Understanding the material
Select the material by its full chemical name and agreed quality specification. Published identity information helps define the enquiry; batch quality, physical grade, packing and availability are confirmed through the current manufacturer documentation and SBS quotation.
Product Identity & Specifications
Chemical identity, physical characteristics and key specifications for Rupatadine Fumarate.
| Parameter | Description / value | Basis / application |
|---|---|---|
| Product identity | Rupatadine Fumarate | Specify the complete product name. |
| CAS number | 182349-12-8 | Published identity reference |
| Molecular formula | C₂₆H₂₆ClN₃·C₄H₄O₄ | Salt / hydrate basis shown |
| Molecular weight | 532.0 g/mol | For the formula shown |
| Physical grade | Fumarate salt | Confirm the offered grade and particle characteristics. |
| Assay and impurities | Current specification and batch COA | Read the calculation basis with water and solvent results. |
| Packaging and retest | Manufacturer-specific | Confirm in the quotation and batch documents. |
Identity and published standard
FDA substance identity record
Use the linked reference to review the chemical identity. The applicable edition and complete quality specification must be agreed for the offered material.
View identity referenceA public identity reference is not evidence that an offered batch complies with a pharmacopoeia.
For further information and current COA/specification, please contact us.
Request current COA & specificationApplications & functional benefits
Formulation development
Assess the API in the intended dosage form, using qualified development material and a defined specification.
Manufacturing qualification
Review the source, analytical methods and batch documentation before commercial process qualification.
Procurement evaluation
Send your target specification, quantity and destination so SBS can review a suitable sourcing proposal.
Identity, physical grade and specification
| Selection point | Material / requirement | Buyer review |
|---|---|---|
| Chemical identity | Fumarate salt | Confirm the exact salt or hydrate in the purchase specification. |
| Physical grade | Particle distribution and bulk characteristics | Agree measurable limits and test methods for the intended process. |
| Quality standard | Required pharmacopoeia or agreed specification | Review the current specification, COA and supporting documentation. |
Formulation & processing
Product-specific considerations
Evaluate particle distribution, blend uniformity and dissolution for the selected oral formulation. Confirm the active-content calculation against the batch COA.
Batch calculations
Use the stated assay basis and current batch results in the approved manufacturing calculation. Distinguish salt or hydrate mass from equivalent active content.
Process suitability
Confirm compatibility and finished-product quality in the complete formulation; a material name or assay result alone does not establish process suitability.
What to check in the specification
- Identity of the active ingredient, salt and hydration state
- Assay method and calculation basis
- Specified, unspecified and total related substances
- Water or loss on drying and residual solvents
- Particle characteristics and microbiological requirements appropriate to the process
Current product documentation
Request the current batch COA, complete specification, SDS and stability/retest information. Discuss manufacturer qualification and applicable regulatory-support documents for your intended market.
Request documents for Rupatadine FumaratePacking, storage & handling
Packing and quotation details
Confirm pack size, inner liner, container type, batch traceability, quantity and delivery terms with the quotation. No standard pack size or stock availability is implied.
Storage and safe handling
Keep the original container closed and protected from contamination. Follow the manufacturer’s labelled storage conditions, retest date and SDS; agree additional light or moisture protection where required.
Frequently asked questions
What should an enquiry include?
Required grade, dosage form, specification, quantity and delivery destination.
Are specifications and documents available?
Request the current batch COA, complete specification, SDS and stability/retest information. Discuss manufacturer qualification and applicable regulatory-support documents for your intended market.
Is the supplied API automatically suitable for every dosage form?
No. Suitability depends on the offered grade, impurity and microbiological controls, intended route and validated manufacturing process.
Technical information sources
Need more information?
Contact SBS for further product details, current COA, specification, packing and a quotation for your requirement.
Contact SBS for details and documents