Understanding the material
The salt name describes both the active molecule and its counterion. A tablet strength expressed as amlodipine is not the same mass as amlodipine besilate raw material. Procurement should connect identity and potency with particle characteristics, impurity controls and the manufacturing process. For low-dose formulations, reliable blending and content uniformity are particularly important development considerations.
Product Identity & Specifications
Chemical identity, physical characteristics and key specifications for Amlodipine Besilate.
| Parameter | Description / value | Basis / application |
|---|---|---|
| Product identity | Amlodipine besilate / besylate | Benzenesulfonate salt |
| Anhydrous CAS | 111470-99-6 | Hydrated forms have separate identifiers |
| Anhydrous formula | C₂₀H₂₅ClN₂O₅·C₆H₆O₃S | Salt identity |
| Anhydrous molar mass | 567.05 g/mol | Excludes crystal water |
| Monohydrate mass | 585.07 g/mol | One molecule of crystal water |
| Published assay | 97.0–102.0% | USP definition, anhydrous basis |
| Hydration state | Anhydrous or hydrated | Match the offered grade |
| Appearance | Solid API; colour described in specification | Assess against approved material description |
| Related substances | Specified and total impurities | Use the applicable API specification |
| Water content | Reported with analytical method | Read with potency calculation |
| Particle distribution | Agreed particle-size profile | Blending and dissolution development |
| Residual solvents | Manufacturing-route dependent | Current API documentation |
Identity and published standard
USP–NF: Amlodipine Besylate
The published definition includes anhydrous and hydrated material, with 97.0–102.0% amlodipine besylate calculated on the anhydrous basis.
View published monographA published standard describes the material; conformity of the offered grade is confirmed through its current specification and COA.
For further information and current COA/specification, please contact us.
Request current COA & specificationApplications & functional benefits
Tablet manufacture
Used in qualified amlodipine tablet formulations. The selected particle grade and mixing process should support uniform API distribution throughout the batch.
Combination products
Can be evaluated for multi-active oral products. Compatibility, impurity formation and finished-product performance are assessed in the complete formulation.
Development and qualification
Useful enquiries include sample requirements, target pharmacopoeia, desired particle distribution and the documentation needed to qualify the manufacturer.
Selecting the salt and physical grade
| Grade / form | Main distinction | Selection consideration |
|---|---|---|
| Anhydrous besilate | Salt without stoichiometric crystal water | Use the anhydrous identity and current assay. |
| Hydrated besilate | Contains crystal water | Account for water and the reported potency basis. |
| Particle-controlled grade | Defined distribution within the same chemical identity | Qualify blending and dissolution with the intended process. |
Formulation & processing
Calculate on the correct active basis
Distinguish salt mass from amlodipine-equivalent content. Use the approved manufacturing calculation and current COA instead of taking the nominal formula weight as the complete potency correction.
Control low-dose distribution
Assess the particle-size relationship between API and excipients, order of addition and mixing performance. A visually uniform blend does not establish content uniformity.
Assess source changes
Review impurity profile, water and physical properties when changing manufacturer or grade. Compare the resulting formulation against its approved quality requirements.
What to check in the specification
- Identity and active-content assay, with calculation basis
- Related substances and degradation products
- Water content and residual solvents
- Particle-size requirements for the intended manufacturing process
Current product documentation
Request the current batch COA, full specification and SDS. Stability/retest information, impurity details and manufacturer regulatory documentation can be discussed for your qualification requirements.
Request documents for Amlodipine BesilatePacking, storage & handling
Packing and quotation details
Discuss the required net weight, sample quantity and delivery schedule with SBS. Packaging should be compatible with the material and carry product, manufacturer and batch identification. Confirm the offered pack size and shelf-life or retest information in the quotation; these depend on the selected grade.
Storage and safe handling
Keep containers closed and protected from contamination. Follow the offered manufacturer’s labelled storage conditions and retest date; use its SDS for handling controls.
Frequently asked questions
Are besilate and besylate different salts?
They are alternative spellings of the same benzenesulfonate salt name. The offered chemical form and specification must still match the requirement.
Can hydrated and anhydrous material be exchanged directly?
Their water contributions and formula weights differ. Substitution requires an approved calculation and formulation assessment.
What information helps a quotation?
Provide the dosage form, specification, required particle grade, quantity, delivery location and manufacturer-document requirements.
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