Journal of Pharmacopoeia and Research

Critical Considerations for Related Substance and Impurity Testing

Aman Rajput — 2026-10-15

Related substance and impurity testing is a fundamental component of pharmaceutical quality assurance, ensuring the safety, efficacy, and consistency of drug substances and drug products throughout their lifecycle. Impurities may originate from raw materials, manufacturing processes, degradation pathways, storage conditions, or interactions with packaging materials. Even trace levels of these unwanted components can significantly affect product quality, therapeutic performance, and patient safety, highlighting the necessity for robust analytical methodologies and comprehensive regulatory compliance. Advances in analytical science, together with increasingly stringent international guidelines, have transformed impurity profiling into a critical element of pharmaceutical development, process optimization, quality control, and post-marketing surveillance. This review summarizes the critical considerations involved in related substance and impurity testing, with emphasis on impurity classification, analytical method selection, method validation, and regulatory expectations. The article discusses various categories of impurities, including organic, inorganic, residual solvent, elemental, and degradation impurities, and outlines their potential sources and impact on pharmaceutical quality. Particular attention is given to the selection and optimization of stability-indicating analytical methods, primarily High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), gas chromatography (GC), capillary electrophoresis (CE), and hyphenated techniques such as liquid chromatography–mass spectrometry (LC–MS), which enable sensitive detection, accurate quantification, and structural characterization of impurities. Furthermore, the review highlights critical method validation parameters, including specificity, accuracy, precision, linearity, robustness, detection limit, quantitation limit, and system suitability, in accordance with internationally accepted regulatory recommendations.

Reducing Turnaround Time of Pharmacy Indents: A Study on Process Efficiency and Patient-Centered Strategies

Shekhar shama — 2026-09-17

Background: Timely dispensing of medications is critical for patient safety and hospital efficiency. Delays in pharmacy indents, especially STAT indents, can impact clinical outcomes.

Scope: Within the hospital Pharmacy.

Objective: To reduce the turnaround time (TAT) of pharmacy indents through process optimization and patient-centered safety strategies.

Turnaround time in pharmacy denotes the interval between requisition submission, Indent landing in pharmacy, and the dispatch of medications.

Timely dispatch of medication plays a critical role in patient safety, treatment outcomes, and hospital efficiency. Delays in drug supply to patients can be serious; the effects can be horrifying in terms of Mortality and morbidity for critical patients. Pharmacists are uniquely qualified to manage and support health care organizations by leading utmost efforts to reduce the TAT of pharmacy indents, especially STAT indents or emergency indents, which are required to be dispatched from the pharmacy within the standard time frame.

It is very important to dispense indented medications with strict adherence to quality and accuracy standards to avoid errors. High-alert medications must be dispensed and dispatched from the pharmacy with proper labeling, collected from their specified place in a separate tray, and checked following the standard process of independent double-checking. While dispatching the indent of high-alert medications, a stamp of “High Alert Medication” should be placed on the indent copy to create alertness in receiving staff at the time of indent receipt, ensuring that these items need to be carried and administered effectively. Similarly, medications requiring cold storage must be dispensed along with ice packs in a cold box, with the temperature maintained optimally between 2–8 °C. Stickers indicating “Cold Storage required” should be affixed to such drugs to reinforce proper handling and storage. These measures strengthen patient safety, minimize dispensing errors, and ensure that critical medications are delivered under the required conditions.

Loratadine Chewable Tablets: A Comprehensive Review

Sandeep Kumar Sharma — 2026-09-29

Loratadine is a second-generation selective histamine H1 receptor antagonist that is widely prescribed to deal with allergic signs and symptoms of allergic rhinitis and urticaria. Due to its relative lack of sedative effects, long duration of action and favorable safety profile, it has emerged as an important non-sedative antihistamine. Loratadine chewable tablets are a convenient, patient-friendly oral dosage form that improves the convenience and acceptability of the medication, especially for young people and those who have difficulty swallowing capsules or tablets. Loratadine chewable capsules generally contain 5 mg and should be chewed before swallowing. This comprehensive review covers the physicochemical and pharmacological properties of loratadine, the mechanism of action and pharmacokinetic profile, therapeutic use, protection profile, and system concepts of chewable tablets. Special attention is paid to the component additives such as diluents, binders, super disintegrants, sweeteners, flavouring agents, lubricants, and other auxiliaries that may be necessary to achieve precise hardness, brittleness, flavour, mouthfeel, and dissolution. It also considers weight change, content uniformity, mechanical strength, in vitro degradation, dissolution behavior, and equilibrium as crucial parameters to manipulate appropriately. Optimization of the chewable tablet method is necessary to achieve a balance of adequate mechanical strength, rapid degradation, and true organoleptic properties of the tablet to ensure pharmaceutical quality and appropriate patient acceptability. Loratadine chewable tablets are particularly useful when ease of handling and adherence to the treatment regimen are an issue. Labeling on modern products indicates that they are for the brief symptomatic relief of sneezing, runny nose, itching, watery eyes, and itchy nose or throat in patients with allergic reactions. Overall, Loratadine chewable tablets are a convenient and effective dosage form for administering antihistamine therapy. Ongoing research on excipients, flavor overlay, person-centered formulation setup, manufacturing time, and the development of their dissolution profile should similarly improve the performance, acceptability, and therapeutic potential of loratadine chewable capsules.