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| 원래 장소: | 중국 |
| 브랜드 이름: | Golden Grain |
| 인증: | ISO, HALAL, KOSHER, HACCP |
| 모델 번호: | GMAL-847 |
| 최소 주문 수량: | 100kg |
|---|---|
| 가격: | USD1.00-USD1.65/KG FOB QINGDAO, CHINA |
| 포장 세부 사항: | 크래프트 및 PE INNER 포함 25kg/가방 |
| 배달 시간: | 일이 7일부터 10일까지 일합니다 |
| 지불 조건: | L/C (신용장), 전신환, D/P (지급도 조건), 웨스턴 유니온, 인수 인도 |
| 공급 능력: | 한달에 1000MT |
| 밀도: | 1.49g/cm3 | 유형: | 제약 등급, BP, USP, EP |
|---|---|---|---|
| 모습: | 백색 결정성 분말 | CAS번호: | 50-70-4 |
| 용법: | 껌 | 식품 첨가물: | 습윤제 |
| 유통기한: | 2년 | CAS 번호: | 50-70-4 |
| 애플리케이션: | 산업 응용 | 화학식: | C6H14O6 |
| 화학 공식: | C6H14O6 | 청정: | 99% 최소 |
| 대용량밀도: | 0.6-0.8g/cm3 | 굴절률: | 420 |
| 보관조건: | 서늘하고 건조한 곳에 보관하세요 |
Our Sorbitol Crystalline Powder is a high-purity polyol excipient produced via catalytic hydrogenation of glucose followed by controlled crystallization and micronization. It delivers a clean, cooling sweetness with excellent humectancy and tablet compactability — making it the preferred bulk sweetener and functional excipient for oral care formulations and solid oral dosage forms.
Unlike generic food-grade sorbitol, our Pharma Grade conforms to USP-NF (United States Pharmacopeia) and EP (European Pharmacopoeia) standards, with tighter control on reducing sugars (≤0.2%), heavy metals (≤5 ppm), and microbial limits (TAMC <100 CFU/g), ensuring full compliance with ICH Q3D, EMA, and FDA requirements for pharmaceutical excipients.
| Parameter | Specification | Method |
| Assay (D-Sorbitol, anhydrous basis) | 98.0% – 101.0% | USP-NF / EP |
| Appearance | White crystalline powder or granular powder | Visual |
| Identification | Conforms (IR / HPLC) | USP-NF / EP |
| Water Content | ≤ 1.0% | Karl Fischer |
| Reducing Sugars (as glucose) | ≤ 0.2% | Titration |
| Heavy Metals | ≤ 5 ppm | USP <231> |
| Chloride | ≤ 50 ppm | USP-NF |
| Sulfate | ≤ 100 ppm | USP-NF |
| Nickel | ≤ 1 ppm | AAS / ICP-MS |
| Residue on Ignition | ≤ 0.1% | USP <281> |
| Total Aerobic Microbial Count (TAMC) | < 100 CFU/g | USP <61> |
| Total Yeast & Mold Count (TYMC) | < 20 CFU/g | USP <61> |
| Melting Range | 95 – 99 °C | USP <741> |
| Particle Size (D50) | 100 – 300 μm (customizable) | Laser Diffraction |
| Bulk Density | 0.55 – 0.75 g/mL | USP <616> |
Our crystalline sorbitol powder is spray-dried and sieved for controlled particle size distribution, delivering superior flowability (Carr's Index <15%) and high tensile strength upon compression. It serves as a filler-binder in:
Chewable vitamin & mineral tablets
Antacid tablets
Lozenges & throat drops
Effervescent tablets
Sorbitol is recognized by FDA (21 CFR 184.1835) and EU Sweeteners Directive as non-cariogenic — it does not promote dental caries. In toothpaste and mouthwash:
pleasant sweetness
without fermentable sugar substrates
mild cooling sensation
(negative heat of solution: –111 J/g) that enhances the "fresh clean" mouthfeel
humectant
to prevent tube-drying and maintain paste consistency throughout shelf life
Typical use levels: Toothpaste 10–20% w/w | Mouthwash 5–15% w/w | Chewing Gum 30–60% w/w
Glycemic Index ~4–9 (compared to glucose = 100). Minimal insulin response. Suitable for sugar-free pharmaceutical syrups, pediatric formulations, and functional foods targeting diabetic consumers.
