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PHR1304

Supelco

Butylated hydroxyanisole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

2(3)-t-Butyl-4-hydroxyanisole, 2(3)-t-Butylhydroquinone monomethyl ether, BHA

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About This Item

Linear Formula:
(CH3)3CC6H3(OCH3)OH
CAS Number:
25013-16-5
Molecular Weight:
180.24
EC Number:
246-563-8
MDL number:
MFCD01779059
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. B1212000
traceable to USP 1083008

vapor density

6.2 (vs air)

API family

butylhydroxyanisole

CofA

current certificate can be downloaded

autoignition temp.

599 °F

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

58-60 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

InChI

1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3

InChI key

MRBKEAMVRSLQPH-UHFFFAOYSA-N

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General description

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

Butylated hydroxyanisole (BHA) may be used as a reference standard for the determination of the analyte in pharmaceutical creams by spectrophotometry.
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 (PhEur) 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 LRAB3751 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Environment
GHS09

Hazard Statements

H411

Precautionary Statements

P273 - P391 - P501

Hazard Classifications

Aquatic Chronic 2

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

241.9 °F - Pensky-Martens closed cup

Flash Point(C)

116.6 °C - Pensky-Martens closed cup

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD4394
LRAD6784
LRAD2154
LRAC9831
LRAB3751

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Determination of miconazole in pharmaceutical creams using internal standard and second derivative spectrophotometry.
Wrobel K, et al.
Journal of Pharmaceutical and Biomedical Analysis, 20(1-2), 99-105 (1999)
In vivo studies on butylated hydroxyanisole.
F Iverson
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 37(9-10), 993-997 (1999-10-29)
H C Grice
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, 26(8), 717-723 (1988-08-01)
Butylated hydroxyanisole (BHA) induces tumours of the squamous epithelium of the forestomach of rodents, but not at other sites. Although humans do not have squamous epithelium in their stomach the likelihood that BHA will induce tumours of the squamous epithelium
[Modification of the processes of chemical mutagenesis and carcinogenesis by synthetic phenol antioxidants such as butylated hydroxyanisole].
K Demkowicz-Dobrzański et al.
Postepy biochemii, 38(1), 37-42 (1992-01-01)
J Whysner et al.
Pharmacology & therapeutics, 71(1-2), 137-151 (1996-01-01)
Butylated hydroxyanisole (BHA), at high doses, has been found to induce forestomach squamous cell carcinomas in rodents, but not glandular cell or other types of neoplasms. BHA is not DNA-reactive, and the epigenetic mechanism of tumor formation involves cytotoxicity and
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