O`zbekiston respublikasi sog`liqni saqlash vazirligi toshkent farmasevtika instituti

47. 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.
48. 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. 
49. 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). 
50. Impurity: Any component of the new drug substance that is not the chemical 
entity defined as the new drug substance. 
51. LD
50
: The dose of a material which results in 50% mortality in an animal test. 
52. 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. 
53. 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. 
54. Operational Qualification (OQ):The documented verification that the 
facilities, systems and equipment, as installed or modified, perform as intended 
throughout the anticipated operating ranges. 
55. Overage : Increased content of drug substance, usually due to loss of potency 
on storage.  
56. 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. 
57. 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. 
58. Placebo: A product which stimulates the marketable product but has no 
active ingredient present. 

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59. Process Validation: The documented evidence that the process, operated 
within established parameters, can 
60. perform effectively and reproducibly to produce a medicinal product meeting 
its predetermined specifications and quality attributes. 
61. 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. 
62. Qualification Threshold: A limit above (>) which an impurity should be 
qualified. 
63. 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. 
64. 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. 
65. 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. 
66. 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). 
67. Reproducibility: Reproducibility 
expresses 
the 
precision 
between 
laboratories (collaborative studies, usually applied to standardization of 
methodology). 
68. 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. 
69. Screening: The process of reducing agglomerates, sorting particles by size 
and removing oversized particles and contaminants using a woven metal screen or 
perforated plate. 
70. 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. 

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369 
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. 
71. Stability: Ability of a material to maintain a stated property value within 
specified limits for a specified period of time, when stored under specified 
conditions. 
72. 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. 
73. Surfactant: A substance that decreases the surface tension of a liquid. 
74. Tincture: A medicine consisting of an extract in alcohol solution. 
75. 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). 
76. 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. 
77. 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. 
78. Quantitative analysis -sets quantitative composition of the substance or 
object is called analiza.Protseduroy quantitative analysis to determine the 
concentration or mass. 
79. 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. 
80. 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). 
81. Physical methods of analysis - the main stage - analytical signal 
measurement and its interpretation. 
82. Physico-chemical methods of analysis - analytical signal used in the analysis 
of the reaction or after the conference. 
83. 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.