Natural L-Menthol Crystals Bulk Supplier | USP/EP Grade Wholesale

Pharmaceutical buyers need batch identity, applicable compendial methods, impurity controls and an approved manufacturing site. Industrial procurement teams need confirmed drum packing, supply-lot availability, logistics and commercial terms. EXBIOL addresses these as two distinct qualification tracks.

Natural L-menthol is the (1R,2S,5R) isomer of menthol. The material is a monoterpene alcohol with formula C₁₀H₂₀O and molecular weight approximately 156.27 g/mol. CAS 2216-51-5 identifies the L-form, while CAS 1490-04-6 is used for menthol without the same L-isomer specificity in some catalogues. Procurement should not substitute one identity for the other without confirming stereochemistry.

Buyer check: ask for lot-matched identification, specific rotation with stated measurement conditions, and the applicable compendial identity method. A negative optical rotation supports identity but is not by itself proof of a 100% enantiomeric composition.

The supplier’s technical dossier describes natural L-menthol obtained from Mentha arvensis mint oil by cooling and fractional crystallization, followed by separation and refinement. This is distinct from synthetic menthol manufacture. Exact farm-of-origin, raw-oil origin, cultivation claims and manufacturing records are subject to source-document confirmation.

For natural-origin qualification, buyers may request the raw-material declaration, process flow, relevant compositional tests and manufacturing-site traceability. EXBIOL does not represent the material as an extract of peppermint leaves sold in powder form: it is an isolated crystalline constituent of mint oil.

The following results are transcribed from the submitted April 13, 2026 COA for reference batch 260318; they must not be confused with a current sellable batch or independently verified pharmacopeial compliance.

The reference COA reports a total menthol result of 99.4%; the test-method column in the supplied summary does not specify the corresponding assay procedure. Before supplier approval, the buyer should confirm the complete method, the compendial edition and the applicable acceptance criteria for the offered lot.

EXBIOL coordinates monograph-specific quality review covering USP, Ph. Eur., BP or CP requirements as appropriate to the project. Compliance should be based on the complete current-lot records and selected official methods rather than on an isolated summary result.

The reference COA reports a specific rotation of −50°, within its own listed −51° to −45° range. This provides a useful identity screen for levorotatory menthol when test temperature, solvent, concentration and path length are documented. It is not a substitute for an enantiomer-specific chromatographic method if a customer requires a numerical L/D-isomer ratio.

Ask for a defined rotation method and available chiral analysis where enantiomeric purity is a contractual acceptance criterion. Claims of “100% L-isomer” or “no synthetic adulteration” require more than the available COA summary.

Natural L-menthol is characterized by colorless crystalline morphology and a strong minty, cooling aroma. The supplied COA describes hexagonal or needle-like crystals and records odor and appearance as conforming. Particle-size distribution, needle dimensions and individual sensory-panel results are not supplied for this reference batch.

Industrial buyers should assess crystal size, handling, odor characteristics and compatibility in their own intended manufacturing process. Do not infer specific capsule filling performance or exact sensory intensity from appearance alone.

The supplier process statement describes physical crystallization without added organic process solvents. This is a process declaration, not an independent analytical demonstration that every possible solvent is absent. Requests for residual-solvent testing should state the target solvents, method detection limits and applicable USP <467>/ICH Q3C interpretation.

The reference COA records related substances as “Conform” but does not include an impurity chromatogram or named related-compound concentrations. These can be reviewed through the appropriate controlled technical package when available.

The reference COA uses specification limits of Pb ≤5 ppm, Cd ≤3 ppm, As ≤2 ppm, Hg ≤0.1 ppm and Cu ≤20 ppm, with results recorded as Conform. It does not provide numerical measured values or a lot-specific ICP-MS laboratory report in this dossier.

For pharmaceutical projects, ICH Q3D(R2) is a risk-based framework addressing the final drug product and route-specific exposure. Elemental impurity management should therefore be evaluated by the customer’s regulatory and formulation team, rather than described simply as “ICH Q3D approved.”

The supplied technical dossier asserts USP, EP, BP and Chinese Pharmacopoeia alignment. For supplier approval, request a monograph-to-result matrix identifying the official edition, test method, applicable acceptance range, current-lot result and any deviations. The submitted summary is a starting point, not a substitute for complete monograph verification.

