logging in or signing up Reference standard in analysis of any new drugs gitesh_pharma Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 412 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: March 22, 2011 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript REFERENCE STANDARD: REFERENCE STANDARD Mr. Gitesh Patel GUIDE BY: Dr. P. Malairajan M. Pharm 1 st yearDEFINATIONS: DEFINATIONS Drug Substance: These are new chemical entity(NCE) or the active pharmaceutical ingredient(API), in early phases of drug development consist consist of the following components: Active moiety Counter ion Water or solvent molecules (DS)Slide 3: Active Moiety: Drug Product: These is the pharmacologically active species. These are the finished product or finished dosage form , DS formulated with inactive ingredients (excipients) to appropriate delivary to human.TYPES OF REFERENCE STANDARDS: TYPES OF REFERENCE STANDARDS 1) Analytical Reference Standard (ARS) (Primary Standard / Gold standard) 2) Working Standard (WS) (Secondary Standard /In House Standard/ Laboratory Standard)Slide 5: ARS : It is defined as a batch of drug substance, whose purity is independently established & accepted without reference to other standard. (purity>99.5%) WS : It is used for routine analytical comparition of batches of API or dosage forms in cases where a high purity ARS is difficult to obtain. (purity > 95%)Techniques Commonly Applied to the Qulification of Reference Standard: Techniques Commonly Applied to the Qulification of Reference Standard 1. Appearance (physical description) a) Visual inspection b) Optical microscopy 2. Identification (proof of structure) a) Elemental analysis b) UV/Visible spectroscopy c) Infrared spectroscopySlide 7: d) Raman spectroscopy e) X- ray diffraction f) Highresolution mass spectroscopy g) NMR spectroscopy h) Optical rotatory dispersion 3. Assay a) Titration b) Phase solubility analysisSlide 8: 4. Purity a) Loss on drying b) Karl fischer titration c) Residue on ignition d) Thermogravimetry analysis f) HPLC g) Ion chromatography h) Electrophorotic separation i) Supercritical fluid chromatography j) TLC k) chiral chromatography l) Gas chromatographyGovernance: Governance The requirements for the laboratory control of reference standards was embedded in the Code of Regulations(CFR). Title 21 CFR Part 211 section 194 subsection 8b states “Complete records shall be maintained of any testing & standardization of laboratory reference standards, reagents, and standard solution.”Slide 10: Reference standards SOPs typically fall into two categories: a) Reference standard control & use procedures b) Reference standard qualification procedures.Control & Use procedure: Control & Use procedure A scope for the reference standards covered by the procedure has been identified. Proper documentation should be maintained for RS.(COA & qualification reports) RS entering into lab. with name, number, lot No.,storage condition,retest date & the analyst to whom the RS is assigned. All RS labeled with their identity, potency, correct use & storage condition. The RS is removed from lab & properly disposed on or before the date of requalification or expiry.Qualificatin procedure: Qualificatin procedure It state whats types of standards wiil be qualified according to procedure & which types of standards are excluded. Approved source for RS are identified. Analytical test for each RS. RS categorised for their use. Scientific defencible process for purity. Retest ,requalification & expiry are assigned. The test result recorded properly for regulatory agency. Potency of RS same up to expiry.Slide 13: THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.