The SDS Labs blog
Practical, regulation-aware guides for QC, QA and R&D teams — impurity standards, nitrosamines, method validation and the techniques behind reliable data.
Impurity Reference Standards: A Buyer's Guide for Pharma QC and R&D
What to check before you buy an impurity reference standard: CoA contents, characterisation data, purity basis, and primary vs working standards.
ImpuritiesNitrosamine Impurities Testing: Risk Assessment, AI Limits and Methods
A practical guide to nitrosamine control: root-cause risk assessment, CPCA acceptable intakes, converting AI to ppm and choosing a validated test method.
Method developmentHPLC Method Validation under ICH Q2(R2): Parameters, Criteria, Protocol
What ICH Q2(R2) changed, which performance characteristics apply to assay and impurity HPLC methods, typical acceptance criteria and a worked range example.
TechniquesLC-MS vs GC-MS: How to Choose for Impurity and Trace Analysis
When to use GC-MS and when to use LC-MS for pharmaceutical impurities, with a comparison table, sensitivity worked example and a decision checklist.
TechniquesNMR Structure Elucidation of Unknown Impurities: 1D, 2D and qNMR
How to identify unknown pharmaceutical impurities with 1D and 2D NMR: when ICH requires it, isolating enough material, choosing experiments and using qNMR.
Method developmentForced Degradation Studies: ICH Q1A(R2)/Q1B Design and Practice
A practical guide to forced degradation: what ICH Q1A(R2) and Q1B require, typical stress conditions, how much to degrade, and proving a method is stability-indicating.
QualityHow to Choose an ISO/IEC 17025 Analytical Testing Lab in India
Accreditation is granted test by test. How to read a 17025 scope, judge data integrity and Part 11 controls, and the questions to ask a contract testing lab.
ImpuritiesCustom Synthesis of Impurities: From Structure to Characterised Standard
When ICH thresholds call for an authentic impurity standard: choosing a route, purifying to reference grade, building the characterisation package and assigning potency.
TechniquesResidual Solvents Analysis by GC Headspace: ICH Q3C and USP <467>
Solvent classes, ICH Q3C(R9) limits, Option 1 and Option 2 calculations, and how to develop and validate a headspace GC-FID method that holds up.
TechniquesPolymorph and Solid-State Characterisation with XRD, DSC and TGA
How XRPD, DSC and TGA work together to identify polymorphs, hydrates, solvates and amorphous content, with ICH Q6A expectations and a worked hydrate example.
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