Maximum Permissible Concentration (MPC) -
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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
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
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 interval.
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
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 the change.
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 ingredient present.
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 product lifecycle.
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
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).
laboratories (collaborative studies, usually applied to standardization of
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 mass.
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.
84.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
Sensitivity - the applicability of the methodology to determine the lowest
Selectivity (selectivity) methodology - a characteristic analysis method that
determines the effect of interfering extraneous components of the sample;
Express - characterizes the time of the analysis and results.
Sample preparation - a set of actions on the object of analysis (grinding,
homogenization, extraction, hydrolysis, precipitation, etc.) To convert the sample
into a suitable subsequent analysis form (dry residue, solution and so forth.), The
state of a substance (base, salt form, hydrolysis conjugates, etc.), as well as the
concentration or dilution, removal of interfering components analysis.
Chromatography - process based on multiple repetition of acts of sorption
and desorption of substances while moving it in the mobile phase flow along the
Paper chromatography - separation of substances is carried out on the
TLC - separation of substances is carried out in a thin layer of sorbent.
Gas-liquid chromatography (GLC) - one of the most modern methods of
multi-component analysis. (Stationary phase - the liquid applied to the solid
support). The separation process is based on differences in volatility, solubility (or
adsorption) shared components.
High Performance Liquid Chromatography (HPLC) - high pressure liquid
chromatography, high speed liquid chromatography, regardless of the separation
mechanism in the HPLC mobile phase - liquid.
Plates - for the sorbent substrate typically made of glass, aluminum foil or
Chromatography - method of separating mixtures of substances or particles
based on differences in the speed of their movement in the system of immiscible and
moving relative to each other phases.
Column - includes chromatographic sorbent which performs the function
separation into individual components of the mixture.
Eluent - mobile phase (solvent or solvent mixture): gas, liquid, or (rarely) a
The stationary phase - solid phase or fluid, connected to an inert carrier in
adsorption chromatography - sorbent.
Chromatogram - registering result depending on the concentration of the
components of the output of the time column.
Detector - a device for recording the concentration of components of the
mixture at the outlet of the column.
Chromatograph - the device for chromatography.
Spots Rf -value value recovery is not dependent on the size of the plate,
and time division (at a sufficiently small sample weight) of the component
concentration in the sample and the presence of other components, that is a
104 Ultraviolet spectroscopy - (UV spectroscopy), Optically section. spectroscopy,
comprising: providing, research and application of emission spectra, absorption and
reflection in the ultraviolet region, ie. e. in the wavelength range of 10-400 nm.
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