company tower banner
Roquette Company Logo

StarLac® Lactose Monohydrate & Maize Starch Compound

StarLac® Co-processed lactose starch is a filler/binder with strong disintegrant properties. The co-processing offers superior benefit compared to a blend of lactose and starch. It allows to improve the performance (hardness, friability, disintegration time) of your formulation. Specifically designed for direct compression applications, StarLac® is also an excellent filler/binder in dry granulation processes. StarLac® can be used in various oral dosage forms in pharmaceutical applications including granules, swallowable tablets, orally dispersible tablets and hard capsules.

Brand: StarLac (1 products)

Chemical Name: Corn Starch, Lactose Monohydrate

Functions: Binder, Disintegrant, Filler

Dosage Form: Capsules, Granules, Orally Disintegrating Tablets (ODTs), Tablets

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Pharma & Nutraceuticals Functions
Composition

Spray dried compound:

  • 85 parts lactose monohydrate
  • 15 parts GMO free extra white native maize starch

Features & Benefits

Key Attributes
  • Direct Compression
  • Deliver robustness to your formulation
  • Stability of tabletability performance overtime
  • Designed for direct compression and disintegration

Applications & Uses

Manufacturing Technology

Properties

Physical Form
Odor
Odorless
Insoluble in
Cold water
Partially Soluble in
Ethanol (96%)
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 3%(w/w)-
Lactose (on D.S.)82.0 - 88.0 %(w/w)-
Starch (on D.S.)12.0 - 18.0 %(w/w)-
Sulphated Ashmax. 0.2%(w/w)-
Sieve Grain Size Fraction - Residue on 250 mmmax. 20%-
Sieve Grain Size Fraction - Residue on 160 mm35 - 65 %-
Sieve Grain Size Fraction - Residue on 32 mmmin. 85%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 1000per g-
Total Yeasts and Moulds Countmax. 100per g-
Escherichia ColiNot detected in 1g--
SalmonellaNot detected in 10g--

Regulatory & Compliance

Packaging & Availability

Packaging Type
Package Size

25 Kg bag

Storage & Handling

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.
  • Retest date - Manufacturing date + 3 years, in its unopened packaging.