LYCASIN® 75/75

LYCASIN® Maltitol liquids are used as vehicle and humectant for syrups, suspensions and as sweetener in lozenges and medicated confectionary. LYCASIN® has taste and sweetness properties ideal for the preparation of sugar-free syrups made for pediatric and diabetic population.

Brand: LYCASIN (3 products)

Chemical Name: Maltitol

CAS Number: 585-88-6

Dosage Form: Lozenges, Suspension, Syrups

Labeling Claims: Natural, Non-Cariogenic, Sugar-free

Synonyms: (2S,3R,4R,5R)-4-{[(2R,3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl)Tetrahydro-2H-Pyran-2-Yl]Oxy}Hexane-1,2,3,5,6-Pentol, 4-O-alpha-D-Glucopyranosyl-D-Glucitol, D-Maltitol

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Benefit Claims (Health)
Labeling Claims
Key Attributes
  • High chemical and microbial stability
  • Sucrose Replacement
  • Natural Sweetness
  • High stability of medicine syrup
  • Pleasant taste and sweet solution
  • Non cariogenic
  • Multicompendial
  • Low glycemic index
  • Low insulinec index

Applications & Uses

Properties

Physical Form
Soluble In
Odor
Odorless
Appearance
Clear
Miscible in
Water, glycerol
Soluble in
Water (at 20°C)
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Moisture Contentapprox. 25%
pH Value (at 50% w/w in water)approx. 5.8
Freezing Pointapprox. 0°C
Boiling Pointmin. 105°C
Flash Pointmin. 200°C
Vapor Pressureapprox. 17hPa
Vapor Density (Air=1)approx. 0.7
Relative Densityapprox. 1.33
Partition Coefficient (n-octanol/water)max. 0.3REACH data
Viscosity (at 20°C)approx. 1,800mPa.s
Conductivitymax. 10μS/cmEuropean Pharmacopoeia
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Count (**)max. 1000CFU/gUSP-NF Pharmacopoeia
Yeasts and Moulds Count (**)max. 100CFU/gUSP-NF Pharmacopoeia
Escherichia coli(**)0/g-
Salmonella(**)0/10g-
Specifications
ValueUnitsTest Method / Conditions
D-maltitol Content (on DS)min. 50.0%European Pharmacopoeia/USP-NF Pharmacopoeia
D-sorbitol Content (on DS)max. 8.0%European Pharmacopoeia/USP-NF Pharmacopoeia
Reducing Sugars (as is)max. 0.2%European Pharmacopoeia
Reducing Sugars (on DS)max. 0.3%USP-NF Pharmacopoeia
Nickel Content (**)max. 1mg/kgUSP-NF Pharmacopoeia
Dry Substance68.0 - 85.0%European Pharmacopoeia
Water Content15.0 - 32.0%European Pharmacopoeia
Water Contentmax. 31.5%USP-NF Pharmacopoeia
Residue on Ignitionmax. 0.1%USP-NF Pharmacopoeia
pH5.0 - 7.5-USP-NF Pharmacopoeia
Note

(*) Compliance data - Tests not performed

(**) Monitoring plan

Regulatory & Compliance

Packaging & Availability

Packaging Type
Packaging Information
  • Article (SKU) Code: 5100001245
  • Package Size & Type: 275 KG LIQUID DRUM

Storage & Handling

Shelf Life
3 years
Storage and Shelf Life Information

For packed delivery: Expiry date = Manufacturing date + 3 years, in its unopened packaging. The product durability may vary according to packaging type and manufacturing plant. We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
For bulk delivery: Expiry date depends on the Customer storage conditions