A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients
Bashir Daoud Agha Dit Daoudy1, Mohammad Ammar Al-Khayat1, Francois Karabet2
1Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria.
Journal of Analytical Methods in Chemistry
|April 25, 2018
Summary
A new method accurately detects formaldehyde, a pharmaceutical impurity, in excipients. This simple, cost-effective gas chromatography technique ensures drug safety and efficacy.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Formaldehyde is a reactive impurity in pharmaceutical excipients.
- Impurity levels can impact drug product stability, safety, efficacy, and performance.
Purpose of the Study:
- Develop and validate a method to quantify formaldehyde in pharmaceutical excipients.
- Establish a reliable analytical technique for impurity profiling.
Main Methods:
- Static headspace gas chromatography (GC-FID) was employed.
- A derivatization procedure using acidified ethanol formed diethoxymethane.
- Direct analysis of the derivative was performed using GC-FID.
Main Results:
- The method demonstrated specificity, accuracy, and precision.
- Limits of detection and quantification were 2.44 µg/g and 8.12 µg/g, respectively.
- The technique successfully analyzed formaldehyde in common pharmaceutical excipients.
Conclusions:
- A simple, economic, and validated GC-FID method was established for formaldehyde determination.
- This analytical approach is suitable for routine quality control of pharmaceutical excipients.
- Ensuring low formaldehyde levels is crucial for pharmaceutical product quality.
More Related Videos
08:37Measurement of H2S in Crude Oil and Crude Oil Headspace Using Multidimensional Gas Chromatography, Deans Switching and Sulfur-selective Detection
Published on: December 10, 2015
19.9K
09:03Assessment of Methane and Nitrous Oxide Fluxes from Paddy Field by Means of Static Closed Chambers Maintaining Plants Within Headspace
Published on: September 6, 2018
13.1K
Related Concept Videos
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
189
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
189
01:26Pharmaceutical Equivalents
208
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
208
01:05Static Equilibrium - I
18.9K
A rigid body is said to be in dynamic equilibrium when both its linear and angular acceleration are zero, relative to an inertial frame of reference. This means that a body in equilibrium can be moving, but only when its linear and angular velocities are constant. A rigid body is said to be in static equilibrium when it is at rest in the selected frame of reference. The distinction between static equilibrium (e.g., a state of rest) and dynamic equilibrium (e.g, a state of uniform motion) is...
18.9K
01:07Static Equilibrium - II
10.0K
Static equilibrium is a special case in mechanics that is very important in everyday life. It occurs when the net force and the net torque on an object or system are both zero. This means that both the linear and angular accelerations are zero. Thus, the object is at rest, or its center of mass is moving at a constant velocity. However, this does not mean that no forces are acting on the object within the system. In fact, there are very few scenarios on Earth in which no forces are acting upon...
10.0K
01:18Static Friction
1.5K
Static friction is a force that opposes the relative motion or tendency of motion between two surfaces in contact. It plays a crucial role in our daily lives, from walking on the ground to driving a car.
For example, consider a scenario where a truck is connected to a car by a rope, ready to tow it along a road. When no external force is applied by the truck, the car remains stationary and is said to be in static equilibrium. In this case, the forces acting on the car, such as gravity and the...
For example, consider a scenario where a truck is connected to a car by a rope, ready to tow it along a road. When no external force is applied by the truck, the car remains stationary and is said to be in static equilibrium. In this case, the forces acting on the car, such as gravity and the...
1.5K
01:28Problem Solving in Statics
1.7K
Problem-solving in statics is a crucial aspect of engineering and physics that involves resolving issues associated with bodies in a state of equilibrium. In most cases, problem-solving requires several steps to achieve an accurate result. These steps are crucial to ensuring that the solution is accurate and practical.
The physical situation and mathematical modeling must be considered; however, it is challenging to represent all physical situations using mathematical modeling. With the help of...
The physical situation and mathematical modeling must be considered; however, it is challenging to represent all physical situations using mathematical modeling. With the help of...
1.7K