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| Lugar de origen: | Porcelana |
| Nombre de la marca: | Golden Grain |
| Certificación: | ISO, HALAL, KOSHER, HACCP |
| Número de modelo: | GMAL-822 |
| Cantidad de orden mínima: | 100 kilos |
|---|---|
| Precio: | USD1.00-USD1.65/KG FOB QINGDAO, CHINA |
| Detalles de empaquetado: | 25 kg/bolsa con Kraft y PE INNER |
| Tiempo de entrega: | 7 - 10 días hábiles |
| Condiciones de pago: | L/C, T/T, D/P, Western Union, D/A |
| Capacidad de la fuente: | 1000MT por mes |
| Estabilidad: | Estable en condiciones normales de almacenamiento | Fórmula química: | C12H24O11 |
|---|---|---|---|
| Tamaño de partícula: | 30-80mesh | Fuente: | Hidrogenación de maltosa derivada del almidón. |
| apariencia: | cristalina blanca o polvo | Duración: | 24 meses almacenado en un lugar fresco y seco. |
| Aplicaciones: | Caramelos, chocolates, productos de panadería y chicles sin azúcar | Gusto: | Dulce, similar al azúcar. |
| aditivo alimentario: | Edulcorante | Uso: | Sustituto del azúcar en alimentos y bebidas. |
| índice glucémico: | 35 | Número CAS: | 585-88-6 |
| Origen: | Porcelana | Nombre del producto: | Maltitol en polvo |
| seguridad: | Generalmente reconocido como seguro (GRAS) |
Not just a sweetener. A functional excipient.
Maltitol Powder is one of the few sugar alcohols listed in three major pharmacopoeias — BP, USP, and EP — making it globally accepted as a pharmaceutical-grade excipient. With near-sucrose sweetness (90%), negligible cooling effect, excellent compressibility, and low hygroscopicity, it solves multiple formulation challenges in a single ingredient: sweetening, bulking, binding, and plasticizing — without the dental, caloric, or glycemic liabilities of sugar.
Every shipment is traceable to batch-level COA. Below is our production-typical profile from a recent lot.
| Parameter | Pharmacopoeia Limit | This Batch (COA) | Method |
| Assay (Maltitol) | 98.0–102.0% | 99.42% | HPLC |
| Related Substances | ≤ 1.0% | 0.58% | HPLC |
| Specific Optical Rotation | +105.5° to +108.5° | +106.5° | Polarimetry |
| Reducing Sugars (as Glucose) | ≤ 0.1% | 0.02% | Titration |
| Water (Karl Fischer) | ≤ 0.5% | 0.09% | KF Coulometry |
| Sulphated Ash | ≤ 0.10% | 0.02% | Gravimetric |
| Conductivity (20% sol.) | ≤ 20 μS/cm | 4.8 μS/cm | Conductometry |
| Chloride | ≤ 50 ppm | < 50 ppm | Argentometric |
| Sulphate | ≤ 100 ppm | < 100 ppm | Turbidimetric |
| Melting Point | 148–151°C | 149.5°C | Capillary |
| Element | PDE (μg/day, Oral) | This Batch | Method |
| Lead (Pb) | 5 | 0.01 ppm | ICP-MS |
| Nickel (Ni) | 200 | < 0.5 ppm | ICP-MS |
| Arsenic (As) | 15 | < 0.5 ppm | ICP-MS |
| Heavy Metals (total) | — | < 10 ppm | USP <231> |
| Parameter | Pharmacopoeia Limit | This Batch |
| TAMC (Total Aerobic Microbial Count) | ≤ 10³ CFU/g | < 10 CFU/g |
| TYMC (Total Yeast & Mold Count) | ≤ 10² CFU/g | < 10 CFU/g |
| Escherichia coli | Absent in 1 g | Negative |
| Salmonella | Absent in 10 g | Negative |
| Grade | Mesh Range | Typical D50 | Flow (Carr Index) | Best For |
| DC Grade | 20–60 | ~350 μm | 15–18 (Good) | Direct compression tablets, lozenges |
| Fine Grade | 60–100 | ~180 μm | 18–22 (Fair) | Dry syrup blends, sachet powders |
| Micronized | 100–200 | ~75 μm | 25–30 (Poor) | Wet granulation, capsule fills |
| Function | How Maltitol Works |
| Sweetener-Binder-Filler | Single excipient replaces sugar + mannitol + binder in many formulas |
| Direct Compression | DC-grade 20–60 mesh flows freely on high-speed rotary presses; tablet hardness 90–130 N at 8–12 kN |
| Mouthfeel | Smooth dissolution with no cooling spike — critical for pediatric and geriatric formulations |
| Non-Cariogenic | Oral bacteria cannot ferment maltitol; protects teeth rather than decaying them |
| Stability | No Maillard reaction with amino APIs (unlike lactose); no Schiff base formation |
Formulation insight: For chewable vitamin C tablets, maltitol's low hygroscopicity (~0.09% moisture) prevents the sticky, discolored tablets common with sorbitol-based formulas. Vitamin C degradation at 40°C/75% RH is reduced by ~30% vs. sorbitol in accelerated stability studies.
