Oxazepam impurities and related standards
Oxazepam belongs to a subgroup of the benzodiazepines that the older monographs described as the 3-hydroxybenzodiazepinones, and that 3-hydroxyl is what separates its analytics from diazepam's. Placing a hydroxyl on the carbon that closes the diazepine ring turns that carbon into a stereocentre, so the substance exists as two enantiomers, and their ratio is a property of the standard rather than an afterthought. The same hydroxyl makes the molecule a direct glucuronidation substrate, so it clears by conjugation rather than by oxidation and its effect is comparatively short-lived. The ring itself is closed by a lactam and an imine, so acid hydrolysis opens it to a benzophenone, and that ring-opened product is the degradant to expect from aqueous acid stress. The 5-phenyl and 7-chloro substituents account for the positional and dehalogenated process material, and the aryl chloride is the part photolytic stress attacks. The capsule shell and any colourants are formulation questions that a drug-substance standard does not answer, but storage at 20-25 C is stated for the finished product. The monograph specifies the named impurities and their limits and the ICH Q3A/Q3B framework covers the remainder, so a buyer should ask for identity, the stereochemical result and the content basis.
Sources: DailyMed - Oxazepam capsules, FDA-approved label.
29 reference standards related to Oxazepam held in the RSSE catalogue — pharmacopoeial impurities, non-compendial impurities, metabolites and labelled analogues where available.
In this group: 26 impurity reference standards · 2 stable isotope labelled standards · 1 fine chemical. CAS numbers are listed for 29 of 29; 28 entries carry a structure drawing.
On this page
29 reference standards
All entries — structure, identifiers and pack sizes
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Oxazepam 2,3-Dione impurity
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Oxazepam acetate-d5
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Oxazepam-d5
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Oxazepam Impurity 1 (Oxazepam EP Impurity A)
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Oxazepam Impurity 5 (Oxazepam EP Impurity E)
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Oxazepam Impurity 6
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Oxazepam Impurity 7
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Oxazepam Impurity 8
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Oxazepam Impurity 9
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Oxazepam Impurity 10
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Oxazepam Impurity 11
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Oxazepam Impurity 12
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Oxazepam Impurity 13
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Oxazepam Impurity 14
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Oxazepam Impurity 16
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Oxazepam Impurity 21
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Oxazepam Impurity 25
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Oxazepam Impurity 26
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Oxazepam Impurity 27
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Oxazepam Impurity 28
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Oxazepam Impurity 29
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Oxazepam Impurity 37
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Oxazepam Impurity 38
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Oxazepam Impurity 39
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Oxazepam Impurity 43
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Oxazepam Impurity 44
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Oxazepam Impurity 45
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Oxazepam Impurity 47
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29 reference standards
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