Download 5.17 Kb.Pdf ko'rish
Хроматография — метод разделения смесей веществ или частиц,
основанный на различиях в скоростях их перемещения в системе
несмешивающихся и движущихся относительно друг друга фаз.
Колонка — содержит хроматографический сорбент, выполняет функцию
разделения смеси на индивидуальные компоненты.
Элюент — подвижная фаза (растворитель или смесь растворителей): газ,
жидкость или (реже) сверхкритический флюид.
Неподвижная фаза — твердая фаза или жидкость, связанная на инертном
носителе, в адсорбционной хроматографии — сорбент.
Хроматограмма — результат регистрирования зависимости концентрации
компонентов на выходе из колонки от времени.
Детектор — устройство для регистрации концентрации компонентов смеси
на выходе из колонки.
Хроматограф — прибор для проведения хроматографии
-величина подъема пятна ,
не зависит от размера пластинки,
времени разделения и (при достаточно малой массе пробы) от концентрации
компонента в пробе и присутствия других компонентов, то есть это
Ультрафиолетовая спектроскопия -
оптич. спектроскопии, включающий получение, исследование и применение
спектров испускания, поглощения и отражения в ультрафиолетовой области,
т. е. в диапазоне длин волн 10-400 нм.
абсорбционного спектрального анализа, основанных на избират. поглощении
(D), мера непрозрачности слоя вещества толщиной l для световых луче
излучения в слоях различных веществ.
Toxicological chemistry is the science which studies toxic and potent substances,
their physical and chemical characteristics and prepares samples for analysis as well
as methods of isolation and quantitative determination of these substances.
Toxicology is the science that deals with the study of the mechanism of chemicals‘
toxic actions, diagnostics and prevention of poisoning cases as well as treatment of
Toxicology - (in Greek toxikon - poison, logos - study) - the science which studies
the toxic characteristics of chemical substances and their impact on living organisms
Toxicity- is the ability of chemicals substances to affect biological objects by
Toxic substances – in toxicology, any chemical substance which causes disease or
death (such as intoxication, poisoning, etc.) in contact with the body called harmful
Toxicant - substances which cause not only the toxicity but also provoke other
forms of toxic processes
Xenobiotics - is an alien chemicals to the body that have negative impact on the
body despite its amount.
Poisoning - a pathological condition or dysfunction of biological systems
occurring when the toxicant interacts with an organism (it is also called substance
Toximeter - a set of methods and techniques to conduct quantitative assessment
for the toxicity and danger of harmful substances.
Cumulation - Harmful substances may gradually accumulate in the body with
repeated interactions. This phenomenon is called cumulation or cumulation material
occurring when proceeding substance in an organism exceeds the removing poison
Maximum Permissible Concentration (MPC) - hygienic classification is
based on quantitative assessment of danger of chemical compounds obtained on the
basis of experimental data on the determination of their maximum permissible
Approximate Safety Level of Exposure (TSEL) - preliminary MPC value,
obtained by using calculation methods
LD 50 - values of the statistical average lethal doses or concentrations which are
chosen because these values corresponds to 50% death of the experimented objects
Drug addiction - The World Health Organization defined drug addiction as a
state of episodic or chronic poisoning caused by repeated introduction of the drug.
Morphinism – is type of addiction triggered by the usage of opium, morphine,
codeine and other alkaloids containing in milky juice of the poppy.
Cocainism - caused by cocaine, which belongs to the group of the oldest
psychoactive agents. It leads to irresistible desire to repeat the drug consumption.
Hashishism – is the type of drug addiction caused by consumption of Indian or
southern hemp (marijuana, hashish).
Extraction (lat extraho -. Recoverable) - method of extracting a substance from
a solution or a dry mixture with a suitable solvent (extractant). To extract from a
mixture of solvents are immiscible with this mixture.
Extractant - Solvent extraction involves the transfer of one (or more) of soluble
substances contained in the feed solution, in another immiscible liquid (extractant).
Ekstrakt- extractant enriched with soluble substances called extract
Metabolism - The sum of the physical and chemical changes in living cells by
which energy is provided for vital processes and growth in cell mass.
Metabolite - Any of the various organic compounds produced by metabolism.
summation (additivity) - the phenomenon of additive effects induced by the
potentiation (synergy) - Strengthening of effect; Effect more than the
antagonism - the effect of the combined effects of less expected in the simple
Analytical Procedure: The analytical procedure refers to the way of performing
the analysis. It should describe in detail the steps necessary to perform each analytical
test. This may include but is not limited to: the sample, the reference standard and the
reagents preparations, use of the apparatus, generation of the calibration curve, use of
the formulae for the calculation, etc.
Analyte: Substance for which analysis is being performed.
Annual Product Quality Review (APQR): APQR is overall review
of the product manufactured during the whole calendar year , for all the
parameters including critical parameters and trend of the batches .
Batch (or Lot): A specific quantity of material produced in a process
or series of processes so that it is expected to be homogeneous within
specified limits. In the case of continuous production, a batch may
correspond to a defined fraction of the production. The batch size can be
defined either by a fixed quantity or by the amount produced in a fixed time
BET: A toxin that forms an integral part of the cell wall of certain
bacteria and is only released upon destruction of the bacterial cell.
