Description

Urofollitropin CAS NO 97048-13-0 is a highly purified preparation of follicle-stimulating hormone (FSH) extracted from the urine of postmenopausal women. This biologically active glycoprotein is critical for stimulating follicular growth and maturation in the ovaries. It is an essential active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical and biotechnology sectors, particularly those developing and producing fertility treatments and hormone-based therapies.

Application

• Fertility Treatment APIs: Primary active ingredient in injectable formulations used for controlled ovarian stimulation in assisted reproductive technology (ART), such as in vitro fertilization (IVF).
• Hormone Replacement Therapies: Used in the development of treatments for hormonal disorders related to gonadotropin deficiency.
• Biopharmaceutical Research: Serves as a reference standard and critical reagent in reproductive endocrinology research and bioassay development.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for inducing superovulation in livestock for breeding programs.
• Diagnostic Kit Manufacturing: Utilized as a key component in the production of immunoassay kits for measuring FSH levels in clinical diagnostics.

Basic Information

Product Name	Urofollitropin
CAS No.	97048-13-0
Molecular Formula	C860H1347N233O244S22 (Representative for FSH alpha/beta subunits)
Molecular Weight	Approx. 30,000 - 35,000 Da (Glycosylated Heterodimer)
Synonyms	Follicle-Stimulating Hormone, Human; FSH (Human); Urofollicotropin; Follicle Stimulating Hormone, Urinary; Metrodin (Brand Name); Fertinex (Brand Name); Follitropin; Gonadotropin, Follicle-Stimulating
EINECS	Contact for details

Quality Control

Our Urofollitropin is manufactured under strict quality management systems. Each batch is subjected to a comprehensive battery of tests to ensure identity, purity, potency, and safety, aligning with ICH Q7 guidelines for APIs. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting critical parameters including biological activity (in IU/mg), protein content, and purity by HPLC. We support compliance with major pharmacopoeial standards (e.g., USP, Ph. Eur.) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or under refrigerated conditions (2-8°C) as specified for the specific lyophilized or solution formulation. This product is hygroscopic (moisture-sensitive) and must be protected from humidity. For long-term stability, store in the original sealed container in a dry environment.

Specification

Item	Specification
Appearance	White or off-white lyophilized powder
Identification (HPLC/ Bioassay)	Conforms to Standard
Biological Potency	> 10,000 IU/vial (or as per label claim)
Purity (SDS-PAGE / HPLC)	> 95%
Protein Content (UV)	Specified range
pH (Reconstituted Solution)	6.5 - 7.5
Endotoxin (LAL)	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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