Fingolimod Hydrochloride CAS 162359-56-0

Fingolimod Hydrochloride CAS 162359-56-0 is white to off-white solid immunomodulatory API, fully tested against EP impurity limits and internal enterprise standards. It regulates lymphocyte trafficking to reduce autoimmune inflammatory damage in the central nervous system, serving as the core raw material for oral multiple sclerosis capsules. We provide Small Batch Trial Order service and maintain limited spot inventory, only catering to laboratory formulation research and pre-clinical sample preparation demands; mass production bulk supply is not available. All batches are supplied with full export COA issued by the original manufacturer, with strict control over homolog impurities and residual solvents to meet overseas generic drug registration research requirements.

Product Parameters (Specification)

Product Features and Applications

Product Features

Strict EP impurity control: All alkyl homolog and phenethyl analog impurities are extremely low or undetected, greatly reducing impurity research workload for new drug declaration;

Ultra-low residual solvent levels: Six common organic solvents are nearly non-detectable, fully complying with ICH Q3C residual solvent safety guidelines;

Stable crystal form & high purity: Assay reaches 100.5%, low moisture and ignition residue, stable for long-term laboratory storage without degradation;

Distributor authorized supply channel: Directly sourced from formal GMP manufacturer, complete traceable batch documents, suitable for pharmaceutical laboratory R&D and analytical method verification.

Application Scenarios

Multiple sclerosis oral capsule R&D raw material: For pre-formulation research, compatibility test and stability study of relapsing multiple sclerosis oral finished drugs;

Pharmaceutical laboratory analytical reference sample: Used for HPLC impurity methodology validation, system suitability testing and standard curve preparation;

Generic drug declaration research: Small trial batches for impurity profiling, toxicology sample preparation and registration dossier data collection;

Neurological autoimmune disease mechanism research: Academic laboratory raw material for in vitro cell and animal model pharmacological experiments.

Procurement and Service Support

As your authorized Fingolimod Hydrochloride CAS 162359-56-0 Distributor, we provide targeted small-batch research procurement services:

Accept only Small Batch Trial Order: No large bulk wholesale, limit single order quantity to meet laboratory research demand, no mass production supporting capacity;

Limited spot inventory reserve: Only small batches kept in stock, delivery arranged on a first-come-first-served basis for R&D customers;

Complete official export supporting documents: Provide original manufacturer’s full set of COA, MSDS, batch production records and qualification certificates to support laboratory audit and drug registration research;

Exclusive technical consulting service: Professional pharmaceutical team provides guidance on sample storage, dissolution testing and impurity analysis methods for research clients.