Endotoxins are less potent and less specific than most exotoxins and do not
form toxoids. Also calledintracellular toxin.
Binder:An excipient used to increase powder cohesiveness,which
increases the bonding strength of the final product.In wet granulation, they
help to form agglomerates.
Bioavailability: A measure of the fraction of a drug that enters the
systemic blood circulation after oral administration. The usual measure is
the ratio of the AUC of two different formulations of the same drug,
corrected for dose.
Bioequivalence: A high degree of similarity in the bioavailabilities of
two pharmaceutical products (of the same galenic form) from the same
molar dose, that are unlikely to produce clinically relevant differences in
therapeutic effects, or adverse effects, or both
Biopharmaceutical Classification System (BCS):
A system of classification of
drugs based on their solubility and their permeability through the gut wall. The
system was introduced by Professor Gordon Amidon in 1995. A soluble drug is one
whose highest dose is soluble in 250ml or less of aqueous media over the pH range 1
to 7,5. A permeable drug is one that is more than 90% absorbed from the human gut.
Permeability may be determined using in vitro model systems. The BCS classes are
Class 1: high solubility & high permeability. Class 2 = low solubility & high
permeability. Class 3 = High solubility & low permeability. Class 4 = low solubility
& low permeability.
Calibration: The demonstration that a particular instrument or device produces
results within specified limits by comparison with those produced by a reference or
traceable standard over an appropriate range of measurements.
Change-Being-Effected Supplement (CBE) - A submission to an approved
application reporting changes that FDA has identified as having moderate potential to
adversely affect the identity, strength, quality, purity, or potency of a product as they
may relate to the safety or effectiveness of the product. A CBE supplement must be
received by FDA before or concurrently with distribution of the product made using
CEP: CEP stands for Certification of suitability of European Pharmacopoeia
monographs. COS (―Certificate of Suitability‖) means the same and, even if often
used, is not the official acronym.
Combination product: A drug product which contains more than one drug
Contamination: The undesired introduction of impurities of a chemical or
microbiological nature, or of foreign matter, into or onto a raw material, intermediate,
or API during production, sampling, packaging or repackaging, storage or transport.
COS: A certificate provided to the manufacturer by the European Directorate
for the Quality of Medicines & HealthCare to certify that the relevant monograph in
the European Pharmacopoeia adequately controls the substance as manufactured by
the company at the time the certificate was granted.
Degradation Product: An impurity resulting from a chemical change in the
drug substance brought about over time and/or by the action of e.g., light,
temperature, pH, water, or by reaction with an excipient and/or the immediate
container/closure system. Also called decomposition product.
Detection Limit: The detection limit of an individual analytical procedure is
the lowest amount of analyte in a sample which can be detected but not necessarily
quantitated as an exact value.
Dissolution: The process by which drug dissolves out of a dosage form and is
made available for absorption from the gastro-intestinal tract. In vitro measurements
are made in a range of apparatus types. The requirements for different types of
dosage forms are given in each pharmacopoeia.
Diuretics: Drugs that increase the quantity of urine produced by kidney.
Dosage form: A pharmaceutical product type (e.g., tablet, capsule, solution,
cream) that contains a drug substance generally, but not necessarily, in association
Drug substance: The unformulated drug substance that may subsequently be
formulated with excipients to produce the dosage form.
Enantiomeric Impurity: A compound with the same molecular formula as the
drug substance that differs in the spatial arrangement of atoms within the molecule
and is a non-superimposable mirror image.
Endotoxin: A pyrogen (eg:lipopolysaccharide) derived from the cell wall of
gram negative bacteria. Endotoxin can lead to reactions in patients receiving
injections ranging from fever to death.
Extractable: Extractables are chemical entities, both organic and inorganic, that
will extract from components of a container closure system or device into solvents
under controlled conditions.
Generic Drug: A drug for which the patents protecting the originator product
have expired (or may be challenged). Generic products are pharmaceutically
equivalent to a reference listed drug (same drug substance, same route of
administration, same dosage form and same strengths) and are also therapeutically
equivalent (typically bioequivalent for oral solid dosage forms).
Impurity: Any component of the new drug substance that is not the chemical
entity defined as the new drug substance.
: The dose of a material which results in 50% mortality in an animal test.
Linearity: The linearity of an analytical procedure is its ability (within a given
range) to obtain test results which are directly proportional to the concentration
(amount) of analyte in the sample.
Mass balance: The process of adding together the assay value and levels of
degradation products to see how closely these add up to 100% of the initial value,
with due consideration of the margin of analytical error.
Operational Qualification (OQ):The documented verification that the
facilities, systems and equipment, as installed or modified, perform as intended
throughout the anticipated operating ranges.
Overage : Increased content of drug substance, usually due to loss of potency
Performance Qualification (PQ): The documented verification that the
facilities, systems and equipment, as connected together, can perform effectively
and reproducibly, based on the approved process method and product specification.
