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Gas Chromatography Level -1
Pharmacopoeia Update: Why Regular Pharmacopoeia Revisions Are Important for the Pharmaceutical Industry
Introduction A pharmacopoeia update plays an important role in the pharmaceutical industry. New standards are released regularly to improve the quality, safety, and effectiveness of medicines. These updates should be reviewed carefully by pharmaceutical manufacturers, quality control laboratories, and regulatory professionals. Understanding the latest pharmacopoeia revisions helps companies…
Just finished a fun session of HPLC calibration! Time to unwind and rambler a bit about my day.
Play remember all HPLC calibration link given below freeHeadline: Stop Memorizing HPLC SOPs. Start Mastering Them. 🎮🧪We’ve all spent hours poring over SOPs, trying to visualize every step of the HPLC calibration process. But what if you could practice the entire workflow in a risk-free, digital environment?I’m excited to share a project I’ve been developing: An HPLC Calibration Simulator.Designed…
Dissolution investigation
In pharmaceutical quality control, when a product fails the S1 stage of dissolution (like the 78% result in your example), you don’t just blindly move on to testing more units at the S2 stage. The very first action in an Out of Specification (OOS) or atypical result investigation is to **”Check the product history.”** Here is exactly what that means and why it is a critical first step: Why…
FDA Propose Rule That Would Help Hold Foreign Tobacco Manufacturers Accountable, Protect Public Health
product dimensions. For e-cigarettes, manufacturers would also need to provide specifications such as e-liquid volume, battery capacity, and wattage. To streamline and increase efficiency, in most cases manufacturers would be required to submit information electronically through the FDA’s online system, enabling them to register more quickly. They would also be required to review and update…
summary of global nitrosamine regulations FDA, EMA, ANVISA, SWISSMEDC, HEALTHCANDA.
* Nitrosamines are trace chemical impurities. * They are classified as probable human carcinogens. * Global agencies require a strict 3-step risk assessment framework. * Manufacturers must evaluate, test, and fix any impurity risks.1. The Global CPCA SystemAgencies use the **Carcinogenic Potency Categorization Approach (CPCA)** to set safety limits. This system groups impurities into 5 categories…
job interview in chemistry, an academic interview for admission or research, or a general knowledge interview
Got it — you said “Chemistry interview.” That’s a broad request, so let’s narrow it down. Are you preparing for a job interview in chemistry, an academic interview for admission or research, or a general knowledge interview? Each has a different focus. To give you a concrete idea, here’s a sample of the kind of preparation I can help with:—⚗️ Common Chemistry Interview Questions– Basic concepts:…
RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES
RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time of occurrence Product/Batch details Area/Department involved Immediate impact assessment Initial containment action 2. DATA…
Understanding Analytical Method Validation: Interference and Specificity
Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn’t being ‘fooled’ by other things in the mixture. Case 1: (Specificity / No Interference) Like a clear road, the signal you are looking for passes through without being blocked or…
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Acid base titration explain points cover
The Arrhenius TheoryThis theory is based on the production of ions in aqueous (water) solutions.An acid is defined as a substance that releases hydrogen ions (H+) when it is dissolved in water.A base is defined as a substance that releases hydroxide ions (OH-) when it is dissolved in water.A neutralization reaction is viewed as the combination of H+ and OH- to form water (H2O). The Brønsted-Lowry…
What is call Liniarity
The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.What is call Liniarity
How to Manage Your Diet and Mental Health in Shift Duty
Working irregular hours can take a massive toll on the human body. When the natural circadian rhythm is disrupted by rotating schedules, both physical metabolism and psychological well-being are significantly impacted. However, with the right structural changes, health can be effectively maintained. Below is a practical blueprint designed to help professionals thrive while working…
Troubleshooting Retention Time Shift in HPLC: Causes, Solutions, and Best Practices
If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating moment when the peaks start drifting. Suddenly, you are dealing with:System suitability failuresIncorrect peak…
Maximizing Efficiency in Modern Quality Control Labs
Operational excellence is demanded by modern quality control laboratories. Every single day, high testing volumes are managed by laboratory analysts. Accuracy must be maintained during complex testing procedures, including HPLC analysis and Karl Fischer titration. When workflows are optimized, regulatory compliance is easily achieved by pharmaceutical professionals.The Importance of Process…
HPLC troubleshooting related RT
Fluctuating retention times Unstable Pressure, check pressure section If mobile phase is not pre-mixed, there could be problem with the ratio been properly mixed(Inconsistent on-line mobile phase mixing) Unstable Column temperature Increasing Retention Times Decreasing Flow rate Decreasing column temperature Decreasing Retention Times Increasing flow rate Increasing column temperaHPLC…
Global Regulatory PulseWeekly Regulatory Highlights (June 1–3, 2026)
🇺🇸 FDA Updates CAVHANZA (nilotinib) approved (June 2, 2026) for Ph+ chronic myeloid leukemia with improved formulation allowing use alongside PPIs/H2 blockers without restrictions. Ensitrelvir (Xocova) approved (May 29, 2026) as the first oral option for COVID-19 post-exposure prophylaxis. Zaynich (cefepime + zidebactam) approved (May 29, 2026) for complicated urinary tract…
Key FDA Updates (Late May–Early June 2026)
The FDA’s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming regulatory decisions on therapies for COVID-19, urinary tract infections, smoking cessation, and kidney disease. These developments highlight both immediate consumer safety concerns and major advances in oncology and infectious disease treatments.”) —🔑 Key…