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The Ultimate Guide to Pharmaceutical-Grade Squalane: Source, Science & Superior Quality

1. What is Squalane?
Squalane is a fully saturated, highly stable derivative of squalene, a lipid naturally produced by the human sebaceous glands and found in various sources like shark liver and plants (notably olive oil, amaranth seed, sugarcane). Unlike its precursor squalene, which is unsaturated and prone to oxidation, squalane (C30시간62) is hydrogenated, resulting in exceptional oxidative stability, non-comedogenicity, and a lightweight, non-greasy texture. It’s a premier emollient and moisturizing agent extensively utilized in premium cosmetics, nutraceuticals, and pharmaceutical formulations for its superb skin compatibility and transdermal delivery properties.

2. 제품 출처, 화학적 특성 및 식별자

• 원천: Modern, sustainable squalane is primarily derived through the hydrogenation of plant-based squalene. Leading sources include Olive Oil (Olea europaea), Sugarcane (Saccharum officinarum), 그리고 Amaranth Seed (Amaranthus spp.). Shaanxi Zhonghong utilizes sustainably sourced, non-GMO botanical precursors.

• 화학적 특성:

  • 모습: Clear, colorless to pale yellow liquid.

  • Odor: Characteristic, faint odor.

  • 용해도: Soluble in oils, fats, and organic solvents; insoluble in water.

  • 안정: Highly stable against oxidation and rancidity due to saturated hydrocarbon structure.

  • Viscosity: Low viscosity liquid.

• Chemical Identifiers:

  • CAS 번호: 111-01-3

  • 분자식(MF): C30시간62

  • 분자량(MW): 422.83 g/mol

  • EC / EINECS Number: 203-825-6

3. Defining the “Best” Squalane: Key Criteria
Selecting premium squalane requires rigorous evaluation:

• Ingredient Purity: The benchmark is >99.9% purity (GC). Impurities like residual squalene or process contaminants degrade performance and stability. Shaanxi Zhonghong guarantees purity exceeding typical industry standards by 20%+ via advanced chromatographic purification.

• Source & Sustainability: Ethically sourced, 100% plant-derived (Phyto-Squalane) is non-negotiable. Traceability from sustainable cultivation is essential.

• 효능 및 준수성:

  • Cosmetic: Deeply moisturizes, restores skin barrier function, enhances ingredient penetration, reduces TEWL (Transepidermal Water Loss), imparts smoothness. Complies with ISO 16128 (Natural Origin Index), COSMOS, and global regulatory frameworks (FDA, EU CosReg).

  • Nutraceutical/Health: Acts as a lipid carrier, supports cellular membrane health, exhibits potential antioxidant and detoxification support properties (research ongoing). Complies with relevant Food Chemical Codex (FCC), USP-NF monographs, and GRAS status for intended use. *Oral health benefits focus on lipid absorption and cellular function support; specific daily intake dosage varies significantly by application (topical vs. oral) and formulation. Consult product-specific guidelines or a healthcare professional for oral supplements. Typical topical cosmetic formulations use 5-15%.*

• Origin & Manufacturing: Origin should guarantee GMP (Good Manufacturing Practice) compliance and advanced purification technology (e.g., molecular distillation, supercritical CO2 extraction, multi-stage chromatography). Shaanxi Zhonghong operates ISO-certified facilities in China.

• Application: Versatile for anhydrous and emulsion systems in cosmetics (serums, moisturizers, oils, sunscreens), softgels for supplements, and as a pharmaceutical excipient. Compatible with a wide range of actives.

• 대상 고객: Cosmetic formulators, nutraceutical brands, pharmaceutical developers, consumers seeking high-purity natural emollients or supplement carriers.

• 주의사항 및 부작용:

  • Generally recognized as safe (GRAS) and well-tolerated topically and orally.

  • Minimal risk of sensitization; patch testing recommended for individuals with very sensitive skin.

  • No known significant drug interactions. Cosmetic-grade is for external use only.

