Clarke’s Analysis of Drugs and Poisons

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.

31st May 2022

Pharmaceutical Excipients

This update contains 2 new monographs and 39 updated monographs. Pharmacopoeias have been globally updated.

New monographs: Mannitol + Starch, Coprocessed; Sepineo P600.

Revised monographs: Acesulfame Potassium; Acetic Acid, glacial; Aluminum Oxide; Aspartame; Betadex Sulfobutyl Ether Sodium; Canola Oil; Chlorocresol; Cholestyramine Resin; Citric Acid; Coconut Oil; Corn Oil; Dimethylacetamide; Edetate Calcium Disodium; Glyceryl Laurate; Glyceryl Monooleate; Glyceryl Palmitostearate; Hectorite; Heptafluoropropane (HFC); Lanolin Alcohols; Mannitol; Mineral Oil; Norflurane (HFC); Peanut Oil; Phosphoric Acid; Polacrilex Resin; Polacrilin Potassium; Sodium Acetate; Sodium Chloride; Sodium Citrate; Sodium Starch Glycolate; Tagatose; Tetrasodium Edetate; Water; Xanthan Gum.

Selective Revisions: Alpha Tochopherol; Aspartame; Calcium Phosphate, Tribasic; Edetic Acid; Mineral Oil, light.