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The Final Information to Pharmaceutical & Meals Grade Glycerol (Glycerin) – Supply, Advantages & High quality

1. What’s Glycerol (Glycerin)?

Glycerol, generally referred to as glycerin (USP/Ph. Eur. nomenclature: Glycerol), is an easy polyol compound. It is a colorless, odorless, viscous liquid with a candy style, extremely soluble in water and hygroscopic (water-attracting). Chemically categorized as a trihydric alcohol (propane-1,2,3-triol), it serves as a elementary constructing block in lipids (fat and oils) and is a cornerstone ingredient throughout prescribed drugs, meals & beverage (F&B), private care, and industrial purposes. Its distinctive mixture of security, solubility, humectancy, and solvent properties makes it indispensable.

2. Product Supply, Chemical Properties & Identification

• Fornitura: Primarily derived by way of:

  • Saponification: Hydrolysis of triglycerides (fat/oils) throughout cleaning soap manufacturing.

  • Transesterification: Response of triglycerides with methanol (biodiesel manufacturing).

  • Artificial Routes: From propylene by way of epichlorohydrin (much less widespread for high-purity grades).

  • Zhonghong Focus: Makes use of sustainable, non-GMO vegetable oils (e.g., coconut, palm kernel, soy) by way of superior transesterification and purification processes, making certain traceability and purity.

• Proprietà chimiche:

  • Numero CAS: 56-81-5

  • Sistema molecolare (MF): C₃H₈O₃

  • Peso molecolare (MW): 92.09 g/mol

  • EINECS Quantity: 200-289-5

  • Aspetto: Clear, colorless, syrupy liquid.

  • Solubilità: Miscible with water and alcohols; insoluble in hydrocarbons.

  • Boiling Level: 290°C (554°F) with decomposition.

  • Melting Level: 17.8°C (64°F).

  • Density: ~1.261 g/cm³ at 20°C.

  • Viscosity: ~1410 mPa·s at 20°C.

  • Hygroscopicity: Strongly absorbs moisture from the ambiance.

3. What’s the Finest Glycerol? Key Choice Standards

Figuring out the “finest” glycerol hinges on application-specific necessities and stringent high quality parameters. Pharmaceutical Grade (USP/Ph. Eur.) represents the head of purity and security for delicate purposes. Key differentiators embody:

• Ingredient & Purity: Excessive-purity (≥99.5%) glycerol, USP/Ph. Eur. compliant. Free from impurities like diethylene glycol (DEG), ethylene glycol (EG), chlorinated compounds, aldehydes, and heavy metals past strict limits.

• Efficacia e conformità:

  • Pharmaceutical: Solvent, humectant, plasticizer, lubricant (suppositories), cryoprotectant. Meets compendial requirements (USP <471>, Ph. Eur. monograph 04/2013:0497).

  • Meals (FCC Grade): Humectant, sweetener, solvent, bulking agent. GRAS (Usually Acknowledged As Protected) by FDA; complies with JECFA specs.

  • Cosmetici: Superior humectant, emollient, viscosity modifier, solvent. Compliant with world beauty laws (EU, FDA, China).

• Origine: Sourced from sustainable, traceable vegetable oils (non-GMO most well-liked). Origin impacts sustainability profile.

• Utilizzo:

  • Pharma: Formulations (syrups, elixirs, lotions, ointments, suppositories), API processing.

  • Meals/Beverage: Moisture retention (baked items, confectionery), sweetness/texture modifier, solvent for flavors/colours, freezing level depressant.

  • Cosmetici: Moisturizers (lotions, lotions), hair care (conditioners), soaps, toothpaste.

  • Typical Concentrations: Varies broadly (e.g., 1-15% in cosmetics, 5-30% in pharma liquids, as much as 99.5% as API/excipient).

• Goal Customers: Pharmaceutical producers, nutraceutical formulators, F&B producers, beauty chemists, analysis establishments.

• Well being Advantages & Day by day Consumption:

  • Humectancy: Attracts water into pores and skin, bettering hydration and barrier operate (topical).

