Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Benefit Claims
- Labeling Claims
Applications & Uses
- Markets
- Applications
- Dosage Form
Properties
- Physical Form
- Appearance
- White or almost white crystalline powder, Complies in Solution
- Soluble in
- Water
- Slightly Soluble In
- Ethanol(96%)
- Typical Properties
Value Units Test Method / Conditions Identification Test-A Complies EP Identification Test-A (*) Complies USP Identification Test-B Complies EP / USP Identification Test-C Complies USP Identification Test-E Complies EP Identification Test-1 (*) Complies JP Identification Test-2 Complies JP Conductivity max. 20 microS/cm EP / USP / JP Dextrin Complies EP / USP / JP Soluble Starch Sulfites (**) max. 15 EP / USP / JP Water Content 7.5 - 9.5 % EP / USP / JP Heavy Metals (*) max. 4 mg/kg JP Assay (on DS) 97.5 - 102.0 % EP / USP / JP Sum of Impurities A and B (Impurity A:Maltose - Impurity B:Isomaltose) max. 0.4 % EP - USP - JP Impurities C: Maltotriose max. 0.2 % EP - USP - JP Impurities D: Fructose max. 0.15 % EP - USP - JP Unspecified Impurities max. 0.10 % EP - USP - JP Total Impurities max. 0.5 % EP - USP - JP - Microbiological Values
Value Units Test Method / Conditions Total Aerobic Microbial Count max. 100 CFU/g - Bacterial endotoxins max. 1.25 EU/G LAL TEST Total Yeasts and Moulds Count max. 100 CFU/g - Escherichia coli (**) Not detected per gram - Salmonella (**) Not detected per 10g - - Pyrogen Test (**)
COMPLIES (EP)
- Solute at 150 g/L
- Sterilized 10 mn at 110 D.C
- Injection 10 mL/Kg
- Note
- "EP" - stands for European Pharmacopeia
- "USP" - stands for USP Pharmacopeia
- "JP" - stands for JP Pharmacopeia
- (*) - Compliance data - Tests not performed
- (**) - Monitoring plan
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Conformity
Conforms to the requirements of the current monograph
- European Pharmacopeia (EP) GLUCOSE MONOHYDRATE (0178)
- US Pharmacopeia (USP) DEXTROSE
- Japanese Pharmacopeia (JP) Glucose Hydrate
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
- Intended for use in manufacture of parenteral dosage forms.
- 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: 493404
- Article (SKU) Code: 493404107E
- Package Size & Type: 15 kg PE lined cardboard box
Storage & Handling
- Storage
Retest Date Manufacturing date + 2 years, in its unopened packaging.
- 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.