Pharmaceutical Excipients

14th May 2024

Pharmaceutical Excipients

This update contains 23 updated monographs. Pharmacopoeias have been globally updated including 5 new Chinese Pharmacopeia entries.

Revised monographs: Arginine; Cetostearyl alcohol; Hypromellose; Iron oxides; Maltitol solution; Myristic acid; Niacinamide; Palmitic acid; Paraffin; Propylene glycol dilaurate; Sodium benzoate; Sodium Polystyrene Sulfinate; Sodium Stearyl Fumarate; Sucralose; Talc; Zinc oxide.

Selective Revisions: Alpha tocopherol; Croscarmellose Sodium; Glycerin; Lactose Monohydrate; Propylene Glycol; Silicon Dioxide Anhydrous; Sodium ascorbate.

13th February 2024

Pharmaceutical Excipients

This update contains 1 new monograph and 17 updated monographs. Pharmacopoeias have been globally updated.

Information from the US FDA on Diethylene Glycol and Ethylene Glycol testing of drug-components has been incorporated into 10 monographs.

New monographs: Sorbitol solution.

Revised monographs: Almond oil; edetate disodium; potassium phosphate, dibasic; wax, nonionic emulsifying.

Selective Revisions: Dimethyl phthalate; dibutyl phthalate; diethyl phthalate; ethylene glycol stearates; glycerin; maltitol solution; polyethylene glycol; polyoxyethylene castor oil derivatives; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene stearates; polyoxyethylene alkyl ethers; polyoxyl 15 hydroxystearate; propylene glycol.

14th November 2023

Pharmaceutical Excipients

This update contains 1 new chapter and 18 updated monographs. Pharmacopoeias have been globally updated including purity test changes from JP XVIII S1.

New Chapter:  Pharmaceutical excipients in topical semisolid formulations for skin.

Revised monographs: Ammonium alginate; Benzoic acid; Carrageenan; Cetyl palmitate; Cetylpyridinium chloride; Croscarmellose sodium; Glucose, liquid; Glycine; Maltose; Myristyl alcohol; Oleic acid; Proline; Silicon dioxide, anhydrous; Silicon dioxide, hydrated; Silicon dioxide, hydrophobic; Sodium lauryl sulfate; Sorbitol.

Selective revisions: Titanium dioxide.

22nd May 2023

Pharmaceutical Excipients

This update contains 28 updated monographs. Pharmacopoeias have been globally updated.

Revised monographs: Crospovidone; Dibutyl phthalate; Diethyl phthalate; Dimethyl phthalate; Dimethyl sulfoxide; Dodecyl gallate; Ethanol; Ethyl lactate; Glycerin; Glyceryl dibehenate; Histidine; Hydroxypropyl cellulose; Imidurea; Lysine acetate; Poloxamer; Polydextrose; Polyethylene glycol; Polyethylene oxide; Polyoxyethylene sorbitan fatty acid esters; Povidone; Starch, pregelatinized; Triethanolamine.

Selective Revisions: Calcium sulfate; Octyl gallate; Propyl gallate; Propylene glycol; Sorbitol; Vegetable oil, hydrogenated.

Note: This update contains a name change of the Glyceryl behenate record to Glyceryl dibehenate. Additionally, the Corn starch and pregelatinized starch, coprocessed record has been removed.

14th February 2023

Pharmaceutical Excipients

This update contains 1 new chapter and 10 updated monographs. Pharmacopoeias have been globally updated.

New Chapter: Excipients for transdermal drug delivery patches.

Revised monographs: Aluminum hydroxide adjuvant; Aluminum phosphate adjuvant; Ascorbic acid; Butylparaben; Ethylparaben; Glyceryl monostearate; Methylparaben; Poly(methyl vinyl ether/maleic anhydride); Propylparaben; Propylparaben sodium.

Selective Revisions: Acrylamide and sodium acryloyldimethyl taurate copolymer dispersion; Dimethyl sulfoxide; Propylene glycol dicaprylate/dicaprate; Stearic acid.

30th November 2022

Pharmaceutical Excipients

This update contains 1 new chapter and 14 updated monographs. Pharmacopoeias have been globally updated, including the 18th edition of the Japanese Pharmacopoeia.

New Chapter: Excipients in Preformulation of Small Molecule Drug Products.

Revised monographs: Alginic acid; Asparagine; Cellulose, microcrystalline; Cellulose, powdered; Erythorbic acid;

Hydroxypropyl betadex; Magnesium oxide; Nitrous oxide; Polyvinyl Acetate Phthalate; Propylene glycol dicaprylate/dicaprate; Propylene glycol monocaprylate; Sodium cyclamate; Sodium hyaluronate; Zinc acetate.

Selective Revisions: Dextrose; Dextrose anhydrous; Titanium dioxide.