| Function | How Maltitol Works |
| Non-Crystallizing Sweetener | Low supersaturation tendency — no cap-sticking in bottles, no crystals in the neck |
| Viscosity Modifier | Viscosity profile nearly identical to sucrose syrup at equal concentration — familiar pouring behavior |
| Microbial Stability | Non-fermentable by most oral bacteria; reduces preservative load requirement |
| Taste Masking | 90% sucrose sweetness effectively masks bitterness of APIs (ibuprofen, zinc salts) |
| pH Compatibility | Stable in pH 3.0–7.5 range — compatible with acidic APIs and buffer systems |
Formulation insight: In pediatric antibiotic suspensions, maltitol syrup reduces the "medicine taste" rejection rate vs. sugar-free sorbitol formulations. The absence of cooling effect is key — children do not associate the mouthfeel with "medicine."
| Function | How Maltitol Works |
| Plasticizer | Maintains capsule shell flexibility at low RH (20–30%) without overdrying |
| Non-Reducing | No cross-linking with gelatin (unlike reducing sugars that cause pellicle formation and delayed dissolution) |
| Bloom Strength Preservation | Gelatin bloom retention > 95% after 24-month stability vs. 75–85% with glycerol-plasticized shells |
| Taste-Neutral | No sweetness transfer to capsule content — important for bitter API encapsulation |
| Function | How Maltitol Works |
| Bulk Sweetener | Same scoop density as sugar — no reformulation of dosing instructions |
| Flow Agent Compatible | Works with 0.5–1% colloidal silica for anti-caking in high-humidity markets |
| Rapid Dissolution | Complete dissolution in cold water within 15–30 seconds |
| Electrolyte Stable | No interaction with mineral salts in ORS (oral rehydration salts) formulations |
Maltitol powder provides bulk sweetness without the glycemic impact of dextrose or maltodextrin — critical for products targeting the diabetic, pre-diabetic, and metabolic health markets.
| Claim Target | Maltitol Contribution |
| "Low Glycemic" | GI ≈ 35 vs. sucrose GI 65 |
| "Sugar-Free" | Per FDA 21 CFR 101.60(c) and EU Regulation 1924/2006 |
| "Tooth-Friendly" | Meets criterion for "does not promote tooth decay" per FDA 21 CFR 101.80 |
| "Reduced Calorie" | 2.1 kcal/g vs. sugar 4.0 kcal/g — 47.5% calorie reduction |
In pectin-based gummy vitamins, maltitol powder:
| Jurisdiction | Status | Reference |
| EU | Approved food additive E965; pharmaceutical excipient per EP monograph | Regulation (EC) 1333/2008; EP 10.0 |
| USA | GRAS affirmed; USP-NF excipient monograph; FDA "tooth-friendly" health claim eligible | 21 CFR 180.25; USP 43-NF 38 |
| Japan | Approved food additive; JP monograph listed | Japan's Specifications and Standards for Food Additives |
| Codex Alimentarius | INS 965; JECFA ADI "not specified" (safest category) | CAC/GL 3-1989; JECFA Monograph |
| China | GB 28307-2012 food additive specification | National Food Safety Standard |
| ICH Q3D | Elemental impurity risk assessment available upon request | ICH Q3D(R2) Guideline |
| Condition | Duration | Key Finding |
| 25°C / 60% RH (Long-term) | 36 months | All parameters within specification; no degradation |
| 30°C / 65% RH (Intermediate) | 24 months | Assay stable at 99.2–99.5%; moisture < 0.15% |
| 40°C / 75% RH (Accelerated) | 6 months | No discoloration; no caking; reducing sugars stable at < 0.05% |
| Photostability (ICH Q1B) | Per ICH | No photodegradation; no change in optical rotation |
| Item | Details |
| Standard Pack | 25 kg kraft paper bag with food-grade PE inner liner |
| Bulk Pack | 500 kg / 1,000 kg FIBC with PE liner and moisture barrier |
| Pharma Pack | 25 kg fiber drum with double PE liner (cleanroom-packed option available) |
