Description

Sarecycline Hydrochloride is a third-generation, narrow-spectrum tetracycline-class antibiotic specifically designed for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. Its molecular structure is optimized for targeted efficacy with a favorable safety and tolerability profile. This active pharmaceutical ingredient (API) is critical for pharmaceutical manufacturers developing topical and oral formulations for dermatological applications.

Application

• Primary API in the manufacture of prescription acne medications (e.g., Seysara®).
• Formulation of topical gels, creams, and foams for targeted dermatological treatment.
• Development of oral tablet or capsule dosage forms for systemic acne therapy.
• Research and development of novel antibiotic therapies within the tetracycline class.
• Use in clinical studies and bioavailability/bioequivalence (BA/BE) testing.
• Reference standard for analytical method development and quality control laboratories.

Basic Information

Product Name	Sarecycline Hydrochloride
CAS No.	1035979-44-2
Molecular Formula	C27H33ClN4O7
Molecular Weight	561.03 g/mol
Synonyms	Sarecycline HCl; (4S,4aS,5aR,12aS)-4-(Dimethylamino)-3,10,12,12a-tetrahydroxy-9-[[(2-methoxyethyl)amino]methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide hydrochloride; WC 3035; Seysara (brand name); 7-[(S)-3-(Methoxyethyl)amino]methyl]sancycline hydrochloride
EINECS	Contact for details

Quality Control

Our Sarecycline Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical use. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, assay, purity, and specified impurities. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.