Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of tetrapeptide-30 injection in China. Welcome to wholesale bulk high quality tetrapeptide-30 injection for sale here from our factory. Good service and reasonable price are available.
Tetrapeptide-30 injection the full production process strictly follows US and UK injectable GMP standards, with A-grade aseptic filling, It is a safe, BLOOM Production high-stability injectable raw material widely used by local aesthetic clinics and cosmetic formulation brands in the US and UK.
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Tetrapeptide-30 injection COA
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| Certificate of Analysis | ||
| Compound name | Tetrapeptide-30 | |
| Grade | Pharmaceutical grade | |
| CAS No. |
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| Quantity | 32g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090058 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |  |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.88% |
| Loss on drying | ≤1.0% | 0.42% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥97.0% | 99.54% |
| Single impurity | <0.8% | 0.63% |
| Total microbial count | ≤750cfu/g | 80 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 430ppm |
| Storage | Store in a sealed, dark, and dry place below -20°C | |
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| Chemical Formula: | C22H40N6O7 | |
| Exact Mass: | 500 | |
| Molecular Weight: | 501 | |
| m/z: | 500 (100.0%), 501 (23.8%), 502 (2.7%), 501 (2.2%), 502 (1.4%) | |
| Elemental Analysis: | C, 52.79; H, 8.05; N, 16.79; O, 22.37 | |
Terminal Sterilization Process
Pre-sterilization Preparation
All sealed Tetrapeptide-30 injection vials are first sorted and placed in dedicated stainless steel sterilization trays, with reserved gaps between every vial to ensure full circulation of the sterilizing medium. The autoclave chamber is pre-conditioned to drain all non-condensable air through a multi-step vacuum exhaust cycle, eliminating cold spots that could compromise sterilization uniformity. Before loading, the system runs a self-check on temperature sensors, pressure gauges and cycle timers to confirm all parameters are within the calibrated valid range.
Low-temperature Terminal Sterilization Execution
Instead of conventional high-temperature autoclaving that may degrade peptide activity, we adopt a validated 100°C moist heat sterilization cycle with a 12-minute holding phase. The chamber temperature rises at a controlled ramp rate, maintaining consistent temperature across all vials within ±1°C throughout the entire holding period. The process is calibrated to achieve a minimum 6-log microbial reduction, delivering a Sterility Assurance Level (SAL) of ≤ 10⁻⁶, which fully meets the global regulatory requirements for sterile injectable products.
Post-sterilization Cooling and Pressure Equalization
After the sterilization holding phase completes, the system enters a controlled gradual cooling phase. Filtered sterile compressed air is continuously injected into the chamber to maintain balanced internal and external pressure for each vial, preventing container deformation, seal leakage or product bumping caused by sudden pressure drops. The entire cooling process takes no less than 25 minutes, ensuring the product temperature drops below 30°C before unloading from the sterilizer.
Sterilization Validation and Batch Release Check
Every sterilization batch is accompanied by a full set of validation records: temperature mapping data across 12+ monitoring points in the chamber, biological indicator (Geobacillus stearothermophilus) inactivation test reports, and post-cycle seal integrity inspection results. All data must be 100% compliant with pre-set specifications before the Tetrapeptide-30 injection batch can be released to the next production stage.
Solvent Pretreatment and Deoxygenation Process
Initial Purification of Water for Injection (WFI)
The raw solvent, Water for Injection, is first circulated through a two-stage distillation system, with real-time monitoring to control its electrical conductivity below 1.1 μS/cm at 25°C. It then passes through a 0.22 μm double-layer sterile filter to remove all particulate impurities, microbial residues and pyrogens, making it fully meet the pharmacopoeia-grade solvent standard for injectable products.
Thermal Circulation Pretreatment
The pre-purified WFI is transferred to a sealed, jacketed preparation tank, heated and maintained at 80°C for continuous circulating for no less than 30 minutes. This step removes most of the volatile impurities and residual trace organic contaminants, while preheating the solvent to create a favorable condition for the subsequent deoxygenation operation.
Two-Stage Deep Deoxygenation
First, vacuum degassing is applied: the tank pressure is reduced to -0.09 MPa and maintained for 15 minutes, to strip off more than 70% of the dissolved oxygen in the solvent.
Then, high-purity nitrogen (99.999%) is continuously sparged into the solvent through a micron-level porous diffuser for 20 minutes, to displace the remaining dissolved oxygen. After this process, the dissolved oxygen content in the final solvent is controlled below 0.1 mg/L.
