Impurity Profiling definition

Impurity Profiling has the meaning provided in Article 3.4.
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Examples of Impurity Profiling in a sentence

  • An Innovative Impurity Profiling of Avanafil Using Lc and Lc-Ms/Ms with In-Silico Toxicity Prediction.".

  • Organic Impurity Profiling of 3,4- Methylenedioxymethamphetamine (MDMA).

  • Development of Microwave-Assisted Extraction Procedure for Organic Impurity Profiling of Seized 3,4- Methylenedioxymethamphetamine (MDMA).

  • Synthesis and Impurity Profiling of MDMA Prepared from Commonly Available Starting Materials.

  • The purpose of the article is to assist the regulatory professionals to understand the FDA perspective on Impurity Profiling and to avoid queries on the same.Many of the queries are referenced from FDA 483 Notes and Scientific Discussions available on the internet.

  • Cross-Examination of Liquid-Liquid Extraction (LLE) and Solid-Phase Microextraction (SPME) Methods for Impurity Profiling of Methamphetamine.

  • The term "employees" as used herein shall include all full-time and regular part- time cafeteria staff employees or staff to be employed with the Employer including cafeteria managers, but excluding supervisors, substitutes, and all other employees.

  • Drug Characterization/ Impurity Profiling, United Nations Publication Sales No. E.01.XI.10 ISBN: 92-1-148139-2.

  • A good overview of forced degradation testing according to the regulatory guidance documents, with emphasis on what should be considered for late clinical phases and for registration application dossiers (i.e., marketing authorization applications or new drug applications), is provided by the Impurity Profiling Group (Klick et al., 2005).

  • A Review of Impurity Profiling and Synthetic Route of Manufacture of Methylamphetamine, 3,4- Methylenedioxymethylamphetamine, Amphetamine, Dimethylamphetamine and p- Methoxyamphetamine.

Related to Impurity Profiling

  • Disinfection profile means a summary of daily Giardia lamblia inactivation through the treatment plant. The procedure for developing a disinfection profile is contained in s. NR 810.34.

  • pseudonymisation means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person;

  • DNA profile means a letter or number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

  • Prosthesis means an artificial substitute for a missing body part.

  • Category 4 Data is data that is confidential and requires special handling due to statutes or regulations that require especially strict protection of the data and from which especially serious consequences may arise in the event of any compromise of such data. Data classified as Category 4 includes but is not limited to data protected by: the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 45 CFR Parts 160 and 164; the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g; 34 CFR Part 99; Internal Revenue Service Publication 1075 (xxxxx://xxx.xxx.xxx/pub/irs-pdf/p1075.pdf); Substance Abuse and Mental Health Services Administration regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2; and/or Criminal Justice Information Services, 28 CFR Part 20.

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • VOC content means the total weight of VOC in a product expressed as a percentage of the product weight (exclusive of the container or packaging), as determined pursuant to sections 94515(a) and (b).

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

  • ISM Code Documentation includes, in respect of a Ship:

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

  • Impulsive sound means either a single pressure peak or a single burst (multiple pressure peaks) that has a duration of less than one second.

  • Profiling means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements;

  • Pyrolysis means the thermal degradation of a substance in the absence of any oxidising agent, which does not form part of the substance itself, to produce char and gas and/or liquid; and

  • HIV means human immunodeficiency virus.

  • Capture means the process of buffering EDR data in a temporary, volatile storage where it is continuously updated at regular time intervals.

  • Reference evapotranspiration or “ETo” means a standard measurement of environmental parameters which affect the water use of plants. ETo is given expressed in inches per day, month, or year as represented in Appendix C of these Guidelines, and is an estimate of the evapotranspiration of a large field of four to seven-inch tall, cool-season grass that is well watered. Reference evapotranspiration is used as the basis of determining the Maximum Applied Water Allowances.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Microbusiness means a licensee that may act as a cannabis

  • Propagation means the reproduction of Medical Marijuana plants by seeds, cuttings or grafting.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Screening Test Technician (STT) means anyone who instructs and assists individuals in the alcohol testing process and operates an ASD.