  • Laxative: Oral glycerol attracts water into the bowel (osmotic impact). Typical dose: 2-6g (as suppository/enema); oral options range. Seek the advice of a doctor.

  • Power Supply: Metabolized equally to carbohydrates (~4.32 kcal/g), although not a main dietary supply.

  • Protected Day by day Consumption: JECFA established an “Acceptable Day by day Consumption (ADI) not specified” for glycerol, indicating very low toxicity at ranges consumed in meals. Doses for laxative results are particular and non permanent.

• Precautions & Aspect Results:

  • Topical: Usually non-irritating/non-sensitizing at typical use ranges. Excessive concentrations (>50%) could trigger transient stinging or stickiness.

  • Oral (Laxative): Could cause stomach discomfort, cramping, extreme bowel actions, dehydration. Contraindicated in ileus, undiagnosed stomach ache.

  • Common: Guarantee use of meals/pharma grade. Keep away from industrial grade containing poisonous impurities (DEG/EG). Hygroscopic – requires tight packaging.

4. Presentazione dell'azienda: Shaanxi Zhonghong Investment Technology Co., Ltd.

Shaanxi Zhonghong Investment Technology Co., Ltd. is a vertically built-in high-tech enterprise specializing within the analysis, improvement, superior manufacturing, and world distribution of premium botanical extracts and nice chemical compounds for the chemical, materials science, and life science sectors. Our core experience lies in cutting-edge extraction, isolation, and purification applied sciences for plant-derived bioactive compounds.

• Competenze principali: Natural plant extracts, beauty actives, nutraceutical & pharmaceutical intermediates, pure pigments, dietary dietary supplements, meals & beverage components, pure sweeteners.

• Scientific Rigor:

  • R&D Powerhouse: Strategic partnerships with 5 main universities establishing joint innovation laboratories.

  • Portafoglio IP: Holder of Oltre 20 brevetti and a proprietary biblioteca di composti unica al mondo.

• High quality Infrastructure:

  • Chopping-Edge Analytics: Outfitted with HPLC (cromatografia liquida ad alta efficienza), UPLC (Extremely-Efficiency LC), GC-MS (Fuel Chromatography-Mass Spectrometry), NMR (Nuclear Magnetic Resonance Spectroscopy – implied by “superconducting”), making certain id, purity, and hint contaminants detection.

  • Purity Benchmark: Constantly achieves purity requirements exceeding business norms by >20%.

• World Attain: In depth provide community serving Oltre 80 nazioni throughout Asia, Europe, and the Americas. Trusted associate for customized synthesis E opzioni di ingredienti su misura for multinational pharmaceutical companies, analysis institutes, and main FMCG manufacturers.

• Business Legacy: 28 anni of unparalleled expertise in sourcing, processing, and delivering high-purity composti bioattivi.

5. Glycerol Advantages: Well being & Practical Benefits

• Pores and skin Well being (Topical): Enhances pores and skin hydration (corneotherapy precept), improves barrier operate, smooths texture, presents protecting emolliency.

• Pharmaceutical Versatility: Important solvent for poorly soluble APIs, stabilizer, cryoprotectant (biologics), lubricant, osmotic agent (laxatives, ophthalmic options).

• Meals & Beverage Efficiency: Vital humectant stopping staling, texture modifier, delicate sweetener (60% sucrose sweetness), solvent for flavors/colours, improves freeze-thaw stability.

• Industrial Functions: Plasticizer (cellulosics), antifreeze, lubricant, chemical intermediate (alkyd resins, explosives).

6. Glycerol Utilization Tips

• Focus: Varies drastically by utility (e.g., 1-5% humectant in lotions, 15-30% in cough syrups, >95% in some pharma APIs). Adhere to formulation-specific pharmacopoeia or regulatory limits (FCC, INCI).

• Compatibility: Suitable with water, alcohols, glycols. Keep away from sturdy oxidizing brokers. Check compatibility with particular APIs/excipients.

