Sourcing Solutions:

With years of experience in the industry, we have developed in-house proficiency and expertise in handling and understanding chemical and pharmaceutical products. Our extensive experience as a global exporter has given us a deep understanding of the rules and regulations of different countries. To leverage this expertise, we have established a division dedicated to serving clients and customers worldwide. This division specializes in sourcing APIs, intermediates, specialty chemicals, nutraceuticals, and cosmetic ingredients.

 Custom Synthesis Services:

In the pharmaceutical industry, which operates globally and is driven by innovation, custom synthesis plays a crucial role in developing and expanding product ranges. Custom chemical synthesis is deeply rooted in the processes of drug discovery and development.

In custom synthesis, a corporation or customer requests the production of a specific molecule tailored to their requirements. This involves creating the molecule at a designated scale, with the specified purity, and following the provided processes or specifications.

Custom synthesis projects with small-scale or low-volume requirements, typically for new or non-commercially available molecules, are managed by Contract Research Organizations (CROs). Large-scale projects, requiring chemical products in quantities exceeding one ton, are best handled by Contract Manufacturing Organizations (CMOs). Organizations capable of managing both chemical research and manufacturing outsourcing needs are hybrids of CROs and CMOs, known as Contract Research and Manufacturing Organizations (CRAMs).

Custom synthesis is a valuable option for drug developers needing active pharmaceutical ingredients (APIs) or other organic/inorganic chemicals to make their products effective. If it is impossible or impractical to produce these molecules and compounds in-house, outsourcing to professionals specializing in the relevant sector is a prudent choice. It is advisable to consider outsourcing the manufacturing of such products to experts in the field.

In the industry, it is customary for contracts to be executed exclusively for the contracting company, always adhering to confidentiality agreements. Custom synthesis projects can vary in scale, ranging from a few milligrams to 10 kilograms or more.

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.

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.