Avicel® PH - 101 (Low Nitrite Grade)

1 of 23 products in this brand

Avicel® PH - 101 (Low Nitrite Grade) is a specialized grade of microcrystalline cellulose designed to support customers’ Nitrosamine Control Strategy. This grade extends our standard Avicel® PH 101 offering by providing reported Nitrite values on the Certificate of Analysis (CoA) for all delivered batches. The additional information enhances quality assurance for every batch. Nitrite specification on COA Is NMT 100 ppb

Functions: Binder, Compression Aid

Manufacturing Technology: Capsule Filling, Direct Compression, Extrusion, Granulation, Spheronization, Wet Granulation

Dosage Form: Capsules, Effervescent Tablets, Granules, Orally Disintegrating Tablets (ODTs), Pellets, Tablets

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Enhanced TDS

Identification & Functionality

Chemical Name: Cellulose, Microcrystalline
Ingredient Name: Microcrystalline Cellulose
Pharma & Nutraceuticals Functions: Binder,
Compression Aid
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Formulation & Processing Aids

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Effervescent Tablets,
Granules,
Orally Disintegrating Tablets (ODTs),
Pellets,
Tablets
Manufacturing Technology: Capsule Filling,
Direct Compression,
Extrusion,
Granulation,
Spheronization,
Wet Granulation

Properties

Soluble in

Copper tetrammine hydroxide

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Conductivity	max. 75	μS/cm	-
Degree of Polymerization	max. 350	units	-
Ether Soluble Substances	max. 5.0	mg/10g	-
Loose Bulk Density	0.26 - 0.31	g/ml	-
Loss on Drying	3.0 - 5.0	%	-
pH	5.5 – 7.0	-	-
Residue on Ignition	max. 0.05	%	-
Water Soluble Substances	max. 0.25	%	-

Microbiological Values


	Value	Units	Test Method / Conditions
Coliform species	Absent	-	/10g
Escherichia coli	Absent	-	/10g
Pseudomonas aeruginosa	Absent	-	/10g
Salmonella species	Absent	-	/10g
Staphylococcus aureus	Absent	-	/10g
Total Aerobic Microbial Count	max. 100	cfu/g	-
Total Yeast and Mold Count	max. 20	cfu/g	-

Specifications


	Value	Units	Test Method / Conditions
Nitrite	max. 200	μg/kg	-
Particle Size (through 200 mesh (75 microns))	max. 30	wt%	Air Jet
Particle Size (through 60 mesh (250 microns))	max. 1.0	wt%	Air Jet
Particle Size Distribution (D10)	14 - 30	-	-
Particle Size Distribution (D50)	40 - 75	-	-
Particle Size Distribution (D90)	77 - 156	-	-

Packaging & Availability

Packaging Type: Boxes,
Drums

Storage & Handling

Shelf Life: 4 years
Shelf Life and Storage Conditions: Store at ambient conditions. Keep containers sealed; material is very hygroscopic. Four years from date of manufacture if storage conditions stated above are observed.