• Processing: Incorporate into aqueous phases. Pre-dissolving in a part of the water part can assist mixing because of excessive viscosity. Account for hygroscopicity throughout storage and processing.

7. Glycerol Security & Dealing with Precautions

• Common: Low acute toxicity. Non-mutagenic, non-carcinogenic.

• Dealing with: Use normal chemical dealing with procedures (gloves, eye safety). Reduce pores and skin contact with concentrated varieties to keep away from dehydration/stickiness.

• Magazzinaggio: Retailer in tightly sealed, corrosion-resistant containers (chrome steel, HDPE) in a cool, dry place. Shield from moisture absorption.

• Impurity Danger: Crucially, guarantee provide chain integrity. Use solely licensed USP/Ph. Eur./FCC grade glycerol with documented absence of poisonous impurities like DEG or EG, which trigger extreme poisoning. Zhonghong’s rigorous QC ensures this.

8. Glycerol Product Specification & Certificates of Evaluation (COA)

Zhonghong’s Pharmaceutical Grade Glycerol meets or exceeds USP/Ph. Eur. specs. A typical COA consists of:

Desk: Glycerol (USP/Ph. Eur.) High quality Management Specs

9. Superior Glycerol Manufacturing Course of

Zhonghong employs a state-of-the-art, built-in manufacturing system for vegetable-derived glycerol:

1. Feedstock Pretreatment: Purification of sustainably sourced, non-GMO vegetable oils.

2. Transesterification: Response with methanol underneath managed catalysis to yield Fatty Acid Methyl Esters (FAME – biodiesel) and crude glycerol.

3. Acidulation & Separation: Acid remedy to separate soaps, adopted by centrifugation for glycerol-rich part isolation.

4. Major Purification: Vacuum distillation to take away water, methanol, salts, and fatty acids.

5. Secondary Purification: Superior multi-stage fractional distillation underneath excessive vacuum and/or distillazione molecolare to realize excessive purity.

6. Decolorization & Filtration: Activated carbon remedy and precision filtration to take away hint colour our bodies and particulates.

7. Sharpening: Last ion-exchange or electrodialysis for ultralow chloride and sulfate ranges.

8. cGMP Compliant Packaging: Filling into clear, accepted containers (drums, totes) underneath managed setting.

10. Key Glycerol Functions

• Farmaci prescritti: Solvent (oral liquids, parenterals), humectant (lotions/ointments), plasticizer (movie coatings), lubricant (tablets, suppositories), cryoprotectant (vaccines, biologics), API.

• Nutraceuticals & Meals: Humectant (protein bars, baked items), solvent (flavors, colours, nutritional vitamins), sweetener, texture modifier, freezing level depressant (ice cream), preservative assist.

• Cosmetici e cura della persona: Humectant (moisturizers, lotions, serums), emollient, viscosity modifier, solvent, oral care agent (toothpaste), hair conditioner.

• Industrial: Antifreeze, plasticizer (cellophane, resins), lubricant, mildew launch agent, chemical intermediate (polyols, alkyd resins, explosives).

11. Stringent Glycerol High quality Management (QC)

Zhonghong’s QC philosophy is anchored in High quality by Design (QbD) rules and adherence to cGMP (present Good Manufacturing Practices). Our vertically managed course of ensures batch-to-batch consistency and traceability. Rigorous testing happens at a number of phases:

• Incoming Uncooked Materials Inspection: Verification of vegetable oil high quality certificates and id testing (FFA, PV, IV).

• Controlli in corso (IPC): Actual-time monitoring of crucial parameters (pH, temperature, strain, distillation cuts, conductivity) throughout purification phases. IPC samples analyzed by way of speedy strategies (Titration, GC, Refractive Index).

• Last Product Launch Testing: Complete evaluation per related monograph (USP/Ph. Eur./FCC) by our ISO 17025 accredited laboratory, using HPLC, GC, ICP-MS, ICP-OES, UV-Vis, Karl Fischer titration, and superior microbiological strategies. Full compliance with ICH Q3D Elemental Impurities and USP <232>/<233> is ensured.

