Squalane

The Final Information to Pharmaceutical-Grade Squalane: Supply, Science & Superior High quality

1. What is Squalane?
Squalane is a totally saturated, extremely secure by-product of squalene, a lipid naturally produced by the human sebaceous glands and located in varied sources like shark liver and crops (notably olive oil, amaranth seed, sugarcane). Not like its precursor squalene, which is unsaturated and susceptible to oxidation, squalane (C₃₀H₆₂) is hydrogenated, leading to distinctive oxidative stability, non-comedogenicity, and a light-weight, non-greasy texture. It is a premier emollient and moisturizing agent also used in premium cosmetics, nutraceuticals, and pharmaceutical formulations for its very good pores and skin compatibility and transdermal supply properties.

2. Product Supply, Chemical Properties & Identifiers

• Supply: Fashionable, sustainable squalane is primarily derived by way of the hydrogenation of plant-based squalene. Main sources embody Olive Oil (Olea europaea), Sugarcane (Saccharum officinarum), and Amaranth Seed (Amaranthus spp.). Shaanxi Zhonghong makes use of sustainably sourced, non-GMO botanical precursors.

• Chemical Properties:

  • Look: Clear, colorless to pale yellow liquid.

  • Odor: Attribute, faint odor.

  • Solubility: Soluble in oils, fat, and natural solvents; insoluble in water.

  • Stability: Extremely secure towards oxidation and rancidity as a result of saturated hydrocarbon construction.

  • Viscosity: Low viscosity liquid.

• Chemical Identifiers:

  • CAS Quantity: 111-01-3

  • Molecular Components (MF): C₃₀H₆₂

  • Molecular Weight (MW): 422.83 g/mol

  • EC / EINECS Quantity: 203-825-6

3. Defining the “Finest” Squalane: Key Standards
Deciding on premium squalane requires rigorous analysis:

• Ingredient Purity: The benchmark is >99.9% purity (GC). Impurities like residual squalene or course of contaminants degrade efficiency and stability. Shaanxi Zhonghong ensures purity exceeding typical trade requirements by 20%+ through superior chromatographic purification.

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

• Efficacy & Compliance:

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

  • Nutraceutical/Well being: Acts as a lipid service, helps mobile membrane well being, reveals potential antioxidant and detoxing help properties (analysis ongoing). Complies with related Meals Chemical Codex (FCC), USP-NF monographs, and GRAS standing for meant use. *Oral well being advantages deal with lipid absorption and mobile perform help; particular day by day consumption dosage varies considerably by software (topical vs. oral) and formulation. Seek the advice of product-specific tips or a healthcare skilled for oral dietary supplements. Typical topical beauty formulations use 5-15%.*

• Origin & Manufacturing: Origin ought to assure GMP (Good Manufacturing Apply) compliance and superior purification know-how (e.g., molecular distillation, supercritical CO2 extraction, multi-stage chromatography). Shaanxi Zhonghong operates ISO-certified services in China.

• Utility: Versatile for anhydrous and emulsion techniques in cosmetics (serums, moisturizers, oils, sunscreens), softgels for dietary supplements, and as a pharmaceutical excipient. Suitable with a variety of actives.

• Goal Viewers: Beauty formulators, nutraceutical manufacturers, pharmaceutical builders, customers in search of high-purity pure emollients or complement carriers.

• Precautions & Aspect Results:

  • Typically acknowledged as protected (GRAS) and well-tolerated topically and orally.

  • Minimal danger of sensitization; patch testing really helpful for people with very delicate pores and skin.

  • No recognized vital drug interactions. Beauty-grade is for exterior use solely.

  • Guarantee nutraceutical/pharmaceutical grades meet applicable pharmacopeial requirements for inside use.

  • Retailer in cool, darkish circumstances; inert gasoline headspace really helpful for bulk storage.

4. Shaanxi Zhonghong Investment Technology Co., Ltd.: Your Trusted Squalane Companion
A pioneer in bioactive compounds for over 28 years, Shaanxi Zhonghong is a vertically built-in high-tech enterprise specializing within the extraction, isolation, purification, and software of premium plant-derived elements. We serve the worldwide chemical, supplies, and life science industries.

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

• Product Portfolio: Pharmaceutical/Beauty Grade Plant Squalane, Natural Plant Extracts, Beauty Actives, Nutraceutical Elements (Dietary Dietary supplements, Purposeful Meals), Natural Colours & Sweeteners, Meals/Pharma Excipients.

• Scientific Prowess (R&D Barrier): Strategic collaborations with 5 elite universities, 20+ proprietary patents, unique world compound libraries accelerating innovation.

• Unmatched High quality Management: Outfitted with Excessive-Efficiency Liquid Chromatography (HPLC/UHPLC), Superconducting Nuclear Magnetic Resonance (NMR), GC-MS, ICP-MS. Our purity requirements constantly exceed trade norms by >20%, guaranteeing batch-to-batch consistency and traceability.

