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| Place of Origin: | China |
| Brand Name: | Golden Grain |
| Certification: | ISO9001, ISO22000, HALAL, KOSHER, COA, SDS |
| Model Number: | GLMAE-39 |
| Minimum Order Quantity: | 100kg |
|---|---|
| Price: | USD450-USD550/MT FOB QINGDAO, CHINA |
| Packaging Details: | 25 kg kraft paper bag with PE inner liner |
| Delivery Time: | 7 - 10 working days |
| Payment Terms: | L/C, T/T, D/P, D/A |
| Supply Ability: | 1000MT per month |
| CAS No.: | 50-70-4 | E Number: | E420(i) / INS 420(i) |
|---|---|---|---|
| Grade: | Pharmaceutical Grade (USP / BP / EP) | Appearance: | White Crystalline Powder, Anhydrous |
| Mesh Size: | 20-60 Mesh, 100 Mesh Available | Moisture: | 0.5% Max |
| Function: | Tablet Diluent, Filler, Binder And Sweetener | Application: | Direct Compression Tablets, Wet Granulation, Chewable And Effervescent Tablets, Lozenges, Capsules, Sachets, Oral Syrups |
| Sweetness: | About 60% Of Sucrose, Cooling Sensation | Hygroscopicity: | Hygroscopic Above 65% RH, Keep Bag Sealed |
| Solubility: | Freely Soluble In Water | Packaging: | 25 Kg Kraft Paper Bag With PE Inner Liner |
| Synonyms: | D-Sorbitol, D-Glucitol, Sorbitol Anhydrous, E420(i), Sugar Alcohol |
Anhydrous Sorbitol Powder is the crystalline, water-free form of D-glucitol (CAS 50-70-4, E420(i)), supplied as a white, free-flowing powder in 20-60 mesh or 100 mesh cuts. Because the crystal carries no water of crystallisation and residual moisture is held below 0.5%, it enters a formulation as a dry solid and stays that way. That property is what makes it usable as a direct compression and wet granulation excipient, and not merely as a bulk sweetener.
In a direct compression line the powder is blended with the active and pressed without a granulation or drying step. Any water carried in by the excipient has nowhere to go: it migrates towards the active during storage, softens the compact, and later appears as hardness drift or a fall in assay. An anhydrous grade with moisture controlled below 0.5% removes that variable from the batch record, and the low moisture also keeps the blend free-flowing at the press hopper instead of bridging.
As an excipient, sorbitol does three jobs at once. It is a diluent that carries a high active load without the compact turning brittle; it is a sweetener and taste masker, roughly 60% as sweet as sucrose with a cool, clean profile and no aftertaste of its own, which matters in chewable and dispersible forms; and in wet granulation it works as a soluble binder, dissolving into the granulating fluid and recrystallising as bridges between particles during drying.
The grade is released against the BP, USP and EP monographs, and the certificate of analysis reports assay, water, reducing sugars, residue on ignition and the inorganic limits item by item. The material is non-cariogenic and raises the glycemic response far less than sucrose, which is why the same powder also appears in sugar-free chewables and in oral care products.
| Parameter | Specification |
|---|---|
| Product name | Anhydrous Sorbitol Powder, D-Glucitol |
| CAS number | 50-70-4 |
| E number | E420(i) |
| HS code | 2905.44.00 |
| Molecular formula | C6H14O6 |
| Molecular weight | 182.2 |
| Appearance | White crystalline powder or granular, odourless |
| Assay (D-glucitol, dry basis) | 98.0% min, typical 99.5% |
| Moisture (anhydrous) | 0.5% max |
| Total sugar | 0.30% max |
| Reducing sugars | 0.10% max |
| Specific rotation | 4.0 - 7.0 |
| pH (50% solution) | 5.0 - 7.0 |
| Residue on ignition | 0.1% max |
| Heavy metals (as Pb) | 5 mg/kg max |
| Lead | 0.5 mg/kg max |
| Nickel | 1 mg/kg max |
| Arsenic | 1 mg/kg max |
| Chloride | 10 mg/kg max |
| Sulfate | 20 mg/kg max |
| Bacterial endotoxins | 0.25 EU/mg max, tested on request |
| Particle size | 20-60 mesh or 100 mesh, other cuts on request |
| Grade | Pharmaceutical grade, BP / USP / EP monograph |
| Packaging | 25 kg kraft paper bag with PE inner liner, heat-sealed |
The certificate of analysis issued for each shipment is the governing document.
| Test item | Typical result | Method |
|---|---|---|
| Assay (D-glucitol, dry basis) | 99.5% | HPLC |
| Appearance of solution | Clear and colourless | Visual |
| Moisture | 0.16% | Karl Fischer |
| Reducing sugars | 0.04% | Titrimetric |
| Residue on ignition | 0.02% | Gravimetric |
| Chloride | Below 10 mg/kg | Titrimetric |
| Sulfate | Below 20 mg/kg | Turbidimetric |
| Nickel | Below 1 mg/kg | AAS |
| Heavy metals (as Pb) | Below 5 mg/kg | Colorimetric |
| Total aerobic count | Below 100 cfu/g | Plate count |
| E. coli and Salmonella | Absent | Plate count |
| Bacterial endotoxins | Below 0.25 EU/mg | LAL |
A certificate of analysis is issued for every batch. A safety data sheet and a specification sheet are available on request.
