Sulfisoxazole Diolamine

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Cat Number

API0231618

CAS Number

4299-60-9

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Product Detail Description Customer Q&A

CAS Number

4299-60-9

EINECS

224-308-1

Storage

Store at room temperature

Synonyms

Sulfafurazole diolamine; Sulfafurazol 2,2'-imidodiethanol; Sulfafurazole diethanolamine; NU-445; 30S4B46J8B

Molecular Formula

C15H24N4O5S

Molecular Weight

372.4

Smiles

CC1=C(ON=C1C)NS(=O)(=O)C2=CC=C(C=C2)N.C(CO)NCCO

Appearance

White to off-white solid

General Description

Sulfisoxazole diolamine is the diolamine salt of sulfisoxazole, a short-acting sulfonamide antibiotic primarily used in ophthalmic preparations. The diolamine salt improves water solubility, making it suitable for topical eye drops. The drug is available as a 4% ophthalmic solution and was historically used orally for urinary tract infections.

Mechanism of Action

Sulfisoxazole inhibits bacterial dihydropteroate synthase, blocking folate synthesis and DNA production in susceptible organisms. In ophthalmic use, it is bacteriostatic against common pathogens causing conjunctivitis, including Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae. The drug does not penetrate the cornea well, limiting activity to superficial infections.

Application

Sulfisoxazole diolamine ophthalmic solution is indicated for the treatment of bacterial conjunctivitis and other superficial ocular infections caused by susceptible strains. It is also used as adjunctive therapy for trachoma and inclusion conjunctivitis. The solution is instilled 4-6 times daily. Patients should avoid contact lenses during treatment.

Does Sulfisoxazole Diolamine require protection from light during storage?

Yes, it is photosensitive. Prolonged UV exposure can cause discoloration and degradation. Store in light-resistant, tightly sealed containers.

What is the recommended storage temperature for Sulfisoxazole Diolamine?

Store at controlled room temperature (15-25°C). Avoid temperatures above 30°C, which can accelerate hydrolysis of the sulfonamide and degradation of the diolamine salt.

Is Sulfisoxazole Diolamine sensitive to moisture, and how is this prevented?

It is moderately hygroscopic. Storage in tightly sealed containers with desiccant is recommended to prevent caking and potential hydrolysis.

How is the impurity sulfanilamide monitored during stability?

This degradation product is quantified using a validated HPLC method, ensuring it remains below pharmacopoeial limits for ophthalmic or systemic use.