Sarecycline is a narrow-spectrum tetracycline-class antibacterial drug developed primarily for the treatment of inflammatory acne vulgaris. The pharmaceutical product is supplied as sarecycline hydrochloride, the hydrochloride salt of the active moiety sarecycline. FDA describes sarecycline hydrochloride as a tetracycline-class drug for oral administration.
Sarecycline Hydrochloride API is the pharmaceutical active ingredient used in sarecycline formulations. FDA identifies the drug substance with the empirical formula C₂₄H₂₉N₃O₈·HCl and molecular weight 523.96 g/mol. The active sarecycline moiety has the formula C₂₄H₂₉N₃O₈ and molecular weight 487.5 g/mol.
The FDA Global Substance Registration System identifies sarecycline as the active form and sarecycline hydrochloride as its salt/solvate form.
Sarecycline belongs to the tetracycline antibiotic class and contains the characteristic tetracyclic structural framework of this drug family. Its molecular structure incorporates defined stereochemistry, with FDA GSRS identifying four defined stereocenters.
The hydrochloride API is identified by CAS 1035979-44-2 and FDA GSRS UNII 36718856JR. PubChem reports a molecular formula of C₂₄H₃₀ClN₃O₈ and molecular weight of approximately 524.0 g/mol, which is the salt representation equivalent to the FDA expression C₂₄H₂₉N₃O₈·HCl.
Sarecycline is used for the treatment of moderate-to-severe non-nodular inflammatory lesions of acne vulgaris in appropriate patients. It is administered orally as a tetracycline-class antibacterial.
Sarecycline exerts antibacterial activity primarily through inhibition of bacterial protein synthesis. As a tetracycline-class antibiotic, it acts on the bacterial ribosome and interferes with protein production. Its pharmacological activity also contributes to its use in inflammatory acne.
Sarecycline Hydrochloride API quality control should include appropriate testing for identity, assay, related substances, residual solvents, elemental impurities, water or moisture and other applicable quality attributes.
FDA's chemistry review states that the drug substance specification controls the identity, purity, strength and quality of sarecycline hydrochloride. The review also notes that organic and inorganic impurities, residual solvents and genotoxic impurities are monitored and controlled, with non-compendial analytical methods appropriately validated.
Manufacturing of Sarecycline Hydrochloride API requires controlled synthesis, purification and salt formation followed by drying and analytical release testing. Because sarecycline has defined stereochemistry, stereochemical control is an important part of API manufacturing and characterization.
FDA describes sarecycline hydrochloride as a yellow to slightly green powder. It is sparingly soluble in water and methanol, slightly soluble in ethanol, and practically insoluble in acetonitrile. FDA also reports that aqueous solubility increases with increasing pH.
| Property | Value |
|---|---|
| API Name | Sarecycline Hydrochloride |
| Active Moiety | Sarecycline |
| CAS No. | 1035979-44-2 |
| Molecular Formula | C₂₄H₂₉N₃O₈·HCl |
| Salt Formula | C₂₄H₃₀ClN₃O₈ |
| Molecular Weight | 523.96 g/mol |
| Active Moiety Formula | C₂₄H₂₉N₃O₈ |
| Active Moiety Molecular Weight | 487.5 g/mol |
| Appearance | Yellow to slightly green powder |
| Drug Class | Tetracycline-class antibiotic |
| Therapeutic Area | Dermatology / Acne |
Sarecycline Hydrochloride API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and environmental exposure. Storage conditions should be established according to validated stability data and the applicable API specification.
Typical documentation may include:
A qualified Sarecycline API manufacturer should maintain controlled pharmaceutical manufacturing processes, validated analytical methods and comprehensive quality documentation. Particular attention should be given to stereochemical control, impurity profiling, residual solvents and consistent assay and purity of Sarecycline Hydrochloride API.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |