ICH And ANVISA Method Validation Guidelines: Key Differences and Similarities – With Expert FAQs
While the ICH and ANVISA method validation guidelines share the same fundamental goal of ensuring reliability and accuracy, they differ in their level of detail and regulatory expectations. ANVISA generally adopts a more stringent approach, requiring the use of independent stock solutions for linearity assessments, more rigorous statistical analyses (including ANOVA and homoscedasticity testing), and […]
Particle Size Analysis Key Terms: Get Mastery In 9 mimutes with 21+FAQs
Particle size analysis is a set of laboratory techniques to determine the size range and average size of particles in a sample, such as a powder or liquid. Common methods include sieving, sedimentation, laser diffraction, and microscopy. 1. What is Particle Analysis? Particle size analysis is the process of determining the size and distribution of […]
UFLC vs UPLC vs HPLC : Which One Is Best For Pharmaceutical Analysis
UFLC vs UPLC vs HPLC: FAQs 8. Why is UFLC sometimes more practical than UPLC? UFLC offers a balance between speed and cost. It uses standard particle sizes (like HPLC) but with optimized hardware for faster runs, without requiring ultra-high pressure. It’s more cost-effective and compatible with traditional methods. 9. How do I choose between […]
Amorphous And Crystalline Drugs: Which Will Give More Stable Dosage Form And Why
Both amorphous and crystalline drugs play distinct and important roles in pharmaceutical formulation, particularly in terms of stability, bioavailability, solubility, and dissolution. Crystalline drugs possess a well-ordered, stable molecular structure that results in slower dissolution and lower solubility, whereas amorphous drugs, lacking a defined lattice arrangement, exhibit higher solubility and faster dissolution rates but are […]
Polymer Morphology and Crystallinity In Pharmaceuticals: Get Mastery With FAQs
Polymer morphology and crystallinity are fundamental concepts that bridge molecular structure with the pharmacological performance of drug delivery systems. Polymer morphology studies the arrangement of polymer chains—whether amorphous (disordered), crystalline (ordered), or semi-crystalline (partly ordered). The degree of crystallinity determines key properties such as strength, stiffness, and density, and is influenced by factors like chain […]
Top 10 Audit-Ready Practices for Every QA & QC Professional
Discover the top 10 audit-ready practices for QA and QC professionals in the pharmaceutical industry. Learn how ALCOA+, CAPA, change control, and document management ensure GMP compliance and inspection readiness.
Uv Visible Spectrophotometer: How to Perform Assay And Identification Test Quickly
An Uv Visible Spectrophotometer is an analytical instrument that measures the absorbance or transmittance of a sample across the ultraviolet and visible light spectrum (typically 200–800 nm). By passing a beam of light through a sample and detecting the absorbed or transmitted intensity it enables the identification and quantification of substances in liquids or solids. […]
What is Custom API Synthesis in Pharma R&D and Why Is It Important
Custom API synthesis, especially within the pharmaceutical and chemical industries, involves the tailored design and production of Active Pharmaceutical Ingredients (APIs) or other chemical compounds to meet precise client specifications. Unlike the large-scale manufacturing of generic compounds, this process emphasises customising the synthesis to achieve specific molecular structures, purity levels, quantities, and functional properties. Custom […]
Essential Water Treatment Chemicals for Hard Water Removal
Discover the most effective water treatment chemicals for hard water removal — including coagulants, flocculants, chlorine, alum, and antiscalants — to ensure clean, corrosion-free water for industrial and domestic use.
CRO And CMO in Pharma: Key Differences, Roles, FAQs and What is CDMO
Both CROs and CMOs play crucial roles in drug development in the pharmaceutical industry. CROs focus on research activities such as clinical trial design, regulatory support, and data analysis, while CMOs specialise in the large-scale manufacturing of drug substances and finished products. A third type, the CDMO (Contract Development and Manufacturing Organisation), combines both functions—offering […]