Full elemental impurity risk assessment available. Nickel, lead, arsenic, cadmium, and mercury levels are routinely monitored per ICH Q3D guidelines for oral products.
| End Product | Function | Typical Dosage | Grade |
| Toothpaste | Humectant + Sweetener | 10–20% | Pharma |
| Mouthwash | Humectant + Bulk Sweetener | 5–15% | Pharma |
| Chewable Vitamin Tablets | Filler-Binder + Sweetener | 30–60% | Pharma (DC Grade) |
| Lozenges / Throat Drops | Bulking Agent + Cooling Agent | 40–70% | Pharma |
| Effervescent Tablets | Filler + Dissolution Aid | 10–50% | Pharma |
| Sugar-Free Pediatric Syrups | Vehicle + Sweetener | 20–50% | Pharma |
| Antacid Suspensions | Sweetener + Viscosity Modifier | 10–30% | Pharma |
Every shipment includes:
| Document | Description |
| Certificate of Analysis (COA) | Batch-specific test results against USP-NF / EP specifications |
| Material Safety Data Sheet (MSDS) | GHS-compliant safety and handling information |
| HALAL Certificate | Current, issued by recognized halal certification body |
| KOSHER Certificate | Kosher Pareve, valid for current production year |
| GMP Statement | Manufactured under cGMP (21 CFR 211) compliant facility |
| Elemental Impurity Statement (ICH Q3D) | Upon request |
| Residual Solvent Statement (ICH Q3C) | Class 3 solvents only; within PDE limits |
| Allergen-Free Statement | Gluten-free, lactose-free, nut-free, soy-free |
| TSE/BSE Statement | No animal-derived materials; vegetable-origin only |
Third-Party Testing: We welcome customer-appointed third-party lab testing (SGS, Eurofins, Intertek). Pre-shipment samples can be sent to your nominated lab at your cost.
| Option | Net Weight | Material | Pallets |
| Standard Export Bag | 25 kg | Kraft paper + PE inner liner | 40 bags / pallet (1000 kg) |
| Moisture-Barrier Bag | 25 kg | Alu-laminated kraft + PE liner | 40 bags / pallet (1000 kg) |
| FIBC Bulk Bag | 500 kg / 1000 kg | Woven PP + LDPE inner liner | Single bag per pallet |
| Custom | As specified | OEM / Private Label available | Negotiable |
Storage: 15–25 °C, ≤65% RH. Keep away from moisture. Re-seal opened bags immediately. Shelf life: 36 months in original unopened packaging.
Q: Can you provide DMF for this product? A: We are preparing our US FDA Type III DMF. In the interim, we provide a full technical dossier including manufacturing process, impurity profile, stability data, and batch analysis upon signing a CDA.
Q: What is the particle size range available for direct compression? A: Standard DC grades are available at D50 ~100–150 μm and ~200–300 μm. Micronized grades (D50 <50 μm) for specific formulations are available upon request.
Q: Is your sorbitol suitable for clean-label toothpaste formulations? A: Yes. It is a naturally derived (from corn/maize starch), non-GMO ingredient listed under INCI name "SORBITOL" and accepted by ECOCERT / COSMOS for natural and organic cosmetics.
Q: Does sorbitol react with fluoride or silica in toothpaste? A: No. Sorbitol is chemically inert toward fluoride ions, silica abrasives, and surfactants (SLS). It does not undergo Maillard browning because it lacks a reducing aldehyde group.
Request a quote, COA, or free sample today. Our technical team responds to all pharma and oral care inquiries within 12 hours on business days.