• Ricerca sulla stabilità: Ongoing real-time and accelerated stability applications to ensure shelf-life and storage circumstances.

• Documentazione e tracciabilità: Digital Batch Data (EBR) and complete documentation guarantee full traceability from uncooked materials to completed product cargo.

12. Dependable Glycerol Packaging & World Logistics

• Confezione: Accessible in conforme a cGMP choices:

  • Small Scale: 25kg HDPE drums with double LDPE liners.

  • Medium Scale: 250kg UN-certified HDPE drums.

  • Bulk: 1000kg IBC totes (high-density polyethylene, chrome steel choices) or ISO tank containers (meals/pharma grade).

• Magazzinaggio: Retailer beneath 30°C (86°F) in authentic, tightly sealed containers protected against moisture.

• Durata di conservazione: Sometimes 24-36 months from date of manufacture when saved correctly.

• World Logistics: Experience in dealing with hygroscopic supplies. Environment friendly world transport by way of air, sea, or land freight. Compliant with IMDG/IATA/ADR laws. Temperature-controlled choices accessible. Devoted logistics group ensures well timed supply worldwide.

13. Glycerol: Well being Mechanisms, Innovation & Analysis Frontiers

• Well being Mechanisms:

  • Pores and skin Hydration: Modulates aquaporin-3 (AQP3) expression in keratinocytes, enhancing water transport and stratum corneum hydration. Kinds hydrogen bonds with water, making a protecting humectant movie.

  • Osmotic Laxative: Will increase intraluminal water content material and colonic peristalsis.

  • Cryoprotection: Kinds hydrogen bonds with biomolecules, stopping ice crystal harm throughout freezing.

• Innovazione industriale:

  • Inexperienced Chemistry: Catalytic conversion to value-added chemical compounds (propylene glycol, acrolein, lactic acid).

  • Bio-based Polymers: Key monomer for polyglycerols, polyesters, polycarbonates.

  • Gas Components: Conversion to solketal (acetone ketal) as an oxygenated gasoline additive.

  • Zhonghong R&D: Concentrate on novel purification strategies (membrane separation, steady chromatography), derivatization for high-value actives, and sustainable biodiesel co-product utilization.

• Analisi Frontiere e Sfide:

  • Topical Therapeutics: Enhanced penetration for transdermal supply, function in barrier restore for atopic dermatitis.

  • Metabolic Affect: Detailed understanding of glycerol kinase pathway regulation and implications in diabetes/weight problems.

  • Superior Supplies: Nanocomposites, practical hydrogels, bio-lubricants.

  • Sustainability: Scaling economically viable catalytic processes for glycerol valorization, bettering biodiesel manufacturing effectivity to cut back glycerol surplus. Zhonghong addresses this by way of high-purity area of interest markets and R&D into novel derivatives.

14. Glycerol FAQs (Incessantly Requested Questions)

• Q1: What is the distinction between Glycerol, Glycerin, and Vegetable Glycerin?

  • UN: Chemically, glycerol (propane-1,2,3-triol) is the pure compound. “Glycerin” is the industrial time period, typically synonymous with glycerol, particularly USP grade. “Vegetable Glycerin” specifies the supply (plant oils), distinguishing it from animal tallow-derived or artificial glycerol. Pharmaceutical/Meals grade implies purity no matter supply.

• Q2: Is Vegetable Glycerin protected?

  • UN: Sure, high-purity USP/FCC Grade Vegetable Glycerin is acknowledged as protected (GRAS) by the FDA for meals and broadly accepted globally for meals, pharma, and cosmetics when used appropriately. Security relies upon totally on purity and grade.

• Q3: Can I ingest Glycerin?

  • UN: Sure, Meals Grade (FCC) glycerin is protected for consumption in meals merchandise and as a laxative (in particular doses/varieties). By no means ingest industrial-grade glycerin. Seek the advice of a physician earlier than utilizing as a laxative.

• This autumn: Why is purity so crucial, particularly DEG/EG testing?

