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PHR1325

Oxytetracycline Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Oxytetracycline hydrochloride, 5-Hydroxytetracycline hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C22H24N2O9 · HCl
CAS Number:
2058-46-0
Molecular Weight:
496.89
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823310
EC Number:
218-161-2
Beilstein/REAXYS Number:
3853107
MDL number:
MFCD00135815

Key Documents

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Product Name

Oxytetracycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

UBDNTYUBJLXUNN-IFLJXUKPSA-N

InChI

1S/C22H24N2O9.ClH/c1-21(32)7-5-4-6-8(25)9(7)15(26)10-12(21)17(28)13-14(24(2)3)16(27)11(20(23)31)19(30)22(13,33)18(10)29;/h4-6,12-14,17,25,27-29,32-33H,1-3H3,(H2,23,31);1H/t12-,13-,14+,17+,21-,22+;/m1./s1

SMILES string

Cl.CN(C)[C@H]1[C@@H]2[C@@H](O)[C@H]3C(=C(O)[C@]2(O)C(=O)C(C(N)=O)=C1O)C(=O)c4c(O)cccc4[C@@]3(C)O

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. O0500000
traceable to USP 1491015

API family

oxytetracycline

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

Quality Level

300

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Analysis Note

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

Application

Oxytetracycline may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations 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.

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.
Oxytetracycline is a broad-spectrum antibiotic drug widely employed in veterinary applications, particularly for the management of infections in pig productions. It acts by inhibiting the protein synthesis in gram-positive and gram-negative bacteria.

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.
To see an example of a Certificate of Analysis for this material enter LRAA0828 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H361fd

Hazard Classifications

Repr. 2

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
This item has

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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Determination of oxytetracycline and its degradation products by high-performance liquid chromatography-tandem mass spectrometry in manure-containing anaerobic test systems
Loke ML, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 783(1), 11-23 (2003)
Simultaneous determination of sulfathiazole and oxytetracycline in honey by derivative spectrophotometry
Salinas F, et al.
Microchemical Journal, Devoted to the Application of Microtechniques in All Branches of Science, 43(3), 244-252 (1991)
Determination of oxytetracycline and doxycycline in pharmaceutical compounds, urine and honey by derivative spectrophotometry
Salinas F, et al.
Analyst, 114(9), 1141-1145 (1989)
C18 columns for the simultaneous determination of oxytetracycline and its related substances by reversed-phase high performance liquid chromatography and UV detection.
Smyrniotakis CG and Archontaki HA
Journal of Pharmaceutical and Biomedical Analysis, 43(2), 506-514 (2007)
Zhenxing Chi et al.
PloS one, 9(7), e102334-e102334 (2014-07-16)
The study investigated the effect of oxytetracycline (OTC) on the anti-oxidative defense system, the structure (hemolysis rate and morphology) and function (ATP enzyme activity) of human red blood cells (hRBCs) to investigate the possible toxic mechanism of OTC to hRBCs.
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