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HDK® N20 P Pharma

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.

Brand: HDK (36 products)

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

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Pyrogenic Silica
Pharma & Nutraceuticals Functions: Flow Promoter,
Glidant
CAS No.: 112945-52-5
EC No.: 601-216-3
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Base Fluids, Glidants & Lubricants,
Formulation & Processing Aids

Features & Benefits

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

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Dosage Form

Powder & Powder Blends,

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


	Value	Units	Test Method / Conditions
Density (at 20°C, SiO₂)	approx. 2.2	g/cm³	DIN 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 Index	1.46	-	-
Silanol Group Density	2	SiOH/nm²	-
SiO₂ Content (based on the substance heated at 1000°C for 2hours)	min. 99.8	%	DIN EN ISO 3262-19

Specifications


	Value	Units	Test Method / Conditions
Arsennic Content (As)	max. 3	ppm	USP/AAS
BET Surface	175 - 225	m²/g	DIN ISO 9277 DIN 66132
Chloride Content (Cl)	max. 250	ppm	Ph. Eur.
Loss on Drying	max. 1.5	%	USP
Loss on Ignition	max. 2	%	USP
pH (at 40 g/l)	3.8 - 4.3	-	DIN EN ISO 787-9
Sieve Residue (min. 40 µm)	max. 0.03	%	DIN EN ISO 787-18, Mocker Apparatus
Silicone Dioxide Content	min. (99.0 - 100.5)	%	USP
Tamped Density	approx. 100	g/l	DIN EN ISO 787-11

Properties

White colloidal powder of high purity.

Regulatory & Compliance

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)
Grade: Pharma Grade
Quality Standards: BS EN 71:2016 Safety of Toys Standard
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

American Samoa,

Antigua And Barbuda,

Bosnia and Herzegovina,

British Indian Ocean Territory,

Brunei Darussalam,

Cayman Islands,

Central African Republic,

China (Mainland),

Christmas Island,

Czech Republic,

Dominican Republic,

Equatorial Guinea,

Falkland Islands,

French Polynesia,

Heard Island and McDonald Islands,

Libyan Arab Jamahiriya,

Marshall Islands,

Netherlands Antilles,

Norfolk Island,

Northern Mariana Islands,

Palestinian Territory,

Papua New Guinea,

Saint Kitts and Nevis,

Saint Pierre And Miquelon,

Saint Vincent And The Grenadines,

Sao Tome and Principe,

Solomon Islands,

Svalbard And Jan Mayen,

Syrian Arab Republic,

Trinidad And Tobago,

Turks And Caicos Islands,

United Arab Emirates,

United Kingdom,

United States Minor Outlying Islands,

Virgin Islands, British,

Virgin Islands, U.S.,

Wallis And Futuna,

Western Sahara,

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.