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1. Analytical Method Development:

Tailored Approach: Our experts design analytical methods tailored to the specific characteristics of each pharmaceutical compound.

Optimization Strategies: We employ optimization strategies to enhance method sensitivity, selectivity, and robustness.

2. Assay Development and Testing:

Quantitative Analysis: Development of precise assays to quantitatively measure the concentration of active pharmaceutical ingredients (APIs).

Routine Testing: Regular testing to ensure batch-to-batch consistency and adherence to specified potency levels.

3. Related Substance Analysis:

Impurity Identification: Comprehensive testing for the identification and quantification of related substances and impurities.

Regulatory Compliance: Adherence to regulatory guidelines to ensure product safety and efficacy.

4. Dissolution Testing:

Release Profile Assessment: Evaluation of dissolution profiles to ensure proper drug release from pharmaceutical formulations.

Method Validation: Rigorous validation of dissolution methods to guarantee accuracy and reliability.

5. Nitrosamine Detection and Analysis:

Advanced Detection Methods: Utilization of advanced analytical techniques, such as HPLC-MS and LC-MS/MS, for sensitive nitrosamine detection.

Mitigation Strategies: Development of strategies to mitigate and manage nitrosamine-related risks.

6. Peel, Tack, and Shear Testing:

Packaging Integrity: Assessment of packaging materials through peel, tack, and shear testing to ensure product integrity.

Quality Control: Routine testing to maintain packaging quality standards and prevent product contamination.

7. Uniformity Testing:

Content Uniformity: Testing for the uniform distribution of APIs in pharmaceutical formulations.

Blend Uniformity: Ensuring homogeneity in the blending process to prevent dose variations.

8. Microbial Limit Testing:

Microbial Contamination Control: Comprehensive testing to establish and maintain microbial limits in pharmaceutical products.

GMP Compliance: Adherence to Good Manufacturing Practices (GMP) to prevent microbial contamination during production.

9. Assay of Components:

Component Purity Analysis: Accurate assays to determine the purity of individual components in complex formulations.

Regulatory Alignment: Ensuring component assays align with regulatory requirements for safety and efficacy.

Conclusion:

Our analytical method development and testing services provide a holistic approach to ensuring the quality, safety, and regulatory compliance of pharmaceutical products. By combining advanced analytical techniques with optimized testing protocols, we contribute to the overall success of pharmaceutical formulations, meeting the highest industry standards and regulatory expectations.