Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 50-70-4
- EC No.
- 200-061-5
- Technologies
Features & Benefits
- Benefit Claims
- Labeling Claims
Applications & Uses
- Markets
- Dosage Form
- Uses
Neosorb PF is intended for use in preparing parenteral dosage forms.
Properties
- Physical Form
- Appearance
- White or almost white crystalline powder, Clear, colorless in Solubility
- Soluble in
- Water
- Insoluble in
- Ethanol (96%)
- Microbiological Values
- Test Parameter
- Note
- "EP" stands for European Pharmacopeia
- "NF" stands for National Formulary from USP-NF
- (*) Compliance data - Tests not performed
- (**) Monitoring plan
Value | Units | Test Method / Conditions | |
Bacterial endotoxins | max. 2.5 | IU/g | EP / NF |
Escherichia coli (**) | Not detected | per gram | EP |
Total Yeasts and Molds Count | max. 100 | % | EP / NF |
Total Aerobic Microbial Count | max. 100 | CFU/g | EP / NF |
Value | Units | Test Method / Conditions | |
pH Value | 3.5 - 7.0 | — | NF |
D-SORBITOL on DS | 97.0 - 102.0 / 91.0 - 100.5 | % | EP / NF |
Conductivity | max. 20 | microS/cm | EP |
Residue on Ignition | max. 0.1 | % | NF |
Reducing Sugars | max. 0.2 / max. 0.3 | % | EP / NF |
Impurity A: D-Mannitol | max. 2 | % | EP |
Impurity B: D-Iditol | max. 2 | % | EP |
Impurity C: D-Maltitol | max. 2 | % | EP |
Impurity between Maltitol & Mannitol | max. 1 | % | — |
Any Unspecified Impurity | max. 0.10 | % | — |
Amount of Related Substances | max. 3 | % | EP |
Nickel Content | max. 1 | mg/kg | NF (**) |
Water Content | max. 1.5 | % | EP / NF |
Chloride Content | max. 50 | mg/kg | NF |
Sulphate Content | max. 100 | % | NF |
Salmonella | Not detected in 10g | — | EP(**) |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
Packaging & Availability
- Packaging Information
- Pack name: Strippable Paper Bag +Polyethylene Bag
- Net weight: 25 kg
- Pallet description: One Way Pallet 1200 X 1000 Perimeter Base HT
- Units per pallet: 40
Storage & Handling
- Shelf Life
- 3 years
- Storage
- Manufacturing date + 3 years, in its unopened packaging.
- 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.