• World Attain: Dependable B2B provide community spanning 80+ nations throughout Asia, Europe, and the Americas. We ship tailor-made ingredient options to main multinational pharmaceutical firms, analysis establishments, and premium beauty homes.

5. Complete Advantages of Squalane

• Pores and skin Well being (Topical): Superior emolliency, speedy absorption, non-greasy really feel, enhanced pores and skin barrier restore, elevated hydration (lowered TEWL), improved pores and skin smoothness/elasticity, antioxidant help, biocompatibility.

• Nutraceutical Provider (Oral): Environment friendly lipid-soluble nutrient supply (e.g., CoQ10, Nutritional vitamins A/D/E/Okay), helps lipid metabolism pathways, potential mobile membrane stabilization.

• Formulation Benefits: Glorious spreading properties, enhances sensory profile, stabilizes emulsions, improves energetic ingredient bioavailability, inert and non-reactive base.

6. Squalane Utilization Pointers

• Cosmetics: Sometimes used at 5-15% in formulations. Add within the oil section. Suitable with most actives. Ultimate for serums, facial oils, moisturizers, sunscreens, lip merchandise.

• Nutraceuticals: Used as a service oil in softgel encapsulations. Focus relies on the energetic payload and dosage necessities. Strict adherence to oral-grade specs is necessary.

• Prescription drugs: Employed as an excipient in topical formulations (lotions, ointments) or in lipid-based drug supply techniques. Should meet related pharmacopeia (USP/EP/JP) requirements.

7. Essential Product Specs & Certificates of Evaluation (COA)
Shaanxi Zhonghong’s Pharmaceutical/Beauty Grade Squalane meets the best worldwide requirements. A typical COA contains:

Desk: Squalane Certificates of Evaluation (COA) Specs

8. Superior Manufacturing Course of
Our squalane undergoes a stringent, multi-step course of making certain unparalleled purity:

1. Sustainable Sourcing: Choice of non-GMO, ethically cultivated plant materials (e.g., licensed olive pomace, sugarcane).

2. Supercritical CO2 Extraction (SFE): Preliminary extraction of squalene underneath low temperature/stress to protect integrity and keep away from solvent residues.

3. Molecular Distillation: Purification of crude squalene underneath excessive vacuum to take away volatiles, free fatty acids, and pigments.

4. Catalytic Hydrogenation: Exact hydrogenation underneath managed circumstances (catalyst, temp, stress) to transform squalene to completely saturated squalane.

5. Multi-Stage Chromatographic Purification: Core Know-how: Using preparative HPLC, impurities (isosqualane, residual hydrocarbons) are meticulously eliminated, attaining >99.9% purity.

6. Ultimate Filtration & Stabilization: Sub-micron filtration underneath nitrogen ambiance to make sure sterility and forestall oxidation.

7. Rigorous QC Launch: Each batch undergoes full suite analytical testing (HPLC, GC, ICP-MS, NMR, Microbiology) towards stringent specs earlier than launch.

9. Various Utility Situations

• Cosmeceuticals: Excessive-performance facial serums, moisturizers, eye lotions, solar care, anti-aging formulations, lip therapies, hair conditioning serums/oils.

• Nutraceuticals: Provider oil for lipid-soluble nutritional vitamins (A, D, E, Okay), CoQ10, omega concentrates in softgel capsules; element in purposeful meals oils.

• Prescription drugs: Car for topical dermatological lotions/ointments (e.g., for eczema, psoriasis); excipient in lipid nanoparticle (LNP) supply techniques for enhanced bioavailability.

• Superior Supplies: Lubricant in precision devices; element in specialty coatings requiring excessive stability.

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

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

• In-Course of Controls (IPC): Actual-time monitoring at crucial course of steps (distillation cuts, hydrogenation completion through iodine worth, chromatographic fractions) utilizing validated analytical strategies (HPLC, GC).

• Stability Research: Accelerated and real-time stability applications (ICH Q1A) to find out shelf-life, storage circumstances, and packaging suitability.

• Methodology Validation: Full ICH Q2(R1) validation for all analytical procedures (specificity, accuracy, precision, linearity, vary, LOD/LOQ, robustness).

• Documentation & Traceability: Complete batch data, digital information seize (LIMS), and full traceability from uncooked materials lot to completed product cargo.

• Audits & Compliance: Common inside audits and readiness for buyer/regulatory inspections (FDA, EMA, CFDA).

11. Safe Packaging & World Logistics

• Packaging: Out there in pharmaceutical-grade containers: 1kg/5kg aluminum bottles (nitrogen flushed), 25kg HDPE drums (double LDPE liner, nitrogen blanket), 180kg chrome steel barrels (316L). Customized packaging out there (ISO Tanks, Flexitanks).

• Logistics: World delivery experience through air, sea, and land. Documentation contains CoA, CoO, SDS, Certificates of GMP Compliance. Temperature-controlled delivery choices for delicate areas. Strict adherence to INCOTERMS 2020.

