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PHR1537

Oxytetracycline

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Oxytetracycline dihydrate, OTC

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About This Item

Empirical Formula (Hill Notation):
C22H24N2O9 · 2H2O
CAS Number:
6153-64-6
Molecular Weight:
496.46
NACRES:
NA.24
PubChem Substance ID:
329823449
UNSPSC Code:
41116107
EC Number:
201-212-8
MDL number:
MFCD00151234

Key Documents

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Product Name

Oxytetracycline, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

IBZHEBHGZFICKS-IFLJXUKPSA-N

InChI

1S/C22H24N2O9.H2O/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);1H2/t12-,13-,14+,17+,21-,22+;/m1./s1

SMILES string

O.[H][C@@]12[C@@H](O)[C@@]3([H])C(C(=O)c4c(O)cccc4[C@@]3(C)O)=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@H]2N(C)C

grade

certified reference material
pharmaceutical secondary standard

agency

USP 1491004
traceable to Ph. Eur. Y0001896

API family

oxytetracycline

CofA

current certificate can be downloaded

packaging

pkg of 1 g

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 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 chromatography and spectrofluorimetry techniques.
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.

Biochem/physiol Actions

Antibiotic produced by Streptomyces rimosus.
Mode of Action: Inhibits protein synthesis (elongation) by preventing binding of aminoacyl-tRNA to the 30S subunit.
Antimicrobial spectrum: Gram-negative and Gram-positive bacteria.
Mode of Resistance: Active efflux, ribosome protection, tetracycline inactivation.

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 which finds a wide use in veterinary medicine because of its potential to inhibit the protein synthesis in gram-positive and gram-negative bacteria. It can be used on animal species like cattle, sheep, goats and pigs.

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 LRAC0364 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardEnvironment
GHS08,GHS09

signalword

Warning

Hazard Classifications

Aquatic Chronic 2 - Repr. 2

Storage Class

11 - Combustible Solids

wgk

WGK 3

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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Spectrophotometric determination of hydrocortisone, nystatin and oxytetracycline in synthetic and pharmaceutical preparations based on various univariate and multivariate methods.
Gallego JML and Arroyo JP
Analytica Chimica Acta, 460(1), 85-97 (2002)
Quantitative analysis for oxytetracycline in medicated premixes and feeds by second-derivative synchronous spectrofluorimetry.
Fernandez-Gonzalez R, et al.
Analytica Chimica Acta, 455(1), 143-148 (2002)
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)
Shin-Young Park et al.
Journal of biomedical materials research. Part A, 103(1), 38-47 (2014-03-13)
Peri-implantitis is a chronic inflammatory process with advanced bone loss and impaired healing potential. For peri-implantitis treatment, tissue engineering can be applied to enhance bone regeneration of peri-implant defects. This study aimed to evaluate ex vivo bone morphogenetic protein 2
Chris Christou et al.
PloS one, 9(12), e114122-e114122 (2014-12-03)
The healing of critical sized segmental defects is an ongoing clinical problem. No method has achieved pre-eminence. The Masquelet technique is a relatively new innovation involving the induction of a fibrous tissue membrane around the bone defect site taking advantage
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