We provide analytical services for NCEs, APIs and formulation of DS and DP. We are well equipped with high-end instruments for purification like Mass Directed Purification (MDD) and Supercritical Fluid Chromatography (SFC). We also facilitate impurity identification, characterization and isolation. We provide end-to-end support for analytical services. The state-of-the-art infrastructure at our R and D centers is well-equipped with the latest analytical instruments that enable us to provide high-quality, cost-effective services for our customers.
Hyphenated analytical instruments
Experience in handling complex molecules
Strong data integrity and digitization
End-to-end support for analytics
JANUARY 04, 2021
Amino acids, peptides and proteins play multiple roles in the normal functioning of the body.Group of amino acids between 2 to 50 are called peptides. They often act as hormones and play diverse roles in the normal biological processes in the human body such as metabolism, intercellular signaling and neurotransmission.Peptide synthesis based drug have a high pote...Read More
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....Read More
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more....Read More
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...Read More
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...Read More
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...Read More
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...Read More
We can analyze the below development samples related to
Below are the set of guidelines used for method validation
|<1225>&<1226>||US Pharmacopoeia chapter|
|CDER Guidance||Guideline for Submitting Samples and Analytical Data for Methods Validation. February 1987.|
|CDER Reviewer Guidance||Validation of Chromatographic methods. November 19|
|ICH Q2 (R1)||Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization|
|ICH Q6A||Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonization.|
|ICH Q7||GMP Guidance for Active Pharmaceutical Ingredients, International Conference on Harmonization.|
|RDC.N°17||Good Practices for medicament manufacturing|
|RDC.N°53||“Establishes parameters for reporting, identification and qualification of degradation products in synthetic drugs with active substances and semi-synthetic classified as new, generic and the like and other measures”.|
|RE.N°166||Guide for validation of Analytical and Bio-analytical methods|
|USP General chapters||General tests and assays.|
Below is the list of equipments or instruments used
Stability indicating nature of analytical method will be demonstrated during analytical method development of drug substance related substances and assay method. To demonstrate the stability indicating nature of analytical method, degradation samples shall be generated by stressing the test sample with acid, base, water hydrolysis, oxidative, thermal and photostability study. The degraded sample shall be analyzed and demonstrated the separation of degradation impurities from known impurities and analyte peak. Photostability study shall be carried out as per ICH QIB.
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