Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
Features & Benefits
- Benefit Claims
Applications & Uses
- Markets
- Dosage Form
Properties
- Appearance
- White or almost white crystalline powder, Complies in Solution
- Soluble in
- Water
- Slightly Soluble In
- Ethanol(96%)
- Typical Properties
- Microbiological Values
- 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
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 |
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 | — |
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.