Description

Secnidazole Hemihydrate is a potent nitroimidazole derivative widely recognized for its antiprotozoal and antibacterial properties. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of treatments for anaerobic bacterial and parasitic infections.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of anti-infective medications, particularly for anaerobic infections.
• Antiprotozoal Formulations: Used in drugs targeting amoebiasis, giardiasis, and trichomoniasis.
• Veterinary Medicine: Incorporated into veterinary pharmaceuticals for treating similar protozoal infections in animals.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological and microbiological research.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for generic and novel drug production.

Basic Information

Product Name	Secnidazole Hemihydrate
CAS No.	227622-73-3
Molecular Formula	C7H11N3O3 • ½H2O
Molecular Weight	185.18 g/mol (Anhydrous basis)
Synonyms	Secnidazole Monohydrate (common misnomer); 1-(2-Methyl-5-nitro-1H-imidazol-1-yl)propan-2-ol hemihydrate; α,2-Dimethyl-5-nitro-1H-imidazole-1-ethanol hemihydrate; Flagentyl; Sindose; Secnil; Seczol; RP 14539
EINECS	Contact for details

Quality Control

Our Secnidazole Hemihydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.5% - 5.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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