Pharmacopoea: Pharmacopoeia is a book or encyclopedia of Drugs Standards,
their formulas, Methods for making medicinal preparations and other related
information's which is published under the jurisdiction of government body.
Placebo: A product which stimulates the marketable product but has no active
Process Validation: The documented evidence that the process, operated within
established parameters, can
perform effectively and reproducibly to produce a medicinal product meeting its
predetermined specifications and quality attributes.
Qualification: Action of proving and documenting that equipment or ancillary
systems are properly installed, work correctly, and actually lead to the expected
results. Qualification is part of validation, but the individual qualification steps alone
do not constitute process validation.
Qualification Threshold: A limit above (>) which an impurity should be
Quality Risk Management: A systematic process for the assessment, control,
communication, and review of risks to the quality of the drug product across the
Quantitation Limit: The quantitation limit of an individual analytical
procedure is the lowest amount of analyte in a sample which can be quantitatively
determined with suitable precision and accuracy. The quantitation limit is a parameter
of quantitative assays for low levels of compounds in sample matrices, and is used
particularly for the determination of impurities and/or degradation products.
Range: The range of an analytical procedure is the interval between the upper
and lower concentration (amounts) of analyte in the sample (including these
concentrations) for which it has been demonstrated that the analytical procedure has a
suitable level of precision, accuracy and linearity.
Reconcilation: Comparing the total number of an item accounted for against the
number or quantity of the item at the beginning of the process to determine the
difference (Comparison between the theoretical quantity and the actual quantity).
Reproducibility: Reproducibility expresses the precision between laboratories
(collaborative studies, usually applied to standardization of methodology).
Robustness: The robustness of an analytical procedure is a measure of its
capacity to remain unaffected by small, but deliberate variations in method
parameters and provides an indication of its reliability during normal usage.
Screening: The process of reducing agglomerates, sorting particles by size and
removing oversized particles and contaminants using a woven metal screen or
Specificity: Specificity is the ability to assess unequivocally the analyte in the
presence of components which may be expected to be present. Typically these might
include impurities, degradants, matrix, etc.Lack of specificity of an individual
analytical procedure may be compensated by other supporting analytical
procedure(s). This definition has the following implications: Identification: to ensure
the identity of an analyte. Purity Tests: to ensure that all the analytical procedures
performed allow an accurate statement of the content of impurities of an analyte, i.e.
related substances test, heavy metals, residual solvents content, etc. Assay (content or
potency): to provide an exact result which allows an accurate statement on the
content or potency of the analyte in a sample.
Stability: Ability of a material to maintain a stated property value within
specified limits for a specified period of time, when stored under specified
Standard operating procedure (SOP) :An authorized written procedure,
giving instructions for performing operations, not necessarily specific to a given
product or material, but of a more general nature, (e.g. equipment operation,
maintenance and cleaning, validation, cleaning of premises and environmental
control, sampling and inspection). Certain SOPs may be used to supplement product-
specific master and batch production documentation.
Surfactant: A substance that decreases the surface tension of a liquid.
Tincture: A medicine consisting of an extract in alcohol solution.
Unidentified Impurity: An impurity for which a structural characterisation has
not been achieved and that is defined solely by qualitative analytical properties (e.g.,
chromatographic retention time).
Validation: A documented program that provides a high degree of assurance
that a specific process, method, or system will consistently produce a result meeting
pre-determined acceptance criteria.
Qualitative chemical analysis of -sets, the components of a object of analysis,
ie defines chemical elements, ions, atoms, atomic groups, and molecules in the
analyte. The procedure is called a qualitative analysis of the detection, identification (
"identification") or opening.
Quantitative analysis -sets quantitative composition of the substance or object
is called analiza.Protseduroy quantitative analysis to determine the concentration or
Instrumental methods of analysis (physical and physico-chemical) - methods
based on the use of dependency between the measured physical properties of
substances and their qualitative and quantitative composition.
Chemical methods of analysis - the main stage methods - analytical reaction,
with measurement of the analytical signal is carried out without complicated
operations (in the qualitative analysis - is an external effect of the reaction).
Physical methods of analysis - the main stage - analytical signal measurement
and its interpretation.
Physico-chemical methods of analysis - analytical signal used in the analysis
of the reaction or after the conference.
The method of analysis - the general physical principle of obtaining
information about the chemical composition analysis of the object, ie, universal and
theoretically sound method of determining the composition irrespective of the
defined component, and (usually) to the analyzed object.
Methods of analysis - detailed description of all operations required for the
analysis of the object to the content of all or only of the component.
Accuracy, reliability and accuracy of the analysis results - (systematic error
analysis of the results tends to zero) and reproducibility, which shows the degree of
closeness to each other the results of individual measurements in the analysis of the
Download 5.17 Kb.
Do'stlaringiz bilan baham:
Ma'lumotlar bazasi mualliflik huquqi bilan himoyalangan ©fayllar.org 2020
ma'muriyatiga murojaat qiling
ma'muriyatiga murojaat qiling