analytical Archives - SK pharmteco

Keys To Effective Method Development

Effective method development is crucial for the quality control of Active Pharmaceutical Ingredients (API) and Drug Products (DP). Thorough method development enables successful downstream method validation. The regulatory guidance specifies that: Method development and validation vary by application (quantitative, qualitative, etc.). It is phase appropriate. The client may provide additional guidance/validation criteria. The validation guidance […]

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Chiral Purity Analysis – Know What Both Hands Are Doing

Blog / By Bob Brousseau

Background on Chiral Purity Chirality refers to the phenomenon that occurs when a mirror image cannot be superimposed. It is sometimes called “optical rotation”. The origin is from the late 19th-century Greek word kheir (‘hand’) and is one of the easiest demonstrations of the concept. Although a person’s hands may appear virtually identical, if they

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Some Background and Concerns About PFAS

Blog / By Bob Brousseau

The Background and Concerns of PFAS (Per- and) PolyFluoroAlkyl Substances (PFAS) are a class of ubiquitous chemicals that have been found in water, air, fish, and soil across the nation and worldwide. Known as “Forever Chemicals,” there are thousands of different PFAS, and they are present in consumer, commercial, and industrial products.1 Having one of

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Shedding Light on Photo-Stability Forced Degradation

Blog / By Bob Brousseau

Forced Degradation is the testing of a drug product or drug substance using situations more taxing than those if conditions were simply accelerated. This type of stability testing is designed to demonstrate various degradation pathways within the product or substance and assists with developing the product itself and its packaging. Within forced degradation testing, a

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SK pharmteco announces new standalone Analytical Services from its SK biotek Ireland Swords Campus

News / By Bob Brousseau

SK pharmteco (SKPT) a global CDMO, part of SK Inc., is pleased to announce that it has launched SK biotek Ireland Analytical Services offering full cGMP testing services including testing of Highly Potent Active Pharmaceutical Ingredients (i.e. material with Occupational Exposure Levels (OEL) < 0.1 µg/m³) from SK biotek Ireland’s Dublin-based pharmaceutical manufacturing plant. The

SK pharmteco announces new standalone Analytical Services from its SK biotek Ireland Swords Campus Read More »

analytical

Keys To Effective Method Development

Chiral Purity Analysis – Know What Both Hands Are Doing

Some Background and Concerns About PFAS

Shedding Light on Photo-Stability Forced Degradation

SK pharmteco announces new standalone Analytical Services from its SK biotek Ireland Swords Campus

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