  • Ensure nutraceutical/pharmaceutical grades meet appropriate pharmacopeial standards for internal use.

  • Store in cool, dark conditions; inert gas headspace recommended for bulk storage.

4. Shaanxi Zhonghong Investment Technology Co., Ltd.: Your Trusted Squalane Partner
A pioneer in bioactive compounds for over 28 years, Shaanxi Zhonghong is a vertically integrated high-tech enterprise specializing in the extraction, isolation, purification, and application of premium plant-derived ingredients. We serve the global chemical, materials, and life science industries.

• Core Competencies: Natural plant extraction, advanced purification (HPLC prep scale), synthesis of high-value botanically derived compounds.

• 제품 포트폴리오: Pharmaceutical/Cosmetic Grade Plant Squalane, Natural Plant Extracts, Cosmetic Actives, Nutraceutical Ingredients (Dietary Supplements, Functional Foods), Natural Colors & Sweeteners, Food/Pharma Excipients.

• 과학적 역량(R&D 장벽): Strategic collaborations with 5 elite universities, 20+ proprietary patents, exclusive global compound libraries accelerating innovation.

• Unmatched Quality Control: 장착됨 High-Performance Liquid Chromatography (HPLC/UHPLC), Superconducting Nuclear Magnetic Resonance (NMR), GC-MS, ICP-MS. Our purity standards consistently exceed industry norms by >20%, guaranteeing batch-to-batch consistency and traceability.

• 글로벌 도달 범위: Reliable B2B supply network spanning 80+ countries across Asia, Europe, and the Americas. We deliver tailored ingredient solutions to leading multinational pharmaceutical corporations, research institutions, and premium cosmetic houses.

5. Comprehensive Benefits of Squalane

• 피부 건강(국소): Superior emolliency, rapid absorption, non-greasy feel, enhanced skin barrier repair, increased hydration (reduced TEWL), improved skin smoothness/elasticity, antioxidant support, biocompatibility.

• Nutraceutical Carrier (Oral): Efficient lipid-soluble nutrient delivery (e.g., CoQ10, Vitamins A/D/E/K), supports lipid metabolism pathways, potential cellular membrane stabilization.

• Formulation Advantages: Excellent spreading properties, enhances sensory profile, stabilizes emulsions, improves active ingredient bioavailability, inert and non-reactive base.

6. Squalane Usage Guidelines

• 화장품: Typically used at 5-15% in formulations. Add in the oil phase. Compatible with most actives. Ideal for serums, facial oils, moisturizers, sunscreens, lip products.

• 건강기능식품: Used as a carrier oil in softgel encapsulations. Concentration depends on the active payload and dosage requirements. Strict adherence to oral-grade specifications is mandatory.

• 제약품: Employed as an excipient in topical formulations (creams, ointments) or in lipid-based drug delivery systems. Must meet relevant pharmacopeia (USP/EP/JP) standards.

7. Critical Product Specifications & Certificate of Analysis (COA)
Shaanxi Zhonghong’s Pharmaceutical/Cosmetic Grade Squalane meets the highest international standards. A typical COA includes:

Table: Squalane Certificate of Analysis (COA) Specifications

8. 고급 생산 공정
Our squalane undergoes a stringent, multi-step process ensuring unparalleled purity:

1. Sustainable Sourcing: Selection of non-GMO, ethically cultivated plant material (e.g., certified olive pomace, sugarcane).

2. Supercritical CO2 Extraction (SFE): Initial extraction of squalene under low temperature/pressure to preserve integrity and avoid solvent residues.

3. Molecular Distillation: Purification of crude squalene under high vacuum to remove volatiles, free fatty acids, and pigments.

4. Catalytic Hydrogenation: Precise hydrogenation under controlled conditions (catalyst, temp, pressure) to convert squalene to fully saturated squalane.

