Analytical Development
Cetylpyridinium Chloride (CPC) in Dissolution Bath
Cetylpyridinium chloride (CPC) at 0.01% w/v is often used in a dissolution bath to maintain microbial control and ensure the cleanliness of the system. Its inclusion helps prevent microbial contamination, which could interfere with the dissolution process and affect the accuracy of drug release studies. CPC is a cationic surfactant ... Read More
Difference Between C8 and C18 Columns
C8 and C18 are both types of reverse-phase chromatography columns, but they differ in their: Carbon chain length: Hydrophobicity: Retention characteristics: Separation range: Column selectivity: In summary, C8 columns are used for smaller, more polar molecules, while C18 columns are used for larger, more non-polar molecules. The choice between C8 ... Read More
Surfactants in Dissolution
We have many factors to consider when making a dissolution method. What apparatus, speed, filter choice, etc. Of these factors, the one I get the most questions about is media selection – especially surfactants in media selection. So, what is a surfactant and why do we use them? What do ... Read More
Base Line Noise in HPLC
While performing HPLC analysis with an existing method, sometimes we will observe more base line noise. However, we won’t observe that scenario previously. The major probability due to: About dirty mobile phase: Grade of organic solvet used for analysis. Especially In case of THF is there in mobile phase we ... Read More
Role of pKa and pH Values in HPLC
One of the critical factors influencing the success of an HPLC analysis is the control of pH, which directly impacts the ionization state of analytes. The pKa value of a compound, indicating its acid dissociation constant, plays a pivotal role in this process. pKa: A Key Parameter The pKa value ... Read More
Forced Degradation Studies During Method Validation
During method validation, the FDA expects forced degradation studies to be conducted to assess the stability-indicating capability of the analytical method. These studies involve subjecting the drug substance or product to various stress conditions (e.g., heat, light (Day and UV light), acid/base hydrolysis, oxidation) to induce degradation. By monitoring changes ... Read More
Different Types of HPLC Columns in Pharmaceutical Analysis
In High-Performance Liquid Chromatography (HPLC), the choice of column is crucial for successful separation and analysis. Let’s explore the different types of HPLC columns: Normal Phase HPLC Columns Stationary Phase: These columns have a more polar stationary phase than the mobile phase. Silica gel, a polar material, is commonly used ... Read More
Importance of pKa Value in Selection of Dissolution Media
There is a question: How pKa value helps in selection of Dissolution Media during Formulation & Analytical Development? For Dissolution, Ionized form of a drug is required to be solubilized & released passively into dissolution medium. While, For Absorption, only unionized form of drug is important to be absorbed passively ... Read More
Role of Analyst While Performing Method Validation
What should an analyst do during analytical method validation? The responsibilities of an analyst /chemist during method validation typically include the following: Designing the Validation Protocol: The analytical chemist is responsible for developing a detailed validation protocol that outlines the objectives, scope, acceptance criteria, and experimental procedures for method validation. ... Read More
Errors or Incidences During Analytical Method validation
Incidences are any unintentional/ unexpected event that occurs during analysis, discovered during analysis, and after analysis that may adversely affect the data quality and the result. Lets quickly go some of the common incidences which are observed during method validation activity. Instrument related: Analyst related: Chromatography related: Sample related: Read ... Read More