MRL develops and validates customized methods and procedures as needed to meet specific client needs. MRL analytical services include setting specifications, impurity screening, study support and routine analytical testing for raw materials, in-process and release.

Analytical Development & Method Validation
MRL offers development of fully validated analytical methods to isolate the desired product from all measureable impurities, or validation of the clients' analytical methods.

Setting Specifications
MRL will assist in developing specifications that fully describe and control the quality of a client's product.

Stability and Stress Studies
MRL offers stability testing for Active Pharmaceutical Ingredient (API), drug product and related intermediates following ICH guidelines.

Identification and Synthesis of Impurities
MRL will help in identifying all measurable impurities and isolate these by preparative HPLC or synthesis.

Characterization and Synthesis of Standards
MRL can synthesize and characterize all analytical samples provided by or for the client.

Analytical Control
MRL performs routine testing using methods transferred from the client or developed at MRL.

 

MRL Analytical Methods include: Antifoams Pluronic Acid Polysorbate 80 Residual Ethylene Glycol Residual Tri-butyl phosphate MTX Additives Vitamins Amino Acids Phospholipids

 

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