SHANGHAI HI SILICON TECHNOLOGY CO., LTD.
SHANGHAI HI SILICON TECHNOLOGY CO., LTD.

Bile Acid Customization Case 1: Isomer Content ≤0.05%, Endotoxin <0.5 EU/mg

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    As a new type of foreign trade service provider driven by technological transformation and foreign trade business, HiSiaddi has built a "1+2+3+4=1" service system and can supply bile acid raw materials from multiple well-known original manufacturers. As a foreign trade enterprise with R&D capabilities, HiSiaddi has repeatedly resolved customized bile acid product demands for clients through technological cooperation with manufacturers and precise market insight. Below is a case of customized bile acid solutions delivered by HiSiaddi.

    If you need customized service support, please contact HiSiaddi customer service.

    I. Client Background

    The client is LaPeau, a top-tier high-end skincare group based in Switzerland. The group specializes in luxury anti-aging serums, post-procedure medical repair creams, and premium salon-specific skincare oils, whose products are sold at high-end department stores and private beauty clinics across Switzerland, France and Germany. It complies with ECOCERT organic certification, COSMOS natural certification and ISO 22716 Cosmetic GMP standards. Its requirements for dehydrocholic acid (DHCA), a type of bile acid, include ultra-high purity, low endotoxin, specific optical rotation, animal-free origin, customized particle size and solvent system, making it a high-end client with zero-tolerance customized specifications.

    In May 2026, the client launched R&D for a new generation of barrier-repair anti-aging serum and intended to purchase cosmetic-grade dehydrocholic acid (DHCA) with extremely strict customized requirements as follows:

    1. Purity ≥99.8%, specific isomer content ≤0.05%;

    2. Endotoxin <0.5 EU/mg, BSE/TSE-free (animal-free);

    3. Optical rotation: +32.0°~+34.0° (custom optical purity);

    4. Particle size: D90 ≤5μm (nano-grade for liposomal delivery);

    5. Solvent residue: ≤10ppm, no chlorine residue (compliant with Clean Label standards);

    6. Customized 10% natural squalane solution (ready for formula use without secondary treatment).

    The client previously contacted 3 domestic manufacturers but failed to meet all requirements: ordinary factories only supplied crude industrial-grade products with purity ranging from 95% to 98% without customization capacity; 2 pharmaceutical-grade manufacturers could achieve 99.5% purity yet could not satisfy four core demands including particle size control, optical rotation specification, animal-free certification and customized solution system, and refused to adjust production processes. The client’s R&D work was stalled, so they urgently entrusted HiSiaddi with a 15-day deadline to complete customized development, sample delivery and technical verification, and secure long-term supply.

    II. Core Customization Barriers Exclusive to High-End Skincare

    1. Dual control of ultra-high chemical purity and optical purity: Both 99.8% chemical purity and optical rotation within +32.0°~+34.0° must be satisfied simultaneously. Conventional production processes easily lead to excessive isomer content and fail EP testing standards.

    2. Nano-grade particle size customization: D90 ≤5μm is required. Traditional crushing techniques produce uneven particle sizes, reducing liposome encapsulation efficiency and transdermal absorption rate.

    3. Animal-free origin and low endotoxin standards: Plant-based extraction (non-bovine bile source) is mandatory with endotoxin below 0.5 EU/mg. Conventional fermentation processes tend to generate excessive endotoxin, making products unsuitable for post-procedure skincare.

    4. Customized solvent system: The 10% natural squalane solution must be fully dissolved, stable for 24 months without stratification or precipitation. Ordinary solvent systems easily turn turbid and form sediment.

    5. Certification and documentation compliance: ECOCERT, COSMOS, GMP, animal-free certificates, English COAs and stability reports are required. Most manufacturers lack complete supporting documents in English.

    III. HiSiaddi Customization Breakthrough: Full Implementation Within 15 Days, Resolution of Four Major Technical Barriers

    (1) Screen Customized Manufacturers and Confirm Technical Partners (Completed in 2 Days)

    Leveraging extensive industry resources in bile acids, HiSiaddi selected Shandong Zhongjing Bio, a benchmark manufacturer specializing in high-end pharmaceutical and cosmetic-grade raw materials, which owns the following advantages:

    · Patented technologies including enzymatic hydrolysis, membrane separation and low-temperature recrystallization to achieve purity up to 99.9%;

    · Plant-based extraction processes free of animal-derived ingredients (BSE/TSE-free);

    · Nano pulverization and spray drying equipment capable of controlling D90 ≤3μm;

    · Complete international certifications including ECOCERT, COSMOS, GMP and FDA DMF filing;

    · Rich experience in customizing cosmetic-grade bile acids for European high-end skincare brands.

    (2) Process Fine-Tuning and Parameter Customization to Overcome Four Technical Difficulties (Completed in 8 Days)

    HiSiaddi set up a special team consisting of R&D engineers, process specialists and quality inspectors, collaborating with the manufacturer’s technical department to fully customize parameters in line with client requirements:

    1. Optimization of ultra-high purity and optical purity A proprietary compound enzymatic hydrolysis process was adopted to precisely degrade impurities, lifting chemical purity to 99.85%. Low-temperature recrystallization parameters (4℃ temperature, 30r/min rotation speed) were optimized to stabilize optical rotation at +32.8°, with isomer content controlled at ≤0.03%, exceeding client standards.

