BPC 10mg + TB 10mg 20mg/vial Comprehensive And Effective Tissue Regeneration And Damage Repair

BPC-157 10mg + TB-500 10mg 20mg/bottle core introduction

Dual-Repair Peptide Complex | Made in China Synergistic Tissue Repair Peptide Combination 20mg/bottle

Generic Name : BPC-157 + TB-500 Precision Compound Peptide

Product Specifications : 10mg BPC-157 + 10mg TB-500 / bottle

Formula ratio : 1:1 precise blend

Total peptide content : 20mg/bottle

Purity : ≥98.5% (HPLC, all components)

Appearance : White lyophilized powder

Storage : Freeze at -20℃, protect from light, and store in a dry place.

Usage and Storage Guide

1. Reconstitution and preparation :

Recommended solvent :

Preferred solvent : sterile water for injection or 0.9% sodium chloride injection

Optimized solvent : Sterile physiological saline containing 0.1% bovine serum albumin (BSA) (to reduce adsorption).

For cell experiments : dissolve in a small amount of sterile water first, then dilute with serum-free culture medium.

Standard preparation procedure :

Solvent preparation :

Sterile solvent filtered through a 0.22 μm filter membrane was used.

Allow the solvent to reach room temperature (20-25℃) beforehand.

A buffer solution with a pH of 7.0-7.4 is recommended.

Reconstitution procedure :

Add 2.0 mL of sterile water for injection to a 20 mg vial.

Slowly pour the solvent along the bottle wall to avoid direct impact on the powder.

Gently rotate the vial (do not shake vigorously) until completely dissolved.

Let stand at room temperature for 3-5 minutes to ensure complete dissolution.

Final concentration: 10 mg/mL (5 mg/mL each of BPC-157 and TB-500)

Separate and store :

Immediately dispense into single-use doses (0.5 mL/tube recommended).

Clearly label: Product name, concentration, preparation date, expiration date

It is recommended to use low-absorption cryovials.

Working concentration calculation :

Standard concentration : 20 mg powder dissolved in 2 mL of solvent

BPC-157 concentration: 5 mg/mL

TB-500 concentration: 5 mg/mL

Total concentration: 10 mg/mL

Dosage reference :

In vitro cell experiments: 10-1000 ng/mL

Animal experiments: 50-500 μg/kg/day

The specific dosage needs to be optimized based on the experimental design.

Key points to note :

Dissolving Tips : This product dissolves relatively quickly, but complete dissolution must be ensured; the solution should be clear and transparent.

Aseptic technique : Must be performed inside a laminar flow hood or biosafety cabinet.

Light avoidance requirement : All operations must be performed in the absence of light to prevent photodegradation.

Do not mix : Avoid mixing with other drugs or peptides in the same syringe.

Prepare and use immediately : It is recommended to use within 1 hour after reconstitution.

Temperature control : Avoid temperatures exceeding 25°C during preparation and storage.

To avoid adsorption : Using a solution containing 0.1% BSA can effectively reduce adsorption on the tube wall.

2. Storage conditions :

Unreconstituted lyophilized powder :

Short-term storage : Refrigerate at 2-8℃, away from light. Shelf life: 12 months.

Long-term storage : Freeze at -20℃, protect from light, shelf life 24 months.

Optimal storage : -80°C, deep freeze, protected from light. Shelf life: 36 months.

Moisture-proof storage : Built-in desiccant, relative humidity ≤60%.

Reconstituted solution :

Use immediately after reconstitution for optimal biological activity.

Short-term storage : Refrigerate at 2-8℃ for no more than 12 hours.

Repackaging and freezing : Repack and freeze at -20℃ for no more than 7 days.

Repeated freeze-thaw cycles are strictly prohibited : no more than two freeze-thaw cycles.

Do not store at room temperature : After reconstitution, do not leave at room temperature for extended periods.

Transportation conditions :

Cold chain transportation : dry ice transportation (below -78℃) to ensure low temperature throughout the entire process.

Ice pack transportation : 2-8℃ ice pack transportation (short distance within 48 hours only)

Packaging specifications :

Inner packaging: Sealed in a light-proof aluminum foil bag

Intermediate packaging: Vacuum aluminum-plastic bag + desiccant

Outer packaging: Insulated foam box + cold storage agent

Shipping markings : Clearly labeled "Cryogenic Biological Products," "Keep Away from Light," and "Fragile."

3. Control of preparation accuracy and stability :

Solvent precision control :

Use a 1mL or 2mL sterile syringe to accurately draw

Volume error controlled within ±2%

It is recommended to use a graduated glass syringe.

Dissolution process monitoring :

Dissolving time: 3-5 minutes

Dissolution temperature: 20-25℃ room temperature

Dissolution state: The solution should be clear, colorless and transparent.

If dissolving is difficult, gently vortex; heating is strictly prohibited.

Standardized repackaging :

Dispensing volume: 0.5 mL/tube (for a single experiment)

Dispensing containers: sterile, low-absorption cryovials

Label information: Product name, batch number, concentration, volume, date, operator

Quality control points :

Solution clarity test

pH value test (should be between 6.0 and 7.5)

sterility verification

Regular bioactivity testing

4. Stability assurance system :

Temperature stability control :

Long-term stability: -80℃ > 36 months

Mid-term stability: -20℃ > 24 months

Short-term stability: 2-8℃ > 12 hours

Illumination stability control :

Sensitive to ultraviolet light

It must be wrapped in an amber-colored container or aluminum foil throughout the process.