Final Quality Confirmation
After deoxygenation, the solvent is sealed and stored under a continuous nitrogen blanket at 2°C~8°C. Before being used for Tetrapeptide-30 dosing, it will go through a final round of testing to confirm its dissolved oxygen level.
Aseptic Filling and Sealing Process
Pre-filling Aseptic Preparation
Environmental Requirements: The entire filling station is located within a Class A local laminar flow protection zone under a Class B cleanroom environment. Suspended particles, airborne bacteria, and settled bacteria are dynamically monitored throughout the process. The environmental cleanliness fully meets the aseptic standards for injectable drug production in European and American pharmacopoeias.
Media and Packaging Material Pretreatment: Compressed air and drug delivery pipelines entering the filling system undergo SIP (Steam In-Place) sterilization beforehand.
Vials, rubber stoppers, and aluminum caps all undergo independent aseptic cleaning and sterilization processes. All product contact surfaces use disposable components to completely avoid cross-contamination.
Drug Delivery Control: Pre-filtered Tetrapeptide-30 solution is directly delivered to the filling machine's material chamber through a fully enclosed aseptic pipeline. The total time from dilution to filling completion is strictly controlled within 8 hours. The entire process is conducted at a low temperature of 2-8℃ to inhibit microbial growth and prevent peptide degradation.
Core Aseptic Filling Operation Details
Filling Equipment Configuration: Employs a high-precision servo-driven aseptic filling machine, compatible with vials ranging from 1ml to 50ml. Filling accuracy error is controlled within ±0.5%, meeting the stringent requirements for varying injection volume.
Filling Environment Isolation: The main body of the filling machine is housed in a Class 100 cleanroom, utilizing positive pressure clean air circulation throughout the process to prevent the intrusion of unclean external air.
No direct human contact with the medication or vial opening occurs during filling; all operations are completed by automated mechanisms.
Real-time Parameter Monitoring: During the filling process, key parameters such as volume deviation, filling speed, and laminar flow velocity are monitored online in real time. If any value deviates from the preset threshold, the equipment automatically triggers a shutdown alarm, and unqualified products are automatically rejected, preventing abnormal products from entering the next process.
Online Sealing and Seal Integrity Verification
Within one second of completing the drug filling, the rubber stopper pressing and aluminum cap crimping processes are completed simultaneously. The stopping pressure and crimping torque are precisely calibrated to ensure a uniform and gapless seal at the bottle opening. The entire process is completed under Class A laminar flow protection. The product will only leave the sterile and controlled environment after sealing is complete. For non-terminally sterilized Tetrapeptide-30 injections, the total time from dispensing to capping is strictly controlled within 6 hours to minimize the risk of microbial contamination.
References
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FAQ
Q: 1. What is Tetrapeptide-30 injection, and how does it work for skin brightening?
A: Tetrapeptide-30, also known as the skin-lightening tetrapeptide, is a bioactive peptide with the CAS No. 1036207-61-0. As an injectable formulation, it works by downregulating the gene expression of tyrosinase to reduce tyrosinase production, inhibiting α-MSH (melanocyte-stimulating hormone) and its precursor POMC to block melanocyte activation, and lowering UVB-induced inflammatory factors like IL-6, IL-8 and TNF-α. This multi-pathway action effectively reduces excess melanin production, lightens post-inflammatory pigmentation, sun spots, freckles and other uneven skin tone issues.
Q: 2. What is the typical purity and storage requirement for your Tetrapeptide-30 injection raw material?
A: Our Tetrapeptide-30 injection raw material has a purity of ≥99%, with a molecular formula of C₂₂H₄₀N₆O₇ and a molecular weight of 500.6 g/mol. For optimal stability, we recommend storing it at -20°C, protected from light and kept under nitrogen atmosphere during long-term preservation. For short-term handling and transportation, a 2°C~8°C cold chain environment is acceptable to maintain its bioactivity.
Q: 3. Can this product be used to improve stubborn pigmentation such as melasma and post-acne marks?
A: Yes. Multiple clinical application tests have verified that when used in a compatible injectable formulation, Tetrapeptide-30 delivers noticeable improvement effects. For example, formulations containing 0.01% Tetrapeptide-30 can significantly reduce post-acne marks after 12 weeks of consistent use, and show visible lightening of melasma as early as 15 days when combined with other compatible brightening active ingredients. It is suitable for targeting various types of stubborn pigmentation without causing excessive skin irritation.
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