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SweetPearl® P90 - MALTITOL

SweetPearl® P90 - MALTITOL powder is used as a filler and filler/binder. SweetPearl® provides stability to your formulation due to its chemical stability and low hygroscopicity. The SweetPearl® range offers you a choice between various particle sizes and densities to meet your formulation needs. It can be used in pharmaceutical applications such as swallowable tablets, chewable tablets, effervescent tablets, coatings, and medicated confectionery. As a patient-friendly excipient, it allows you to formulate non-cariogenic, non-acidogenic, and sugar-free formulations to address the widest patient population.

Brand: SweetPearl (7 products)

Ingredient Name: Maltitol

Chemical Name: Maltitol

CAS Number: 585-88-6

Functions: Binder, Filler, Nutritive Sweetener, Sugar Substitute, Sweetener

Dosage Form: Tablets

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

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Odor
Odorless
Taste
Cool and sweet
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Water Contentmax. 1%(w/w)
Specific Optical Rotation+105.5 to +108.5Degree
Reducing Sugars (as is)max. 0.1%(w/w)
Maltitol (on D.S.)min. 98%(w/w)
Conductivitymax. 20µS/cm
Residue on Ignitionmax. 0.1%(w/w)
Chloridesmax. 50mg/kg
Sulphatesmax. 100mg/kg
Nickelmax. 1mg/kg
Arsenicmax. 3mg/kg
Leadmax. 1mg/kg
Sieve Grain Size Fraction (Residue on 200 µm)max. 5%
Sieve Grain Size Fraction (Residue on 100 µm)max. 50%
Microbiological Values
ValueUnitsTest Method / Conditions
Total Yeasts Countmax. 10per g
Total Moulds Countmax. 10per g
Escherichia coliNot detected in 1g
SalmonellaNot detected in 25g
Total Aerobic Microbial Countmax. 100per g

Regulatory & Compliance

Certifications & Compliance
Chemical Inventories
Conformity

Meets the requirements (including identification tests) of the current monograph of:

  • FCC : Maltitol
  • FAO JECFA : Maltitol, INS No 965(i)
  • Commission Regulation (EU) No 231/2012 and its amendments : E 965 (i)
  • GB 28307

Packaging & Availability

Packaging Type

Storage & Handling

Shelf Life
5 years
Storage and Handling Information
  • Storage Conditions: The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA.
  • Storage conditions for PACK material: We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations in temperature and humidity.
    Upon opening, use the product as quickly as possible to prevent moisture regain. To minimize the problem of product-lumping, it is highly recommended to avoid the stacking of pallets.
  • Expiry date of the packed product: Manufacturing date + 5 years, in its unopened packaging.
  • Best before date of the packed product: Manufacturing date + 12 months, in its unopened packaging.