Content Determination of Preparation

The drug content refers to the amount of active pharmaceutical ingredients (APIs) contained in the drug, which is an important index to evaluate the quality of the drug. The content of drugs is usually determined by chemical, physical or biological and microbial methods, which is the main means to evaluate the quality of drugs and an important content of drug quality standards. At BOC Sciences, we utilize a wide range of advanced analytical technologies, including spectrography and chromatography, for comprehensive content determination.

Importance of content determination in preparations

The content determination of preparations plays a crucial role in the pharmaceutical industry. It helps in the following areas:

Ensuring consistency: Regular analysis guarantees that the API concentration in each dosage form meets predefined specifications, which is vital for consistent therapeutic effects.

Meeting regulatory requirements: Regulatory agencies such as the FDA and EMA mandate content determination to ensure drug safety and efficacy. Inaccurate content determination can lead to product recalls, legal issues, and risks to patient health.

Identifying impurities: During manufacturing or storage, impurities or degradation products may form. Content determination identifies and quantifies these impurities, ensuring the product remains within safety limits.

Stability studies: Quantifying the API at various stages of production, storage, and use is essential to evaluate the stability and shelf-life of the product. Stability studies also help in setting expiration dates and storage conditions..

Our analytical capabilities for content determination

BOC Sciences offers a broad range of advanced analytical methods for content determination of preparations, ensuring high sensitivity, specificity, and accuracy in the evaluation of pharmaceutical preparations. These methods play a crucial role in detecting and quantifying both APIs and related substances, including impurities that may impact the purity and safety of the drug. Impurities can stem from raw materials, by-products, degradation products, or interactions between drugs and excipients. Since these related substances could lead to toxic effects, their control is paramount in drug development and quality assurance.

The content determination services provided by BOC Sciences encompass several state-of-the-art techniques, including:

UV spectroscopy: A common tool for quantifying APIs and detecting impurities by measuring absorbance at specific wavelengths.

High performance liquid chromatography (HPLC): Can be used to separate, identify and quantify apis and impurities in complex mixtures. This method is widely used to evaluate the purity of raw materials and to determine the content of raw materials in final preparations. It can be used in combination with UV and MS.

Gas chromatography (GC): GC is highly effective in determining the purity of APIs and detecting volatile impurities such as solvents used during the manufacturing process. BOC Sciences utilizes GC for both API purity analysis and impurity profiling in formulations that contain volatile components or excipients. For volatile organic compounds (VOCs), GC offers exceptional resolution and sensitivity, ensuring accurate quantification and regulatory compliance for residual solvent limits.

Mass spectrometry (MS): Often used in conjunction with chromatography, MS offers high sensitivity and specificity, providing both molecular weight information and structural insights into impurities. Mass spectrometry's high sensitivity and specificity allow for the detection of trace impurities that may be missed by other techniques.

Fluorescence spectroscopy: Fluorescence spectroscopy is employed when the API or related substances exhibit fluorescent properties. At BOC Sciences, this method is used for the highly sensitive detection of APIs and impurities, even at very low concentrations. Fluorescence spectroscopy enable the detection of minute quantities of fluorescent substances within a pharmaceutical preparation.

Infrared spectroscopy (IR): A non-destructive analytical method for the identification of molecular functional groups in drug compounds. It can be used to characterize the molecular structure of compounds and also to detect certain types of impurities.

Nuclear magnetic resonance (NMR): In addition to structural analysis, NMR is widely used for quantitative analysis of pharmaceutical compounds to determine the purity and integrity of apis.

NMR can detect and quantify a variety of structural isomers, degradation products, and impurities that may be overlooked by other techniques.

Differential scanning calorimetry (DSC): A method that can be used to determine the absolute content of all impurities contained in a sample to be tested. For the low eutectic system where the melting point of the reference material to be measured is reduced due to the presence of a small amount of impurities, DSC analysis can show many advantages, such as fast analysis speed, simple operation, small amount of sample to be measured, no need to dissolve solvents, and no need to use traceable reference material.

Raw material purity and API content determination

BOC Sciences applies HPLC and GC to assess the purity of raw materials and quantify the API content in formulations, including accelerated testing (3 months or more) to assess stability. The use of MS and NMR enhances the precision of these methods, ensuring the accurate determination of both small molecules and large, complex compounds.

Impurity profiling and degradation product analysis

To monitor impurities that may arise from the manufacturing process, storage, or degradation. BOC Sciences integrates HPLC, GC, and MS techniques. These methods can detect degradation products and impurities even at trace levels, which is critical for maintaining the safety and efficacy of pharmaceuticals.

Sample requirements for content determination

The content determination process requires specific sample types and quantities to ensure accuracy and reproducibility. Below is a general outline of the sample requirements:

Why choose BOC Sciences?

Comprehensive analytical solutions: BOC Sciences offers a broad spectrum of nine advanced analytical techniques, including UV Spectroscopy, HPLC, GC, MS, IR, NMR, and DSC.  combining HPLC with MS achieves a detection sensitivity that can identify impurities at concentrations as low as 0.1% of the total API.

Regulatory compliance: All analyses were conducted in accordance with current Good Manufacturing Practice (cGMP) and international regulatory standards such as ICH Q3A/B, FDA and EMA guidelines.

Advanced equipment: These include high-resolution HPLC-MS systems, ultraviolet-visible spectrophotometers, nuclear magnetic resonance spectrometers, and differential scanning calorimeters (DSC). By utilizing advanced instrumentation, we have reduced turnaround time for API content determination by 30%, providing faster results without compromising data accuracy. Our state-of-the-art high-performance liquid chromatography systems are capable of resolving complex mixtures in 20 minutes with an accuracy level of less than 0.5% relative standard deviation (RSD).

Customization and flexibility: We offer tailor-made solutions, choosing the most appropriate method to ensure accurate and relevant results for each specific product type. Allows adjustment of test conditions based on factors such as API concentration, matrix complexity, and degradation potential. Ensure accurate analysis from liquid injection to oral solid dosage forms.

Experienced team: Over 20 years of experience in the pharmaceutical industry.

FAQ

1. What is the typical turnaround time for content determination analysis at BOC Sciences?

The turnaround time varies depending on the method and complexity of the preparation. However, we typically provide results within 2-4 weeks.

2. Can BOC Sciences analyze trace levels of API or impurities?

Yes, with advanced techniques like HPLC, MS, and Fluorescence Spectroscopy, we can detect and quantify APIs or impurities at trace levels.

3. Does BOC Sciences offer method development services for content determination?

Absolutely. We provide method development and validation services to ensure the chosen analytical method is optimal for your specific formulation.

4. Can you analyze the stability of the API over time?

Yes, we offer stability testing as part of our content determination service, allowing us to monitor API concentration and degradation over time, particularly under accelerated conditions.

5. What are the advantages of using HPLC for content determination?

HPLC offers high sensitivity, precision, and versatility. It is suitable for both simple and complex formulations, providing reliable quantitative data on APIs and impurities.