A deep dive into Nitrosamine impurities in APIs and drug products

Nitrosamine Impurities in APIs and Drug products

In Pharmaceuticals the manufacturers of APIs and Drug products have findings of nitrosamine impurities which may be likely because the human carcinogens in the drugs were of great concern. Detection of nitrosamine impurities was found in some of the commonly prescribed medicine used for treating diabetes, antacids, and others. Background information on Nitrosamine impurities Nitrosamine … Read more

A Glimpse on Quality by Design (QbD) Approach in Pharmaceutical Industry

Quality-by-Design approach in Pharmaceutical Industry

The concept of Quality by design (QbD) means signifies designing and developing pharmaceutical products and manufacturing processes to ensure predefined product quality objectives. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to design, development and manufacturing. The main concept of (QbD) … Read more

A Review On Doxycycline And It’s Impurities

A Review On Doxycycline And It's Impurities

Doxycycline is a tetracycline broad spectrum and an antibiotic for the treatment of bacterial infections. Doxycycline is also used to treat many diseases like Lyme disease, bacterial pneumonia, typhus, and chlamydia infections, and also for the various infection caused by gram-positive and gram-negative bacteria aerobes and anaerobes and also other types of bacteria. What is … Read more

A review on Ofloxacin

A review on Ofloxacin

Ofloxacin is an antibiotic for treating bacterial infections; it is active against gram-positive and gram-negative bacteria. It is from a second-generation fluoroquinolone class and is considered a broader spectrum analog of norfloxacin and was developed and synthesized by the scientists of Daiichi Seiyaku. As an antibacterial agent, Ofloxacin treats urinary infections, pneumonia, and pelvic inflammatory … Read more

Active Pharmaceuticals Ingredients and Excipients in Pharmaceuticals

Active Pharmaceuticals Ingredients and Excipients in Pharmaceuticals

The Active ingredient in a pharmaceutical drug is known as the active pharmaceutical ingredient (API). The active pharmaceutical ingredient(API) provides a biologically active component to a drug product like a tablet, capsule, cream, injectable, etc that produces the intended effects in diagnosing, treating, treating, or preventing diseases. API produces a desired pharmacological effect and excipients’ … Read more

Amoxicillin: Drug Information

Amoxicillin: Drug Information

Amoxicillin is a commonly prescribed antibiotic used to treat a variety of bacterial infections, including respiratory, ear, throat, and skin infections. While it is generally considered safe and effective, there is a risk that impurities may be present in amoxicillin products. These impurities can have potentially harmful effects on patients who take the medication, which … Read more

An Outline on Levothyroxine and It’s Related Impurities 

An Outline on Levothyroxine and Its related Impurities

Levothyroxine is a medicine used for the treatment of thyroid hormone deficiency (hypothyroidism), to treat goiter, and also used to prevent some types of thyroid tumors.   Levothyroxine is also known as? Levothyroxine is a levo-isomer of the thyroid hormone thyroxine (T4) prepared synthetically and is also known as L-thyroxine. Levothyroxine is available in the … Read more

Analytical Balance – Working Range

Analytical balance and working range

Analytical balances are the key instrument of quantitative analysis. It is used to accurately weigh samples and standards. It is one of the primary activities of the analysis process. Its industrial application includes pharmaceuticals, plastic, food, chemical manufacturing, calibration laboratories etc. Analytical balance is used for accurate weighing of samples and standards; it is one … Read more

Analytical Method Development – Forced Degradation Study


Analytical method development finalization for Drug Substance or Drug Product is dependent on finalization of Forced degradation studies or Stress studies as it indicates a clear scenario of potential degradant impurities which may arise during the course of study and we can be prepared for further preparation, isolation, and characterization of Impurities for Regulatory Requirement. … Read more

Analytical Method Development Approach When Compounds Don’t Have UV Chromophore:

Analytical Method Development Approach When Compound Don’t Have UV Chromophore

High-performance liquid chromatography (HPLC) is one of the most important instruments used in the pharmaceutical industry. Most of the pharmacopeial monograph methods are based on HPLC with a UV-Visible detector and It is a useful analytical technique for qualitative and quantitative purposes. In some compound, there is a lack of or absence of chromophore which … Read more