  • UN: DEG and EG are extremely poisonous impurities that may trigger deadly poisoning, even in small quantities. Rigorous testing and provide chain management (like Zhonghong’s) are non-negotiable for pharmaceutical and meals purposes. USP/Ph. Eur. have strict limits.

• Q5: What are the principle purposes of USP Grade Glycerol?

  • UN: Important in syrups, elixirs, lotions, ointments, suppositories, capsules, pill coatings, vaccine stabilizers, and as a solvent for APIs. Requires highest purity and documentation (C of A, DMF/ASMF).

• Q6: How ought to I retailer Glycerol?

  • UN: In tightly sealed, moisture-proof containers (authentic packaging most well-liked) in a cool (<30°C), dry place. Reduce headspace publicity to air.

• Q7: Does Zhonghong provide customized glycerol grades or derivatives?

  • UN: Sure. Leveraging our joint labs and compound library, we specialise in customized purity specs, blends, and research-scale synthesis of glycerol derivatives (e.g., mono/diacetin, glyceryl esters, ethers).

• Q8: Is Zhonghong’s Glycerol Kosher/Halal licensed?

  • UN: Kosher and Halal certification is offered upon request for particular batches/manufacturing traces.

15. The place to Purchase Premium Glycerol & Request Samples

Supply Dependable, Excessive-Purity Glycerol (USP/Ph. Eur./FCC Grade) from a Trusted World Provider:

• Go to our Web site: Discover our full portfolio of plant extracts and nice chemical compounds: https://www.aiherba.com

• Contact Us for Quotes & Technical Information:

  • Posta elettronica: liaodaohai@gmail.com

• Request Your Free Pattern: Contact us right now to debate your particular glycerol necessities (grade, amount, packaging) and request a complimentary pattern of our premium Pharmaceutical or Meals Grade Glycerol on your analysis and formulation trials.

16. Conclusion

Glycerol stays an irreplaceable, versatile, and protected compound underpinning numerous merchandise in well being, vitamin, and business. Choosing the optimum grade – significantly USP/Ph. Eur. for prescribed drugs O FCC for meals – is paramount, demanding rigorous high quality management targeted on ultra-high purity (>99.5%) and the absolute exclusion of poisonous impurities like DEG and EG. Shaanxi Zhonghong Investment Technology Co., Ltd., with its 28-year legacy, cutting-edge purification expertise (HPLC, UPLC, NMR), college partnerships, and cGMP-compliant manufacturing, stands as a worldwide chief in supplying traceable, sustainable, and exceptionally pure vegetable-derived glycerol. We bridge the hole between premium pure sources and the exacting calls for of superior industrial purposes, dedicated to innovation and unwavering high quality for companions worldwide.

17. Riferimenti

1. United States Pharmacopeia (USP). “Monograph: Glycerin.” USP-NF.

2. European Pharmacopoeia (Ph. Eur.). “Monograph: Glycerol (0497).” tenth Version.

3. Meals Chemical compounds Codex (FCC). “Monograph: Glycerin.” twelfth Version.

4. Joint FAO/WHO Knowledgeable Committee on Meals Components (JECFA). “Glycerol.” Monographs & Evaluations.

5. U.S. Meals and Drug Administration (FDA). “Code of Federal Rules Title 21: Substances Usually Acknowledged As Protected (GRAS).”

6. Beauty Ingredient Assessment (CIR). “Security Evaluation of Glycerin as Utilized in Cosmetics.” Last Report, 2016.

7. Nationwide Heart for Biotechnology Data (2023). PubChem Compound Abstract for CID 753, Glycerol.

8. Fluhr, J. W., et al. (2008). “Glycerol regulates stratum corneum hydration in sebaceous gland poor (asebia) mice.” Journal of Investigative Dermatology.

9. Zheng, Y., et al. (2021). “Catalytic Valorization of Glycerol to Worth-Added Chemical compounds.” ChemSusChem.

10. Worldwide Council for Harmonisation (ICH). “Guideline Q3D (R2) on Elemental Impurities.” (2022).