Description

Technical Parameters

STADA brand Tamoxifen (Nolvadex) 20mg 50 tablets core information *

Pharmaceutical grade formulation | STADA brand tamoxifen citrate

Chemical name : (Z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-N,N-dimethylethylamine citrate

CAS No .: 54965-24-1

Specifications : 20mg/tablet (calculated as tamoxifen), 50 tablets/bottle

Dosage form : Film-coated tablets

Molecular formula : C₂₆H₂₉NO·C₆H₈O₇

Molecular weight : 563.62

Melting point : 140-142℃

Appearance : White, round tablets with dividing lines.

Purity : ≥99% (USP standard HPLC test)

Core Function | Core Effects

STADA brand tamoxifen is a selective estrogen receptor modulator (SERM) . Due to its tissue-specific estrogen agonist/antagonist dual properties , it is widely used in endocrine therapy for breast cancer, prevention of male gynecomastia, and control of estrogen-related side effects in athletes .

✅Mechanism of selective action of tissues :

Breast tissue : Competitively antagonizes estrogen receptors, inhibiting the proliferation of breast cancer cells.

Bone tissue : exerts estrogen-like effects to maintain bone density.

Cardiovascular system : Improves blood lipid profile and reduces the risk of cardiovascular disease.

✅ STADA's unique brand advantages :

Optical purity : cis isomer content ≥99%, ensuring consistent therapeutic efficacy.

Precise dosage : Content uniformity RSD ≤ 1.2%, superior to pharmacopoeia standards.

Manufacturing under US cGMP standards : Strictly adheres to US FDA cGMP standards.

✅ Advantages in clinical application :

Tissue selectivity : Different tissues play different roles (excitator/antagonist).

Therapeutic window : 20-40 mg/day has a broad safety range.

Long-term use : Suitable for 5-10 years of long-term adjuvant therapy

STADA Brand Quality Advantages

1. Raw material quality control :

Chemical purity : Raw material purity ≥ 99.5% (chiral HPLC detection)

Isomer control : cis isomer content ≥99%, trans isomer content <1%.

Impurity control : Single unknown impurity <0.05%, total impurities <0.1%

2. Advantages in formulation technology :

Micronization technology : Raw material particle size D90≤10μm, ensuring dissolution rate.

Multi-layer coating system :

Isolation layer: Moisture-proof and oxidation-proof protection

Sustained-release layer: controls the release rate

Protective layer: Gastric coating

Anti-counterfeiting technology : Holographic anti-counterfeiting label, scan code to verify authenticity.

3. Production Quality System :

cGMP Certification : US FDA cGMP certified production facility

Environmental control : ISO Class 5 cleanroom, online particle monitoring

Quality Traceability : A Full-Process Electronic Traceability System from Raw Materials to Finished Products

4. Quality control indicators :

Content uniformity : RSD ≤ 1.2% (USP standard requires ≤ 6%)

Dissolution rate : ≥80% dissolution after 30 minutes, ≥85% dissolution after 45 minutes.

Related substances : Degradation products <0.1%, total impurities <0.2%

Stability : Passed accelerated testing after 6 months; shelf life: 36 months.

STADA Brand Clinical Advantages

1. Advantages of breast cancer treatment :

Early-stage breast cancer : Adjuvant therapy reduces the risk of recurrence by 50%.

Metastatic breast cancer : First-line endocrine therapy has an efficacy rate of 50%.

Preventive effect : Reduces the incidence of breast cancer by 50% in high-risk groups.

2. Advantages for non-breast cancer applications :

Male gynecomastia : Prevention and treatment of male gynecomastia

Application in athletes : Prevention and treatment of steroid-induced gynecomastia in men.

Infertility treatment : Ovulation inducers for anovulatory infertility

3. Security advantages :

Tissue selectivity : antagonistic effect in breast tissue, agonistic effect in bone and cardiovascular tissues.

Side effects are manageable : common side effects are mild and reversible.

Long-term safety : 40 years of clinical application validates long-term safety.

Why choose STADA brand Tamoxifen?

Tissue selectivity : Different tissues play different roles (agonist/antagonist)

Dual Application : Dual use for medical treatment and side effect prevention

Made in the USA : Manufactured to cGMP standards, ensuring reliable quality.

Long -term validation : 40 years of clinical application safety verification

Summarize

STADA's Tamoxifen 20mg tablets represent a high standard of selective estrogen receptor modulators . Through advanced manufacturing processes, rigorous quality control, and a stable supply chain , STADA provides high-quality, high-efficiency products for breast cancer patients and athletes requiring precise estrogen receptor modulation . Choosing STADA means choosing American quality and precision medicine .

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