AFFINISOL™ HPMC HME 15LV

1 of 1 products in this brand
AFFINISOL™ HPMC HME 15LV is a versatile polymer used in hot melt extrusion and spray drying manufacturing technologies. It is soluble in both water and organic solvents, making it ideal for a variety of pharmaceutical formulations, enhancing solubility and stability.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Labeling Claims: Allergen-free, Diethylene Glycol-free, Ethylene Glycol-free, Glycerin-free, Halal, Palm Oil-free

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, Halal, ICH Q3C, ISO 14001, Japan Pharmacopeia (JP), National Formulary (NF), REACH (UK), 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

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Enhanced TDS

Identification & Functionality

Features & Benefits

Labeling Claims
Benefits
  • Extrudable HPMC with processing versatility that requires no plasticizer and provides expanded IR or CR functionality
  • Soluble in many common spray drying solvents. HPMC helps stabilize the solid dispersion and prevent recrystallization

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%)5.0 - 8.0-CE-8.7
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ash Content (Residue on Ignition)max. 1.5%CE-91.34
Moisture Content (Loss on Drying)max. 5.0%CE-7.1
Viscosity (at 2%)12.0 - 18.0mPa.sUbbelohde, CE-91.9
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCE-92.1
Pseudomonas aeruginosa*AbsentgCE-92.1
Salmonella*Absent/10gCE-92.1
Staphylococcus aureus*AbsentgCE-92.1
Yeast and Mold Count*max. 100/gCE-92.1
Total Bacterial Count*max. 100/gCE-92.1
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content25.0 - 32.0%CE-91.25
Methoxyl Content22.0 - 27.0%CE-91.25
Methanol Content (Residual Solvents)max. 3,000mg/kgPSM 102747
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.
  • Specification limits apply to the material as packaged in the original containers. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
  • Samples returned for analysis must have been obtained under conditions which prohibit the introduction of microbial contamination. Sterile containers and sampling equipment must be used.
  • *Audit Basis

Regulatory & Compliance