Serdexmethylphenidate API is a novel prodrug of dexmethylphenidate and belongs to the CNS stimulant class of pharmaceutical compounds. The pharmaceutical ingredient is commonly encountered as serdexmethylphenidate chloride, the chloride salt of the active moiety.
Serdexmethylphenidate chloride has the molecular formula C₂₅H₃₀ClN₃O₈ and molecular weight 535.97 g/mol. Its primary CAS Number is 1996626-30-2, while the corresponding inner-salt form of serdexmethylphenidate is listed under CAS 1996626-29-9. FDA's Global Substance Registration System identifies serdexmethylphenidate chloride under UNII FN54BT298Y.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API solutions and supports requirements involving Serdexmethylphenidate and its chloride form with emphasis on chemical identity, analytical testing, documentation and controlled pharmaceutical handling.
Serdexmethylphenidate is a prodrug of dexmethylphenidate. It is designed to provide conversion to dexmethylphenidate following oral administration. The FDA-approved product AZSTARYS combines serdexmethylphenidate with dexmethylphenidate and is indicated for the treatment of ADHD in patients 6 years of age and older.
Serdexmethylphenidate chloride is a chemically defined small molecule with three defined stereocenters. FDA GSRS records its absolute stereochemistry and identifies it as the salt/solvate form of serdexmethylphenidate.
| Parameter | Value |
|---|---|
| Product Name | Serdexmethylphenidate |
| Preferred API Form | Serdexmethylphenidate Chloride |
| API Type | Small-Molecule API / Prodrug |
| Primary CAS – Chloride | 1996626-30-2 |
| Alternate CAS – Inner Salt | 1996626-29-9 |
| UNII – Chloride | FN54BT298Y |
| UNII – Active Moiety | 0H8KZ470DW |
| Molecular Formula – Chloride | C₂₅H₃₀ClN₃O₈ |
| Molecular Weight – Chloride | 535.97 g/mol |
| Molecular Formula – Inner Salt | C₂₅H₂₉N₃O₈ |
| Molecular Weight – Inner Salt | 499.51 g/mol |
| Development Code | KP415 |
| Pharmacological Role | Prodrug of dexmethylphenidate |
| Therapeutic Area | CNS / ADHD |
| Stereocenters | 3 defined |
| Physical Form | White to off-white crystalline powder |
FDA and PubChem records support the chemical identity and numerical values above.
Serdexmethylphenidate chloride is a structurally complex pyridinium-containing compound related to dexmethylphenidate. It contains a covalently linked dexmethylphenidate-derived moiety and is converted to dexmethylphenidate after administration.
FDA identifies the chemical formula of serdexmethylphenidate chloride as C₂₅H₃₀N₃O₈·Cl⁻ and molecular weight as 535.98 g/mol in the approved product documentation.
The corresponding inner-salt form has the molecular formula C₂₅H₂₉N₃O₈, molecular weight 499.5 g/mol, and CAS 1996626-29-9.
FDA's pharmaceutical documentation describes serdexmethylphenidate chloride as a white to off-white crystalline powder. Its solutions are acid to litmus. FDA also reports that the chloride form is freely soluble in water, soluble in methanol, and slightly soluble in alcohol and acetone.
These are useful verified physical-property values for the CMS product information and should be preferred over generic estimates.
Serdexmethylphenidate is used as a prodrug of dexmethylphenidate in CNS stimulant pharmaceutical development.
The FDA-approved product AZSTARYS contains serdexmethylphenidate and dexmethylphenidate and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
Pharmaceutical applications include:
The current FDA labeling identifies AZSTARYS as a Schedule II controlled-substance product because it contains dexmethylphenidate, while serdexmethylphenidate itself is listed as a Schedule IV controlled substance.
Serdexmethylphenidate is a prodrug of dexmethylphenidate. Following administration, it is converted to dexmethylphenidate, which is the pharmacologically active CNS stimulant.
Dexmethylphenidate increases extracellular dopamine and norepinephrine primarily by inhibiting their reuptake into presynaptic neurons. The FDA labeling describes serdexmethylphenidate as the prodrug component of AZSTARYS.
Quality testing should be performed using validated analytical procedures appropriate for the exact API form, particularly because serdexmethylphenidate and serdexmethylphenidate chloride are chemically distinct records.
Typical testing may include:
Published analytical research has demonstrated validated RP-HPLC methods for simultaneous determination of serdexmethylphenidate and dexmethylphenidate, including degradation-product evaluation. One reported HPLC method used a 2.5–25 µg/mL linearity range for serdexmethylphenidate, with LOD 0.051 µg/mL and LOQ 0.165 µg/mL. These are analytical-method performance parameters, not API release specifications.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API solutions with an emphasis on chemical identity, analytical quality, documentation and controlled handling.
For Serdexmethylphenidate API, particular attention should be given to the exact salt form, CAS number, molecular weight and analytical specification.
Available technical documentation may include:
Serdexmethylphenidate chloride should be packaged in suitable pharmaceutical-grade containers that protect the material from environmental exposure.
Storage requirements for bulk API should be based on validated stability data and the applicable manufacturer's specification.
The finished AZSTARYS product is stored at controlled room temperature according to its approved labeling; however, finished-product storage conditions should not automatically be presented as bulk API storage specifications.
Typical documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on pharmaceutical API solutions with attention to accurate chemical identity, quality documentation and analytical support.
Key advantages include:
For Serdexmethylphenidate API requirements, contact Swapnroop Drugs and Pharmaceuticals for specifications, documentation, availability and commercial information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |