METHOD VALIDATION

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METHOD VALIDATION

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ANALYTICAL DEVELOPMENT : 

ANALYTICAL DEVELOPMENT R & D a ALKEM Monthly report of June 08

ANALYTICAL DEVELOPMENTWork accomplished June 2008 : 

ANALYTICAL DEVELOPMENTWork accomplished June 2008 R & D a ALKEM

ANALYTICAL DEVELOPMENT Work planned for July 2008 : 

ANALYTICAL DEVELOPMENT Work planned for July 2008 R & D a ALKEM

ANALYTICAL DEVELOPMENT Accomplishments/Likely to accomplishments in the month of June 2008 : 

ANALYTICAL DEVELOPMENT Accomplishments/Likely to accomplishments in the month of June 2008 R & D a ALKEM Lisinopril tablets method transfer (Gr C) Risperidone tablets methods pre-validation and evaluation of Risperidone tablets related substances (USP 31) (Gr C) Losratan tablets and Losartan + HCTZ tablets dissolution investigation in pH 2.1 and 4.5 media (Gr C) Work started for Kajakistan projects related Risedronote Sodium method developments completed and method validation going on (API) Hold time study for Pantoprazole Sodium for injection completed (Domestic) Asprin and Clopdogrel Capsules method validations completed (Domestic) Mimimisation of errors in method validation documents Establishment of Central compliance and documentation system. Completion of hard ware validation of 10 Agilent HPLC systems (software validation is going on) Installation of 2 new sophisticated balances with full security and protection of date and time with password Updation of exisitng Shimadzu HPLC with auto samplers Set up of Analytical Development group to support API Chemical, Biotechnology and Nutraceuticals

ANALYTICAL DEVELOPMENTworks planned in month of July 2008 : 

ANALYTICAL DEVELOPMENTworks planned in month of July 2008 R & D a ALKEM Uniform implementation of GLP Systems across AD departments. Chromeleon software validation for 10 HPLC systems To further improve support level versus timelines of targets for Group C projects Renovation of existing lab to accommodate more no. of HPLC and dissolution apparatus. Installation/Validation of Dissolution and HPLC’s systems Risperidone tablets method validation/documentation and preparation for scale up batches Ramipril Capsules methods pre-validation Stability charging for Olanzapine API Method validations for Olanzapine API