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HDK® N20 P Pharma

1 of 36 products in this brand
HDK® N20 P Pharma is a synthetic, hydrophilic, amorphous silica powder produced via flame hydrolysis. It is a white, high-purity colloidal powder. This product serves as a glidant for tableting, effectively improving the flow of powders. Furthermore, HDK® N20 P Pharma undergoes testing according to the EP and USP/NF standards.

Functions: Flow Promoter, Glidant

Chemical Name: Pyrogenic Silica

Labeling Claims: Animal Products-free, BSE-free, GMO-free, Non-GMO, TSE-free

Certifications & Compliance: BSE & TSE, BfR 52 Recommendation , BfR Recommendation, Coalition of Northeastern Governors (CONEG), Consumer Product Safety Improvement Act (CPSIA), Directive 2000/53/EC, Directive 2001/83/EC, Directive 2003/15/EC, Directive 2010/75/EU, Directive 2011/65/EC amended through EU/2015/863 (RoHS), EC No. 1935/2004, EC No.1907/2006, EU Packaging Directive (94/62/EC), European Pharmacopeia (Ph. Eur.), FDA 21 CFR 175.105, FDA 21 CFR 175.300, FDA 21 CFR 175.350, FDA 21 CFR 175.390, FDA 21 CFR 176.170, FDA 21 CFR 176.180, FDA 21 CFR 176.200, FDA 21 CFR 176.210, FDA 21 CFR 177.1200, FDA 21 CFR 177.1400, FDA 21 CFR 177.2420, FDA 21 CFR 177.2600, FDA 21 CFR 178.3120, FDA 21 CFR 178.3297, FDA 21 CFR 178.3570, FDA 21 CFR 182.90, GB 9685-2016, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 9001, National Formulary (NF), Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Swiss Ordinance (SR 817.023.21), USP Class IV, United States Pharmacopeia (USP)

Dosage Form: Powder & Powder Blends, Tablets

Synonyms: Fumed Silica, Silica, Silicon Dioxide

Technical Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
112945-52-5
EC No.
601-216-3

Features & Benefits

Applications & Uses

Applications
  • Pharma
  • Rheology Control & Free-Flow Agent
Application Details
  • HDK® N20 P PHARMA is intended for use in pharmaceuticals. It improves the flow of powders and is used as glidant for tableting.
  • A good mixing and dispersion of HDK® N20 P PHARMA is a must to assure optimum performance.

Properties

Physical Form
Appearance
White colloidal powder
Typical Properties
ValueUnitsTest Method / Conditions
Density (at 20°C, SiO₂)approx. 2.2 g/cm³DIN 51757
Loss of Weight (at 1000°C, 2hours (based on the substance dried at 105 °C for 2 hours))max. 2 %DIN EN ISO 3262-19
Refraction Index1.46
Silanol Group Density2SiOH/nm²
SiO₂ Content (based on the substance heated at 1000°C for 2hours)min. 99.8%DIN EN ISO 3262-19
Specifications
ValueUnitsTest Method / Conditions
Arsennic Content (As)max. 3ppmUSP/AAS
BET Surface175 - 225 m²/gDIN ISO 9277 DIN 66132
Chloride Content (Cl)max. 250 ppmPh. Eur.
Loss on Dryingmax. 1.5 %USP
Loss on Ignitionmax. 2%USP
pH (at 40 g/l)3.8 - 4.3DIN EN ISO 787-9
Sieve Residue (min. 40 µm)max. 0.03 %DIN EN ISO 787-18, Mocker Apparatus
Silicone Dioxide Contentmin. (99.0 - 100.5)%USP
Tamped Densityapprox. 100 g/lDIN EN ISO 787-11
Properties

White colloidal powder of high purity.

Regulatory & Compliance

Complaince

HDK® N20 P PHARMA is tested according to the pharmacopeias EP and USP/NF. (Produced according to ISO 9001, ISO 14001, HACCP and IPEC).

Safety & Health

Safety Notes

During transportation and processing HDK® N20 P PHARMA may cause electrostatic charges. Like other amorphous silicas HDK® N20 P PHARMA does not show either carcinogenic (IARC classification, Volume 68, 1997) or mutagenic properties.

Packaging & Availability

Country Availability
Packaging Type
Regional Availability
  • Africa
  • Asia
  • Europe
  • Latin America
  • Middle East
  • North America
  • Oceania
Packaging Information

Pallet with paper bags: 20 kg bags.

Storage & Handling

Storage Information

HDK® N20 P PHARMA should be stored in the original packaging in dry storage areas. Due to the high surface area HDK® adsorbs volatiles and should be protected from humidity and volatiles. If single bags are taken away from an original pallet, the remaining bags of this pallet must again be protected against humidity and volatiles.