Major Regulatory Changes in 2025

In January 2025, the US FDA published a draft regulatory guidance entitled “The Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”.

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In focus: Dimenhydrinate USP

Dimenhydrinate is an antihistamine drug commonly used to prevent and treat motion sickness, nausea, and vertigo. It is a combination of diphenhydramine and 8-chlorotheophylline, where the latter reduces the sedative effects of diphenhydramine. It is available in tablet, liquid, and injectable forms under various brand names.

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In focus: o-Nitrophenyl Disulfide

o-Nitrophenyl Disulfide is a chemical compound used in organic chemistry and biochemistry. It is a disulfide derivative where two o-nitrophenyl groups are connected by a disulfide bond (-S-S-) It is used in various organic synthesis reactions, as a reagent in the preparation of thiol-reactive compounds, in pharmaceutical research and laboratory applications.

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In focus: Tetrasodium Pyrophosphate, Anhydrous

Tetrasodium pyrophosphate (TSPP) anhydrous is a white, crystalline or granular inorganic compound, soluble in water but insoluble in alcohol. TSPP is widely used in food, industrial, and cleaning applications due to its sequestrant, dispersing, buffering, and emulsifying properties.

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In focus: Potassium Sodium Tartrate

Potassium sodium tartrate commonly known as Rochelle salt, is a double salt of tartaric acid. It is a white crystalline solid that is highly soluble in water. This compound is well known for its piezoelectric properties and has been historically used in various scientific and industrial applications.

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Biomanufacturing proliferates in chemicals

In the quest for increased sustainability, a lot has been made of the potential to use bio-based raw materials, captured CO2 and recycled plastics as raw materials for new chemicals. But what about using biotech processes to manufacture chemicals? Could it offer a more sustainable alternative to traditional petrochemical processing, and be more amenable to biobased raw materials?

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In focus: Tert – Amyl Alcohol

Tert-Amyl Alcohol (TAA) also known as 2-Methyl-2-butanol, is a branched-chain alcohol. It is a colorless, flammable liquid with a mild alcoholic odor and moderate water solubility. Due to its unique structural properties, it is widely used as basic organic chemical in synthetic fragrances, pharmaceuticals and pigment industries.

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In focus: Lithium Orotate, Monohydrate

Lithium orotate is a compound consisting of lithium, an alkali metal, and orotic acid, a natural substance involved in nucleic acid metabolism. It is a popular dietary supplement due to its potential neuroprotective and mood-stabilizing effects.

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In focus: 3-Quinuclidinone Hydrochloride

Quinuclidinone Hydrochloride is a derivative of bicyclic amine quinuclidine. The hydrochloride form of quinuclidinone is the salt form, often used for its stability in different reactions. Quinuclidinone Hydrochloride is typically used as an intermediate in the synthesis of various pharmaceuticals and other chemical products.

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