CELSENTIAL™ E5 Premium LV HPMC

1 of 3 products in this brand

CELSENTIAL™ E5 Premium LV HPMC, a cellulose ether known as hypromellose, adeptly modifies viscosity. It's certified BSE-free and CMR substance-free, guaranteeing safety and adherence to strict regulatory standards.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Viscosity Modifier

CAS Number: 9004-65-3

Labeling Claims: BSE-free, CMR Substances-free, Endocrine Disruptor-free, Halal, Kosher, Odor-free, TSE-free

Certifications & Compliance: Directive 1333/2008/EC, Directive 2001/83/EC, Directive 2002/95/EC, Directive 2011/65/EU (RoHS 2), Directive 2023/2055/EU, EC No.1907/2006, FDA 21 CFR 172.874, FDA Food Safety Modernization Act (FSMA), GMP, ICH Q3C, IFANCA Halal, ISO 9001, Indian Pharmacopeia, Kosher, REACH Exempt (Europe), Turkish RoHS Regulation, United States Pharmacopeia (USP)

Synonyms: Hydroxypropyl methyl cellulose ether, Methyl hydroxypropyl cellulose, Cellulose hydroxypropyl methyl ether, 2-Hydroxypropyl methyl cellulose, 2-Hydroxypropyl methyl cellulose ether, Hydroxypropyl methyl cellulose, HPMC, Hypermellose, Hypromellose

Technical Data Sheet Safety Data Sheet

TypeDocument Name

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Enhanced TDS

Identification & Functionality

Chemical Family: Cellulose & Cellulosics,
Cellulose Ethers
Chemical Name: Hydroxypropyl Methylcellulose
Pharma & Nutraceuticals Functions: Viscosity Modifier
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Formulation & Processing Aids

Features & Benefits

Labeling Claims: BSE-free,
CMR Substances-free,
Endocrine Disruptor-free,
Halal,
Kosher,
Odor-free,
TSE-free

Applications & Uses

Segments: Pharmaceutical
Applications: Pharmaceutical — Immediate release

Properties

Physical Form

Physical Properties


	Value	Units	Test Method / Conditions
pH (at 2%)	5.0 - 8.0	-	Current USP/EP/JP

Typical Properties


	Value	Units	Test Method / Conditions
Identification*	Pass	-	Current USP/EP/JP
Residual Solvents*	Pass	-	Current USP/EP/JP
Loss on Drying	max. 5.0	%	Current USP/EP/JP
Residue on Ignition	max. 1.5	%	Current USP/EP/JP
Apparent Viscosity (at 20°C, 2% in Water)	4.0 - 6.0	mPa.s	Current USP

Microbiological Values


	Value	Units	Test Method / Conditions
E. coli*	Absent	/g	Current USP
Pseudomonas aeruginosa*	Absent	g	Current USP
Salmonella*	Absent	/10g	Current USP
Yeast and Mold Count*	max. 100	/g	Current USP Total Count

Composition


	Value	Units	Test Method / Conditions
Hydroxypropoxyl Content	7.0 - 12.0	%	Current USP/EP/JP
Methoxyl Content	28.0 - 30.0	%	Current USP/EP/JP
Chloride Content	max. 0.5	%	Current IP Total Content

Heavy Metals


	Value	Units	Test Method / Conditions
Lead Content*	max. 20	mg/kg	Current USP/EP/JP

Note

All section names come under PHS.
The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.