Description

Cefaclor Monohydrate CAS NO 70356-03-5 is a second-generation cephalosporin antibiotic, chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. It is valued for its broad-spectrum antibacterial activity against a wide range of Gram-positive and Gram-negative pathogens. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry formulating oral dosage forms such as capsules, tablets, and suspensions to treat various bacterial infections.

Application

• Primary Active Pharmaceutical Ingredient (API) in the manufacture of oral antibiotic formulations.
• Used in the production of generic and branded cefaclor capsules, tablets, and dry powder for oral suspension.
• Critical component in pharmaceutical R&D for developing new combination therapies or improved drug delivery systems.
• Essential raw material for compounding pharmacies requiring high-purity antibiotic ingredients.
• Reference standard in quality control laboratories for analytical method development and validation.
• Used in veterinary pharmaceutical applications for treating bacterial infections in animals, where approved.

Basic Information

Product Name	Cefaclor Monohydrate
CAS No.	70356-03-5
Molecular Formula	C15H14ClN3O4S • H2O
Molecular Weight	385.82 g/mol
Synonyms	Cefaclor Hydrate; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Monohydrate; 3-Chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic Acid Monohydrate; Ceclor (brand name basis); Cefaclorum Monohydricum; CEFACLOR MONOHYDRATE (USP); Cefaclor Monohydrate (EP)
EINECS	Contact for details

Quality Control

Our Cefaclor Monohydrate is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards such as USP and EP for identity, purity, and potency. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing all critical quality attributes, ensuring it is suitable for pharmaceutical manufacturing. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 6.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Specific Optical Rotation	+105° to +120°
pH (suspension)	3.0 - 5.0

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