Analytical Testing
Lot Release Testing
Finished product release testing includes Identification, Assay, Dissolution, Sustained release, Delayed release, Weight variation, Content Uniformity and Impurity profile
Microbiology Testing
USP water test, USP (61/62) Routine microbial enumeration tests and routine tests for specified micro-organisms and USP (51) Antimicrobial effectiveness test.
Product Stability Testing
Chroma performs accelerated stability (at 40C/75%RH) testing on many different products in different packaging components to determine the shelf life of the product. This includes Pharmaceutical, Nutraceutical and Cosmetic products. The stability study may include, appearance, assay, dissolution and impurity determination.
ICP-MS-Inductively Coupled Plasma Mass Spectrometry
Assay of Minerals and Heavy metals analysis using Inductively Coupled Plasma Mass Spectrometry.
HPLC-High Performance Liquid Chromatography
Chroma Research Labs is assisting Pharmaceutical, Nutraceutical and Cosmetic companies and chemists in developing and validating or verifying chromatographic test procedures. HPLC testing includes, Assay, Identification and Trace Impurity Analysis of raw materials, intermediates, finished products, and stability samples.
hplc method validation
Method Validation is based on current USP and ICH guidelines. Accuracy, Precicion, Linearity, Ruggedness, Robustness, Limit of Detection, Limit of Quantitation and Specificity will be studied as well as the filter study and solution stability studies based on client's requirements.