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NEOSORB® XTAB 200S Sorbitol Powder - Pharma

1 of 20 products in this brand
NEOSORB® Sorbitol pharma is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener for oral dose applications. It can also be used as a plasticizing agent well-adapted to starches in coating/film forming applications. Applications Powder blends Premixes Granules Pellets Swallowable, chewableand effervescent tablets Medicated confectionary Features Excellent tableting properties Non-cariogenic Non-acidogenic Sugar-free Suitable for use in formulations addressing pediatric and diabetic patient populations

Chemical Name: D-Glucitol

Functions: Binder, Filler, Sweetener

Labeling Claims: Non-Carcinogenic

Synonyms: D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
50-70-4
EC No.
200-061-5

Features & Benefits

Labeling Claims

Applications & Uses

Dosage Form

Properties

Physical Form
Odor
Odorless
Appearance
White Powder
Taste
Sweet and cool
Typical Properties
ValueUnitsTest Method / Conditions
Poured Bulk Densityapprox.0.5 kg/l
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 3mg/kg
Chloride Contentmax. 50mg/kg
Conductivitymax.20 μS/cm
Heavy Metals Contentmax. 5mg/kg
Lead Contentmax. 1mg/kg
Melting Point95 - 98°C
Particle Size (Residue on 100 microns)min. 90%
Particle Size (Residue on 500 microns)max. 10%
Reducing Sugarsmax. 0.3%
Nickel Contentmax. 1mg/kg
Sorbitol Contentmin. 97%
Sulphate Contentmax. 100mg/kg
pH3.5 - 7.0
Sulphated Ash Contentmax. 0.02%
SO₂ Contentmax. 10mg/kg
Total Sugarsmax. 1%
Water Contentmax. 1%
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot detectedper gram
SalmonellaNot detectedper 25g
Total Aerobic Microbial Count (**)max.1000CFU/g
Total Moulds Countmax.100CFU/g
Total Yeasts Countmax.100CFU/g

Regulatory & Compliance

Chemical Inventories
Conformity
  • Food additive E 420 (i)
  • Commission Regulation (EU) nr.231/2012 of 9 March 2012 (OJ EC L-83/1 dated 22.03.2012) for Food additives. 
  • Commission Regulation (EU) nr.724/2013 of 26 July 2013 amending Regulation nr.231/2012. 
  • Current Monograph JECFA on Food additives.
  • US GRAS STATUS 21 CFR, § 184.1835. 
  • Current FOOD CHEMICALS CODEX. 
  • Current JAPANESE STANDARD FOR FOOD ADDITIVES.

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 423212
  • Article (SKU) Code: 423212106
  • Package Size & Type: 20 kg POLY INNER LINER + CARDBOARD BOX

Storage & Handling

Storage and Handling

We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity. Upon opening, use the product as quickly as possible to prevent moisture regain.

Minimum durability date of the packaged product manufacturing date + 12 months.

Expiry date of the packaged product manufacturing date + 5 years.