A 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP of the European Pharmacopoeia monograph is often referred to as a 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- Certificate of Suitability (COS). The purpose of a 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- to their clients by showing that a 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP has been issued for it. The manufacturer submits a 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP (COS) as part of the market authorization procedure, and it takes on the role of a 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP holder for the record. Additionally, the data presented in the 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- DMF.
A 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 4-Thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-((2-phenoxyacetyl)amino)-, potassium salt (1:1), (2S,5R,6R)- CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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