METHOCEL™ E50 Premium LV (Low Nitrite Grade)

1 of 65 products in this brand

METHOCEL™ E50 Premium LV (Low Nitrite Grade) is a low nitrite grade of hydroxypropyl methylcellulose in powder form. It is used in the production of capsules and tablets through tablet coating and wet granulation processes. This product functions as an immediate release agent and is suitable for modified and controlled release formulations in pharmaceutical and nutraceutical applications.

Functions: Immediate Release Agent

Manufacturing Technology: Tablet Coating, Wet Granulation

Dosage Form: Capsules, Tablets

Certifications & Compliance Search Terms: National Formulary (NF)

Safety Data Sheet Brochure

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Enhanced TDS

Identification & Functionality

Chemical Family: Cellulose & Cellulosics,
Cellulose Ethers
Chemical Name: Hydroxypropyl Methylcellulose
Pharma & Nutraceuticals Functions: Immediate Release Agent
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Modified & Controlled Release

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Capsules,
Tablets
Manufacturing Technology: Tablet Coating,
Wet Granulation

Properties

Physical Form

Soluble In

Physical Properties


	Value	Units	Test Method / Conditions
pH (at 2%)	5 - 8	-	USP/EP/JP/CHP

Typical Properties


	Value	Units	Test Method / Conditions
Sulfated Ash	max. 1.5	%	USP/EP/JP
Loss on Drying	max. 5.0	%	USP/EP/JP/CHP
Residue on Ignition	max. 1.5	%	USP/JP/CHP
Nitrite	max. 200	μg/kg	PSM 300040
Water Insoluble Substances (cyclohexylpiperazine)	max. 0.5	%	PC
Apparent Viscosity (at 20°C, 2% in water)	40 - 60	mPa·s	USP/EP/JP/CHP

Microbiological Values


	Value	Units	Test Method / Conditions
Yeasts and Molds Count	max. 100	/g	USP Total Count
Total Plate Count	max. 100	/g	USP Total Aerobic

Composition


	Value	Units	Test Method / Conditions
Hydroxypropoxyl Content	7.0 - 12.0	%	USP/EP/JP/CHP
Methoxyl Content	28.0 - 30.0	%	USP/EP/JP/CHP

Heavy Metals


	Value	Units	Test Method / Conditions
Arsenic Content	max. 0.1	mg/kg	E464/CHP
Cadmium Content	max. 0.1	mg/kg	E464
Mercury Content	max. 0.1	mg/kg	E464
Lead Content	max. 0.1	mg/kg	E464

Regulatory & Compliance

Certifications & Compliance Search Terms: National Formulary (NF)
Chemical Inventories: TSCA (USA)

Packaging & Availability

Packaging Type: Bags,
Boxes