AKUMS DRUGS & PHARMACEUTICALS LTD. Provides analytical support to comply with all GMP & Regulatory requirements.

New analytical methods development and transfer to the customer's site

Method Validation	Parameters for method validation:
Pre validation study Preparation of validation protocol Conducting  Validation Study as per Protocol Validation Report Conducted as per ICH guidelines Q2B	Specificity Linearity Accuracy Precision Limit of detection Limit of Quantification Robustness Ruggedness Solution stability.

        
                                                                                                                           

Pharmacopeial methods verification

Analytical method validations using diversified instrumentation and traditional wet chemistry techniques based on ICH requirements

Pharmaceutical services with reference to Pharmacopeias for Raw Materials, Intermediates and Finished Products for release testing.

Stability studies at various temperature stations according to ICH guidelines.

Isolation and characterization of impurities, report generation and qualification, and inclusion into specifications

Dosage forms: dissolution, tablet hardness, thickness, disintegration and friability, and uniformity of content

Testing of drug substances and drug products for light sensitivity, including and excluding packaging material.

Reference material and standards: controlling and supplying reference materials including securing reference  standard, testing and certification and then shipping to facilities requiring reference materials

Design, implement and validate cleaning procedures for processes that are compliant with current regulations

Primary container/packaging compatibility studies for various dosage forms, packaging development for drug substance and
drug product

Identification of extractables from primary packing material