Review on Mass Balance

 Mass balance in the pharmaceutical analysis is very much important. It is representing the degradative losses of parent drug compare well with the measured increase in the degradation products. Equally, if one observes, for example, a 10% loss of parent drug but only measures a 2 % increase in degradation products, it is expected that additional degradation products formed are not accurately determined by the present method(s).

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Reference Standards, Types, Uses, Preparation & Qualification:

 

A reference standard material is defined as highly purified compound that is well characterized by FDA (US Food and Drug Administration) or company or laboratory. Reference standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators by USP (US Pharmacopeia). Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results

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Review on Drug Master File (DMF)

 Drug master file (DMF) is a submission to Food and Drug and Administration (FDA) and is a kind of confidential document which contains detailed information about the facilities, processes, manufacturing, processing, packaging, and storing of human drug products. In DMF the details mentioned may be used to support an (IND) Investigational New Drug Application,( NDA) New Drug Application, (ANDA) Abbreviated New Drug Application.

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Separation of Closely Eluting Impurities by Selecting Appropriate Stationary Phase

 

HPLC column is the heart of HPLC hence selecting the appropriate stationary phase is the most important part of method development. The selection of the stationary phase plays an important role in selectivity. There are numbers of regulatory queries on the inappropriate resolution between closely eluting impurity hence it is important to develop the suitable stability-indicating analytical method. There are more complex drug products hence analytical scientists need to develop the specific, accurate, precise and robust method to attain the optimum resolution between closely eluting impurities.  Adequate resolution and recovery between the closely eluting peaks are the definitive goals for good chromatography. The resolution, means the distance between the center of two peaks measured by the retention time or volume divided by the average width of the individual peaks.

USFDA recommends the resolution should be more than 2. If there are closely eluting peaks in the method then it is essential to give minimum resolution criteria between the two peaks.

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Assessment of Genotoxic Impurities

A potential genotoxic impurity (PGI) has been defined as an “Impurity that shows a structural alert for genotoxicity but that has not been tested in an experimental test model. Here potentially relates to genotoxicity, not to the presence or absence of this impurity”. Genotoxic impurities impact the genetic material using mutations through chromosomal breaks, rearrangements, covalent binding, or insertion into the DNA during replication which may result in carcinogenesis.

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Difference between ICP-OES and ICP-MS

Elemental impurities affect drug effectiveness, it doesn’t have any therapeutic benefit but has a toxic effect on the patients. Elemental impurities may be present in drug products due to different sources such as catalysts, raw materials, excipients, equipment, or packing materials. As per recent necessities, elemental impurities guidance of ICH Q3D, USP Chapters <232>, made effective shifting the old requirements for heavy metals. The limits are much lower for most toxic metals. The earlier heavy metal method was not specific and accurate for each one hence new testing procedure applied by using sophisticated, costly, and sensitive technology such as inductively coupled plasma optical emission spectroscopy (ICP-OES) or inductively coupled plasma mass spectrometry (ICP-MS). 

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Polymorphic Impurities: Risk Assessment & Investigation

 

Introduction

Polymorphism arises when a solid compound present in two or more crystal forms. If polymorphic impurities or anything else other than the predicted crystalline forms is present in a drug substance of a pharmaceutical product, it may impact the performance, quality, safety, efficacy, and stability of the drug product. Different polymorphic forms can have different melting points, spectral properties, and thermodynamic stability. Amorphous

Assessment of Risk to the Quality of Drug Substance and Drug Product

Polymorphs are one type of solid form. Other solid form types include solvates, hydrates, and amorphous forms. Many organic and inorganic compounds, including drug substances, can exist in multiple solid forms. In the manufacturing of drug substance, polymorphism of crystals must be strictly controlled, because it significantly affects the bio-availability of a drug Impurity is one of the important aspects in control of crystal polymorphism.

Polymorphism is regularly affected by a trace number of impurities. Many drug substances are synthesized through many reactions. It is significant to know the impact of the impurities in the presence of crystal polymorphs.

Crystallization from different solvents may give rise to different crystal forms or solvates. Excessive humidity or heat are the most visible cause of polymorphism. Changes in polymorphism can also be induced as a significance of numerous common stages of drug substance processing such as granulation, melting, spray drying, compression, and milling that are required to produce the final dosage form.

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