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PHR2068

Supelco

Efavirenz Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
(S)-1-(2-Amino-5-chlorophenyl)-1-(trifluoromethyl)-3-cyclopropyl-2-propyn-1-ol, (S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol
Empirical Formula (Hill Notation):
C13H11ClF3NO
CAS Number:
209414-27-7
Molecular Weight:
289.68
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to USP 1234125

CofA

current certificate can be downloaded

packaging

pkg of 50 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

InChI

1S/C13H11ClF3NO/c14-9-3-4-11(18)10(7-9)12(19,13(15,16)17)6-5-8-1-2-8/h3-4,7-8,19H,1-2,18H2/t12-/m0/s1

InChI key

KEMUGFRERPPUHB-LBPRGKRZSA-N

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General description

Efavirenz USP Related Compound A is an impurity of the non-nucleoside HIV-1 reverse transcriptase inhibitor, efavirenz. Efavirenz is an antiretroviral medication used to treat and prevent Type-1 HIV.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Efavirenz USP Related Compound A may be used as a reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB8450 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Development and validation of a reverse-phase HPLC method for analysis of efavirenz and its related substances in the drug substance and in a capsule formulation
Montgomery ER, et al.
Journal of Pharmaceutical and Biomedical Analysis, 25(2), 267-284 (2001)
Efavirenz
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 36(3), 1554-1554 (2019)

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