Microscopical analysis for structural identification.
Elemental impurities analysis encompasses trace metal/heavy metal testing to evaluate pharmaceutical products for elevated concentrations of elements such as Lead, Mercury, Cadmium and Arsenic that are of significant toxicological concern.
Oxigen Lab has expertise to analyse elemental impurities
Residual solvents in ayurvedic are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques.
Lab has capability to analysis of Residual solvents in raw materials and finished products as per Ayurvedic Pharmacopoiea/IP/BP/USP/In-house method
The purpose of stability testing is to provide evidence on how the quality of Ayurvedic products varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the Ayurvedic Products
Oxigen Labs has walk-in stability chambers and photo stability chamber to carry out stability studies.
A method is a set of experimental conditions designed to create a good analysis of a particular sample. Method development encompasses many stages and can take months to complete, depending on the complexity and goals of the method. An analytical procedure is developed to test a defined characteristic of the Ayurvedic products against established acceptance criteria for that characteristic. Early in the development of a new analytical method, the choice of analytical instrumentation and methodology are selected based on the intended purpose and scope of the analytical method. Parameters that may be evaluated during method development are specificity, linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy, and precision.
Analytical method validation is a critical activity in the pharmaceutical industry. Validation data are used to confirm that the analytical procedure employed for a specific test is suitable for its intended purposes. These results demonstrate the performance, consistency, and reliability of the analytical method. Validation data is generated under an protocol approved by the sponsor following current good manufacturing practices with the description of methodology of each characteristic test and predetermined and justified acceptance criteria, using qualified instrumentation operated under current good manufacturing practices. Protocols for both drug substance and product analytes or mixture of analytes in respective matrices is developed and executed.
Analytical method transfer activity is a documented process that qualifies a laboratory to use a metyhod that originated in another laboratory, this ensuring that receiving laboratory has procedural knowledge and ability to perform the transferred analytical method as intended.
Microbial contamination is a serious concern in any industry. The presence of microbes may effect on quality, safety, efficacy of the product, personnel and environment; particularly with the pharmaceutical products as they are administered in various forms to the patients.
To protect public health and comply with regulatory requirements, testing for the presence of potentially hazardous micro-organisms is a crucial requirement for Ayurvedic industries.
Pathogens Testing
E. Coli
Salmonella
Staphylococcus aureus
Pseudomonas aeruginosa
Candida albicanes
Aspergillus species (mold)
Streptococcus pyogenes
Shigella
Bile Tolerant gram negative bacteria
Clostridium
Coliform
Burkholderia sp.
Gluconacetobacter liquefaciens
Total microbial testing
Sterility testing
Bioburden testing
We have capability to identify the microbe upto species level.
