Gazette APVMA 9, 6 September 2005 page 16

NOTICE

Ferric subsulfate

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is considering the approval, under s.14A of the Agvet Code, ferric subsulfate, a new active constituent for use in veterinary chemical products. Ferric subsulfate is a styptic and astringent that may stop bleeding when applied topically.

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of ferric subsulfate should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to the matters that the APVMA is required to take into account in deciding whether to grant the approval. Comments must be received by the APVMA within 28 days of the date of this Gazette.

Particulars of Active Constituent

Common Name: Ferric subsulfate
IUPAC Name: Ferric subsulfate
Synonyms: Ferric subsulphate, Monsel’s salt, Ferric sulphate basic, iron hydroxide basic, iron subsulfate
CAS Number: 1310-45-8
Minimum Purity: Not less than 25% w/w and not more than 31% w/w iron
Molecular Formula: Fe4(OH)2(SO4)5
Molecular Weight: 737.4 g/mol

Summary of the APVMA’s Evaluation of Ferric Subsulfate Active Constituent

The Chemistry and Residues Program of the APVMA has evaluated the chemistry aspects of ferric subsulfate active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

Ferric subsulfate is not the subject of an accepted pharmacopeia monograph. However, ferric subsulfate solution is the subject of a United States Pharmacopeia monograph. It is proposed that the following APVMA Active Constituent Standard be established for ferric subsulfate active constituent:

Constituent	Specification	Level
Ferric subsulfate	Ferric subsulfate	Not less than 25% w/w and not more than 31% w/w iron

The APVMA is satisfied that the proposed importation and use of ferric subsulfate would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

Written submissions on the APVMA’s proposal to grant approval for ferric subsulfate should be addressed in writing to:

Dr Paul Sethi
Chemistry Manager
Chemistry and Residues Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 3987
Fax: (02) 6272 3551