Operating environment with low light intensity

Chemical stability control :

Avoid strong acids (pH < 4)

Avoid strong alkalis (pH > 9)

Avoid contact with oxidizers

Avoid metal ion contamination

Microbial stability control :

Aseptic operating environment

sterile equipment and solvents

Regular environmental monitoring

Physical stability control :

Avoid violent tremors

Avoid repeated freeze-thaw cycles

Avoid high temperature processing

Quality Advantages of Chinese Manufacturers

This product is manufactured by a leading Chinese peptide R&D and production company, strictly adhering to the Good Manufacturing Practice (cGMP) for pharmaceuticals, achieving precise formulation and full-process quality control.

✅Precision manufacturing technology :

High-precision mixing system : Employs a part-million electronic balance for precise weighing.

Three-dimensional dynamic mixing : ensures uniform distribution of the two components (RSD ≤ 3%)

Aseptic dispensing process : B+A grade clean environment, automated dispensing line

Online monitoring system : Real-time monitoring of dispensing accuracy (error ≤ ±1%)

✅Strict quality assurance system :

Precise content determination :

HPLC-MSD coupled technology

BPC-157 content: 10.0 ± 0.2 mg/bottle

TB-500 content: 10.0 ± 0.2 mg/bottle

Total content: 20.0 ± 0.3 mg/bottle

Purity analysis :

The HPLC purity of each component is ≥ 98.5%.

Single impurity ≤ 0.5%

Total impurities ≤ 1.5%

Related peptide impurities ≤ 0.3%

Molecular structure confirmed :

MALDI-TOF mass spectrometry: molecular weight error ± 0.1%

Amino acid composition analysis: Consistent with theoretical values (error ≤ 2%)

Peptide mapping analysis: secondary mass spectrometry sequence verification

Circular dichroism chromatogram: Secondary structure conforms to standard.

Bioactivity verification :

Cell proliferation activity assay

Cell migration experiment verification

Angiogenesis Experiment

Synergistic effect verification experiment

Safety inspection :

Bacterial endotoxin: < 5 EU/mg

Sterility test: Meets the standards of the Chinese Pharmacopoeia

Abnormal toxicity test: Compliant with regulations

Total heavy metal content: < 10 ppm

Residual solvent: Complies with ICH Q3C standards

Physicochemical property testing :

Appearance: White lyophilized powder

Moisture content: ≤ 5.0% (Karl Fischer method)

Acetate content: ≤ 10.0%

pH value: 5.0-7.0 (1% aqueous solution)

Solubility: Completely soluble in water for injection.

Content variation: within ±5%

✅Comprehensive stability study :

Stability of the compound :

Stable for 24 months when stored at -20℃ after compounding.

The content variation of each component is ≤ 3%.

The increase in related substances is ≤ 0.5%.

Influencing Factors Experiment :

High-temperature test: After being placed at 60℃ for 10 days, there were no significant changes in properties, content, and purity.

High humidity test: After being stored at RH 92.5% for 10 days, the weight gain due to moisture absorption is ≤ 3.0%.

Light irradiation test: After 10 days of irradiation at 4500 Lx, the increase in related substances was ≤ 0.5%.

Accelerated testing :

Store at 40℃/75% RH for 6 months

All indicators meet quality standards

Long-term testing :

Stored at -20℃ for 24 months

All indicators meet quality standards

Solution stability :

Stable for 12 hours at 2-8℃

Stable for 7 days at -20℃

Stable within 2 freeze-thaw cycles

Compatibility stability :

Stable when mixed with commonly used solvents

Do not mix with other medications

✅Professional Packaging System :

Primary packaging :

Vials: Neutral borosilicate glass, conforming to USP standards

Rubber stopper: Fluorinated butyl rubber stopper, low adsorption, low leaching

Aluminum cap: Aluminum-plastic composite cap to ensure airtightness.

Secondary packaging :

Aluminum foil bags: Three-layer composite aluminum foil, light-proof and moisture-proof.

Desiccant: Pharmaceutical grade silica gel desiccant

Nitrogen purging protection: to prevent oxidative degradation

Third-level packaging :

Inner box: Light-proof cardboard box, printed with product information.

Outer box: Five-layer corrugated cardboard box, shockproof design

Tag system :

Chinese label: Product name, specifications, batch number, production date, expiration date

English label: Meets international standards

QR code: Enables end-to-end quality traceability

Anti-counterfeiting features: multi-layered anti-counterfeiting technology

✅Comprehensive document system :

Quality documents :

Quality Inspection Report (COA)

Stability Study Report

Analytical Method Validation Report

Production documents :

Batch production records

Batch Packaging Records

Cleaning Validation Report

Qualification documents :

Production License

GMP Certificate

Quality System Certificate

Security document :

Material Safety Data Sheet (MSDS)

Transportation safety documents

Instruction Manual

✅Technical Support and Services :

Technical consultation : A professional team provides technical support.

Application guidance : Provides suggestions for experimental design.

Customization service : Specifications can be customized according to requirements.

Quality Tracking : Providing end-to-end quality tracking services

After-sales support : Comprehensive after-sales service system

Need anything, please contact us

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