In particular, check total menthol assay acceptance, optical rotation procedure, chromatographic related substances, non-volatile matter and identity. Product-level pharmacopoeial conformity does not automatically constitute a CEP, DMF, drug manufacturing authorization or approval of a finished pharmaceutical.

The external manufacturing partner’s supplied flow diagram describes incoming mint-oil testing, controlled cooling/fractional crystallization, centrifugation, further refinement, vacuum drying, sifting, QC and sealed drum packing. This is valuable for a qualification discussion but it does not establish EXBIOL as the physical manufacturer.

The dossier contains a dated statement about a drug manufacturing licence and historic GMP inspection. Current licence scope, inspection status and legal manufacturer identity must be checked through up-to-date documents as part of formal vendor qualification.

L-menthol is readily soluble in suitable organic media such as ethanol, while it has limited solubility in water. The reference COA reports a clear solution when 1 g is dissolved in 5 mL of 90% ethanol. Directly adding neat menthol crystals to aqueous oral-care or beverage systems may cause floating crystals, insufficient dissolution or later recrystallization.

For mouthwash, gels, creams, rubs and topical formulations, evaluate allowable solvent/solubilizer systems, process temperature, compatibility and shelf-life under the applicable finished-product requirements. The raw ingredient data do not establish an instantly clear water solution or a universally stable product concentration.

The supplier’s TDS recommends storage below 25°C, in dry, closed packaging away from heat and light. Shelf life, batch-specific expiry or retest dating, and any stability support are confirmed against the quality-approved documentation for the actual shipment lot.

Menthol can be lost through volatilization or affected by temperature-dependent phase changes. For distribution, confirm the exact primary liner, seal integrity, transport temperature and the expiry or retest date on the shipment-lot label. No unsupported 6-month accelerated stability or guaranteed zero loss is claimed here.

Reference lot 260318 records 25 kg/drum packing and a manufacturing quantity of 3,502.40 kg. This is a historical manufacturing quantity, not a statement of current stock. Current net weight, inner-liner material, pallet configuration, MOQ, lead time and forwarding route must be confirmed in the quotation.

For bulk menthol crystals, ask whether the requested quantity is a sample, pilot lot, drum order or recurring supply programme; give destination, requested quality standard and Incoterm. EXBIOL can coordinate the applicable commercial review without promising fixed stock or guaranteed delivery.

Natural L-menthol is relevant to pharmaceutical development involving approved topical, oral-care and other regulated formulations. The suitability of any ingredient grade for an API, excipient, flavoring substance or finished medicine depends on jurisdiction, manufacturing authorization, intended use, dose and customer regulatory requirements.

Drug product efficacy and approval must not be inferred solely from raw-material identity or pharmacopoeial-related specification statements. Buyers should consult the applicable national drug monograph and development programme.

Buyers of toothpaste, mouthwash, cooling personal-care products, topical balms and mint-flavored compositions may evaluate natural L-menthol for its sensory cooling character and mint odor. These sectors may impose different limits and documentation obligations from pharmaceutical supply.

For cosmetic and food applications, identify the relevant INCI/ingredient designation, market rules, formulation limits, allergen considerations and finished-product stability independently. Material with a pharmaceutical-grade dossier is not automatically certified for every flavor or fragrance use.

EXBIOL acts as the B2B supply and technical qualification interface for this product, coordinating with an external identified manufacturing partner. For qualified pharmaceutical purchasers, the actual manufacturing entity, relevant site documents, source declaration, quality agreement pathway and lot traceability can be reviewed subject to appropriate authorization and confidentiality arrangements.

Supplier qualification should distinguish the actual producer, the exporter, the responsible document issuer and any regulatory dossier holder. EXBIOL does not claim this lot was manufactured inside its own facility.

For a formal Natural L-Menthol Crystals bulk quotation, share your desired USP/Ph. Eur./BP/CP specification, annual volume, initial order quantity, intended application, required documents and delivery destination. EXBIOL will confirm offerable grade and terms for the proposed batch.

Reference framework: USP Menthol monograph; PubChem L-Menthol identity data; applicable Ph. Eur./BP/CP monographs; USP <467> / ICH Q3C for residual solvents; ICH Q3D(R2) for drug-product elemental impurity risk assessments. Product-specific tests must be demonstrated by the selected supply lot.

USP Menthol monograph preview · PubChem (-)-Menthol · EXBIOL Technical Dossiers