Purification and Impurities isolation

Purification and Impurities isolation services

Purification of peptides and method development scale ranging from milligram to grams.

Intermediate purification

Impurities isolation and purification

Impurities characterization

Process development for isolation of purification project.

Analytical Method Development and validation

Analytical method development and validation are vital in the pharmaceutical industry to ensure relevant, reliable, and reproducible results. At Sythicure Laboratories, we offer regulatory-focused, phase-appropriate, and sample-specific technology for pharmaceutical validation and method development.

Our methods for development and validation in the pharmaceutical industry conform to the regulatory requirements prescribed by ICH, USP, and other pharmacopeia guidelines. We also emphasize maintaining client-specific protocols in our analytical method development and validation processes. Our sophisticated analytical technology, extensive knowledge of chemicals and drugs, and thorough understanding of current regulatory practices guarantee sensitive, accurate, specific, and precise results.

We undertake analytical method development and validations for chemical and pharmaceutical analytical procedures. The samples are tested against the following validation parameters:

  • Specificity
  • Linearity and Range
  • Accuracy
  • Precision
  • Limit of Detection and Limit of Quantification
  • Robustness

We also provide Analytical Method Development, including process validation and cleaning validation, for pharmaceutical products and bulk drugs.

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Process validation

Process validation is a documented series of actions that demonstrate that any equipment, process, procedure, material, activity, or system performs its intended functions adequately and consistently, leading to uniform batches that meet the required specifications and quality attributes.

This validation is carried out using a documented plan that outlines how validation will be conducted. The plan includes test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable results.

In the pharmaceutical industry, process validation is a crucial part of the validation cycle. Based on the initial formulation development of the drug, critical parameters are identified, optimized, and validated.

Validation tests are conducted at each stage of the process, with results compared against benchmarked acceptance criteria. Replication studies are performed on a minimum of three consecutive batches to ensure validation, precision, and repeatability, which are critical in the pharmaceutical industry.

At Sythicure Laboratories, we assess existing validation methods for the pharmaceutical industry, identify any gaps, and implement suitable improvement techniques to ensure validation success.

Cleaning validation

Cleaning validation is a technique used to verify that the processes and procedures for cleaning product residue from process equipment and components consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to concentrations within calculated acceptance limits.

In the pharmaceutical industry, factors such as microbial contamination, residue levels, and active ingredient levels are critical in determining the success or failure of drug validation. Therefore, cleaning validation is conducted according to a documented plan that outlines how cleaning will be performed. This plan includes the sampling strategy, test parameters, product characteristics, and acceptance limits.

Chemical determination of the previous product is performed at ppm levels, and detergent residues are also analyzed at ppm levels. Additionally, microbial contamination is checked to ensure optimized validation.

At Sythicure Laboratories, we are ready to be your partner in pharmaceutical validation. Explore our world-class analytical method development and validation services for high-level precision.