12. Well being Efficacy, Mechanism & Analysis

• Mechanism of Motion (Pores and skin): Integrates into the pores and skin’s lipid matrix, reinforcing the stratum corneum barrier, decreasing TEWL. Its similarity to pores and skin sebum enhances biocompatibility and occlusive properties. Potential modulation of peroxisome proliferator-activated receptors (PPARs) concerned in lipid metabolism and irritation.

• Nutraceutical Analysis: Focuses on its function as a service for lipophilic bioactives, enhancing bioavailability. Rising analysis explores potential in modulating lipid profiles and mobile detoxing pathways (e.g., Nrf2 activation), although sturdy medical proof for particular inside well being advantages remains to be evolving.

• Industrial Purposes: Key in stabilizing delicate actives (retinoids, vitamin C derivatives) in cosmetics. Essential excipient in superior drug supply techniques (LNPs for mRNA vaccines/therapeutics).

• Innovation: Enzymatic synthesis pathways, novel plant sources (microalgae), and functionalized squalane derivatives (e.g., PEGylated) are energetic analysis areas. Shaanxi Zhonghong’s unique compound library facilitates novel by-product growth.

• Challenges: Scaling sustainable sourcing, cost-effective purification to >99.99% for area of interest pharma purposes, establishing definitive medical endpoints for particular well being claims (oral).

13. Incessantly Requested Questions (FAQ)

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

  • A: Completely. We use solely sustainably sourced olive, sugarcane, or amaranth squalene. NO shark-derived materials.

• Q: What purity degree do you assure?

  • A: We assure >99.9% purity (GC), verified by our superior QC (HPLC, GC, NMR). This considerably exceeds typical trade requirements.

• Q: Do you supply completely different grades?

  • A: Sure. We provide Beauty Grade (ISO 22716), Meals/FCC Grade, and Pharmaceutical Grade (USP/EP compliant). Specs fluctuate; request the related CoA.

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

  • A: Minimal 24 months when saved unopened in authentic hermetic containers, protected against gentle and warmth, beneath 30°C (86°F). Nitrogen headspace extends stability.

• Q: Is squalane protected for oral use?

  • A: Our Meals/FCC and Pharmaceutical grades are produced underneath GMP for oral use as a service/excipient. All the time use the grade applicable in your software. Beauty grade is for exterior use solely.

• Q: Are you able to present stability information?

  • A: Sure. Accelerated and real-time stability information for our squalane is on the market upon request underneath confidentiality settlement (CDA).

• Q: What are your minimal order portions (MOQs)?

  • A: MOQs fluctuate. Contact us for particular particulars based mostly on grade and packaging.

14. The place to Purchase & Request Samples
Supply Premium, Excessive-Purity Plant Squalane Instantly from Shaanxi Zhonghong – Your World Companion in Bioactive Elements.

• Go to our web site: https://www.aiherba.com (Discover our full product portfolio and firm capabilities)

• Contact our Gross sales Group:

  • E-mail: liaodaohai@gmail.com (For inquiries, quotes, technical information sheets)

  • Free Pattern Request: Contact us through e-mail to request complimentary samples of our pharmaceutical or beauty grade squalane. Specify your meant software and required grade.

15. Conclusion
Squalane stands as a cornerstone emollient and purposeful ingredient throughout cosmetics, nutraceuticals, and prescription drugs as a result of its distinctive stability, biocompatibility, and efficiency. Selecting a provider with demonstrable experience in purification, sustainable sourcing, and rigorous high quality management is paramount. Shaanxi Zhonghong Investment Technology Co., Ltd., with its 28-year legacy, cutting-edge know-how (HPLC purification, superconducting NMR), unwavering dedication to purity (>99.9%), and world provide chain excellence, is the premier companion for manufacturers demanding uncompromising high quality and innovation in plant-derived squalane. Contact us in the present day to raise your formulations.

16. References (Illustrative – Embrace Particular Current Research if Doable)

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

2. Kim, S. Okay., & Karadeniz, F. (2012). Advances in Meals and Vitamin Analysis, 65, 223-233. (Organic significance of squalene).

3. Ottaviani, M., et al. (2010). Worldwide Journal of Beauty Science, 32(5), 347-353. (Squalane pores and skin absorption/barrier).

4. US Pharmacopeia Nationwide Formulary (USP-NF). (Present Version). Monograph.

5. European Pharmacopoeia (Ph. Eur.). (Present Version). Monograph.

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

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

8. Assessment articles on lipid nanoparticles (LNPs) and excipients in drug supply (e.g., in journals like Superior Drug Supply Evaluations, Worldwide Journal of Pharmaceutics).

9. *Current research (2020+) on enzymatic synthesis or novel plant sources of squalene/squalane (e.g., in Inexperienced Chemistry, Journal of Agricultural and Meals Chemistry).*