Description

High-Purity Methylphenidate Hydrochloride API (CAS 298-59-9) | Wholesale Supply & Technical Specifications

Executive Summary & Procurement Overview

Buy Methylphenidate Hydrochloride API (CAS: 298-59-9) online at China Chem Supplies, pharmaceutical-grade manufactured under strict cGMP and EU-GMP compliant protocols. As a central nervous system (CNS) stimulant active pharmaceutical ingredient, our Methylphenidate HCl strictly complies with USP, EP (Ph. Eur.), and IP compendial monographs.

We support full regulatory documentation—including Drug Master Files (USDMF/EDMF), Certificates of Analysis (COA), HPLC/NMR verification, and stability testing data—to ensure fast, seamless customs clearance and regulatory validation for commercial formulation production.

Key Product Specifications & Identification Data

Parameter / Specification	Technical Value / Standard
Product Name	Methylphenidate Hydrochloride API
IUPAC Chemical Name	Methyl α-phenyl-2-piperidineacetate hydrochloride
CAS Registry Number	298-59-9
EC / EINECS Number	206-071-6
Molecular Formula	C₁₄H₁₉NO₂ ⋅ HCl
Molecular Weight	269.77 g/mol
Monoisotopic Mass	269.118g/mol
Compendial Grade	USP / EP / Ph. Eur. / IP / BP
Assay Purity (HPLC)	98.0% – 102.0% (Dried basis)
Physical Form	White to off-white fine crystalline powder
Melting Point Range	224°C – 226°C (435°F – 439°F)
Solubility	Freely soluble in water and methanol; soluble in ethanol; slightly soluble in acetone/chloroform
Stereochemistry	Racemic mixture of (R*, R*) d,l-threo-methylphenidate HCl
InChIKey	JUMYIBMBTDDLNG-UHFFFAOYSA-N
Harmonized System (HS) Code	293399 / 300490

Analytical Quality Control & Impurity Standards (USP / EP)

Our quality assurance protocols guarantee low trace levels of residual solvents and related impurities in accordance with ICH Q3A / Q3B guidelines:

Analytical Test Parameter	Target Acceptance Limit	Testing Method
Appearance of Solution	Clear and colorless	Visual Inspection
Loss on Drying	≤ 0.5%	Gravimetric / Thermogravimetric
Residue on Ignition	≤ 0.1%	Ignition Analysis
Heavy Metals	≤ 0.001% (10 ppm)	ICP-MS / Colorimetric
Phenylacetic Acid	≤ 0.1%	High-Performance Liquid Chromatography (HPLC)
$(\pm)$–$erythro$-Isomer Impurity	≤ 0.2%	Chiral HPLC
Ethylphenidate Impurity	≤ 0.1%	LC-MS / HPLC
Individual Unspecified Impurities	≤ 0.10%	HPLC
Total Impurities	≤ 1.0%	HPLC

Therapeutic Indications & Industrial Applications

Methylphenidate Hydrochloride acts as a norepinephrine-dopamine reuptake inhibitor (NDRI). The API is supplied to licensed pharmaceutical formulators globally for the production of finished dosage forms:

• Attention-Deficit/Hyperactivity Disorder (ADHD): Used in standard oral solid dosage forms including Immediate-Release (IR) tablets, Extended-Release (ER/XR) capsules, and orally disintegrating tablets (ODT).

• Narcolepsy Management: Formulation into alertness-promoting therapies for sleep disorders.

• Controlled-Release Matrices: Optimized crystal particle distribution for specialized multi-layer beads, osmotic pump systems (e.g., ORAS delivery), and transdermal patches.

Technical Documentation & Regulatory Compliance

To facilitate registration with global health authorities (FDA, EMA, NMPA, PMDA), China Chem Suppliessupports commercial orders with full documentation packages:

• USDMF & EDMF Available: DMF numbers provided upon execution of a Letter of Authorization (LOA).

• CEP / COS Compliance: Certified European Pharmacopoeia dossier support.

• Full Batch Documentation: Batch Certificate of Analysis (COA), HPLC Chromatograms, FTIR Spectra, NMR Analysis, and Mass Spectrometry reports.

• ICH Stability Studies: Accelerated (40°C ± 2°C / 75% RH ± 5% RH) and Long-Term stability testing data.

Packaging, Storage & Handling Protocols

Packaging Options

• Commercial Bulk Packaging: 1 kg, 5 kg, 10 kg, and 25 kg fiber drums lined with double anti-static food/pharma-grade polyethylene bags.

• Custom R&D Packaging: Available starting from 25 g, 100 g, and 500 g amber glass bottles or aluminum foil pouches for analytical and formulation testing.

Storage Conditions

Store in tightly sealed containers protected from light, heat, and moisture. Store at room temperature (15°C to 30°C or 59°F to 86°F).

Sourcing & Regulatory Notice

⚠️ Controlled Substance Notice: Methylphenidate Hydrochloride (CAS 298-59-9) is a strictly regulated Schedule II / Class B controlled substance in most international jurisdictions. China Chem Supplies strictly enforces global compliance laws. All orders require valid regulatory documentation, including:

• Valid Import/Export Permits issued by appropriate national regulatory bodies (e.g., DEA, MHRA, NMPA).

• Business/Manufacturing Licenses verifying legitimate commercial or research intent.

• Execution of an End-User Declaration (EUD).

Where can I buy Methylphenidate Hydrochloride?

Looking to secure a reliable, high-capacity supply chain for Methylphenidate Hydrochloride API? Contact the China Chem Supplies technical sales team today to request pricing, batch COAs, or regulatory documentation.

• Website: ChinaChemSupplies.com

• CAS: 298-59-9

• MOQ: Flexible based on regulatory authorization and project scale

• Inquire Direct: Request a Formal B2B Quotation & COA Sample

Frequently Asked Questions (FAQ)

What grade of Methylphenidate Hydrochloride is available?

We supply USP, EP, and IP grade Active Pharmaceutical Ingredients (APIs) suitable for commercial finished dosage manufacturing.

Do you provide Drug Master Files (DMF) for regulatory filings?

Yes, USDMF and EU-GMP/CEP documentation are available upon request for authorized clients.

What is the lead time for bulk orders?

Standard API lead times range from 7 to 15 business days post-license verification and customs export clearance, supported by air and ocean transport routes.