Description

Lutropinalfa CAS NO 152923-57-4 is a highly purified recombinant human luteinizing hormone (r-hLH) analog, representing a critical active pharmaceutical ingredient (API) for advanced biopharmaceutical applications. Its primary value lies in providing a consistent and reliable source of LH activity, essential for therapeutic formulations where precise biological function is paramount. This product is specifically engineered for use by pharmaceutical manufacturers and research institutions developing treatments for fertility disorders and endocrine-related conditions, ensuring high standards of purity and biological activity.

Application

• Fertility Treatment APIs: Core active ingredient in injectable formulations for assisted reproductive technology (ART), such as in vitro fertilization (IVF).
• Hormone Replacement Therapies: Used in the development of treatments for luteinizing hormone deficiency and related endocrine disorders.
• Biopharmaceutical Research: Serves as a reference standard and key reagent in preclinical studies and bioassay development.
• Drug Discovery & Development: Utilized in screening assays and for elucidating the role of LH in various physiological pathways.
• Veterinary Pharmaceuticals: Applied in the development of fertility management solutions for livestock and companion animals.

Basic Information

Product Name	Lutropinalfa
CAS No.	152923-57-4
Molecular Formula	C~990~H~1527~N~263~O~301~S~21~
Molecular Weight	~28,900 Da (Glycosylated protein)
Synonyms	Recombinant Human Luteinizing Hormone (r-hLH); Luteinizing Hormone, Human, Recombinant; LH, Recombinant Human; Lutropin Alfa; r-hLH; Foliltropin Alfa Component (when combined with FSH); Luveris® (Brand Name API); Gonadotropin, Pituitary, Luteinizing Hormone, Recombinant
EINECS	Contact for details

Quality Control

Our Lutropinalfa is manufactured under strict cGMP guidelines to ensure the highest standards of purity, potency, and consistency. Each batch is subjected to a comprehensive battery of tests including HPLC for purity and related proteins, in vivo or in vitro bioassays for potency, and rigorous checks for endotoxins, host cell proteins, and residual DNA. Full Certificates of Analysis (COA) documenting compliance with relevant pharmacopoeial standards (e.g., USP, EP) are provided.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled temperature of 2°C to 8°C. Do not freeze. This product is hygroscopic (moisture-sensitive) and must be protected from exposure to high humidity. For long-term stability, store under the recommended conditions in the original packaging.

Specification

Item	Specification
Appearance	White or off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (RP-HPLC)	≥ 98.0%
Potency (Bioassay)	90% - 115% of labeled activity
Protein Content	≥ 95.0% (by UV)
Endotoxin	< 1.0 EU/μg
Host Cell Proteins (HCP)	< 10 ppm
Residual DNA	< 10 pg/mg
Moisture (KF)	< 3.0%

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