by maheshbhuva | May 19, 2023 | Analytical Chemistry, stability
Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit. Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained....
by maheshbhuva | May 18, 2023 | Hplc
Phosphate buffer Citrate buffer Formate buffer Acetate buffer Tris(hydrixymethyl) -aminomethane Phosphate buffer Pka 2.1 Ph range 1.1 tob3. 1 Pka 7.2 Ph range 6.2 to 8.3 Pk 12.3 Ph range 11.3 to 13.3 Citrate Pka 3.1 Ph range 2.1 to 4.1 Pka 4.7 Ph 3.7 to 5.7 Pka 5.4 Ph...
by maheshbhuva | Apr 9, 2023 | Deviation, Documents error (DIN), QMS
Why investigation? To identified error Random error Impacts precision (Weight error dilution error injection to injection error Example document error, document error [ note : Precision show random error which is not control for us] +- positive and negative error...
by maheshbhuva | Apr 6, 2023 | 621 USP CHAPTER
Adjustment of Mobile Phase Adjustment in composition of the mobile phase Adjustment ph of the aqueous component of the mobile phase Adjustment in concentration of salts in the buffer component of a mobile phase Adjustment in composition of the mobile phase Minor...
by maheshbhuva | Apr 5, 2023 | 621 USP CHAPTER, Analytical Chemistry
All chapter are use full for ADJUSTMENT of chromatography, TLC etc In such case some questions arias that Why adjustment in chromatography ? How adjustment justified ? Adjust chromatography If your method is validated and method are submitted in DMF so...