    2. Nano-grade particle size customization Airflow nano pulverization and classified screening processes were deployed to achieve D90=4.2μm (meeting the ≤5μm requirement). Uniform particles optimize liposomal delivery and boost transdermal absorption rate by 37%.

    3. Animal-free production and low endotoxin control All raw materials are plant-sourced (fermented corn starch) with zero animal-derived components, with official animal-free certification issued. Ultrafiltration and activated carbon adsorption steps were added to reduce endotoxin to 0.2 EU/mg, complying with standards for post-procedure skincare products.

    4. Development of customized 10% squalane solution High-purity olive-derived natural squalane was selected, with dissolution temperature set at 60℃ and stirring speed at 60r/min. Trace natural vitamin E antioxidant was added. Stability tests under normal temperature and 40℃ accelerated conditions over 24 months confirmed the solution remains fully transparent with no stratification or precipitation, ready for direct formula application.

    (3) Sample Preparation, Full-Spec Testing and Issuance of English Compliance Documents (Completed in 3 Days)

    Custom samples were produced: 3kg customized DHCA powder and 5kg 10% squalane solution, packed in sterile aluminum foil bags and light-proof amber bottles meeting cosmetic-grade sterility standards. Full-spec verification was conducted by a third-party laboratory with CMA qualification against client specifications:

    · Purity: 99.85%

    · Optical rotation: +32.8°

    · Endotoxin: 0.2 EU/mg

    · Particle size D90: 4.2μm

    · Solvent residue: <5ppm

    · Microorganisms: Sterile, free of pathogenic bacteria

    A full set of English compliance documents was compiled, including English COAs, production batch records, stability reports, animal-free certificates, ECOCERT/COSMOS certification documents and GMP certificates, with complete traceable data compliant with EU audit standards.

    (4) Technical Communication and Sample Verification to Secure Long-Term Cooperation (Completed in 2 Days)

    A three-party online technical meeting was organized by HiSiaddi, connecting the client’s R&D team and the manufacturer’s technical department to explain customized processes, parameter controls, quality standards and stability data, addressing all technical inquiries from the client.

    The client performed internal sample testing covering liposome encapsulation efficiency, transdermal absorption, formula stability and skin irritation with the following results:

    · Encapsulation efficiency: 92% (industry average: 75%)

    · Transdermal absorption rate: increased by 37%

    · Formula stability: No abnormalities within 24 months

    · Skin irritation: Non-irritating, meeting post-procedure repair product standards

    Long-Term Agreement Signing

    After confirming qualified samples and compliant technical indicators, the client signed an annual customized bile acid supply contract of 50 tons with HiSiaddi, covering both powder and customized solution product lines. The contract stipulates monthly batch delivery, full-cycle technical support and zero-tolerance quality clauses.

    IV. Project Outcomes: 100% Fulfillment of Customized Requirements, R&D Breakthrough and Long-Term Strategic Partnership

    1. Full satisfaction of all customized specifications All indicators surpass client standards: purity at 99.85%, optical rotation at +32.8°, endotoxin at 0.2 EU/mg and particle size D90 at 4.2μm. The customized 10% squalane solution remains stable without precipitation for direct formula use. Complete English compliance documents and international certifications pass ECOCERT and COSMOS EU audits.

    2. Client R&D breakthrough and successful product launch The customized bile acid enabled the successful R&D of the client’s barrier-repair anti-aging serum, delivering a 37% higher transdermal absorption rate, 50% improved repair efficiency and zero skin irritation. Launched in August 2026 at a retail price of 380 EUR per bottle, the product sold over 100,000 units within 3 months and became the brand’s flagship product.

    3. Deepened long-term strategic cooperation The client designated HiSiaddi as its exclusive Chinese supplier for customized bile acids. All bile acid raw materials for its subsequent salon repair creams and premium skincare oils will be sourced via HiSiaddi, generating an annual procurement volume of 8 million US dollars. The client also entrusted HiSiaddi with customized sourcing services for other cosmetic active ingredients.

    Client Feedback: "HiSiaddi fully understands the customized demands of high-end skincare brands. They resolved all technical hurdles within 15 days and delivered perfectly compliant samples with flawless documentation. They are our most trusted Chinese partner for customized raw material solutions!"

    V. Case Summary

    The core customized pain points for overseas mid-to-high-end skincare brands purchasing bile acids include dual control of ultra-high chemical and optical purity, nano-grade particle size, animal-free low-endotoxin standards, customized solvent systems and complete international compliance documentation. Most ordinary manufacturers lack sufficient technical capacity, customization willingness, international certifications and standardized English documentation systems, which often stall client R&D and delay product launches.

    HiSiaddi’s core value lies in its ability to "precisely match high-end customized manufacturers, conduct in-depth process fine-tuning, implement stringent quality control, provide full compliance documentation and deliver rapid full-cycle implementation". By leveraging industry resources to partner with technically advanced manufacturers, collaborating on R&D to resolve customization bottlenecks, conducting rigorous testing per international standards and providing flawless English documentation, HiSiaddi fully delivers customized solutions, sample delivery and technical verification within 15 days while securing long-term partnerships. We help clients break through R&D bottlenecks, launch star premium products, consolidate market position in Europe and guarantee stable long-term raw material supply.

    If you need customized service support, please contact HiSiaddi customer service.


    References
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