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APIs, Raw materials, and Excipient

APIs, Raw materials, and Excipient testing: Ensure quality and compliance

Residual Solvents Analysis

APIs, Raw materials, and excipient testing play a very significant role in the pharmaceutical industry. They ensure the safety, effectiveness, and compliance of the product with regulations. Chromak Research offers relatively affordable APIs, raw materials, and excipient testing (APIS, RM & EXP testing), which meets the rigorous demands of pharmaceutical manufacturing companies. Modern techniques and up-to-date instruments guarantee the quality and reliability of the results obtained.

APIs, Raw Materials, and Excipient Testing Significance

Raw materials (RM) form the raw body of pharmaceutical products, while excipients aid in stabilizing, preserving, and optimizing APIs. The components have to be tested for purity and safety purposes to abide by all regulatory requirements from all around the world. APIs, Raw materials, and excipient testing are essential to ensure:

Purity and Safety

Contaminants and residual solvents should be identified and removed along with other impurities ensuring product integrity in the outcome.

Consistency

Variation in batches is controlled to eliminate diversity in the pharmaceutical manufacturing process.

Compliance

Ensure that standards set by FDA, EP, USP, JP, BP, etc., are met.

Our Services of APIs, Raw materials, and Excipient testing

At Chromak Research, we follow strict protocols in the APIs, raw materials, and excipient testing for our clients. Our services encompass of following:

The analytical solution to all compliances required from EP, USP, JP, BP, ACS, and FCC standards.

Volatile compounds may degrade the product or may affect safety. So these residual solvents have to be identified and quantitated.

Minimize or reduce the toxicological risk by testing under USP <232> and <233> for heavy metals.

Provides elemental composition characterization in detail of the compound.

Gives information on various types and number of microorganisms present in a sample.

Our Advanced Techniques for Accurate Testing

APIs, raw materials, and excipient testing are done here with the new technologies at economic precision. Our advanced technologies or instruments are as follows:

GC-MS (Gas chromatography Mass spectrometry) and GC-HS (Gas Chromatography-head space) are utilized for detailed impurity profiling.

Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) for the elemental quantification of the material.

Total Organic Carbon (TOC) and Non-Volatile Residue (NVR) to confirm that the product is clean and pure.

UV /Visible spectrophotometry gives the composition with the concentration of the Sample.

LC-MS (Liquid chromatography Mass spectrometry) providing excipient API analysis in a deep,

Fourier Transformation Infrared-FTIR Spectroscopy to identify it with functional group rapidly.

Specialized Testing for Pharmaceutical Applications

We ensure excellence in laboratory testing of raw materials for the determination of particulates, residues, extractable, and leachable while ensuring them to be up to par with very tight safety standards. Similarly, lab testing of our excipients assures their functionality, which enables longer shelf life and controlled release of the drug with high thermodynamic stability.

Our practices cover:

  • Testing for Pharmaceutical Water according to EP, USP, and JP.
  • Closure Integrity Testing on the Container – ensuring packaging component safety and robustness.

Why Choose Chromak Research for APIs, Raw materials, and Excipient testing?

Our laboratories have been optimized, which means our analysts can work through specialized techniques to the project’s specific requirements.

This is one of the most complete testing packages, found within this industry, that also comes with 24/7 online data access.

Our expert team is well versed in scientific problem-solving and compendial consultation to solve the most complex issues.

Prevent costly production delays and guarantee compliance with our comprehensive testing solutions. We offer affordable APIs, raw materials, and excipient testing.

We provide results that are accurate based on international standards with the use of the latest technology.

If you are looking for accurate testing for APIs, raw materials, and excipients, Chromak Research is a major provider of these testing services that tailor solutions according to the client’s specific needs. Rely on us for reliable and cost-effective APIs, raw materials, and excipient testing services to ensure the quality and safety of your pharmaceutical products. Partner with us to comply with laws and gain consumer trust.