Description

Technical Parameters

Clomiphene Citrate Core Introduction

Pharmaceutical Grade Ingredients | Clomiphene Citrate Selective Estrogen Receptor Modulator (SERM )

Chemical Name : 2-[4-(2-chloro-1,2-diphenylvinyl)phenoxy]-N,N-diethylethylamine citrate

CAS number : 50-41-9

Molecular formula : C₂₆H₂₈ClNO·C₆H₈O₇

Molecular weight : 598.09

Melting point : 116-118°C

Appearance : White or off-white crystalline powder

Purity : ≥98% (HPLC)

Core Effects

Clomiphene citrate is a selective estrogen receptor modulator (SERM) that is widely used for ovulation induction, treatment of male hypogonadotropic hypogonadism, and post-steroid cycle recovery (PCT) due to its hypothalamic-pituitary-gonadal axis (HPG axis) regulatory properties .

✅ Hypothalamic-pituitary axis stimulation :

Competitively blocks estrogen receptors and relieves negative feedback inhibition

Increased GnRH pulse frequency and amplitude

Stimulates the pituitary gland to secrete follicle-stimulating hormone (FSH) and luteinizing hormone (LH )

✅ Gonadal function restoration :

Stimulates interstitial cells and increases endogenous testosterone secretion

Promote sperm production and improve oligospermia and azoospermia

Restore ovulation function for the treatment of female infertility

✅ Post-Cycle Recovery (PCT) Advantages :

Quickly activate endogenous testosterone secretion and shorten recovery time

Prevent estrogen side effects and maintain hormone balance

End Product Preparation Guidelines

1. Oral tablet preparation (50 mg/tablet) :

Example recipe (for 1000 tablets):

Clomiphene citrate raw material: 50.0g (calculated as clomiphene)

Microcrystalline cellulose: 80.0g

Lactose: 50.0g

Cross-linked carboxymethyl cellulose sodium: 8.0g

Magnesium stearate: 2.0g

Preparation process :

Raw material pretreatment : micronization (D90≤10μm)

Equal amount incremental mixing : gradually mix with diluent

Wet granulation : granulate with appropriate amount of purified water and dry in fluid bed at 50°C

Granulation : 20 mesh sieve granules, add flow aids and lubricants

Tableting : 8mm round die, 8-10kN pressure tableting

Film coating : Gastro-soluble film coating to improve stability and palatability

Quality Control :

Content uniformity : RSD≤3% (UV-HPLC detection)

Dissolution rate : ≥85% in 30 minutes (paddle method, 50 rpm)

Related substances : Single impurity ≤ 0.5%, total impurities ≤ 1.0%

2. Preparation Notes :

Raw material characteristics : mixture of cis (enclomiphene) and trans (zuclomiphene) isomers

Production environment : relative humidity ≤ 40%, moisture-proof treatment

Packaging requirements : Aluminum foil blister packaging, light-proof and moisture-proof

Why choose Clomiphene ?

One of the most classic SERMs with a good safety record

Dual function benefits , can be used for fertility treatment and cycle recovery

Easy to use , less painful to take orally

Quality Assurance :

GMP -compliant production , each batch HPLC purity tested (≥98% )

Third-party laboratory report (COA) is included with the goods

Microbial limit testing to ensure safety

Worldwide Shipping :

Original sealed packaging , moisture-proof and light-proof

Private delivery , no logo on the outer packaging

Temperature -controlled transportation to ensure stability

Conclusion

Clomiphene citrate can be manufactured into an oral dosage form using a standard tableting process . It is particularly suitable for ovulation induction, treatment of male hypogonadism, and recovery after a steroid cycle . The recommended dose is 50-100mg/day .

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