Glycérine

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. Fourniture du produit, propriétés chimiques et identification

• Fournir: Primarily derived by way of:

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

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

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

  • Focus sur Zhonghong : Utilise huiles végétales durables et sans OGM (e.g., coconut, palm kernel, soy) by way of superior transesterification and purification processes, making certain traceability and purity.

• Propriétés chimiques :

  • Numéro CAS : 56-81-5

  • Système moléculaire (MF) : C₃H₈O₃

  • Poids moléculaire (PM) : 92,09 g/mol

  • Quantité EINECS : 200-289-5

  • Regarder: Liquide clair, incolore et sirupeux.

  • Solubilité: Miscible à l'eau et aux alcools ; insoluble dans les hydrocarbures.

  • Boiling Level: 290°C (554°F) avec décomposition.

  • Melting Level: 17,8°C (64°F).

  • Densité: ~1,261 g/cm³ à 20°C.

  • Viscosité: ~1410 mPa·s à 20°C.

  • Hygroscopicité : 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. Qualité pharmaceutique (USP/Ph. Eur.) represents the head of purity and security for delicate purposes. Key differentiators embody:

• Ingrédients et pureté : 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.

• Efficacité et conformité :

  • Pharmaceutique: 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.

  • Produits de beauté: 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.

• Utilisation:

  • Pharmaceutique : 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.

  • Produits de beauté: Moisturizers (lotions, lotions), hair care (conditioners), soaps, toothpaste.

  • Concentrations typiques : 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:

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

  • Laxatif: 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.

• Précautions et résultats d'aspect :

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

  • Oral (laxatif) : 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. Présentation de l'entreprise : 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 pour les composés bioactifs d'origine végétale.

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

• Rigueur scientifique :

  • Centrale de R&D : Partenariats stratégiques avec 5 main universities établissement laboratoires communs d'innovation.

  • Portefeuille de propriété intellectuelle : Titulaire de 20+ brevets et une propriété exclusive bibliothèque de composés unique au monde.

• High quality Infrastructure:

  • Analyses de pointe : Équipé de HPLC (chromatographie liquide à haute efficacité), UPLC (LC extrêmement efficace), GC-MS (Chromatographie en phase gazeuse-Spectrométrie de masse), RMN (spectroscopie de résonance magnétique nucléaire – sous-entendu par « supraconducteur »), making certain id, purity, and hint contaminants detection.

  • Référence de pureté : Constantly achieves purity requirements exceeding business norms by >20%.

• Atteindre le monde : In depth provide community serving plus de 80 nations throughout Asia, Europe, and the Americas. Trusted associate for customized synthesis et options d'ingrédients sur mesure for multinational pharmaceutical companies, analysis institutes, and main FMCG manufacturers.

• Business Legacy: 28 ans of unparalleled expertise in sourcing, processing, and delivering high-purity composés bioactifs.

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.

• Polyvalence pharmaceutique : 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: Plastifiant (cellulose), antigel, lubrifiant, intermédiaire chimique (résines alkydes, explosifs).

6. Glycerol Utilization Tips

• Se concentrer: 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).

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

• Traitement: 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: Faible toxicité aiguë. Non mutagène, non cancérigène.

• 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.

• Stockage: 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. Prétraitement des matières premières : Purification d'huiles végétales issues de sources durables et sans OGM.

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

3. Acidulation et séparation : 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. Purification secondaire : Supérieur multi-stage fractional distillation underneath excessive vacuum et/ou distillation moléculaire to realize excessive purity.

6. Décoloration et 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. Emballage conforme aux BPF : Filling into clear, accepted containers (drums, totes) underneath managed setting.

10. Key Glycerol Functions

• Médicaments prescrits : 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.

• Cosmétiques et soins privés : Humectant (hydratants, lotions, sérums), émollient, modificateur de viscosité, solvant, agent de soins bucco-dentaires (dentifrice), après-shampooing.

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

11. Stringent Glycerol High quality Management (QC)

La philosophie du contrôle qualité de Zhonghong est ancrée dans Haute qualité par conception (QbD) rules and adherence to cGMP (Bonnes Pratiques de Fabrication actuelles). 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).

• En cours de contrôle (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.

• Recherche sur la stabilité : Ongoing real-time and accelerated stability applications to ensure shelf-life and storage circumstances.

• Documentation et traçabilité : Digital Batch Data (EBR) and complete documentation guarantee full traceability from uncooked materials to completed product cargo.

12. Dependable Glycerol Packaging & World Logistics

• Conditionnement: Accessible in Conforme aux BPF choices:

  • Petite échelle : Fûts en PEHD de 25 kg avec double doublure en PEBD.

  • Échelle moyenne : Fûts en PEHD certifiés UN de 250 kg.

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

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

• Durée de conservation : Sometimes 24-36 months from date of manufacture when saved correctly.

• Logistique mondiale : 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

• Mécanismes de bien-être :

  • 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.

  • Laxatif osmotique : Will increase intraluminal water content material and colonic peristalsis.

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

• Innovation industrielle :

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

  • Polymères biosourcés : Monomère clé pour polyglycérols, 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.

• Frontières et défis de l'analyse :

  • Thérapeutiques topiques : 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.

  • Durabilité: 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 Glycérine végétale de qualité USP/FCC 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 : Puis-je ingérer de la glycérine ?

  • 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 laboratoires communs et bibliothèque de composés, 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:

  • Courrier électronique : liaodaohai@gmail.com

• Demandez votre modèle gratuit : Contact us right now to debate your particular glycerol necessities (grade, amount, packaging) and demander un modèle gratuit 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 ou FCC for meals – is paramount, demanding rigorous high quality management targeted on ultra-haute pureté (>99,5%) et le absolute exclusion of poisonous impurities comme DEG et EG. Shaanxi Zhonghong Investment Technology Co., Ltd., avec ses 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. Références

1. Pharmacopée des États-Unis (USP). « Monographie : Glycérine. » 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 de dermatologie d'investigation.

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

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