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 pharmaceuticals 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.
Oxigen Labs has capability to analysis of Residual solvents in raw materials and finished products as per IP/BP/USP/In-house method.

Rate of dissolution is a critical quality attribute of a pharmaceutical tablet/capsules. Dissolution is typically studied by examining the form of the dissolution profile, which is the percentage of the tablet dissolved at various points in time.

Impurity profiling describes the account or description of maximum possible types of identified or unidentified impurities present in any APIs. These impurities can be API related impurities, process related impurities or stability related impurities. API related impurities include stereochemistry, crystallization, and functional group of APIs. Process related impurities include chemicals, reagents, catalysts, residual solvents, synthetic intermediate products, by product, degradation products, method conditions related impurities, and formulation related impurities. Stability related impurities include degradation or transformation of APIs, mutual interactions among APIs, excipients present in drug product. Presence of these unwanted impurities may influence bioavailability, safety and efficacy of APIs.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product 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 drug substance or a shelf life for the drug products as per ICH guidelines.

Lab conducts:

Accelerated stability studies

Long term stability studies

Photo stability studies

Degradation studies

Oxigen Labs has walk-in stability chambers and photo stability chamber to carry out stability studies.

Pharmaceutical equivalents are drug products in identical dosage forms and route(s) of administration that contain identical amounts of the identical active drug ingredient.

Multimedia dissolution profile with similarity factor (F1 & F2)

Comparison of excipient content, reverse engineering.

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 drug substance or drug product 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 method 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 across pharmaceutical Industry.

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

Vitamin B12, Folic Acid and antibiotics assay

Antimicrobial efficacy testing

Bacterial endotoxins test as per LAL/ Gel clot method

Preservatives efficacy/ antimicrobial effectiveness testing

Bioburden testing

MLT, BET, Bioburden, Sterility method validations

Environment monitoring for clean rooms

Chemical disinfectant testing and cleaning studies

Microbial identification

Cleaning validation