Small-Molecule APIs

Access to simpler and more direct methodologies for the incorporation of fluorinated substituents remains an unmet need in pharmaceutical synthesis. An analysis of recent trends in fluorination chemistry.

Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.

Visual mapping can provide a particle-size distribution estimate.

As contract API manufacturers, fine-chemical producers, and pharmaceutical companies prepare to attend Informex in Anaheim this month, the state of the industry shows improving conditions in certain sectors.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.

Flow chemistry and microreactors offer an alternative to traditional batch manufacturing.

Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.

Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

Direct dosing APIs during R&D studies can reduce the overall testing time of a drug candidate by allowing for a greater throughput of compounds through the R&D department.

The increasing cost of crucial manufacturing input factors, such as energy and raw materials, has been a severe threat to several companies.

As contract manufacturers and fine-chemical suppliers gather for CPhI/ICSE, effective strategies for technology differentiation are key in an increasingly competitive environment.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

The potent nature of HPAPIs means there must be careful evaluation of the compound for its level of toxicity when considering manufacture.

Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

The pharmaceutical industry must address the release of nonbiodegradable APIs into the environment.