Description

Technical Parameters

STADA Brand Growth Hormone 100IU/set: Core Introduction

Pharmaceutical-grade biological agent | STADA brand recombinant human growth hormone (Somatropin rDNA )

Product Name : Recombinant Human Growth Hormone Injection

CAS No .: 12629-01-5

Specifications : 100 IU/set (10 vials × 10 IU/vial + 1 vial of water for injection)

Dosage form : Lyophilized powder for injection

Molecular weight : 22,124 Da

Sequence : 191 amino acid single-chain polypeptide

Appearance : White lyophilized lumpy powder + clear transparent solvent

Purity : ≥98% (HPLC detection)

Endotoxin : <0.5 EU/mg

Storage conditions : Store at 2-8℃ away from light; do not freeze.

Core Effects

STADA brand recombinant human growth hormone is a recombinant protein of 191 amino acids . Because it has the same amino acid sequence as endogenous growth hormone , it is widely used for the treatment of growth hormone deficiency, anti-aging treatment, and improvement of athletic performance .

✅ Multiple physiological functions :

Growth-promoting effect : stimulates bone and soft tissue growth

Metabolic regulation : Promotes protein synthesis and reduces fat storage.

Cell repair : Promotes cell regeneration and repair

Immune function : Enhance immune function

✅ STADA brand quality advantages :

High-purity formulation : HPLC purity ≥98%, monomer content ≥96%.

Aseptic process : Fully automated aseptic filling production line

Manufacturing in strict accordance with US FDA cGMP standards:

✅Advantages of US-based cold chain logistics :

Domestic production : Manufactured in cGMP biological facilities in the United States

Professional cold chain : 2-8℃ cold chain transportation throughout the United States

Express Delivery : 24-48 hour cold chain delivery within the United States

Temperature monitoring : Record temperature throughout the process to ensure stable activity.

STADA Brand Quality Advantages

1. Raw material quality control :

Purity testing : RP-HPLC purity ≥98%, SEC-HPLC monomer purity ≥96%.

Structural confirmation : Mass spectrometry confirmed the correct molecular weight, and peptide mapping analysis showed accurate sequence.

Bioactivity : Potency ≥3.0 IU/mg in rat weight gain assay.

2. Advantages in formulation technology :

Freeze-drying process : temperature-controlled freeze-drying, residual moisture ≤3.0%

Pre-filling system : Equipped with dedicated water for injection, easy to use.

Aseptic assurance : Fully automated aseptic filling, sterility test passed.

3. Production Quality System :

FDA Biologics License : U.S. FDA Biologics License

Environmental control : ISO Class 5 cleanroom, online particle monitoring

Virus safety : Rigorous verification of virus removal/inactivation

4. Quality control indicators :

Content accuracy : 10 IU/bottle ± 5% (bioassay method)

Aseptic assurance : Sterile growth was observed after 14 days of culture using membrane filtration method.

Endotoxin : <0.5 EU/mg (USP standard)

Stability : ≥90% activity is maintained after 24 months of storage at 2-8℃.

Application characteristics and advantages

1. Efficacy characteristics :

Growth-promoting effects : Significantly promotes linear growth and weight gain.

Metabolic Improvement : Improves body composition and increases lean body mass

Anti-aging effects : Improves skin elasticity and reduces wrinkles

Repair function : Accelerates tissue repair and wound healing

2. Key Features and Advantages :

Natural sequence : Identical to the 191-amino acid sequence of endogenous growth hormone.

High purity : HPLC purity ≥98%, monomer content ≥96%.

High biological activity : potency ≥3.0 IU/mg, exceeding the pharmacopoeia standard.

3. Advantages of service in the United States :

Professional cold chain : 2-8℃ cold chain distribution throughout the United States

Express delivery : Cold chain orders will be shipped within 24 hours.

Professional consultation : Local medical teams provide usage guidance.

Quality Assurance : Made in the USA, fully traceable.

Why choose STADA brand growth hormone ?

FDA Certification : FDA-approved biological product, quality guaranteed.

High purity : HPLC purity ≥98%, monomer purity ≥96%

Professional cold chain : 2-8℃ cold chain delivery throughout the United States

Made in the USA : Produced in a domestic cGMP biopharmaceutical facility

Summary

STADA brand recombinant human growth hormone 100IU/set represents the highest standards of high-quality growth hormone formulations . Manufactured under FDA-approved cGMP standards, with a rigorous quality control system and professional cold chain distribution within the United States , STADA provides users requiring growth hormone therapy with a high-quality, highly active product option. Choosing STADA means choosing the quality of domestically produced American biologics and professional cold chain service .

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