) and heavy metals (<= 10 ppm)-prevents catalytic inhibition during chemical synthesis and minimizes purification steps in downstream API processing. Controlled particle size distribution eliminates dusting issues during powder transfer and prevents agglomeration during direct-blend tableting operations.

Grade & Quality Requirements:

USP Grade: Meets United States Pharmacopeia standards; ICH Q3C compliant regarding residual solvent limits.

EP Grade: Conforms to European Pharmacopeia requirements for pharmaceutical preparations within EU regulatory jurisdictions.

Technical Grade: Optimized for industrial organic synthesis and non-pharma manufacturing where strict biological limits are secondary to reaction kinetics.

REACH Status: Fully registered for import and commercial distribution within the European Union under applicable tonnage bands.

Quality Control:

Every production batch undergoes analytical testing at our in-house laboratory prior to commercial release. Assay validation and impurity profiling are conducted via calibrated High-Performance Liquid Chromatography (HPLC); heavy metals tracking uses Atomic Absorption Spectroscopy (AAS); and thermal verification utilizes Differential Scanning Calorimetry (DSC). Retained samples are archived for a minimum of 3 years to ensure traceability.

Technical Documents:

COA (Certificate of Analysis): Batch-specific analytical data sheet supplied with every shipment, verifying compliance with pharmacopeial limits.

SDS (Safety Data Sheet): GHS-compliant documentation detailing hazard classifications, personal protective equipment (PPE) requirements, handling precautions, and spill procedures.

TDS (Technical Data Sheet): Complete data profile covering physical characteristics, packaging parameters, and storage guidelines.

Packaging & Storage:

Standard Packaging: 25 kg fiber drums lined with dual-layer low-density polyethylene (LDPE) moisture-barrier films. Palletized and shrink-wrapped for containerized ocean transit.

Bulk Packaging: 500 kg or 1000 kg polypropylene woven FIBC bulk bags (supersacks) equipped with inner protective liners upon request.

Storage Conditions: Store in a dry, cool, well-ventilated enclosure away from direct sunlight, strong oxidizing agents, and strong alkaline materials. Keep containers hermetically sealed to prevent moisture absorption and sublimation.

Shelf Life: 24 months from the date of manufacture under specified storage conditions.

Bulk Supply, MOQ & Procurement:

MOQ (Minimum Order Quantity): 100 kg for standard drum packaging; 1 metric ton for custom particle sizing or private label stenciling.

Sample Policy: 100 g analytical samples available for laboratory testing and incoming QA evaluation. Freight charges apply.

Lead Time: 7 to 14 business days for standard stock items dispatched from regional hubs; 25 to 35 days for factory-direct full container load (FCL) shipments.

Bulk Supply: Annual supply agreements (ASAs) available featuring fixed pricing structures and scheduled quarterly call-offs.

OEM / Custom Specification:

Particle Size Customization: Milling options available to achieve specific mesh distributions (e.g., passing 80 mesh or 100 mesh) to optimize dissolution rates in liquid or semi-solid formulations.

Private Labeling: Custom drum stenciling, client-provided artwork on packaging labels, and specific pallet configuration requirements accommodated for verified distributors.

FAQ:

Q: What differentiates USP grade from Technical grade Salicylic Acid?

A: USP grade complies with pharmacopeial purity thresholds (>= 99.0%) with strict limits on heavy metals, phenol, and chlorinated residues, qualifying it for pharmaceutical and dermatological applications. Technical grade is designated for industrial chemical synthesis and dye manufacturing.

Q: Is the product of synthetic or natural origin?

A: The material is synthetically produced via the Kolbe-Schmitt process using phenol, sodium hydroxide, and carbon dioxide, ensuring batch-to-batch chemical consistency and eliminating agricultural variability.

Q: How is moisture absorption controlled during ocean freight?

A: Packaging utilizes dual-layer LDPE liners heat-sealed inside rigid fiber drums, combined with container desiccant placement during ocean transit to prevent caking and hydrolysis.

Q: Are regulatory files like DMF available for audit?

A: Drug Master Files (DMF) and regulatory support documentation are available to support client validation and regulatory filing upon execution of a confidentiality agreement (CDA).

Request a Quote:
Submit your required volume, destination port, and target delivery schedule to receive a commercial quotation including FOB/CIF terms and current market pricing. Direct technical inquiries can also be sent to our application engineering team via email or WhatsApp.

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