Successful analytical method development requires more than demonstrating that a procedure can produce accurate and reproducible results. Methods must also be robust, practical, and suitable for transfer to commercial Quality Control (QC) laboratories, where they will be used for routine pharmaceutical testing.
At PD Partners, we emphasize commercial QC requirements from the earliest stages of analytical development. Our scientists develop and validate methods with careful consideration of instrument compatibility, method robustness, sample preparation, testing efficiency, and long term reliability. This approach helps minimize complications during method transfer, reduce unnecessary redevelopment, and facilitate the transition from product development to commercial quality control.
Our analytical expertise also includes specialized testing for pharmaceutical products packaged in unit-dose cups and multidose bottles, with capabilities encompassing content uniformity, impurity profiling, related substances and degradation product analysis, container closure integrity, and extractables and leachables evaluations.
How It Works
Analytical method development begins with a thorough understanding of the product’s composition, dosage form, packaging configuration, and intended testing requirements. Our scientists evaluate appropriate analytical techniques, establish testing conditions, and optimize procedures to achieve reliable performance while considering the practical demands of routine commercial testing.
PD Partners maintains an extensive range of analytical instrumentation, including:
- 15 Waters HPLC systems
- 5 Vankel/Distek dissolution apparatus
- HPLC-Mass Spectrometry (HPLC-MS)
- Gas Chromatography (GC)
- UV-Vis Spectrophotometer
- Karl Fischer
- Disintegration Testing Equipment
- pH Measurement Equipment
Our laboratory also performs testing in accordance with applicable USP, BP, and EP compendial standards. Our analytical capabilities support assay determination, impurity and related substances analysis, stability-indicating method development, dissolution testing, and other pharmaceutical quality evaluations.
Our Integrated Development & Analytical Process
1. Analytical Assessment
Evaluate product characteristics, existing analytical methods, compendial requirements, and regulatory expectations to establish an effective analytical strategy.
2. Formulation Prototyping
Evaluate prototype formulations, ingredient compatibility, and critical quality attributes to identify challenges and guide formulation optimization.
3. Method Development
Develop and optimize robust, reproducible analytical methods designed for reliable testing and eventual transfer to commercial QC laboratories.
4. Method Validation
Validate analytical procedures to demonstrate suitability for their intended purpose in accordance with applicable regulatory requirements and ICH guidelines.
5. Scaling Design
Evaluate analytical requirements associated with manufacturing scale-up to ensure testing procedures remain suitable for commercial production.
6. Method Transfer
Facilitate the transfer of validated analytical methods to commercial QC laboratories, emphasizing consistent performance, reliable implementation, and appropriate documentation.
7. Labeling and Regulatory Assessment
Evaluate product specifications, stability data, and analytical requirements to support appropriate labeling and regulatory compliance.
8. Submission Preparation
Prepare analytical documentation, validation reports, specifications, and supporting data for FDA regulatory submissions, including ANDAs.
Benefits of Working with PD Partners
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Analytical methods developed with commercial QC transferability in mind
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Emphasis on method robustness, reproducibility, and routine testing efficiency
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Specialized expertise in impurity profiling, related substances, and stability indicating analytical methods
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Comprehensive analytical method development and validation capabilities
- Specialized testing for unit-dose and multidose pharmaceutical products
- Extensive analytical instrumentation and compendial testing capabilities
- Experienced scientific personnel with an understanding of both development and commercial QC requirements
Our Commitment to Quality
As a DEA registered, FDA inspected, and cGMP compliant laboratory, PD Partners maintains established quality systems and analytical procedures designed to support the accuracy, reliability, and integrity of laboratory data.
We recognize the importance of properly developed and validated analytical methods in pharmaceutical quality control and regulatory submissions. Our commitment to scientific integrity, thorough documentation, and regulatory compliance helps clients establish confidence in their analytical results and maintain consistent testing standards throughout the product lifecycle.