What is Gonadorelin Acetate

Gonadorelin Acetate is a white powder

pGlu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2

Available registration documents (CTD format): EU and US DMF. Both the purity and potency of the drug substance, the lyophilized product for injection, and the reconstituted material that would be transferred to the infusion pump system were monitored using high-performance liquid chromatography. [CAS No.] 71447-49-9.

Please note that regional minor differences in analytical procedures and acceptance criteria might occur. [Molecular Formula] C55H75N17O13. Although the cause of these reactions has been associated with GnRH itself, the contributions of impurities and degradation products in the administered drug have not been determined, suggesting that the use of high-purity material may be advantageous in controlling unwanted side effects. Specific Optical Rotation [a]eq \o(\s\up 6   

 (20),\s\do 2( D))20 D(c=1,1% HAc) : -55.0~-65.0°

Water Content(Karl Fischer) :≤8.0%

Acetate Content(by HPLC) :≤10.0%

Amino Acid Composition :±10% of theoretical

Purity (by HPLC) :≥98.0%

Single Impurity(by HPLC) :≤1.0%

Peptide Content(by %N) :≥80%

Assay(By Anhydrous, Acetic Acid-free ) :95.0~105.0%

Becterial Endotoxins :≤5EU/mg

Soluble in water at a concentration of 10 mg/mL to give a clear solution not more intensely colored than reference solution Y5. For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

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