Product Overview
Sorbitol Solution 70% is a clear, colourless D-Glucitol syrup at 70% dry substance, manufactured to BP, USP and EP monographs and identified by CAS 50-70-4 and E420. It is used as a vehicle and sweetening base for oral liquids where sucrose is unsuitable, most often because the product has to be sugar-free or because a high sugar load would push the osmolality of the dose too far.
The formulation problem in an oral syrup is osmotic, not simply sweet. A syrup is dosed by volume, often 5 mL or 10 mL, and everything dissolved in that volume contributes to the osmotic load that the gut sees. Sorbitol is a smaller molecule than sucrose and a larger one than glycerin, so it sits in a useful middle: it gives body and sweetness at a lower solids load than a sugar syrup, and it lets a formulator hit a target osmolality without the laxative effect that appears when a polyol is dosed too high. That balance is the single most important number to settle at development stage, and it is the reason addition rates differ so widely between products.
Practically, the syrup is easy to handle in a liquid manufacturing area. It is non-crystallizing, so a batch tank or a holding vessel does not need to be kept warm to prevent seeding, and it mixes into water without the slow dissolution step that a crystalline excipient requires. It is also chemically stable and does not carry the reducing sugar load that would drive colour formation with an amine-containing active or a flavouring aldehyde.
Technical Specification
| Parameter |
Specification |
| Product name |
Sorbitol Solution 70% |
| Chemical name / CAS number |
D-Glucitol / 50-70-4 |
| E number |
E420 |
| Appearance |
Clear, colourless, odourless viscous liquid |
| Identification |
Conforms, IR and retention time |
| Assay (D-Glucitol) |
68.0-72.0% |
| Water content |
28.0-31.0% |
| pH (25 °C) |
5.0-7.0 |
| Conductivity |
20 µS/cm max |
| Grade |
BP / USP / EP |
Typical specification. The certificate of analysis issued for each shipment is the governing document.
Typical Certificate of Analysis
| Test item |
Typical result |
Method |
| Identification |
Conforms |
IR / HPLC |
| Assay (D-Glucitol) |
70.2% |
HPLC |
| Appearance |
Clear, colourless |
Visual |
| Water content |
29.9% |
Karl Fischer |
| pH (25 °C) |
6.2 |
pH meter |
| Conductivity |
6 µS/cm |
Conductivity meter |
| Reducing sugars |
0.03% |
Titrimetric |
| Nickel (Ni) |
< 1 mg/kg |
ICP-MS |
| Total heavy metals (as Pb) |
< 5 mg/kg |
Colorimetric |
| Total plate count |
< 100 cfu/g |
Plate count |
| Yeast and mould |
< 10 cfu/g |
Plate count |
A certificate of analysis is issued for each lot against the drum number, and the safety data sheet is supplied with the shipment.
Applications
Sugar-free oral syrup. A non-cariogenic vehicle that carries an active and a flavour without sucrose, with a clean sweetness that does not mask the active's taste.
High-dose liquid formulations. Lower solids than a sugar syrup for the same body, which keeps the osmotic load of a 5 mL dose within a tolerable range.
Paediatric and geriatric liquids. A mild taste and a smooth mouthfeel help compliance where a bitter or salty active is otherwise difficult to swallow.
Suspension and emulsion bases. It contributes to the continuous phase viscosity and improves freeze-thaw recovery in a liquid that may be stored cold.
Oral drops and concentrates. Non-crystallizing at high solids, so a concentrate does not seed in a holding tank between campaigns.
Addition rates are set against the target osmolality and the sweetness required to balance the active, and are confirmed on stability before the formula is fixed.
Quality Control
Release testing follows the BP, USP and EP monographs: identification by infrared and by retention time, assay by HPLC within the 68.0-72.0% window, water by Karl Fischer, pH, and conductivity as an indicator of residual ionic material from the ion exchange and hydrogenation steps. Colour and clarity are read against a fresh reference, since a tinted or hazy vehicle is visible in a clear bottle.
Nickel is tested because it is the hydrogenation catalyst, and the limit is held below 1 mg/kg. Reducing sugars are held low to limit colour formation with amine or aldehyde-containing actives during stability storage. Each lot is retained, and the certificate of analysis, batch record and drum number are filed together so a finished batch of oral liquid can be traced back through the process.
Packaging & Shipping
Product is filled into 250 kg blue tight-head drums with food-grade lining, sealed bungs and tamper-evident caps, labelled with product, grade, net weight, lot number and the pharmacopoeial designation. Four drums are palletised per pallet and 80 drums load into a 20 ft container; a 1000 kg food-grade IBC is available for plants with bulk receiving. Neutral or buyer-branded labelling and a sealed sampling port can be arranged before dispatch.
Storage & Handling
Store between 15 °C and 30 °C, upright and closed, in a dry area reserved for excipients and away from active materials. Cold thickens the syrup and may seed crystals at the drum wall, so a chilled drum should be brought back to room temperature and homogenised before sampling. Warm storage slowly develops colour. Keep bungs sealed to prevent moisture pickup, and record the drum number on the dispensing sheet so the material used in a batch can be reconciled against the certificate.
Why Choose Us
Pharmacopoeial grade, documented. Every lot is released against the BP, USP and EP monographs, with identification, assay, water and conductivity reported on the certificate.
Nickel under control. Catalyst residue is tested by ICP-MS and held below 1 mg/kg, which is the limit that matters for a hydrogenated polyol.
Osmolality support. Our technical team can work through the addition rate against a target osmolality for a given dose volume before the formula is locked.
Non-crystallizing in the tank. No heating jacket needed to keep a holding vessel clear, and no seeding between campaigns.
Low reducing sugars. Colour formation with amine and aldehyde actives is limited, which protects a clear syrup through stability storage.
Traceable to the drum. Certificate of analysis, batch record and drum number are filed together, so an audit trail runs from the tank to the lot
