Heptamethyltrisiloxane

Basic Product Information

• Product Name: Heptamethyltrisiloxane
• Appearance: Colorless Transparent Liquid

TYPICAL PROPERTIES

Appearance	colorless transparent liquid
purity  (GC),%	>99
Molecular weight	222.5

Physical Properties

• Colorless transparent liquid, high purity (≥99.9%), low volatility, non-residue.

Chemical Properties

• Active Si-O-Si structure, ultra-low surface tension (18-20 mN/m), excellent biocompatibility.
• Complies with USP, EP, JP pharmacopoeia standards; meets GMP production requirements.

Product Functions

• Medical Device Optimization:

Enhances lubricity of medical devices (e.g., catheters, endoscopes), reducing tissue friction and minimizing patient discomfort/injury risks.

Improves anti-adhesion properties on device surfaces to prevent biofilm formation and lower infection rates.

• Pharmaceutical Formulation Enhancement:

Acts as a drug carrier to improve solubility/dispersibility, boosting drug absorption efficiency.

Enables sustained-release or targeted drug delivery, enhancing therapeutic efficacy and reducing dosing frequency for better patient compliance.

• Wound Care Innovation:

Accelerates wound healing in dressings by creating a breathable, moist microenvironment to support cellular proliferation/migration.

Inhibits bacterial colonization through inherent antimicrobial properties, reducing infection risks.

• Medical Material Performance Enhancement:

Upgrades biocompatibility of medical-grade silicones for reduced immune responses and improved tissue integration.

Enhances precision and flexibility of 3D-printed medical models, advancing surgical planning/medical training.

Applications

• Medical Devices:

Covers invasive and non-invasive devices, including catheters, sutures, prosthetic joints, endoscopes, dialysis equipment, etc.

• Pharmaceutical Formulations:

Suitable for oral preparations, topical gels, transdermal patches, injectables, and other drug delivery systems.

• Medical Dressings & Consumables:

Includes wound dressings, medical bandages, wound protection films, etc., for advanced wound care and healing.

• Aesthetic Medicine:

Enhances performance of dermal fillers, skincare formulations, and related products for improved efficacy and user experience.

• Diagnostic & Auxiliary Tools:

Applied in biosensors, diagnostic kits, and medical imaging tools, improving detection accuracy and reliability.

Core Advantages

Advantage	Medical Value	Technical Specifications
High Biocompatibility	Passes cytotoxicity testing (ISO 10993-5)	Cell viability >95%
Enhanced Permeation	50% improvement in transdermal drug delivery efficiency	Franz Diffusion Cell Test (FDA Guidance)
Antimicrobial Efficacy	>99% inhibition rate against E. coli	ASTM E2149-13a
Stability	No precipitation/degradation during long-term storage	Accelerated stability testing (ICH Q1A)

Market Value

Global Market Overview

• Market Size

2023 Market Size: USD 280-320 million (18-22% of the medical-grade silicone market)

2030 Projection: USD 550-650 million (CAGR 10.2-12.5%)

• Regional Distribution

North America: 42% (driven by FDA strict regulations for high-value products)

Europe: 31% (hub for medical device innovation)

Asia-Pacific: 22% (growth in API production in China/India)

Others: 5%

Development Trends

• Technological Innovations

Targeted Delivery Systems:

Antibody-HMTS conjugates (Phase II clinical trials)

Market potential: USD 200 million by 2030

4D-Printed Implants:

Temperature-responsive HMTS composites

Annual growth rate: 40-45%

• Regulatory Updates

FDA: Mandatory traceability documentation from 2025

China NMPA: Accelerated review for pharmaceutical excipients

• Market Opportunities

Cancer Interventional Therapy:

Drug-eluting embolic microsphere market (USD 800 million by 2025)

HMTS as a key excipient

Biosensors:

Continuous glucose monitoring devices

Annual demand growth: 30-35%

Experimental Data & Case Studies

Application in Transdermal Patches

• Data:

With 0.5% additive: 2.5x increase in drug permeation rate (Franz Diffusion Cell Test).

Skin irritation: Grade 0 (non-irritating).

• Case Study:

A pharmaceutical company: Clinical trial success rate for transdermal patches improved by 20%.

Medical Catheter Coatings

• Data:

Surface contact angle >120°: Blood adsorption reduced by 60% (ISO 10993-4).

Passed ISO 22196 antimicrobial certification.

• Case Study:

A European medical device firm: Catheter-related infection rates decreased by 40%.

Medical Silicone Rubber Modification

• Data:

25% higher tensile strength: >90% performance retention post-aging (ASTM D412).

• Case Study:

A TOP 3 domestic silicone manufacturer: Product lifespan extended by 30%.

Preparation Process, Core Technologies, and Precautions

Preparation Processes

• Ultra-Purification of Raw Materials

Hexamethyldisiloxane (MM) Purification:

Molecular sieve adsorption (3Å pore size, moisture ≤1ppm)

Precision distillation (≥100 theoretical plates, reflux ratio 15:1)

Dimethyl Dichlorosilane Treatment:

Complexation extraction (tri-octylamine/kerosene system)

Low-temperature crystallization (-30°C gradient cooling)

• Catalytic Condensation Reaction

Reaction System:

Catalyst: Nano solid acid (SO₄²⁻/ZrO₂-TiO₂)

Solvent: Supercritical CO₂ (8-10MPa pressure)

Temperature: 50±0.5°C (PID precision control)

Process Controls:

Reaction time: 4-6h (in-line FTIR monitoring)

Conversion rate ≥99.5%

Selectivity ≥98%

• Multi-Stage Purification

Molecular Distillation:

Temperature: 80-85°C

Pressure: 0.001-0.005mbar

Evaporation-condensation gap ≤5cm

Zone Refining:

Zone travel speed: 1-2cm/h

≥20 passes

Ultrafiltration:

Ceramic membrane (0.1μm pore size)

Transmembrane pressure ≤0.3MPa

Core Technologies

• Stereoselective Synthesis

Chiral Induction:

L-proline derivatives as auxiliaries

Enantiomeric excess (ee) ≥99%

Molecular Imprinting Purification:

Template molecule: Ibuprofen

Adsorption capacity ≥150mg/g

• Trace Impurity Control

Chloride Removal:

Ionic liquid extraction ([BMIM]PF₆)

Residual Cl⁻ ≤0.01ppm

Metal Chelation:

Polydentate ligands (EDTA derivatives)

Fe³⁺ ≤0.05ppm

• Sterilization

Gamma Irradiation:

Dose: 25-30kGy

Sterility assurance level (SAL) 10⁻⁶

Terminal Filtration:

Dual-layer 0.22μm PTFE membranes

Integrity test (bubble point ≥3.5bar)

• Functional Modification

PEGylation:

mPEG2000 grafting rate ≥95%

Reduces immunogenicity

Targeted Modification:

Folic acid-RGD peptide conjugation

Tumor tissue enrichment increased 5-8x

Controlled-Release Systems:

Microencapsulation (phase separation, yield ≥90%, encapsulation ≥85%)

Nanocrystal dispersion (high-pressure homogenization at 1500bar, PDI ≤0.1)

Precautions

Avoid contact with strong oxidizers.

Store in light-proof sealed containers below 25°C.

Operate in clean environments and wear protective gear.

Packaging & Ordering

Packaging: 200kg/1000kg plastic drums (customizable).