Chorionic gonadotropin (hCG) 5,000 IU per vial

Basic Info

CAS Number	9002-61-3
Active Ingredient	Chorionic gonadotropin (hCG), a glycoprotein gonadotropin
Dosage Form	Lyophilised powder for injection
Specification & Packaging	Strength: 5,000 IU per vial Pack: 1 vial + 3 mL diluent Group: 03 Item No.: 38

Storage & Common Excipients

Storage Conditions	2–8 °C, protected from light (unreconstituted lyophilised powder); after reconstitution it is generally not refrigerated and should be used promptly; follow the label
Common Excipients	Typical lyophilisate: mannitol, sucrose or lactose, edetate disodium, buffer (phosphate); reconstituted with sodium chloride injection or sterile water. Confirm against COA

Product Introduction

A placental glycoprotein hormone that is highly homologous to LH and shares LH-like biological activity. The reference product is hCG for injection (5,000 IU/vial with 3 mL sterile water for reconstitution). The source file marks CAS 9002-61-3 as "identity to confirm"; this check confirms that 9002-61-3 is indeed the CAS for hCG components, but as hCG is a **glycoprotein mixture** with no single chemical structure, it has no unique single CAS — the documentation should state "glycoprotein, CAS 9002-61-3 (mixture CAS)"

Therapeutic Use

Women: ovulation induction (assisted reproduction), luteal support, threatened/habitual miscarriage; men: spermatogenesis stimulation in azoospermia/oligospermia (with gonadotropins), treatment of cryptorchidism; oncology: tumour marker and therapy for metastatic testicular and germ-cell tumours; indications follow the locally approved label

Mode of Action

Highly homologous to LH and acts through the same receptor; comparatively long half-life so a single injection lasts several days; causes luteinisation and follicular rupture in women and stimulates Leydig cells and spermatogenesis in men; also functions as a tumour marker (β-hCG)

Administration & Monitoring

Intramuscular (subcutaneous for oil-based/long-acting presentations); used under ultrasound and serum hormone monitoring; monitor for OHSS, testosterone levels and semen analysis; monitor β-hCG levels as an efficacy and recurrence marker in oncology

Important Safety Information

Prescription medicine. Can precipitate OHSS; causes a sharp rise in testosterone in men (theoretical risk of tumour progression, so oncology use requires specialist management). Timing relative to GnRH antagonists must be managed to avoid luteal insufficiency

Adverse Reactions

Injection-site reactions; OHSS (ascites, enlarged ovaries, weight gain); headache, fatigue, mood change; raised testosterone, acne and hirsutism in men; rare hypersensitivity; rare acute pulmonary oedema/dyspnoea in germ-cell tumour treatment

Important Risks

OHSS, including thrombosis and pulmonary oedema; unexpectedly raised tumour-marker levels (disease progression or prior pregnancy); polycythaemia and lipid monitoring in men

Contraindications

Hypersensitivity; malignancy (other than defined germ-cell tumour indications under specialist protocol); inappropriate use outside a recognised indication; isolated use in primary hypogonadism in men

Special Populations

Women of childbearing potential are treated under their reproductive indication; men require reproductive assessment; paediatric use for cryptorchidism evaluation requires specialist management; no specific geriatric indication

Usage Limitations

Prescription-only; professional administration technique; repeated or long-term use only under reproductive or oncology supervision; prohibited for athletes (see anti-doping); the medicinal use must be distinguished from illicit weight-loss/bodybuilding use

Anti-Doping Testing

**hCG is on the WADA Prohibited List S2.1 (peptide hormones)** and is prohibited for performance enhancement. Urinary β-hCG is the target analyte, detected by LC-MS/MS and immunoassay; low physiological urinary hCG concentrations in female athletes can cause immunoassay false positives, requiring laboratory confirmation

Product Quality Testing

Identification (immunoassay/ELISA, SEC-HPLC molecular-weight analysis), assay (bioactivity or immunoassay), specific activity, residual host-cell protein and DNA, endotoxin, sterility and fill volume, reconstitution time and in-use stability; viral safety documentation for biological products; COA

Source & Verification Note

Source file marked "identity to confirm". CAS 9002-61-3 is confirmed for hCG components, but hCG is a glycoprotein mixture with no unique chemical CAS; the wording has been regularised.