5. Multi-Stage Chromatographic Purification: Core Technology: Utilizing preparative HPLC, impurities (isosqualane, residual hydrocarbons) are meticulously removed, achieving >99.9% purity.

6. Final Filtration & Stabilization: Sub-micron filtration under nitrogen atmosphere to ensure sterility and prevent oxidation.

7. Rigorous QC Release: Every batch undergoes full suite analytical testing (HPLC, GC, ICP-MS, NMR, Microbiology) against stringent specifications before release.

9. 다양한 응용 시나리오

• 화장품: High-performance facial serums, moisturizers, eye creams, sun care, anti-aging formulations, lip treatments, hair conditioning serums/oils.

• 건강기능식품: Carrier oil for lipid-soluble vitamins (A, D, E, K), CoQ10, omega concentrates in softgel capsules; component in functional food oils.

• 제약품: Vehicle for topical dermatological creams/ointments (e.g., for eczema, psoriasis); excipient in lipid nanoparticle (LNP) delivery systems for enhanced bioavailability.

• Advanced Materials: Lubricant in precision instruments; component in specialty coatings requiring high stability.

10. Robust Quality Control System
Shaanxi Zhonghong implements a state-of-the-art Quality Management System (QMS) adhering to cGMP, ISO 9001, and ISO 22716 (Cosmetics). Our QC paradigm encompasses:

• Raw Material Qualification: Strict vendor approval, identity (FTIR, NMR), purity (HPLC, GC), and contaminant testing (pesticides, heavy metals) for all botanical inputs and reagents.

• 공정 중 제어(IPC): Real-time monitoring at critical process steps (distillation cuts, hydrogenation completion via iodine value, chromatographic fractions) using validated analytical methods (HPLC, GC).

• 안정성 연구: Accelerated and real-time stability programs (ICH Q1A) to determine shelf-life, storage conditions, and packaging suitability.

• 방법 검증: Full ICH Q2(R1) validation for all analytical procedures (specificity, accuracy, precision, linearity, range, LOD/LOQ, robustness).

• Documentation & Traceability: Comprehensive batch records, electronic data capture (LIMS), and full traceability from raw material lot to finished product shipment.

• Audits & Compliance: Regular internal audits and readiness for customer/regulatory inspections (FDA, EMA, CFDA).

11. 안전한 포장 및 글로벌 물류

• 포장: Available in pharmaceutical-grade containers: 1kg/5kg aluminum bottles (nitrogen flushed), 25kg HDPE drums (double LDPE liner, nitrogen blanket), 180kg stainless steel barrels (316L). Custom packaging available (ISO Tanks, Flexitanks).

• 기호 논리학: Global shipping expertise via air, sea, and land. Documentation includes CoA, CoO, SDS, Certificate of GMP Compliance. Temperature-controlled shipping options for sensitive regions. Strict adherence to INCOTERMS 2020.

12. Health Efficacy, Mechanism & Research

• Mechanism of Action (Skin): Integrates into the skin’s lipid matrix, reinforcing the stratum corneum barrier, reducing TEWL. Its similarity to skin sebum enhances biocompatibility and occlusive properties. Potential modulation of peroxisome proliferator-activated receptors (PPARs) involved in lipid metabolism and inflammation.

• Nutraceutical Research: Focuses on its role as a carrier for lipophilic bioactives, enhancing bioavailability. Emerging research explores potential in modulating lipid profiles and cellular detoxification pathways (e.g., Nrf2 activation), though robust clinical evidence for specific internal health benefits is still evolving.

• Industrial Applications: Key in stabilizing sensitive actives (retinoids, vitamin C derivatives) in cosmetics. Critical excipient in advanced drug delivery systems (LNPs for mRNA vaccines/therapeutics).

• Innovation: Enzymatic synthesis pathways, novel plant sources (microalgae), and functionalized squalane derivatives (e.g., PEGylated) are active research areas. Shaanxi Zhonghong’s exclusive compound library facilitates novel derivative development.

