Pharmacopoeia Standard Of Hydroxypropyl Methyl Cellulose

Hydroxypropyl Methylcellulose (HPMC) is a widely used pharmaceutical excipient, and its quality and specifications are defined by various pharmacopoeias around the world. Here are some of the pharmacopoeial standards for HPMC:

United States Pharmacopeia (USP):

• The United States Pharmacopeia (USP) sets standards for the quality, purity, and performance of pharmaceutical ingredients and dosage forms. HPMC monographs in the USP provide specifications for various parameters such as identification, assay, viscosity, moisture content, particle size, and heavy metals content.

European Pharmacopoeia (Ph. Eur.):

• The European Pharmacopoeia (Ph. Eur.) provides standards for pharmaceutical substances and preparations in European countries. HPMC monographs in the Ph. Eur. specify requirements for parameters such as identification, assay, viscosity, loss on drying, residue on ignition, and microbial contamination.

British Pharmacopoeia (BP):

• The British Pharmacopoeia (BP) contains standards and specifications for pharmaceutical substances and dosage forms used in the UK and other countries. HPMC monographs in the BP outline criteria for identification, assay, viscosity, particle size, and other quality attributes.

Japanese Pharmacopoeia (JP):

• The Japanese Pharmacopoeia (JP) establishes standards for pharmaceuticals in Japan. HPMC monographs in the JP include requirements for identification, assay, viscosity, particle size distribution, and microbial limits.

International Pharmacopoeia:

• The International Pharmacopoeia (Ph. Int.) provides standards for pharmaceuticals worldwide, particularly for countries that do not have their own pharmacopoeias. HPMC monographs in the Ph. Int. specify criteria for identification, assay, viscosity, and other quality parameters.

Other Pharmacopoeias:

• Pharmacopoeial standards for HPMC may also be found in other national pharmacopoeias such as the Indian Pharmacopoeia (IP), Chinese Pharmacopoeia (ChP), and Pharmacopoeia of the People’s Republic of Bangladesh (BPC).

Harmonization Efforts:

• Harmonization efforts among pharmacopoeias aim to align standards and specifications for pharmaceutical ingredients and products globally. Collaborative initiatives such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) help promote consistency and facilitate international trade.

In summary, Hydroxypropyl Methylcellulose (HPMC) is subject to pharmacopoeial standards and specifications established by organizations such as the USP, Ph. Eur., BP, JP, and other national pharmacopoeias. Compliance with these standards ensures the quality, purity, and performance of HPMC in pharmaceutical formulations.