Pharmaceutical and nutraceutical
Food and confectionery
Personal care
What the powder has to do on a direct compression line. The press runs on flow. The blend has to leave the hopper at a steady weight, fill the die evenly and release cleanly, and a coarse, narrow cut does that better than a fine powder that traps air. The 20-60 mesh cut is the usual starting point for a DC grade blend; the 100 mesh cut is chosen when a smoother mouthfeel or a denser compact is wanted and the flow can be supported elsewhere in the formulation. Whichever cut is used, the moisture ceiling matters more than the particle size, because water is what changes compaction behaviour between the start and the end of a campaign.
What it does in wet granulation. Sorbitol dissolves in the granulating fluid and recrystallises as the granule dries, forming solid bridges between the primary particles. That is why it can carry part of the binder duty and still leave a tablet with a smooth, sweet chew. The trade-off is that a water-based granulation is the wrong route for a hydrolysis-sensitive active, which is where the anhydrous powder belongs in a dry blend instead.
Moisture-sensitive actives. Effervescent systems, ascorbic acid combinations, and actives that hydrolyse on storage all put a premium on the water the excipient brings in. An anhydrous carrier with a 0.5% ceiling keeps that contribution small and, more importantly, keeps it constant from lot to lot. The powder is hygroscopic above about 65% relative humidity, so the protection depends on the bag staying sealed and the dispensing area being kept below that level.
Chewables, dispersibles and taste. Sorbitol sweetens at roughly 60% of the strength of sucrose with a cooler profile and no aftertaste of its own, which makes bitter actives easier to mask and keeps a reduced-sugar chew from tasting thin. Its negative heat of solution produces the cooling sensation that chewable and lozenge manufacturers formulate for deliberately, and it does not feed the bacteria responsible for tooth decay.
Every lot is tested against the pharmacopoeial specification before release: assay by HPLC on a dry basis, water by Karl Fischer, reducing sugars by titration, residue on ignition by gravimetry, and chloride and sulfate against their limits. Nickel is monitored as a marker of hydrogenation catalyst carryover. Microbiological testing covers the total aerobic count plus the absence of E. coli and Salmonella, and bacterial endotoxins are tested where the intended use requires a limit.
Sampling is taken at the crystalliser, after drying and at the packing head, and traceability runs with the lot code, which links the bag, the pallet label and the certificate. Retained samples are held so that a complaint about hardness, colour or clarity in a finished batch can be traced back to the powder that went into it.
The plant operates under ISO 9001 and ISO 22000, and the product is Halal and Kosher certified. A certificate of analysis accompanies every shipment; a specification sheet, a safety data sheet and a sample of the current batch are available on request.
The powder ships in 25 kg kraft paper bags with a PE inner liner, heat-sealed at the filling head to protect the low moisture content in transit. Bags can be palletised and shrink-wrapped on request, and neutral or buyer-labelled packing is available for bulk volumes. Loading is confirmed per order against the destination port and pallet pattern, with full container, LCL and mixed shipments all arranged and the certificate of analysis issued before dispatch.
Store in a cool, dry, well-ventilated area away from direct sunlight, with the bags closed, off the floor and away from walls that condense. Keep the pallets clear of solvents, fragrance drums and other odoriferous goods, since the powder takes up foreign smells and would carry them into a batch. Avoid storage above 40 degrees C, keep the relative humidity of the store below 65%, and do not compress the pallet beyond the bag print. In unopened original packaging the material holds its specification for 24 months; once opened, reseal and use within the current production campaign.
Anhydrous, not merely pharmacopoeial. The 0.5% moisture ceiling and the water-free crystal are the reason this grade suits direct compression and dry blends, rather than being a general purpose powder sold under a pharma label.
Two cuts for two processes. 20-60 mesh for flow on a DC line, 100 mesh where a finer, smoother compact is wanted. Other cuts are made to order, so the particle size can be matched to the press instead of the press being matched to the powder.
Documented per lot. Release against BP, USP and EP, with assay, water, reducing sugars and the inorganic limits reported item by item, and retained samples behind every lot code.
Solid form, controlled water. Buying powder lets the batch record carry the exact solids load, instead of accepting the water that arrives with a ready-made solution.
Documentation for audits. Certificate of analysis with every shipment, specification sheet and safety data sheet on request, and export paperwork prepared before the container is released.
Support through scale-up. If a formulation needs its particle size, flow or compaction behaviour adjusted for a new actives system, our technical team will work through the dissolution and stability questions with your formulation group.
Contact us for samples, COA, and bulk pricing.