• 과제: Scaling sustainable sourcing, cost-effective purification to >99.99% for niche pharma applications, establishing definitive clinical endpoints for specific health claims (oral).

13. 자주 묻는 질문(FAQ)

• Q: Is your squalane 100% plant-derived?

  • 에이: Absolutely. We use only sustainably sourced olive, sugarcane, or amaranth squalene. NO shark-derived material.

• Q: What purity level do you guarantee?

  • 에이: We guarantee >99.9% purity (GC), verified by our advanced QC (HPLC, GC, NMR). This significantly exceeds typical industry standards.

• Q: Do you offer different grades?

  • 에이: Yes. We supply Cosmetic Grade (ISO 22716), Food/FCC Grade, and Pharmaceutical Grade (USP/EP compliant). Specifications vary; request the relevant CoA.

• Q: What is the shelf life and storage condition?

  • 에이: Minimum 24 months when stored unopened in original airtight containers, protected from light and heat, below 30°C (86°F). Nitrogen headspace extends stability.

• Q: Is squalane safe for oral use?

  • 에이: Our Food/FCC and Pharmaceutical grades are produced under GMP for oral use as a carrier/excipient. Always use the grade appropriate for your application. Cosmetic grade is for external use only.

• Q: Can you provide stability data?

  • 에이: Yes. Accelerated and real-time stability data for our squalane is available upon request under confidentiality agreement (CDA).

• Q: What are your minimum order quantities (MOQs)?

  • 에이: MOQs vary. Contact us for specific details based on grade and packaging.

14. Where to Buy & Request Samples
Source Premium, High-Purity Plant Squalane Directly from Shaanxi Zhonghong – Your Global Partner in Bioactive Ingredients.

• 저희 웹사이트를 방문하세요: https://www.aiherba.com (Explore our full product portfolio and company capabilities)

• 영업팀에 문의하세요:

  • 이메일: liaodaohai@gmail.com (For inquiries, quotes, technical data sheets)

  • Free Sample Request: Contact us via email to request complimentary samples of our pharmaceutical or cosmetic grade squalane. Specify your intended application and required grade.

15. 결론
Squalane stands as a cornerstone emollient and functional ingredient across cosmetics, nutraceuticals, and pharmaceuticals due to its exceptional stability, biocompatibility, and performance. Choosing a supplier with demonstrable expertise in purification, sustainable sourcing, and rigorous quality control is paramount. Shaanxi Zhonghong Investment Technology Co., Ltd., with its 28-year legacy, cutting-edge technology (HPLC purification, superconducting NMR), unwavering commitment to purity (>99.9%), and global supply chain excellence, is the premier partner for brands demanding uncompromising quality and innovation in plant-derived squalane. Contact us today to elevate your formulations.

16. References (Illustrative – Include Specific Recent Studies if Possible)

1. Huang, Z. R., et al. (2009). Biochemical Pharmacology, 78(11), 1462-1469. (Squalene/Squalane biological activity).

2. Kim, S. K., & Karadeniz, F. (2012). Advances in Food and Nutrition Research, 65, 223-233. (Biological importance of squalene).

3. Ottaviani, M., et al. (2010). 국제 화장품 과학 저널, 32(5), 347-353. (Squalane skin absorption/barrier).

4. US Pharmacopeia National Formulary (USP-NF). (Current Edition). Monograph.

5. European Pharmacopoeia (Ph. Eur.). (Current Edition). Monograph.

6. ICH Q3C (R8): Impurities: Guideline for Residual Solvents. (2023).

7. ICH Q1A(R2): Stability Testing of New Drug Substances and Products. (2003).

8. Review articles on lipid nanoparticles (LNPs) and excipients in drug delivery (e.g., in journals like Advanced Drug Delivery Reviews, International Journal of Pharmaceutics).

9. *Recent studies (2020+) on enzymatic synthesis or novel plant sources of squalene/squalane (e.g., in Green Chemistry, Journal of Agricultural and Food Chemistry).*