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PEARLITOL® PF Mannitol Pyrogen Free - Pharma

PEARLITOL® PF is a pyrogen-free mannitol that is used for parenteral preparations and Rx injectables. Applications Osmotic diuretic agent in small and large volume parenteral injectables Isotonic agent and bulking agent for freeze-dried powder for Rx injection or infusion Pharmaceutical API used to reduce elevated pressure in the brain (cerebral oedema) and in the eyes (note: production has to comply with the internationally accepted GMP standards)

Brand: PEARLITOL (13 products)

Chemical Name: Mannitol

CAS Number: 87-78-5

Functions: Bulking Agent, Diuretic, Isotonic Agent, Osmotic Agent

Dosage Form: Injectables, Powder & Powder Blends

Labeling Claims: BSE-free, Halal, Kosher, Melamine-free, Non-GMO, Non-Hazardous, Pyrogen-free, TSE-free, Vegan

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Halal, ISO 50001, ISO 9001, Indian Pharmacopeia, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

Synonyms: 1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Appearance
White crystals
Soluble in
Water, Ethanol
Insoluble in
Ether
Typical Properties
ValueUnitsTest Method / Conditions
AcidityComplies--
Chlorides Content30mg/kg-
Clarity and Color of SolutionComplies--
Escherichia Coli (**)Not detected in 1g
Specific Optical Rotation+137 to +145Degree
Heavy Metals Content (*)max. 10mg/kg-
Identification Test 1 (*)Complies-ChP
Identification Test 2 (*)Complies-ChP
Melting Point166 - 170°C-
Oxalate Content (*)max. 0.0002%-
Reducing SugarsComplies--
Residue on Ignitionmax. 0.001--
Sulfates Content100mg/kg-
Total Impuritiesmax. 2.0%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 2mg/kg-
Assay Content (on DS)98.0 - 102.0%-
Loss on Dryingmax. 0.5%-
Microbiological Values
ValueUnitsTest Method / Conditions
Total Yeasts and Moulds Countmax. 100CFU/g-
Bacterial endotoxinsmax. 2.5IU/g-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Salmonella (**)Not detectedper 10g-
Note
  • "ChP" stands for Chinese Pharmacopeia
  • (*)-Compliance data - Tests not performed
  • (**)-Monitoring plan

Regulatory & Compliance

Certifications & Compliance
Chemical Inventories
Grade
Conformity

Conforms to the requirements of the current monograph

- Chinese Pharmacopeia (ChP) MANNITOL

Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Technical Details & Test Data

Test Data

This substance is suitable for use in manufacture of parenteral preparations. Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.

Packaging & Availability

Packaging Information
  • ROQ Product Code: 450002
  • Article (SKU) Code: 450002107K
  • Package Size & Type: 25 kg lined strippable paper bag

Storage & Handling

Storage & Shelf Life
  • Retest date Manufacturing date + 3 years, in its unopened packaging.
  • The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA.
  • 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.