Quantitation of Crystalline Material within a Liquid Vehicle using 1H/19F CP/MAS NMR

Farrer, Brian T.; Peresypkin, Andrey; Wenslow, Robert M.

doi:10.1002/jps.20759

Cited by 11 publications

(1 citation statement)

References 11 publications

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“…However, HPLC is powerless to speak to the crystal form of the API. For crystal form analysis, scientists have placed emphasis on techniques such as XRPD, − infrared and Raman spectroscopy, , and solid-state NMR. , For the characterization of the API, these “fingerprint” techniques are excellent individually and even more powerful in combination . However, the API is often a minor component by weight in a tablet or other formulation.…”

Section: Introductionmentioning

confidence: 99%

Separation of Active Pharmaceutical Ingredients (APIs) from Excipients in Pharmaceutical Formulations

Atwood

2015

Crystal Growth & Design

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The active pharmaceutical ingredient (API) may be physically separated from the excipients in a pharmaceutical formulation by making use of the difference in density of the API and that of the excipients. The API may then be fully characterized by standard techniques. In the density separation process, the API is not dissolved, and the crystal form of the API is not changed. As examples, Form I fexofenadine hydrochloride is separated from Allegra Allergy 24 h Tablets, and Form I lansoprazole is separated from Equate Lansoprazole Delayed Release Capsules.

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Section: Introductionmentioning

confidence: 99%

Separation of Active Pharmaceutical Ingredients (APIs) from Excipients in Pharmaceutical Formulations

Atwood

2015

Crystal Growth & Design

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Solid‐state Nuclear Magnetic Resonance of Polymorphic Materials

Vogt¹

2011

Encyclopedia of Analytical Chemistry

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Solid‐state nuclear magnetic resonance (SSNMR) spectroscopy is a powerful analytical technique for the analysis of polymorphs, which are molecules that exist in different crystalline phases. In this review, applications of SSNMR to polymorphism and related phenomena in a variety of chemical systems are discussed, including pharmaceuticals, food materials, explosives, dyes and pigments, biomolecules, inorganic materials, and organometallic compounds. The advantages of SSNMR are highlighted in relation to other analytical techniques, such as diffraction methods. The SSNMR techniques commonly used to analyze these systems and probe aspects of their polymorphic structure are reviewed, and illustrative examples from each class are given. In recent years, increasingly sophisticated SSNMR methods have been applied to the analysis of polymorphism, including 2‐D correlation methods, methods that measure chemical shift tensors, methods that extract quadrupolar parameters at high static field strengths, and computational methods that assist in interpreting and understanding the experimental data in relation to crystal structure. Multicomponent crystals including salts, solvates, and cocrystals also display polymorphism, and are often included with polymorphs in investigations of supramolecular chemistry and crystal engineering. The relationship between crystalline and amorphous materials is also discussed to emphasize the applicability of the analytical technique and the complementary information often obtained. Finally, the importance of SSNMR within multidisciplinary studies of polymorphism using other techniques is emphasized.

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Solid‐State Nuclear Magnetic Resonance of Pharmaceutical Formulations

Lubach¹,

Munson

2000

Encyclopedia of Analytical Chemistry

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Analysis of pharmaceutical solids using solid‐state nuclear magnetic resonance ( NMR ) spectroscopy is finally coming of age. The wealth of information that solid‐state NMR can provide is unmatched by any other single technique used to characterize pharmaceutical solids. Perhaps the area where NMR can provide the most benefit to pharmaceutical scientists is in the analysis of formulated drug products, where the active pharmaceutical ingredient ( API ) is diluted in the presence of one or more inactive ingredients, or excipients. Unlike most other techniques, NMR has the ability to selectively characterize the physical states of the API as well as excipients, as they exist together within the formulation, without separation or sample destruction. Critical issues such as crystal form, crystallinity, amorphous content, ionization states, hydration states, molecular mobility, and drug–excipient interactions may all be studied using modern solid‐state NMR . Here we examine some of the presently available literature, provide relevant references, and demonstrate examples of how to best utilize the technique and interpret the results.

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Quantitation of Crystalline Material within a Liquid Vehicle using 1H/19F CP/MAS NMR

Cited by 11 publications

References 11 publications

Separation of Active Pharmaceutical Ingredients (APIs) from Excipients in Pharmaceutical Formulations

Separation of Active Pharmaceutical Ingredients (APIs) from Excipients in Pharmaceutical Formulations

Solid‐state Nuclear Magnetic Resonance of Polymorphic Materials

Solid‐State Nuclear Magnetic Resonance of Pharmaceutical Formulations

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