CELSENTIAL™ E15 Premium LV HPMC

1 of 3 products in this brand

CELSENTIAL™ E15 Premium LV HPMC, recognised as a cellulose ether, specifically hypromellose, is proficient as a viscosity modifier. This product boasts certifications affirming its freedom from BSE and CMR substances, ensuring safety and compliance with stringent regulatory standards.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Viscosity Modifier

CAS Number: 9004-65-3

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

Certifications & Compliance: FDA 21 CFR 172.874, FDA Food Safety Modernization Act (FSMA), GMP, ICH Q3C, 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,
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)	12.0 - 18.0	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.

Regulatory & Compliance

Certifications & Compliance: FDA 21 CFR 172.874,
FDA Food Safety Modernization Act (FSMA),
GMP,
ICH Q3C,
Indian Pharmacopeia,
Kosher,
REACH Exempt (Europe),
Turkish RoHS Regulation,
United States Pharmacopeia (USP)
Chemical Inventories: AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NDSL (Canada),
PICCS (Phillipines)