Your Partner in Pharmaceutical Excellence
Analytical method development and validation Services
Energon Labs can develop and validate methods for raw materials, excipients, drug substance and drug products. With our diverse experience and research background we work with you to develop and validate a method to meet your specific requirements. Method development and validations are done compliance to compendial and regulatory requirements as per ICH Q2 (R2) guideline “Validation of Analytical Procedures: Text and Methodology” and USFDA guidelines.
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Extractables and Leachables Studies
Energon Labs is a one Stop solution for testing Extractables in Container closure systems, Single-use manufacturing components, Ink migration, Glass delamination, Chemical characterization of Medical devices and Leachable studies in all dosage forms.
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GTI & Nitrosamine Impurities Analysis
Genotoxic Impurities are chemicals that can harm by causing damage to DNA. Regulatory agencies worldwide require thorough testing for these impurities. We can help you ensure compliance to safeguard consumer health.
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Elemental Impurities Analysis Services
Drug substance/ products may contain trace amounts of elemental impurities that could be harmful, even at low concentrations. We test heavy metal or elemental impurity residues to ensure compliance with current regulatory requirements. Energon Labs offers highly sensitive ICP-MS testing services in line with ICH Q3D Guideline for Elemental Impurities.
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Stability and Photostability Studies
Energon Labs can support our client for execution of stability studies through well designed stability protocols, coordination for stability program, timely pull out and analysis of stability samples. We provide stability testing and storage services to the pharmaceutical industry. Our facility conducts ICH stability studies using methods supplied by clients, compendial methods, or internally validated procedures.
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Cation & Anion Testing
Cation and Anion testing services are a vital part of the development process in the pharmaceutical, cosmetic, and food industries. They play a crucial role in ensuring the quality, safety, and efficacy of these products. The primary goal of Cation and Anion testing services is to monitor the physical, chemical, and biological properties of a product over a predetermined period.
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Peptide Analysis Services
Effective Characterization of peptide therapeutics at each step of manufacturing is necessary to minimize lot-to-lot variation in product quality. Ensuring the quality and equivalence between generic and brand name peptide drug products raises a number of challenges and those challenges differ according to the type of peptide drug. To prove the pharmaceutical equivalence of such synthetic peptides with the innovator drugs (Synthetic or rDNA origin), it is required to have a thorough understanding of advanced analytical and bioanalytical tools.
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In-Vitro Binding Studies Services
The BE approach is not applicable for Locally Acting Gastro Intestinal Drugs since they are not intended to be absorbed into the systemic circulation and thus, drug concentration needs to be estimated at the local GI tract site. These drugs dissociate in the acid environment of the upper GI tract to release ionic drug species that bind to dietary phosphate or bile acids to form an insoluble complex that is eliminated via feces.
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Peptide Impurities and Synthesis Services
We make AAD’s with utmost quality at an affordable cost that can be used as SMs for your peptide API. Having sound experience with AAD’s and other starting material, we also provides quality API with highest possible purity.
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RLD Supply Services
Reference Listed Drug (RLD) supply services are a critical part of the development process in the pharmaceutical and biotech industries. These services involve sourcing and supplying RLDs as required (specific batches & expiries) on an international scale. The primary goal of RLD supply services is to provide the necessary reference drugs for bioequivalence studies and clinical trials.
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ENergon Labs is Equipped with the state-of-the art Equipment
Accreditations
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