| Shelf Life | 24 months under recommended storage (15–25°C, ≤ 60% RH) |
| Documentation Package | COA, MSDS/SDS, Specification Sheet, Non-GMO Statement, Halal/Kosher Certificate, Stability Data Summary, ICH Q3D Elemental Impurity Statement, Nitrosamine Risk Assessment (upon request), TSE/BSE Statement |
| Factor | Impact |
| Multi-Pharmacopoeia Manufacturing | One supplier for BP, USP, EP, and FCC-grade maltitol — simplifies your supplier qualification |
| ICH Q3D Compliant | Full elemental impurity profiling per current ICH guidelines; no Class 1 or 2A elemental concerns |
| Audit-Ready | ISO 22000 + HACCP certified; welcome customer and third-party audits |
| Change Control | Formal notification for any change to manufacturing process, raw material source, or packaging |
| Stability Program | Ongoing ICH-compliant stability studies with real-time data available |
| Regulatory Support | DMF可行性讨论; full documentation for ANDA/MA filing support |
| Batch Traceability | From non-GMO corn starch lot through finished product; full backward and forward traceability |
Our company
Qingdao Golden Grain Chemical Co., Ltd, invested by Golden Grain Group Limited, one professional manufacturer and exporter since 2000, is devoted to supplying products and solutions to food & beverage, medicine, animal feed & nutrition, personal care & household, construction, agriculture.
Golden Grain Group Limited have professional staff, advanced production lines and complete lab equipment, pass GMP, HACCP, ISO, HALAL, KOSHER, BRC, GMP-Free, and other necessary certificates, which ensure our quality to be international standard. For many years' experience, we are exporting our products to more than 60 countries in the world.
"Quality Products", "Efficient Service", Golden Grain Group Limited hope to enter good business cooperation with customers at home and abroad for long.
Q: Is your maltitol suitable as a direct compression excipient? A: Yes. Our DC Grade (20–60 mesh) is optimized for direct compression. Carr Index 15–18, tablet hardness 90–130 N at 8–12 kN, friability < 0.5%. No wet granulation required.
Q: What is your nitrosamine risk position? A: Maltitol is not a secondary or tertiary amine; no nitrosamine formation pathway exists. We provide a nitrosamine risk assessment statement per EMA/FDA guidance. No nitrosamine impurities have ever been detected in our product.
Q: Can you provide an ICH Q3D elemental impurity risk assessment? A: Yes. Our production process uses stainless steel equipment exclusively. No metal catalysts. Elemental impurity profile is well within ICH Q3D oral PDE limits — documented in our batch COA and available as a standalone statement.
Q: Do you maintain a DMF? A: We can discuss DMF filing feasibility based on your market and registration pathway. Full manufacturing process, specifications, stability data, and site master file are available for your regulatory submission.
Q: Is your maltitol free from animal-derived materials? A: Yes. Derived from non-GMO corn starch via enzymatic hydrolysis and catalytic hydrogenation. No animal-derived raw materials, processing aids, or equipment contact. TSE/BSE statement provided.
Q: What is your minimum order quantity for pharma grade? A: 1 MT for qualification batches; 5 MT for regular supply. Free samples (100–500 g) available for formulation screening with full documentation.
For pharmaceutical and nutraceutical formulators: Request our complete technical dossier including batch COA, ICH stability data, elemental impurity profile, and multi-pharmacopoeia compliance statements. Technical consultation with our application scientists is included at no charge.
Pharma-grade maltitol. One excipient. Multiple functions. Global compliance.
