China Factory Direct
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| CAS number | 202825-46-5 |
| Product name | Safinamide mesylate |
| Stock | Stock readily available; annual supply capacity exceeding 1,000 tons. |
| Grade | Industrial Grade |
| Packaging | 25KG/bag |
| Sample | Test Samples Available (Click to Request Samples) |
| COA | View COA |
| Price | Get Quote |
| Supply Type | Bulk / Contract manufacturing / OEM |
| Shipping | FCL / LCL available |
| Payment Terms | Support FOB \ CIF \ EXW quotations, and accept Letter of Credit (L/C). |
| Manufacturer | Greenrock Chemical(China Factory) |
Based on current marketvolatility and material availability.
17+ years in chemical exports.Fully compliant, reliable supply.Your B2B partner in bulk chemical procurement.
| Industry | Application | Process |
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| Pharmaceuticals | Treatment of Parkinson’s disease as a selective monoamine oxidase B (MAO-B) inhibitor; commonly co-administered with levodopa/carbidopa to prolong therapeutic effect and reduce motor fluctuations | Synthesis of active pharmaceutical ingredient (API), followed by formulation into oral tablets; safinamide mesylate is prepared via chemical synthesis and subsequently processed into tablets through compression or coating |
| Test Item | Commonly Used Testing Method | Method Overview |
|---|---|---|
| Identification | Infrared Spectroscopy (IR) | Confirm consistency of molecular structure characteristic peaks by comparing the infrared absorption spectrum of the sample with that of the reference standard. |
| High-Performance Liquid Chromatography (HPLC) | Confirm the presence of the target component by comparing the retention time with that of the reference standard. | |
| Assay | High-Performance Liquid Chromatography (HPLC) | Quantitative analysis of the main component using external or internal standard method under specified chromatographic conditions, ensuring compliance with pharmacopoeia standards. |
| Related Substances / Impurity Check | High-Performance Liquid Chromatography (HPLC) | Separate the main component from related impurities using gradient or isocratic elution and quantify using area normalization or external standard method. |
| Residual Solvents | Gas Chromatography (GC), Headspace Injection | Detect residual organic solvents (e.g., methanol, acetonitrile) in the active pharmaceutical ingredient using headspace gas chromatography, in compliance with ICH Q3C limits. |
| Loss on Drying | Drying to Constant Weight (105°C) | Dry the sample at the specified temperature until constant weight, and calculate the mass loss to evaluate moisture and volatile content. |
| Residue on Ignition | High-Temperature Ashing (600–800°C) | Weigh the residual inorganic material after high-temperature incineration of the sample to control total inorganic impurity content. |
| Heavy Metals | Atomic Absorption Spectroscopy (AAS) or ICP-MS | Determine the content of heavy metal elements such as lead, cadmium, mercury, and arsenic using atomic absorption spectroscopy or inductively coupled plasma mass spectrometry. |
| Water Content | Karl Fischer Titration | Determine trace moisture in the sample using volumetric or coulometric methods, suitable for thermally unstable or easily decomposed samples. |
| Crystal Form / Polymorphism | X-Ray Powder Diffraction (XRPD) | Identify whether the drug's crystal form matches the target crystal form by diffraction pattern, ensuring consistency in stability and bioavailability. |
| Particle Size Distribution | Laser Particle Size Analyzer | Measure the particle size distribution of the API, which affects formulation processes and dissolution behavior. |
| pH Value (Solution) | pH Meter | Prepare a solution of the sample at a certain concentration and measure its pH using a calibrated pH meter to assess stability. |
| Microbial Limits | Pharmacopoeia Microbial Testing Method | Perform testing for aerobic bacteria, molds, yeasts, and specified microorganisms according to the requirements of the Chinese Pharmacopoeia or USP to ensure microbial safety. |
| Test Item | Specification |
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| Appearance | White powder |
| Purity | >=98.5% (HPLC) |
| Water Content (KF) | <=0.5% |
| Total Impurities | <=1.5% |
| Single Impurity | <=0.5% |
| Melting Point | 162–166°C |
| Optical Rotation | +9.5 to +14.0° (c=1, in methanol) |
| Residue on Ignition | <=0.1% |
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| CAS/Product ID | *Required fields | |
| Lot/Batch Number | *Required fields | |
1. How do you ensure product quality consistency?
We rely on a mature China-based manufacturing system and implement strict batch control and quality inspection for every shipment. Our production process complies with ISO 9001 standards, and a COA is provided for each batch to ensure consistent and reliable quality.
2. Do you offer competitive pricing for bulk orders?
Yes, as a China-based manufacturer and bulk supplier, we provide tiered pricing based on order volume. We support FOB and CIF quotations, as well as L/C payment terms for large transactions to meet international trade requirements.
3. Can you support large-volume or long-term supply?
We have stable production capacity and a well-established supply chain, enabling continuous bulk supply. We support ton-level and container-level orders, as well as long-term cooperation projects.
4. What is your typical lead time?
For in-stock products, shipment can be arranged within 1–3 days. For bulk packaging or customized orders, lead time depends on the specific quantity and production schedule.
5. What documents do you provide?
We can provide complete documentation upon request, including COA, SDS, TDS, and other compliance certificates, meeting industrial procurement and export requirements.
6. Can you customize product specifications or packaging?
Yes, we support customization of parameters such as purity, impurities, residual solvents, and heavy metals. We also offer various bulk packaging options, including 25kg bags, drums, and IBC tanks, suitable for industrial applications and transportation.
7. What shipping options do you support?
We support both FCL (Full Container Load) and LCL (Less than Container Load) shipments, and can flexibly arrange logistics solutions based on order size to meet bulk chemical export needs.
8. Do you provide technical or application support?
Yes, we provide basic application guidance and technical support based on industry experience to help customers optimize product usage.
9. How do you handle compliance and export regulations?
We are familiar with international trade and export regulations, ensuring all products comply with relevant requirements. We also provide complete documentation to support smooth customs clearance and global delivery.